The Regulatory Environment for Science

February 1986

NTIS order #PB86-182003
Recommended Citation:

U.S. Congress, Office of Technology Assessment, The Regulatory Environment for Science

—A Technical Memorandum, OTA-TM-SET-34 (Washington, DC: U.S. Government Printing Office, February 1986).

Library of Congress Catalog Card Number 86-600503

For sale by the Superintendent of Documents

U.S. Government Printing Office, Washington, DC 20402
Foreword

The vitality of American science is a principal component of our country’s economic and intellectual success. Congress, among other institutions, bears responsibility for nurturing creativity and exploration in science while providing appropriate safeguards. Various direct and indirect forces, however, are continually altering the agenda

for scientific endeavor, its methods and practices, and the dissemination of results. It

is therefore essential that Congress, in providing direction and funding for science at

the Federal level, understands these forces and how they are changing.

This technical memorandum, requested by the Task Force on Science Policy of the

House Committee on Science and Technology, provides a “snapshot” of factors affecting science in the 1980s, and focuses on emerging issues that will require consideration

by Congress.

- JOHN H. GIBBON S

Director

iii
Regulatory Environment for Science

OTA Project Staff

John Andelin, Assistant Director, OTA

Science, Information, and Natural Resources Division

Nancy Carson Naismith

Science, Education, and Transportation Program Manager

Project Staff

Marcel C. LaFollette, Project Director, OTA Fellow

Kathi Hanna Mesirow, Analyst

Barbara Berman, Research Analyst

Eugene Frankel, Senior Analyst

Administrative Staff

Marsha Fenn, Administrative Assistant

Betty Jo Tatum, Secretary

Christopher Clary, Secretary

Gala Adams, Clerical Assistant

Contractors

Michael S. Baram

Bracken and Baram

Sheldon Krimsky

Department of Urban and Environmental Policy

Tufts University

Jon D. Miller

Public Opinion Laboratory

Northern Illinois University

Dorothy Nelkin

Program on Science, Technology, and Society

Cornell University
Diana Dutton

School of Medicine

Stanford University

Regulatory Environment for Science

Advisory Panel

Harvey Brooks, Chairman

Benjamin Peirce Professor of Technology and Public Policy

Harvard University

Harold P. Green

Associate Dean for Post J.D. Studies

The National Law Center

George Washington University

Clifford Grobstein

Department of Biological Science and

Public Policy

University of California, San Diego

Jonathan A. King

Professor of Molecular Biology

Massachusetts Institute of Technology

Alan McGowan

President

Scientists’ Institute for Public Information

John Shattuck

Vice President of Government, Community, and

Public Affairs

Harvard University

Irving S. Johnson

Vice President of Research

Lilly Research Laboratories

Contributors

Philip Alexander

Massachusetts Institute of Technology

Nicholas A. Ashford

Massachusetts Institute of Technology

R.J. Augustine

National Institutes of Health

George Bush

Council on Governmental Relations

Daniel Callahan

The Hastings Center

Arthur Caplan

The Hastings Center

Rosemary Chalk

American Association for the Advancement

of Science

David Cheney

U.S. Congress, Library of Congress

Congressional Research Service

Daryl E. Chubin

Georgia Institute of Technology

John Doble

The Public Agenda Foundation

George Dummer

Massachusetts Institute of Technology

John T. Edsall

Harvard University

Howard Gobstein

U.S. General Accounting Office

Milton Goldberg

Council on Governmental Relations

Loren Graham

Massachusetts Institute of Technology

Susan P. Hadden

University of Texas, Austin

Judith C. Harris

Arthur D. Little, Inc.

Gerald Holton

Harvard University

Eric Holtzman

Columbia University

Mary E. Curtis

John Wiley & Sons, Inc.
Deborah Marquis Kelly

American Psychological Association

Melvin Kranzberg

Georgia Institute of Technology

Sanford P. Lakoff

University of California, San Diego

Rachel Levinson

National Institutes of Health

Charles MacKay

National Institutes of Health

Louis Menand

Massachusetts Institute of Technology

Alexander Morin

National Science Foundation

Herbert Morton

American Council of Learned Societies

Thomas H. Moss

Case Western Reserve University

Thomas Murray

Medical Branch

University of Texas, Galveston

Mark V. Nadel

U.S. General Accounting Office

Dorothy Nelkin

Cornell University

Robert Pearson

Social Science Research Council

Carroll Pursell

University of California, Santa Barbara

Harold Relyea

U.S. Congress, Library of Congress

Congressional Research Service

Sal Restivo

Rensselaer Polytechnic Institute

Jurgen Schmandt

University of Texas, Austin

Jeffrey K. Stine

U.S. House of Representatives

Committee on Science and Technology

Judith Swazey

Acadia Institute

Ed Tocus

U.S. Food and Drug Administration

Charles Weiner

Massachusetts Institute of Technology

Dael Wolfle

University of Washington, Seattle

Leo Young

U.S. Department of Defense

Robert Newton

National Science Foundation

vi
Contents

Page

CHAPTER l: Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Forces Shaping Science. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Importance of This Issue for Congress . . . . . . . . . . . . . . . . . . . . 7

CHAPTER 2: Historical and Political Context for Regulation of Research . . . . 11

Changing Political Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

The 1960s: Public Criticism of Science . . . . . . . . . . . 19

The “Limits to Inquiry" Debate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Recent Restrictions on Scientific Communication . . . . . . . . . . . . . . . . . . . . 27

Political Influences on Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

CHAPTER 3: Social and Political Rationales for Controls on Research . . . . . . . . . . . . . . . . . . . . 33

Regulatory Forces on the Research Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

To Fulfill Political Objectives or Avoid Political Effects . . . . . . . . . . . . . . . . . . . 34

To Avoid Environmental Damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

To Promote or Avoid Predictable Economic Consequences . . . . . . . . 37

To Preserve Moral Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Regulation of Research Procedures and Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

To Protect Human Health and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

To Protect Animals Used in Experimentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

To Protect the Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Regulation of the Dissemination of Scientific Knowledge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

To Uphold Scientific Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

To Protect a Professional or Economic Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

To Protect the Health, Privacy, or Safety of Individuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

To Protect National Military and Economic Security . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

CHAPTER 4: The Mechanisms for Direct Control of Research . . . . . . . . . . . . . . . . . . . . . . 51

Mechanisms for Individual or Research Group Control . . . . . . . . . . . . 53

Agenda Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Controls on Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Communication Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Regulations Imposed by Institutions . . . . . . . . . . . . . . . . . . . . 55

Controls by Professional Organizations in Science and Engineering . . . . . . . . . . . . . . . . . 57

Mechanisms for Government Regulation . . . . . . . 58

Agenda Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Controls on Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Communication Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

The Role of the Courts in the Regulation of Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Mechanisms for Social Control Outside of Government . . . . . . . . . . . . . . . . . . . . . 68

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

CHAPTER 5: Mechanisms for Indirect Control of Research . . . . . . . . . . . . . . . 73

Administrative Requirements on Universities That Accept Federal Grants or Contracts. . . . . 73

Protective Legislation and Agency Rulemaking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Antidiscrimination Statutes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Small Business Innovation Research Programs and Use of Services Regulations . 76

Privacy Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Environmental Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Occupational and Public Health and Safety Regulations. . . . . . . . . . . . . . . . . . . . . . . . 78

Right-To-Know Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

CHAPTER 6: Institutional Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Profile of a Representative Industrial Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Control of the Research Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Controls on the Research Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Management of Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Restrictions on Communication of Information . . . . . . . . . . . . . . . . . . . . . . . . . 87

vii
Page

Profile of a Representative Nonprofit Independent Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Control of the Research Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Control of the Research Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Management of Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Controls on Communication of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Profile of a Representative University Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Controls on the Research Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Controls on the Research Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Management of Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Restrictions on Communication of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

CHAPTER 7: Community Control of Research: Two Case Studies . . . . . . . . . . . . . . . . . . . . . . . . 99

Research Involving Recombinant DNA Molecules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Testing Chemical Warfare Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......................101

Comparison of the Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ... ... ... ..103

Origins of Local Regulations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....103

Types of Local Interventions, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104

Stage of the Scientific Enterprise Affected . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. ... ... ... ..105

Social Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ..105

Parties Affected by the Proposed or Actual Regulations . . . . . . ........................106

Legal Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..., . . . .107

Impacts of the City’s Interventions Beyond Its Borders, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...108

Arguments For and Against Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .............109

Recombinant DNA Controversy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .........109

The Case of Chemical Weapons Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .........110

General Policy Implications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...................112

CHAPTER 8: Research Policy Issues That May Warrant Congressional Attention

in the Future. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . .117

Who Bears the Burden of Proof?.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .................117

The Scientist’s Role in Assuring Safe Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......118

Ex Post Facto Restrictions on Research Communication . . . . . . . . . . . . . . . . . . . . . . ..........119

“Gray Areas” of Sensitive Information and Broader Classification . ......................120

Impact of New Communications Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......120

Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...................121

Public Education on the Basis and Procedure for Regulation. . . . . . . . . . . . . . . . . . . . . . .. ....121

Shift in the Jurisdiction for Regulation . . . . . . . . . . . . . . . . ..........................122

General Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ... ... ..122

APPENDIX A: The Regulatory Environment for Science . . . . . . . . . . . . . . . . . . . . . ............127

APPENDIX B: Public Attitudes Toward Science . . . . . . . . . . . . . . . . . . . . . . ..................130

APPENDIX C: Environmental Concerns and Laboratory Siting:

The Morris Township-Bellcore Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .............136

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....143

List of Tables

Table No. Pag e

2-1. Funding of Research and Development by Source in 1960 and 1985. . . . . . . . . . . . . . . . . . . 12

3-1. Justifications for Control of Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

B-1. European Attitudes Toward Science, 1978 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...131

B-2. Expectations for Future Scientific Achievements, 1979-83 . ...........................132

B-3. Attitude Toward Contribution of Science, by Attentiveness, 1957-83 . . . . . . . . . . . . . .. ...132

B-4. Expectation for Future Achievements, by Attentiveness, 1979-83 . . . . . . . . . . . . . . . . . .. ...133

B-5. Public Concerns About Science, 1957-83 . . . . . . . . . . . . . . . . . . . . . . . . . .................133

B-6. Concerns About Science, by Attentiveness, 1957-83 . . . . . . . . . . . . . ....................134

B-7. Public Assessment of the Risks and Benefits of Science, 1972-85 . . . . . . . . . . . . . . . . . .. ...135

B-8. Public Confidence in Science and Selected Other Institutions, 1973-84 . . . . . . . . . . . . . ....135

C-1. Comparison of Three Cases Involving Local Control of Research . . . . . . ..............140

Vlll
Chapter 1

Executive Summary

Photo credit: National Institutes of Health
Chapter 1

Executive Summary

This OTA technical memorandum examines the

social and legal forces that act to restrict or regulate scientific and engineering research in the

United States today. Recent controversies over the

use of animals in experimentation, the risks associated with recombinant DNA research, and national security controls on scientific communication have focused congressional attention on the

policy issues raised when government intervenes

in the research process. As each issue has arisen,

Congress has been called on to decide when and

where intervention is appropriate, and how to

structure intervention so as to protect public

health and safety or national security without unduly retarding scientific progress. At the request

of the Task Force on Science Policy of the House

Committee on Science and Technology, OTA

looked at the entire “regulatory environment” for

research, with the goals of analyzing the structures and mechanisms for regulation and of identifying significant policy issues that may require

congressional attention in the future.

Although scientists have always exercised restraints on their work, the present system of government-based, legally enforceable regulations is

relatively new (ch. 2). Until 1945, constraints were

limited to social prohibitions on sensitive topics,

some controls on agricultural research, and national security controls on technical communication during wartime. Post-1945 arrangements for

the support of science treated it as distinct from

other types of government programs in that it

should be free from direct government control or

economic self-interest and that scientists could be

trusted to govern their own affairs.

The uncovering of a number of examples of

abuses of human subjects, growing fears that scientific research was posing high risks to human

health, the identification of research with government-sponsored activity, and the social and political climate of the 1960s and 1970s (ch. 2), led

to a series of regulatory actions that began to constrain not just what topics scientists should pursue, but also how they should be pursued and the

results disseminated. More recent controversies

over controls on scientific and technical information deemed vital to national military or economic

interests indicate further erosion of the trust in

scientists’ governance which characterized the

postwar arrangements. The increased regulation

may also indicate that science is simply included

as a target of society’s increasing willingness to

regulate all types of institutions, professions, or

activities.

A wide spectrum of social and political rationales (ch. 3) may justify controls linked to a specific part of the research process: selection of

topic, experimentation or other procedures, and

dissemination of results. The moral and ethical

concerns expressed in attempts to restrict research

are not new. What is new, however, is the raising of such concerns to the level of government

action or legally enforceable regulations. Some

governmental regulations manifest concerns about

the potential risks of a line of research; they demonstrate that society wants to protect the health

and safety of experimental subjects. Government

restraints on the communication of scientific and

technical information seek to protect militarily

sensitive information or to curtail economic losses

associated with international technological competition. Public opinion data show that such regulation may reflect the American public’s willingness to restrict research when the risk is perceived

to be too great, despite the concurrent existence

of widespread public support for science as a cultural activity deserving Federal support.

Analysis of the mechanisms by which restraints

are imposed at the laboratory, institutional, or

governmental levels (ch. 4) shows that controls

in the modern research environment are widespread, synergistic, and cumulative. They affect

every stage of the research process—what topics

may be pursued, how they may be pursued, and

when and to whom the research may be disseminated. Institutional mechanisms include formal

administrative policies, institutional review committees, or institutional cooperation with external requests for constraints. Professional societies set up codes and guidelines and may cooperate

3
4

with government attempts to impose dissemination controls. Government control mechanisms

include: review commissions and ethics advisory

boards, legislative review of proposals or projects,

moratoria, regulations on the use or possession

of substances used in research, interpretation of

agency regulations, contract provisions, and dissemination or publication controls. The channels

through which government can affect research—

legal regulations, formal administrative controls,

judicial actions, priority-setting through budget

allocations—have increased in the last decade,

largely because of increased Federal support of

science (and, therefore, increased channels for implementation of regulations), but also because of

general demands for accountability and the widening impact of science on society. The very multiplicity of mechanisms for restraint increases the

possibility that such regulations will be implemented piecemeal, in isolation, and without coordination, and that they therefore may produce

an adverse synergistic effect on the progress of

science and the research base for innovation.

As the case study in chapter.5 shows, the regulatory effects, especially on the research process, are not confined to basic research in universities, even though most of the discussion of and

complaints about overregulation has been concentrated there. Many of the mechanisms described in chapter 4—e.g., controls on research

materials, human subjects regulation, dissemination controls—apply with equal force to research

in industry and private laboratories.

In many cases, science may not have been so

much singled out for control, however, as simply sharing in society’s growing propensity for

regulating all types of specialized institutions or

activities. Such regulations include administrative

reporting requirements for Federal grants and contracts, social programs legislation (e.g., affirmative action), Occupational Safety and Health

Administration (OSHA) regulations and rightto-know laws, and laws and policies relating to

international diplomatic relations. Although these

actions are designed to serve a public objective

and not to restrain research, they can add to an

existing financial and administrative burden of intentional controls and their effects can be much

more difficult to avoid after they are legally in

force. Such regulations could have a long-term

adverse effect on innovation and progress in research, There is clearly a need for better documentation and monitoring of possible unintentional

adverse effects on research and, in some cases,

there may be a need to consider specific legislative exemptions for research.

The local government interventions described

in chapter 7, and in the case study in appendix

C, point to a potential for increased confrontations between State and local authorities and the

Federal Government regarding the jurisdiction for

regulation. Should science be controlled through

a combination of self-regulation and broad Federal oversight, insulated from local laws? The

emergence of a number of cases in which research

facilities have been the subject of local protests

indicates that research no longer wears a mantle

of unquestionable civic respectability. Instead, it

is subject to the same political influences and attitudes at the local level as are other institutions.

Given these circumstances, several changes may

occur in the near future (ch. 8). One is a shift in

who must bear the burden of proof for control

of research. That responsibility is increasingly

shifting to the regulated researcher, who must

prove that the research is safe or anticipate

whether dissemination of the research results may

have some adverse effect on the national interest. As this situation changes, the Federal Government will increasingly have to consider the

appropriate role for scientists in the regulatory

process itself. How much should be left to informal practice and how much required through legally enforceable regulation? Congress can also expect to confront a number of communications-related issues in the future. These issues relate to

the need to protect both freedom of speech and

the freedom of scientific inquiry necessary to cultivate progress and innovation. How should these

freedoms be balanced with the very real need to

protect national military and economic interests?

Whether through ex post facto restrictions on

hitherto unclassified research or through the

broadening of “gray areas” of sensitive information, the short-term goals of communication controls must be balanced carefully against their longterm effects on the Nation’s science and technology base and on opportunities for U.S. scientists
to benefit from interactions with

leagues.

foreign colcommunicanext decade

Computerization of the scientific

tion system may also raise in the

equally difficult issues regarding not only the protection of intellectual property but also the ease

and speed of classification of information. Issues

of patent reform will continue to create the potential for significant secondary effects on the research system—both in what type of basic research is sponsored by industry and in interference

with intercollegial communication of ideas. Finally, the apparent increase in regulatory activity at

the State and local level may be an indication of

a jurisdictional shift in the initiative for regulation, from Federal to State or local, with the accompanying potential for “Balkanized” regulations and differential strictness of regulation.

This new “regulatory environment for research”

raises many important questions for the Science

FORCES SHAPING SCIENCE

Scientific research* —i.e., the organized, systematic search for knowledge about, insight to,

or understanding of a subject—is significantly influenced by its social and political context. For

example, the pressures of U. S, economic competition in world markets and the linking of research

accomplishments to national stature affect which

research is funded and which research results may

be widely disseminated. Increased public awareness of the negative side effects of the research

results or processes have created pressure for government control. Thus, scientific research can be

constrained both for political and social purposes,

and when it is regarded as a negative force out

of control or a force that may become negative

if allowed to continue.

No matter what the field or institutional setting (university, government, or industry), the research process has certain common characteristics—e.g., in the use of a scientific knowledge

base, in the methods of investigation, and in the

● The report is not concerned with controls on the application of

research knowledge in medical practice, commercial development

of a product, or similar exploitation of research results.

5

Policy Task Force and for Congress. First, how

can Congress assure balance among the protection of public health and safety, the rights of

citizens to govern their local communities, and

the freedom of individual scientists, whether of

speech or action? Second, how can the regulatory

process and the opportunities for public discussion of regulation be structured so that competing interests are negotiated before issues reach a

stage of controversy and hostility? Third, which

issues should receive congressional or State or local attention and which are best left to the selfregulation of the research communities? And,

fourth, what can Congress do to assure that this

environment does not unduly erode innovation

and creativity in U.S. industry or unreasonably

damage the Nation’s investment in university

research?

training and education of its participants—that

are independent of specific project goals. Restraints on research may affect the choice of which

subject to investigate or which to fund (controls

on topic); the method by which that investigation proceeds, including the tools of research and

the objects or animals manipulated during the research (controls on procedure); and the timing of

and audience for descriptions of the research and

its results (controls on communication). This report analyzes the influences at each of these stages.

Different social or political mechanisms can influence the research process in different ways.

Public approval or disapproval of research topics

or procedures may be expressed in political demonstrations against laboratories, through referenda and local initiatives, as well as through moral

condemnation and social pressure.1

More formal control is exercised through, for

example, laws passed specifically to direct some

‘Loren R. Graham, “Concerns About Science and Attempts to

Regulate Inquiry, “ Limits of Scientific lnquir~, Gerald Holton and

Robert S. Morison (eds. ) (New York: W.W. Norton & Co., IQ7Q),

pp. 1-22.
6

aspect of the research process, through Federal

interpretation of the language of such laws, or

through the provision or denial of research funding.

Other economic or political forces can affect

research through government actions intended to

have some other effect. Economic considerations,

the need to protect proprietary interests, Federal

protections on public health and safety, and other

Federal and State legislation may influence industrial or other nonacademic research, For example, the Food and Drug Administration’s (FDA)

regulatory requirements, which govern the introduction of new drugs, are reported to have slowed

pharmaceutical industry research on new drugs,

particularly on “orphan drugs” (drugs for rare diseases), z where the cost of those regulations has

not been outweighed by favorable economic and

market conditions. In contrast, however, the even

more stringent requirements of Nuclear Regulatory Commission and FDA regulations on radiopharmaceuticals appear not to have affected that

research adversely. More favorable economic and

market forces allow these firms to overcome the

effect of any regulatory burden.

The attitudes and professional values of the scientific community itself have played a prominent

role in influencing and sometimes constraining research activities. Self-imposed constraints were

used in the 1970s, for example, during the debate

over recombinant DNA. Molecular biologists exercised “restraint and caution” in their research

procedures and adhered to a voluntary moratorium on recombinant DNA research, even though

they “had no certain proof that the need for limitation existed or that the consequences of it would

be positive. ”3

Finally, control on the communication of scientific and technical information may be impleIBarry S. Roberts and David Z. Bodenheim, “The Drug Amendment of 1962: The Anatomy of Regulatory Failure, ” Arizona State

[Jw Journal, vol. 1982, No. 3, 1982, p. 587,

‘Clifford Grobstein, A Double Image of the Double Helix (San

Francisco, CA: W.H. Freeman & Co., 1979), p. 2 .

mented for reasons associated with economic or

military protection. For both basic and applied

research, such controls may take the form of a

prior restraint on research publication or a denial

of access to laboratories. When controls are imposed on basic research in universities, however,

the benefits of such controls may not be perceived

by the institution as outweighing the adverse effects on the education and training of students.

Because such restrictions often appear to violate

traditions of academic freedom, universities may

oppose their implementation. Critics of sweeping

controls argue that, in the long run, such restraints

could harm the quality of the scientific work force,

the traditional climates for creativity, and the

progress in basic science which is necessary to

technological advancement.

This OTA report takes a look at the entire range

of social, political, and economic forces that restrain all stages of the research process, in all types

of institutional settings, and that prompt changes

in research projects or create sufficient political

pressure for the development of legislation or administrative controls. In examining this “regulatory environment, ” the OTA project attempts to

locate the common ground, the similarities among

what on the surface may seem to involve dramatically different issues and controversies. Restrictions on communication, for example, are not

only confined to basic researchers in universities.

Controls and regulations—both internally and externally imposed—also affect scientists in industry and in government at all stages of research.

The OTA study looks at research—regardless of

where or by whom it is conducted—as a universal activity, searching for common factors in the

mechanisms, justifications, and effects of the regulatory environment. A few restrictions apply

equally to all parts of the research system, to industries as well as universities; others apply to specific parts of the process or only to one field. The

differences may be only in the extent to which restrictions are enforced or publicly discussed.
7

IMPORTANCE OF THIS ISSUE FOR CONGRESS

Increased awareness of how science and technology affect both social structure and social

values and vice versa has prompted increased

pressure for political intervention in what heretofore has been a decisionmaking activity dominated by scientists or science managers; but such

interaction worries researchers who are accustomed to substantive control over all aspects of

their own work. So there is a search underway

for institutional forms that could permit more

public involvement in critical policy decisions and

yet still preserve “the flexibility y needed for the pursuit it of scientific research.”4 Congress may desire

or may be asked to play a role in developing these

new arrangements.

Agency regulations-and many of the secondary controls on research —are also related directly

to the amount of Federal support available to scientific and engineering research and to priority

setting for allocation of that support. As the Task

Force document, An Agenda for a Study of Government Science Policy, states:

. . . the immediate goals to which science can be

expected to contribute, such as improved health,

a cleaner environment, and enhanced technological innovation, cannot be considered in isolation.

Broader societal goals . . . should be taken into

consideration when formulating the goals for

science.5

Another aspect that relates directly to the work

of Congress is the suggestion that some regulations instituted for legitimate and laudable social

or political reasons may be having secondary, unanticipated, and adverse effects on the quality of

science and may thereby diminish science’s usefulness to society. Regulation, according to the

Task Force Agenda, “is one of the few areas in

which the aims of science and the aims of society

are not necessarily congruent. The manner in

which these conflicting aims are accommodated

is of significant importance to both science and

‘1’~ncl on .R-len(c and Te(hn(>logJ,: Science and IIangrrh (\\’a\h-

]ngt(~n, I)C I’re\]dent’s C (,mm]sti(,n for a N“ational Agenda for the

Elxhtl[>> 1 Q80J, p 1 ~.

[ I $ ( (~n~re~>, I {OLIW C(\mm]ttc,e on Sclt, nce and Technology,

rc14. F(~rce (Jn Sclcnce I)OIIC~ .An Agenda t(lr J .Studjr of C;OL’ernrnt’nt S[ It’nc e 1‘(1/IcIr Q8t h Con~ ~c~ ~c~ss ( \\rash I n~t (}n, I )( : [~ .$.

( ,(~lernmc’nt [’r]nt;ng (l ft]ce, 1 Q85 }, p 8

society. . . .“ The Task Force has focused on two

aspects of this issue in particular: 1) how to shape

the future regulatory environment for science

while still responding to the necessity to avoid the

ill effects arising from regulating science;6 and 2)

how “the legislative and regulatory authorities

representing society as a whole can protect public health, safety, and values while avoiding the

imposition of unnecessary restraints on science.”7

The topic of the regulatory environment for research thus involves discussion of some of the

most basic questions of American political philosophy: public control v. self-rule, Federal v. local jurisdiction, the feasibility of regulation and

the importance of consent by the regulated, government regulation v. individual liberty, and how

to balance the conflicting rights and values of

different social institutions. The events and the

debate will continue. Congress can expect to confront these issues again and again.

For many research areas, the question in the

1980s is not whether there should be any limits

but, instead, “what those limits should be. . . .

[A]nd, if we can define those boundaries, what

control options will maintain them most effectively?” 8 The organized scientific community now

appears to acknowledge the need for “some political and public input to the setting of the general directions and agenda of scientific research, ”

just as the political sphere appears to have accepted the importance of “some degree of selfgovernance and internal agenda-setting” by the

scientific community. The real issues have become, as Harvey Brooks notes, “where the lines

should be drawn and the appropriate processes

by which the scientific and political communities

should negotiate the scientific agenda.”9
Chapter 2

Historical and Political Context

for Regulation of Research
Chapter 2

Historical and Political Context

for Regulation of Research

In the context of the current extensive and often

generous support for scientific and engineering research in the United States, it is easy to forget that,

although scientists have always exercised a variety of restraints on their own work, the present

governmentally imposed, legally enforceable constraints on research topics, procedures, and communication are relatively new. Most of the current regulatory schemes were developed alongside

the post-World War II arrangements for Federal

financing of research and were influenced by the

political attitudes and assumptions governing

those arrangements and how they were instituted.

Before World War II, many scientists considered Federal research grants to private universities—where most basic research was conducted—

to be improper if not unconstitutional. ’ In the

1930s, for example, the leaders of the National

Academy of Sciences “objected on principle to

letting private universities accept government

funds. ”2 In part, this attitude had to do with the

scientists’ fears of losing autonomy. Some university research was supported by the professors

themselves. They were not required to account

to the government for their time or for minor expenditures; “They simply did what research their

other duties and their pocketbooks allowed them

to do. ”3 But objections were also linked to concern that government funding might provide the

opportunity for restraints on research, as had hapID(~n K. Price, “Enclless Frontier or Bureaucratic Morass?” The

Lrnits ot .%entific inquiry, Gerald Holton and Robert S, Morison

(eds. ) (New York: W,W. ,Norton & Co., 1979), pp. 75-92.

‘Ibid, In 1445, Frank B. Jewett, President of the National Academy of Sciences and also of Bell Labs, opposed the creation of the

National Science Foundation on these grounds. In letters to Vannevar Bush, ]ewett stated that private initiative should furnish the

means for fundamental research:

Ever\ d]rect or ]ndlrect subvention by Government is not only coupled

]newltab[y w]th bureaucratic types of control, but []kewwe w]th polit]-

cal cent rol and w] th the urge to create pressure groups seek]ng to advance \peclal Interests

Merton J, England, A Patron for Pure Science (Washington, IX

National Sc]ence Foundatlorr, 1Q82), p. 35,

‘James I’enick, Jr., et al. (ecis. ), Politics of American Science, 1930

to the Present (Cambridge, MA: The MIT Press, 1972), p. 7,

pened during wartime. During World War I, for

example, scientists had accepted military restrictions on their communications; they were subject

to censorship and were, in some cases, persuaded

to delay publication until the end of the war.4 The

American Chemical Society had even opposed

President Wilson’s order transferring gas warfare

research from Bureau of Mines control to War Department control, not out of anti-war fervor but

because it “feared the numbing effect of the . . .

‘red tape’ of War Department methods upon the

spirit of originality, daring and speed in following new trails, so essential to the successful prosecution of research. ”5

The chemists predicted a

“national disaster” if the “fast machine” of gas research was slowed. Such attitudes of arms-length

cooperation with government were prevalent in

the scientific community during the first part of

the century.

Before the 1940s, industry supported a substantial proportion of the Nation’s research and development (R&D) effort; the Federal Government

played a relatively minor part. Scientists in the

1930s felt confident in asserting that “most of our

great advances in the past have been through private initiative, “ including both industry and private foundations.6 Even as late as 1940, the Federal Government paid only for about 19 percent

of the Nation’s $345 million expenditures for scientific research and development.7

Since 1940, these funding patterns have changed

dramatically and, along with them, the regulatory environment for U.S. research in science and

4 A. Hunter Dupree, Science in the Federal Government (Cambridge, MA: Harvard University Press, 1957); also see Harold C,

Relyea, “Increased National Security Controls on Scientific Communication, ” Government Information Quarter/j’, vol. 1, No. 2,

1984, pp. 187-188.

‘David Rhees, American Philosophical Society, personal communication, 1985,

‘Robert H. Kargon (ed. ), The Maturing of American Science

(Washington, DC: American Association for the Advancement of

Science, 1974).

7John R. Steelman, ScJence and Public Policy, vol. 1 (New York:

Arno Press, reprinted from 1947), p. 11,

11
engineering. As the Federal Government has assumed an ever larger share of all U.S. research

funding, the institutional responsibility for

nourishing the research system has begun to shift.

In 1960, the government was funding about 57

percent of all basic and applied research in the

United States; industry, 37 percent; universities,

3 percent. By 1985, the government’s share was

nearly 50 percent; industry’s, over 41 percent; and

universities’, 6 percent. The responsibility for

basic research also appears to be shifting to the

Federal Government (from 60 percent in 1960 to

almost 67 percent in 1985) while the responsibility for applied research has shifted to industry

(from 40 percent in 1960 to nearly 55 percent in

1985). (See table 2-l. ) Who funds and sponsors

research can have considerable impact on the locus for regulation and on the type of regulatory

mechanism chosen. The shifts of funding source

in the last 5 to 10 years, therefore, may be one

explanation for the signs of strain described in this

report, as industry becomes subjected to regulations originally intended for basic research conducted in a university setting (e.g., recombinant

DNA regulation), and universities are asked to

comply with regulations originally intended for

industry.

Table 2-1 .—Funding of Research and Development by

Source in 1960 and 1985

1960 1985

Basic research:

Federal Government. . . . . . . . .

Industry . . . . . . . . . . . . . . . . . . .

Universities/colleges . . . . . . . .

Applied research:

Federal Government. . . . . . . . .

Industry . . . . . . . . . . . . . . . . . . .

Universities/colleges . . . . . . . .

Basic and applied research:

Federal Government. . . . . . . . .

Industry . . . . . . . . . . . . . . . . . . .

Universities/colleges . . . . . . . .

Development:

Federal Government. . . . . . . . .

Industry . . . . . . . . . . . . . . . . . . .

Universities/colleges . . . . . . . .

Research and development:

Federal Government. . . . . . . . .

Industry . . . . . . . . . . . . . . . . . . .

Universities/colleges . . . . . . . .

60.00/0

28.5

6.0

56.0

40.0

2.0

57.0

37.0

3.0

68.0

31.6

—

64.6

33.4

1.0

66.60/0

18.7

10.0

39.7

54.6

3.6

49.5

41.4

6.0

45.2

54.3

—

46.7

50.0

2.0

SOURCE: Division of Science Resources Studies, National Science Foundation,

1985

Prior to the postwar infusion of Federal funds,

government aid to science in the universities had

also been managed with a philosophy of “loose

control’’—sponsors of unclassified research left the

researchers more or less free to conduct their research as they believed scientifically appropriate

and free to disseminate their results, subject to minor supervision and general accountability. The

scientists perceived any threat to their autonomy

as a questioning of their authority and expertise,

During World War II, of course, that autonomy

had been curtailed, but after the wartime security restrictions were lifted, government control

of research tended to return to the prewar management model, expressing a basic political trust

in the productiveness and reliability of scientists.

George Pimentel, Professor of Chemistry at the

University of California at Berkeley, characterizes that post-1945 philosophy as one of “fund

creative people, but don’t tell them what to do.”8

Especially over the last 40 years, however, the climate of unassailable autonomy has evolved into

the current climate of strong economic support

coupled with attentive direction. Researchers now

operate in a mixed environment of incentives and

restrictions, 9 which often replace scientists’ own

professional judgments about what subjects to

work on and how to proceed.

A quite different shift in emphasis has also occurred in where the research is performed and

therefore in who actually does the research. In

1940, 70 percent of government-funded basic research took place in government facilities. By

1944, only 30 percent was performed in government facilities; 50 percent was performed by private firms; and 20 percent in universities.10 After

the war, the pattern of funding again changed,

but the distribution among performers remained

similar. Industrial spending for R&D began to increase. By 1982, industry was carrying out even

more of the Nation’s research (72 percent); universities, 9 percent; Federally Funded Research and

8U. S. Congress, House Committee on Science and Technology,

Science Policy Task Force, Hearing, Feb. 28, 1985.

‘Thane Gustafson, “Survey of the Structure and Policies of the

U.S. Federal Government for the Support of Fundamental Scientific Research, ” Systems [or Stimulating the Development of Basic

Research Washington, DC: National Academy of Sciences, 1978),

p. I-82.

1ODavid Noble, The Forces of J’roductjon (New York: Alfred A.

Knopf, Inc., 1984).
13

Development Centers, 3 percent; nonprofit institutions, 3 percent; and government labs, 13 percent. ” The impact of this shift was to extend government control of research—through grant and

contract provisions—into the private sector.

Finally, the discovery during World War II–

and in the subsequent U.S. nuclear program—

that basic research could have considerable value

for maintaining the Nation’s military security led

1 I William C. Boes man , Science Policy Research Division, “U.s.

Civilian and Defense Research and Development Funding, ” Report

No, 83-183, Congressional Research Service, Aug. 29, 1983.

CHANGING POLITICAL CONCERNS*

to a fourth change in how science was funded and

organized. Increased Department of Defense

spending led to an increased proportion of research either totally classified—and hence performed away from traditional research networks—

or else having the potential for classification (or

similar control) because of its potential military

applications. The course of the last 40 years has

also seen significant shifts in the proportion of

basic research sustained by the defense agencies

and, as a consequence, shifts in the climate of

more or less classification of new areas of basic

research.

Before World War II, national politics had only

minimal influence on the research agenda for science and engineering. Because the Federal Government funded very little university research, for

example, it did not have the administrative mechanisms for exerting influence. Only in a few selected fields, such as agriculture, did the agenda

respond to political influence. 12 Moreover, even

if scientists wanted society to benefit from their

activities, the traditions of science offered no patterns to guide them and few mechanisms through

which to provide advice to society. Scientists who

were distrustful of government argued that financial dependence on government might damage the

“autonomy of their intellectual activities” in unpredictable ways.13

This independence was put aside temporarily

during World War II, when thousands of scientists and engineers worked, either as military or

civilian personnel, in such government research

projects as the Committee on Medical Research

(part of the Office of Scientific Research and Development (OSRD)) and the Manhattan Project.

Most were required to shift to a different line of

research. They conducted their inquiries under

government control and with government fund-

*This section benefits from work done at OTA by George Hoberg,

Massachusetts Institute of Technology, in August 1984.

IZAndr~ Mayer and Jean Mayer, “Agriculture: The Island Empire, ” Daedalus, vol. 103, summer 1974, pp. 83-96,

1 ~Lewis E, Auerbach, “Scientists in the New Deal, ” fkfjnerva, vol.

3, summer 1965, pp. 457-482.

ing. Although new and different, this relationship

with government proved to be successful for both

parties.

As the war was ending, the scientists who had

been administering the Federal research effort began to discuss how the science-government relationship might be sustained and structured after

the war, The incentives were many. Not only had

World War 11 fostered the creation of a formal

administrative relationship between government

and science but the results of scientific projects

such as radar and penicillin had also demonstrated

the power and potential of government-funded,

government-directed science. By and large, the

community of scientists and friends of science

agreed on the need for a government agency to

channel funding for basic research. They disagreed, however, about the institutional structure

of such an organization and about who would exercise (and to what extent) political control over

the research agenda .14

There were two well-defined perspectives on

how the postwar relationship should be structured. The most prominent spokesman for a

model of loose Federal control was Vannevar

Bush, a Massachusetts Institute of Technology

engineer who was Director of the wartime Office

of Scientific Research and Development, President

of the Carnegie Institution of Washington, and

IJNoble, op. cit., p. 192.
14

a principal science advisor to President Roosevelt.

Actively opposed to the Bush position was Senator Harley Kilgore, (D-WV), who was supported

by such scientists as Harold C. Urey, Edward U.

Condon, and Harlow Shapley. A group within

the executive branch, led by Presidential Assistant John R. Steelman, also opposed the Bush position and participated in the postwar debate on

how the National Science Foundation would be

structured.

Bush’s perspective on control of research was

most clearly articulated in the 1945 report Science

—The Endless Frontier. Written at President

Roosevelt’s request, the “Bush report” outlined a

plan for organizing science after the war. Bush

wanted to create a secure funding base for American scientific research while protecting science’s

traditional independence in matters of agenda,

procedure, and communication. Because there

had been such clear separation between science

and government before the war (and because the

circumstances that had brought them together

during the war were clearly unusual), the Bush

report had to construct a basic argument for support. It found the justification in a classic American metaphor: “Basic United States policy” had

traditionally been to advance all types of frontiers, thus the Federal Government must take on

new funding responsibilities to assure adequate

cultivation of those “areas of science in which the

public interest is acute” but where private sources

may not supply sufficient resources.15 “Scientific

progress is essential, ” the Bush report stated, to

wage war on disease, to assure the future of American industry, and to prevent future military conflicts. 16

In its plan for how such responsibilities would

be fulfilled, the Bush report provides a measure

for subsequent change in the regulation and control of research. The report proposed five principles to guide the government’s new role in science:

1) Whatever the extent of support may be, there

must be stability of funds over a period of years

so that scientists may undertake long-range research programs. 2) The agency to administer

“Vannevar Bush, Science—The Endless Frontier, a report to the

President on a Program for Postwar Scientific Research (Washington, DC: National Science Foundation, 1980 (reprinted from Office of Scientific Research and Development, 1945)), p. 12.

‘* Ibid., p. 5,

such funds should be composed of citizens selected

only on the basis of their interest in and capacity

to promote the work of the agency. They should

be persons who understand the peculiarities of

scientific research and education, but need not be

scientists. 3) The agency should promote research

through contracts or grants to organizations outside the Federal Government, but should not operate any laboratories of its own. 4) Control of policy, personnel, and the method and scope of

supported research should be left to the research

institutions themselves. 5) And finally, the agency

should be responsible to the President in that policies and procedures would be guided by the executive branch. The advocated policy was that

“scientists should have control over how these

funds were distributed, to ensure that the best

science was supported as it had been by OSRD

during the war."17 Bush was not, however, “asking for free access to the Treasury; funds expended

in this way would represent only a small proportion of those spent on research and development

through the mission agencies of the Executive

Branch . . . .“18

Although the report acknowledged the necessity of wartime security restrictions, it advocated

that, when the war was over, scientists should

once again enjoy freedom of inquiry. Controls

should also be lifted on scientific information—

especially that related to medicine—of potential

use to civilian institutions. 19 Bush believed that

removing the wartime controls would help to recover “that healthy competitive scientific spirit so

necessary for expansion of the frontiers of scientific knowledge. ”20 Scientific progress, the report

continued, results from “the free play of free intellects, working on subjects of their own choice,

in the manner dictated by their curiosity for exploration of the unknown. ”21 And open publication of the research would be to the benefit of the

Nation.

1’Alex Roland, testimony before the U.S. Congress, House Committee on Science and Technology, Science Policy Task Force, Mar.

7, 1985.

1‘Ibid.

,~Eush, op. cit. r P. 28’

201 bid., p. 12.

* i Ibid,
15

One of the committees that assisted Bush, the

Committee on Science and the Public Welfare, *

gave strong support to the idea that traditional

models of university research be preserved. University research must not be “distorted” by the

government’s encouragement to examine shortrange problems at the expense of more fundamental problems, for “. . . the freedom of the scientist may be decreased by the introduction of some

degree of commercial control. ”22 Society must

guard science against too much control by industry as well as by government. That committee

urged the new agency “to devise ways and means

of allocating funds in large measure without determining what particular problems are to be

worked on and who is to carry them out. ” “Variety” and “decentralization” foster novelty, they

wrote. 23

The Medical Advisory Committee voiced similar concerns. If Federal aid was “misdirected, ” it

could do “serious harm” to the development of

medical science. Therefore, the new agency’s direction and policies should be administered by

people “who are experienced in research and who

understand the problems of the investigator. “24

The government should encourage “individual initiative and freedom of research. ” Control that is

too close (or, in the Committee’s words, “regimentation”) could lead to “mediocre work” and “disastrous impairment . . . of research itself. ”25

Industry-based research, if it was to flourish

after the war, also required some special arrangements. Patent laws designed to “stimulate new

inventions” would “make it possible for new industries to be built around new jobs and new

processes” and would help small industries, the

Bush committees asserted. Although they were

concerned about the domination of markets by

big industry, the committees did not support government ownership of patents;26 patent policy was

‘Chairman of the Comrnlttee was Isaiah Bowman, I)resldent Ok

the J[>hns Hopk]ns University.

‘

2 Bush, (>p. cit , p. Q]

“lbld,, p Q4

‘Ibid., p. 02

‘ Ibid p 03

‘bl)anlel Ke\les, The [%~wclsts (New }’ork: Alfred A, Kn~]pf, Inc ,

1Q78), pp. 342-344,

to be left to the discretion of the new science agency’s governing board .27

These and many other of the Bush report’s recommendations were subsequently incorporated in

legislation (which Bush helped to draft) introduced

by Senator Warren Magnuson (D-WA) in 1945.

The Bush report did not, however, represent

a consensus in either the scientific or political communities. During the war, Senator Harley Kilgore

held a series of hearings on post-war planning for

science, before a subcommittee of the Senate

Committee on Military Affairs. And in 1945, he

introduced a bill which expressed his ideas for a

national science foundation. He favored a director who was appointed by and much more politically responsible to the President than had been

advocated in the Bush report. Moreover, Kilgore’s

position was that “organizations receiving funds

should be free to conduct their research and development work in a manner which they think

most productive, subject only to a routine supervision and review by the foundation. “28

Soon after the publication of Science— The Endless Frontier, President Truman’s Scientific Research Board, objecting to what they considered

to be an “underlying anti-democratic sentiment”

in the Bush report, issued their own report. The

White House study, directed by John R. Steelman,

placed the basic questions of science policy in a

political context: “Public policy cannot be shaped

in a vacuum and recommendations for a national

policy on science must necessarily reflect many

considerations but remotely connected with the

laboratory. ”29

The “Steelman report” was just as effusive as

the Bush report in its praise of the social benefits

emanating from scientific advance and in the tone

of its underlying rationale for support of science:

“It is difficult to think of any other national activity which more directly benefits all the people or

which makes a larger contribution to the national

"

30 welfare and security. But, despite agreemen t

on the need for a significant Federal role in fund-

‘-blerton J. England, A Patron tor I’ure Science (Washington, DC

National Science Foundatl[)n, 1Q82 }, p. 14

2HI’en]ch, et al., op. c]t,, w>] 1, p. O

“Steelman, op cit., vol. 1, p. b,

“’Ib]d., v()] 1, p, Zb.
16

ing basic science and in training scientific personnel, the reports differed on the organization of

funding and on the control of the research process. The Steelman report did not object to funding research in government laboratories; it recommended maintaining the extant distribution of

funds among universities, industry, and government labs31 and it recommended that the new

agency’s director be appointed by and responsible to the President.

The Steelman report also concluded that government security regulations should not be applied

widely but instead should be applied “only when

strictly necessary and then limited to specific instruments, machines or processes. They should

not attempt to cover basic principles or fundamental knowledge. ”32 In the conclusion to Volume I,

“A Program for the Nation, ” the report states:33

. . . it is sometimes argued that . . . the world

is in its present state because the physical sciences

have developed too rapidly and have unleashed

forces too strong for us to control. It has even

been suggested that a moratorium should be

called in science, while we catch our breaths.

This is a doctrine of weaklings and of men of

little faith in the ultimate capacity of our people. There can never be too much knowledge,

though it can be discovered at uneven rates in

various fields. The cure is not to slow down the

runner who is ahead—but to extend a helping

hand to those who are behind.

The differences between the Bush and Steelman

reports represented more than the usual political

disagreements about the administration of a new

agency. They reflected fundamentally different

conceptions of the relationship between government and science. The political perspective represented by the Kilgore hearings and the Steelman

report regarded science as a special interest. Although large-scale government support for science

was a new phenomenon, science was not considered to be sufficiently different from other policy areas to warrant any special political relationships. 34 The characteristics of science were not

believed to “justify a departure from our tradiSllbid,, vO1. 1, p. 27.

~ZIbid, , vol. 3 p. 37.

Sslbid,, VO1. 1, p. 68.

JdNob]e, op. cit., P. 15

tions of democratic government or from tested

principles of administrative organization, ”35 including the principles of close accountability and

avoidance of the concentration of power.

The conservative view represented by the Bush

report regarded government intervention as a potential threat to scientific liberty,36 an attitude

viewed by some as reflecting a lack of faith in the

competence of government administrators. But

the Bush report supporters were also convinced

that science was distinct from other types of government programs, that it must be free from political control, and that, to be successful, scientists should be able to direct their own affairs.

Non-scientists might administer the foundation

but it would be the scientists who, through advisory groups and a system of review by scientific

peers, would decide how research should be conducted and would influence the research agenda,

This demand to have “support without control, ”

according to one commentator, amounted to “bestowing upon science a unique and privileged

place in the public process—in sum, for science

governed by scientists, and paid for by the publie. ”37

On July 22, 1947, Congress passed legislation

(S.526, National Science Foundation Act of 1947,

80th Congress, 1st session) to establish a National

Science Foundation (NSF), This legislation contained no patent provisions, no authority for support for the social sciences, no mechanisms for

geographical distribution, and a large degree of

autonomy from Presidential control .38 The governing structure was the most important point of

argument, however. When President Harry Truman vetoed this first NSF legislation, he objected

primarily to the bill’s provisions for lack of political control. In his veto message, Truman stated:39

. . . this bill contains provisions which represent

such a marked departure from sound principles ——- -——

‘

5 Sleelman, op. cit., vol. 1, p, 31.

‘bEngland, op. cit., pp. 35-36,

“Daniel S. Greenberg, The Politics of Pure Science (New York:

New ,4merican Library, 1967), p. 107, There was precedent for this

arrangement in the National Advisory Committee on Aeronautics

(NA(’A), of which Bush was chairman in 1939. See James Killian,

Sputrik, Scientists and Eisenhower (Cambridge, MA: The MIT

Press 1977).

3aEng]and, op. Cit., Pp. 78-80.

3’Congressiona/ Record, vol. 93 (Washington, DC: U.S. Government Printing office, Nov. 17, 1947), p. 10568.
17

for the administration of public affairs that I cannot give it my approval. It would, in effect, vest

the determination of vital national policies, the

expenditure of large public funds, and the administration of important governmental functions in

a group of individuals who would be essentially

private citizens. The proposed National Science

Foundation would be divorced from control by

the people to an extent that implies a distinct lack

of faith in democratic processes.

Three years later, after extended debate and political maneuvering, another bill was passed by

Congress (National Science Foundation Act, May

10, 1950, 64 Stat. 149) and signed by President

Truman. This bill represented a compromise between the opposing political groups, but probably

reflected the preferences of a substantial portion

of the scientific community. The director of the

NSF would be appointed by the President, and

the bill included a mandate for evaluating and coordinating all Federal research efforts. It also provided that these responsibilities be shared with a

part-time National Science Board, organized along

the lines suggested by Bush. The bill did not

change patent granting procedures.

The Foundation’s first director, Alan Waterman, was previously the chief scientist at the Office of Naval Research (ONR). He considered any

“centralized evaluation of Federal research impossible and inappropriate. ”40 His experience at ONR

undoubtedly influenced the shape he gave to the

new foundation, for that agency had maintained

an unusual contract research program, especially

in basic research. Established by an Act of Congress in 1946, ONR was to “provide scientific liaison with the War Department and with that novel

and highly effective civilian organization, the Office of Scientific Research and Development. ”41

The philosophy that guided ONR was best understood in its view of the basic researcher as one

“motivated by curiosity and interest in science

rather than applicability, ” and the administrator

as influenced by the agency’s “practical mission. ”

The key was to keep these perspectives separate:

“In this way selected mission-related basic research

dOKev]es, op. cit., p. 360; England, oP. cit., P. 149,

‘]Alan T. Waterman, “Pioneering in Federal Support of Basic Research, ” Research in the Service of National Purpose: Proceedings

of the Office of Naval Research Vicennial Convocation, F. Joachim

Weyl (cd. ) (Washington, DC: Office of Naval Researchr 1966), p. 3,

may be supported. . . without controlling or disturbing the aim of the investigator or the course

of the research. “42

The ONR contracting system

extended the traditional military R&D contracting with industry to research establishments, particularly academic institutions, thereby enabling

the government to utilize the most skilled scientists and engineers available to do weapons research.

After several years of debate between the Budget

Bureau, NSF, and other agencies over NSF’s role

in Federal science policy, on March 19, 1954,

President Eisenhower issued Executive Order

10521 that established the new agency’s role.43

NSF’s role in policy development and evaluation

was to be “cooperative rather than . . . regulatory. ” NSF was not made the principal Federal

sponsor of basic research; instead, the order sanctioned a pluralistic system of Federal support. It

encouraged other agencies to sponsor basic research that was “closely related to their missions. “44

The Order declared that one of the purposes

for NSF’s establishment had been to develop and

encourage pursuit of an appropriate and effective

national policy for the promotion of basic research

and education in the sciences. From time to time,

NSF would recommend to the President Federal

policies that would strengthen the national scientific effort and it would furnish guidance toward

defining the responsibilities of the Federal Government in the conduct and support of scientific

research. The Foundation, in concert with each

Federal agency concerned, would review the scientific research programs and activities of the Federal Government in order to formulate methods

for strengthening the administration of such programs and activities by the responsible agencies;

it would study areas of basic research where gaps

or undesirable overlapping of support may exist;

and it would make recommendations to the heads

of agencies concerning the support given to basic

research.

dlwarren weaver, quoted in Weyl, oP. cit., P. 5

‘

3 England, op. cit., ch, 10.

4 4 1 bid., ch, 15.
18

Sharp divisions over the political control of research were not unique to the debate on the National Science Foundation. In the late 1940s and

1950s, intense debate preceded the creation of

both the Atomic Energy Commission (AEC) and

the National Aeronautics and Space Administration (NASA), debates that also focused on patent policies, communication restrictions, and

mechanisms for political control of each agency.

The legislation creating the Atomic Energy

Commission–the Atomic Energy Act of 1946

[Public Law 585] –gave the Federal Government

“an absolute monopoly over all aspects of atomic

energy research, development, and production, ”

including provisions to control the dissemination

of data related to atomic weapons and the production, or use of fissionable material .45 This tight

Federal structure essentially removed control of

even peacetime atomic energy research, or research directed at civilian power applications,

from the scientific community that had developed

the research field in the first place. Moreover, it

created a situation in which all atomic weapons

or atomic energy information was “born classified.” As political analyst Harold Relyea and

others have pointed out, these provisions meant

that no special governmental effort was necessary

to bring such information under the statute’s “umbrella of secrecy.”46 The Act also prohibited the

issuance of patents for inventions useful in the

production or utilization of fissionable material.

Although these patent provisions were relaxed

somewhat in the subsequent Atomic Energy Act

of 1954 and although that revision also authorized the controlled involvement of private industry in nonmilitary atomic technologies, many of

the most stringent controls on research initiated

by the original Act—including those on who may

do such research or have access to technical information for such research—remained in force.

The initial legislation in 1958 to create the National Aeronautics and Space Administration contained language that would have created a much

looser policy on patents for that agency. But draft

bills in both the House and the Senate, which

45 Harold C. Relyea, “Information, Secrecy, and Atomic Energy, ”

New York University Review of Law and Social Change, vol. 10,

No. 2, 1980-1981.

401 bid., p. 269.

modeled their patent provisions on the Atomic

Energy Act, would have enabled the government

to maintain ownership of patents generated by

NASA-funded research. The final legislation gave

patent ownership to the government, but also

gave the administrator of NASA the authority to

waive title. Similar discussions and debates over

the political control of research or of research

products took place during the development of

other Federal agencies and programs.

Another critical outcome of the postwar support of science was the burgeoning of the National

Institutes of Health (NIH), which before the war

had been a small “oldline” Federal health research

organization. The Public Health Service had been

created in 1912 to increase biomedical research

directly related to large public health problems.

At the end of the 1920s, an effort to establish NIH

promoted a stronger Federal role in the encouragement of research, and in 1930, the Ransdall Act

expanded and redesigned the Hygenic Laboratory

of the Public Health Service into NIH. Public and

congressional desire to find a cure for cancer resulted in the creation of the National Cancer Institute in 1937.

During World War II, advances in biomedical

research had helped to demonstrate dramatically

the effects of Federal funding of biomedical research. This success reinforced intensive lobbying during the 1950s, by public interest groups and

a number of powerful individuals, for aggressive

NIH-funded research focused on specific health

problems, Congress often responded to this pressure by identifying and funding research areas that

had broad public appeal, but that were scientifically misunderstood. The director during this

period, James V. Shannon, was able to moderate, however, between the call for targeted research and the need for basic medical research;

he persuaded Congress that funding of both basic

and applied research was essential to reach the

goals of diagnosing and curing disease.

Reflecting on the sweep of events during the formation of the current bureaucratic arrangements

for science, Don K. Price has observed that the

scientists engaged in constructing these arrangements adopted a three-part tactic to avoid, in particular, the constraints in choice of topic which

had characterized pre-war agricultural research .47 ——~7PriCe, op. cit., p. 77.
19

First, they sought to combine research with

university teaching. They regarded such an arrangement as “the best way of strengthening basic

research in the one setting most free of commercial self-interest or political pressure—the university, ”48 thereby obtaining a stable base from which

to defend science’s independence against “popular passions or economic self-interest. ” Second,

they focused on the mechanism of the project

grant, because it “offered a tactic to avoid detailed

congressional control of funds” and also allowed

Federal support to universities “without adopting a general program of aid to higher education. ”49 And third, the pattern of organization

——

“Ibi~ , p. 78

“Ibid,

proposed by the scientists gave them a political

authority not dependent on popular votes .50 In

many cases, they gained this control through a

growing system “of policy planning by part-time

advisers under government grants and contracts. ”

But as Price notes carefully, the authority gained

by the scientists was not the type defensible as

a Constitutional right; rather, it was a delegated

authority. “[I]t depended on the continued confidence among elected politicians in the assumption

on which the tacit bargain was founded—that

basic research would lead automatically to fruitful developments. ”51

‘“Ibid.

“Ibid., p, 80.

THE 1960s: PUBLIC CRITICISM OF SCIENCE

In the 1960s, questioning of several of these

basic assumptions began to shape a new political

receptivity to science. More and more questions

were raised about the negative effects of scientific

knowledge, including both its informative value

and its use as technology. News reports of calloused abuse of human subjects in scientific experimentation led to political calls for increased

social accountability. Vigorous criticism of science

came from a number of quarters: intellectual and

theological questioning of the philosophical foundations of science; the linking of science with war

(which came out of the protest against the Vietnam war and nuclear escalation); concerns about

science’s “technological side effects” on the environment; and ethical questions about research

procedures. As a 1971 Organisation for Economic

Co-Operation and Development report, Science,

Growth, and Society, observed, “Scientific research itself became associated in the minds of

many with war, and with environmental and social deterioration resulting from the large-scale application of technology.”52

It is important to recognize, however, that theological or political efforts to control or regulate

research are neither unique to the United States

nor new. In 1927, for example, an English cleric

“Science, Growth and %ciet} (Parisr France: Organisation for

Economic Co-Operation and Development, 1971 ).

suggested that “every physical and chemical laboratory be closed for about ten years to enable

society at large to assimilate the staggering amounts

of new scientific knowledge. ” Although he reportedly spoke partly in jest, the shock of such a suggestion produced considerable reaction in the

United States as well and the Bishop’s remark became the stimulus for debate over the “primacy

of ends over means” and the moral depth of

science. 53 In the 1930s, many scientists expressed

their apprehension about “anti-intellectuals who

wish to impose ideological or theological constraints on research, ”54 and humanists and theologians voiced their concern that science was like

an engine out of control. Many of these same concerns cropped up again in the 1960s in several

widely-circulated intellectual criticisms of the

scientific establishment and social values, such as

Herbert Marcuse’s One-Dimensional Man (1964).

An early example of the 1960s questioning was

the controversy that arose over Project Camelot ,55

“Carroll Purse]], “ ‘A Savage Struck by Lightning’: The Idea of

A Research Moratoriumr 1927 -37,” Lex et Scierrtia, vol. 10, OctoberDecember 1974, pp. 146-158.

Siprice, Op. cit., P . 76.

5’For more extensive discussion of Project Camelot, see TecAnical information for Congress, report to the U.S. Congress, House

Committee on Science and Technology, Subcommittee on Science,

Research, and Technology, July 1979, pp. 145-179. Also see Irving

L. Horowitz, “The Life and Death of Project Camelot, ” Transaction, November-December 1965, pp. 4-10.
20

In his 1961 message on the defense budget, President John F. Kennedy, motivated by the first

Cuban crisis and growing instability in some developing countries, had proposed to increase the

U.S. capability in dealing with “guerilla forces,

insurrections, and subversion, ” by strengthening

military resources of anthropological, cultural,

and other social science data in relevant geographic regions. The result of this proposal was

Project Camelot, a Department of Defense (DOD)

project in applied research in the social sciences.

The project would have attempted to study the

political, economic, and social preconditions of

instability and potential Communist usurption of

power in several developing countries. Political

reaction to the project, however, was strong and

significantly negative. Congress opposed DOD intrusion into foreign policy and the military takeover of foreign policy research, and feared the potential damage in foreign relations with Latin

American countries. Social scientists were concerned about military sponsorship of social science

research and, more generally, about the relationship between the Federal Government and the social science community in the utilization of social science research and data in serving national

purposes. As a result of the controversy, Project

Camelot was eventually suspended.

Later in the decade, as the universities became

the institutional arena for protest against the Vietnam War, some of that activity was directed

against university involvement in scientific research supported by the Department of Defense.

Boycotts and petitions were spearheaded by Scientists and Engineers for Social and Political Action,

later renamed Science for the People. One of its

founders, Charles Schwartz, described the animating beliefs of this group as a reaction to the “specific corruption of science”: “Science as a whole

is being abused by the powerful political, industrial and military interests, and we are all losers. ”56

This political movement was strengthened when

scientists at over 30 schools, following the lead

of scientists at Harvard University and Massachusetts Institute of Technology, held a work stoppage for one day on March 4, 1969, interrupting

their research to protest the war and the use of

s~penjck, et al,, op. cit., p. 430.

science for military purposes .57 At some institutions, the result of such activities was that classified weapons research was transferred to laboratories that were off-campus and separately

administered.

Concerns about military domination of academic science were not confined to campus activists and scientists. Senator William J. Fulbright

proclaimed in a 1967 Senate speech: 58

The universities might have formed an effective counterweight to the military-industrial

complex by strengthening their emphasis on

traditional values of our democracy, but many

of our leading universities have instead joined

the monolith, adding greatly to its power and influence.

Acting on these concerns, Congress passed an

amendment in August 1969 to the Defense Authorization Bill of 1970 which included language

prohibiting DOD from funding basic research not

directly related to a specific military function or

operation. Called the “Mansfield Amendment” after Senator Mike Mansfield (D-MT), who was a

cosponsor and one of its most outspoken defenders, Section 203 of Public Law 91-121 sought

to realign the funding patterns for basic science :59

The intent of the provision is clear. It is a mandate to reduce the research community’s dependence on the Defense Department when it appears that the investigation under consideration

could be sponsored more reasonably by a civilian agency. After all, the National Science Foundation was created by Congress back in 1950 specifically to channel federal funds into basic

research.

Mansfield proclaimed that the amendment was

“neither anti-military nor anti-research”; rather,

its intention was to reinforce the role of the NSF

as the “primary source” of basic research funds,

because the role of DOD in sponsoring basic research was “intended to be incidental rather than

predominant.“60

5’Jc~nathan Allen (cd.), A4arch 4: Scientists, Students, and Society (Cambridge, MA: The MIT Press, 1970).

s8Davjd Dickson, The New Politics of Science (New York: pantheon, 1984).

59U. S. Congress, House Committee on Science and Astronautics,

Subcommittee on Science, Research, and Development, “National

Science Policy, ” Hearings on H. Con. Res. 666, U.S. House of Representatives, 91st Cong., 2d sess., 1970.

~orenjck et a]., Op. cit., pp. 344-346. Also sw Rodney W. Nichols,

“Miss~on-Onented R& D,” Science, vol. 172, Apr. 2, 1971, pp. 29-37.
21

The direct and immediate effect of the Mansfield Amendment was not very great. It was legally in effect for only 1 year and was not renewed. Only 220 of the 6,600 research projects

that were reviewed were affected by the amendment, involving a total of $8.8 million, or only

4 percent of Defense funds for academic research.

In the following year, the amendment’s language

was changed from “direct and apparent relationship” to military needs, to “in the opinion of the

Secretary of the Defense, a potential relationship. “61 Nevertheless, the Mansfield Amendment

did signify a change in policy toward the support

of basic science, and in the words of former

Presidential science advisor, Edward E, David, Jr.,

“its influence has continued to be felt throughout

the Department of Defense . . . [and] it has drastically reduced the willingness of many other Federal agencies to fund basic scientific work that cannot be clearly related to their current missions. “62

The amendment appears to have created a climate

of greater caution and uncertainty in making research grants, not only in DOD but in other

agencies.

By the 1960s, the Federal agencies were also

playing an active role in shaping the Nation’s environmental future, often without any clear statement of national environmental policy. The U.S.

Bureau of Reclamation, the U.S. Corps of Engineers, the U. S. Department of Agriculture, the

Federal Highway Administration, and similar

agencies had been reshaping the landscape.63 Their

actions, however, were not always benign; some

appeared to result in inadvertent, unanticipated

degradation of the environment or destruction of

plant or animal species, or chemical contamination of waterways. Although some of the environmental degradation may have actually been

due more to deployment and expansion in the

scale of old technologies, or due to actions taken

to accomplish political goals, the negative effects

were often blamed on science and technology.

“Dickson, op. cit., p. 122.

~ZEdward E, David, Jr., “The Federal Support of Mathematics, ”

Scientific American, vol. 2.52, May 1985, p. 45.

b ~Lynton K, Cajdwe]l, Science and the ~ationa~ En vironmenta)

Policy Act; Redirecting Policy Through Procedural Reform (University, AL: The University of Alabama Press, 1982), p. 8.

A legislative result of this concern was the passage of the National Environmental Policy Act of

1969 (NEPA), which focused on the Federal Government’s role in shaping and protecting the environment. The legislation gave a message that there

was a need to anticipate environmental impact

and to do some of that through research. Lynton

Caldwell has observed that: “The task set for its

authors was to redirect national policy toward the

environment, ” but “the method was procedural

reform, ” including the instigation of research.64

In attempting to make Federal agencies accountable for “actions that significantly affected the

quality of the human environment,”65 NEPA requires Federal agencies to prepare environmental

impact assessments for all major actions significantly affecting the environment66 and it creates

administrative requirements that agencies either

cite research knowledge as evidence for decisions

or, as necessary, commission and conduct research of their own. NEPA, Title 1, Section 102

mandates agencies to “utilize a systematic, interdisciplinary approach which will insure [sic] the

integrated use of the natural and social sciences

and environmental design arts in planning and

decisionmaking. ”67 One of the responsibilities of

the Council on Environmental Quality created by

NEPA was “to conduct investigations, studies,

surveys, research, and analyses relating to ecological systems and environmental quality.”68 The

Council on Environmental Quality later specified

in new regulations that “if scientific uncertainty

exists but can be cured by further research, the

agency must do or commission the research.”69

In recent years, the courts have taken a more active role in requiring the agencies to fulfill this

mandate.

The increased environmental regulation of industry—as well as other social legislation—had

a number of unplanned effects on the scientific

research system. * In the late 1960s and early

b41bi~, p. 9,

b51bid.

‘dMark Reeve, “Scientific Uncertainty and the National Environmental Policy Act—The Council on Environmental Quality’s Regulation 40 CFR Section 1502 .22,” Washington Law Review VOI. 60,

No. 1, 1984-1985, p. 101.

b’CaldwelI, op. cit., p. 12.

b~Nationa] Environmental Policy Act, Title 11, Section 205(5).

b~Reeve, Op. cit., p. 101.

*To be discussed in more detail in ch, 5.
22

1970s, Congress created the Environmental Protection Agency, the Occupational Safety and

Health Administration, the National Highway

Safety Commission, the Consumer Product Safety

Commission, the Mining Safety and Enforcement

Administration, and the Equal Employment Opportunity Commission. In addition, the jurisdiction and enforcement powers of several existing

Federal agencies (such as the Federal Trade Commission) were expanded. This explosion in protective regulation can be attributed to many

things, such as changes in the underlying technology of industry or changes in perception about

what constitutes potential risk, combined with increasing awareness and growing intolerance of

risks. Traditional protections, especially market

and liability laws, seemed inadequate to encourage socially responsible behavior. Moreover, the

scientific research system—as it participated in the

regulation—was becoming increasingly visible

and more federally dependent. In addition to its

use in forming regulatory policy, science was expected to comply with protective regulations and

social programs originally directed at industry or

the professions.

Perhaps the most significant science policy debate of the 1960s-–in its long-term effects on public and political attitudes toward research and in

resulting regulation—surrounded the use of human subjects in scientific experiments. The U.S.

mass media had in the 1960s carried a number of

reports about unsavory situations—here and

abroad—in which prisoners, children, the poor,

and the elderly were exposed to unwarranted risks

in the name of “experimentation. ” The issue was

politically volatile, and it touched on fundamental questions of who should set the standards for

control of scientific research. In a 1966 article that

captures the spirit of that debate, Henry K. Beecher

wrote: 70

. . . it is absolutely essential to strive for [informed consent to experimentation] for moral,

sociologic and legal reasons. The statement that

consent has been obtained has little meaning unless the subject or his guardian is capable of understanding what is to be undertaken and unless

all hazards are made clear. If these are not

70 Henry K. Beecher, “Ethics and Clinical Research, ” The New England Journal of Medicine, vol. 274, June 16, 1966, p. 1360.

known, this, too, should be stated. In such a situation the subject at least knows that he is to be

a participant in an experiment. . . . Ordinary patients will not knowingly risk their health or their

life for the sake of “science.”

Prior to 1963, investigational or experimental

new drugs, for example, could be used in research

involving human subjects if the drugs were labeled

and intended solely for investigational use.71 The

Food and Drug Administration (FDA) had no direct control over the drugs, the investigators, or

the research to be done; “there was no requirement that a patient be told that he or she was to

receive an investigational drug. ”72 That autonomy

changed in 1963 when FDA, in response to the

1962 Drug Amendments (known as the KefauverHarris Amendments), issued Investigational New

Drug regulations requiring that “any person or

manufacturer seeking to study a new drug in human subjects . . . prepare and present to the FDA

an acceptable plan for the investigation .”73 In

1966, the U.S. Public Health Service began to require all institutions (e.g., universities, commercial laboratories) to which it made grants to establish boards to review investigations involving

human beings: “. . . to safeguard the rights and

welfare of research subjects, to ascertain whether

the methods used to gain their consent were appropriate, and to evaluate the risks and benefits

of the experiment .“74 One analyst has characterized events of this time as the “legalization of ethical choices. ”75 By the early 1970s, several legislative and administrative actions had attempted to

implement such safeguards. Requirements for institutional review of research involving human

subjects had gone from a matter of agency policy to one of Federal law. The institutional review

boards required for each institution receiving Department of Health and Human Services (DHHS)

‘

] Alexander M. Schmidt, “The Politics of Drug Research and Development, ” The Social Context of Medical Research, Henry Wechsler

(cd. ) [Cambridge, MA: Ballinger Publishing Co. r 1981), p. 243

7zIbid.

‘31bid., p. 253.

74 Stanley Joel Reiser, “Human Experimentation and the Convergence of Medical Research and Patient Care, ” Annals of the American Academy of Political and Social Science, vol. 437, May 1978,

p. 18.

psFrank p. Grad, “Medical Ethics and the Law, ” Annals of the

American Academy of Political and Social Sciences, vol. 437, May

1978, pp. 19-36.
23

funds became the principal means for enforcing regulate so that detailed Federal Government regnational political and social expectations. The ulations might not be necessary.76

7’Dael Wolfle, Emeritus Professor, Graduate School of Public Afsearchers and the grantee institutions to self- fairs, University of Washington, personal communication, 1985.

THE “LIMITS TO INQUIRY” DEBATE

These various controversies, protests, and political debates took their toll on both the complacency and the autonomy of the scientific community. And in the 1970s, many researchers

themselves became actively engaged in an intense

debate revolving around social accountability and

the acceptability of limits on scientific inquiry.

The 1960’s “human subjects” debate was by no

means resolved and had stimulated regulation of

research procedures at both the Federal and State

levels. Advances in molecular biology raised new

questions about the risks of genetic manipulation.

Social surveys of public opinion were showing

that the American people did not have an unqualified faith in science and were willing to support

some controls on the research process. And, finally, general political calls for increased fiscal accountability in government accounting led some

politicians to focus attention on shortcomings in

the research grants and contracts system. These

and many other issues and controversies became

the fodder for discussions throughout the scientific community—in journals and at meetings—

about science’s social responsibility, about ethical behavior of researchers, and about the appropriateness of limitations on scientific inquiry.

A central focus for one of the debates was how

to balance the potential risks and benefits of the

“new” biology. The controversy was heightened

by two factors: the rapidity of advances in the

research, and the connections—often pointed out

by the researchers themselves—between the potential applications of the research and public

policy. When, for example, a research team at

Harvard Medical School successfully isolated a

human gene in 1969, a scientific frontier with unusual potential had been extended, but biologists

on that team also recognized that misuse of the

techniques of genetic manipulation would be undesirable. A member of the team, Jon Beckwith,

in fact, publicly voiced his concern over undesirable side effects. As molecular biologists began to

develop exciting laboratory techniques for manipulating and recombining DNA across species barriers, more and more biologists began to discuss

the potential outcomes. These discussions led to

a dramatic example of self-regulation by the scientific community.

In 1973, immediately following a major research conference, biologists Maxine Singer and

Dieter Soil wrote a letter to Science 77 in which they

appealed to the National Academy of Sciences to

establish a committee to study various problems

of recombinant DNA research and to recommend

specific actions or guidelines in the light of potential hazards .78 That committee recommended

the instigation of a voluntary moratorium on certain forms of rDNA research and the formation

of what later became a national committee to

review proposals for research using these techniques, the NIH Recombinant DNA Molecule

Program Advisory Committee, organized in 1974.

Molecular geneticists who voluntarily imposed the

moratorium asked others in the world to do likewise. Fears that flaws in these techniques might

allow ecological disaster or create “new diseases”

were also the impetus for proposals for regulation at State and local levels. 79 In February 1975,

however, an international group of biologists,

meeting at the Asilomar Conference Center in Pacific Grove, California, agreed that the voluntary

moratorium be lifted and that future research be

conducted under a set of rigid guidelines to be developed by the NIH Advisory Committee.

“’’Letters to the Editor, ” Science, vol. 181, Sept. 21, 1973.

‘“Daniel Callahan, “Recombinant DNA: Science and the Public, ”

Hastings Center Report, vol. 7, April 1977, p. 20.

“

q

Judith A. Johnson, “Regulation of Recombinant DNA Products, ”

Issue Brief 85090, Library of Congress, Congressional Research Service, Science Policy Research Division, Apr. 3, 1984; and Sheldon

Krimsky, Genetic A)chemy: The %cia) Histor}’ of the Recombinant

DNA Contrivers.v (Cambridge, MA: The MIT Press, 1982).
24

.

The justification for that moratorium—and for

subsequent regulation of the research—is discussed in chapter 3, but it is important to emphasize that, in this case, researchers were generally

supportive of formal government commissions

and legislation; most accepted some regulation as

inevitable and realized the importance of shaping the controls to fit their research needs. There

was also relatively little public input to the early

stages of the debate.80 The result of the national

scientific debate and congressional attention was

the implementation in 1976 of a National Institutes of Health document Guidelines fez-Research

Involving Recombinant DNA Molecules, which:

1) imposed restrictions on the types of experiments

that might be performed at NIH grantee institutions, and 2) specified minimum levels of physical and biological containment for permissible recombinant DNA experiments. In 1977, in compliance with the National Environmental Policy

Act, NIH adopted an environmental impact statement for the 1976 Guidelines.

At about this same time, a number of public

opinion surveys appeared to be indicating a decline in the public’s traditionally high support for

and confidence in science .81 (See app. B for a general discussion of public attitudes toward science. )

Some survey data indicated that more and more

non-scientists were inclined to question science’s

traditional autonomy or to express a lack of confidence in science’s ability to solve social problems through research. People seemed to confuse

science with technology, and to see science “in a

very technological, instrumental light. ”82 As a part

of its new Science Indicators series, the National

Science Board (NSB) decided to include a chapter on public attitudes toward science. Using data

from Opinion Research Corporation surveys in

1972, 1974, and 1976, the chapters of the NSB

reports described a public that, although still holding science and technology in high regard, was

much less supportive than it had been in 1957,

the date of the last previous comprehensive survey. While 90 percent of the public thought that

the world was “better off” because of science in

Soca]lahan, op. cit., p. 20.

“Amitai Etzioni and Clyde Nunn, “The Public Appearance of

Science in Contemporary America, ” Daedalus, vol. 103, summer

1974, pp. 191-206.

‘ZIbid., p. 203.

1957, only 70 percent of the public held the same

view in 1972. 83 Similar results were obtained in

the 1974 and 1976 studies.84 The percentage of

those willing to say that the world was worse off

because of science did not increase significantly,

but the percentage of persons who were uncertain, undecided, or felt that things were about

equal did increase substantially over the 15-year

period spanned by the four studies.

In a 1979 national study also sponsored by the

National Science Board, several of the 1957 questions were repeated, offering an opportunity for

comparison across two decades. In 1979, 81 percent of the public still agreed that scientific discoveries were making their lives “healthier, easier,

and more comfortable” and 86 percent expressed

the view that scientific discoveries were “largely

responsible” for the standard of living in the

United States.85 In a comparable national study

in 1983, Jon D. Miller found that 85 percent of

American adults continued to agree that science

made their lives healthier, easier, and more comfortable. 86 Contradictory evidence, however, was

provided by other surveys sponsored by NSB,

which had asked respondents to assess the relative benefits and harms of science and to weigh

the two.

The data from the 1970s thus indicated that although only about one in 20 Americans believed

that science does more harm than good, about

one-third were not sure where the balance fell.

Some of this uncertainty may have reflected a

wary attitude toward science; some may have

been due to a lack of interest or information. In

the 1970s “limits of inquiry” discussion, however,

the scientists found the potential “wariness”

frightening.

If there was a significant change in public opinion, why did it occur? Some argue that respect

~JScjence ~ndicators—~ 972 (Washington, DC: National Science

Board, 1973).

EdScience zn~icators — z 974 (Washington, DC: National Science

Board, 1975); and Science Indicators–1976 (Washington, DC: National Science Board, 1977).

8SJ(>n D. Miller, et al., The Attitudes of the U.S. Public Toward

Science and Technology (Washington, DC: National Science Foundation, 1980).

SbJon D. Mil]er, “A National Survey of Adult Attitudes TOWardS

Science and Technology in the United States, ” Annenburg School

of Communications, University of Pennsylvania, Philadelphia, 1983.
25

for scientists diminished because the scientific

establishment became “identified with the general

power structure”; others believe that it was because of “an exchange of roles between science

and religion in relation to the stability of the

prevailing political system.”87 Some senior scientists, unaccustomed to public criticism, sincerely

believed at the time that scientific values and traditions were under serious attack.

Many linked the change to science’s new status as a visible target in the Federal budget. Congressional attitudes—which were moving away

from relatively unquestioning support—may have

been influenced by the social discussion. Some

criticism was undoubtedly prompted by the scientists’ own doubts about “the omnicompetence of

science in human affairs. ” But political scientist

Don K. Price speculated in 1972 that the politicians’ questioning resulted most “from the normal disposition of anyone who lends or grants

money to want to know what use is being made

of it, and whether the terms of the bargain are

being kept."88

Such normal policy questions received widespread publicity when, in 1975, Senator William

Proxmire (D-WI) launched an unprecedented attack against National Science Foundation funding of social science research. Proxmire, then

Chairman of the Senate Appropriations Subcommittee that reviews the NSF budget, established

the “Golden Fleece of the Month” awards to illustrate what he regarded as examples of waste

in the government—occasionally attacking projects that he asserted “at best, of nominal value

to the American taxpayer. ” Scientists, angered at

the attack, countered that projects with obscure

titles and subjects may nevertheless deal with relevant and important problems, They feared a dangerous precedent if immediately applicable science

was perceived to be the only worthwhile science.

The political momentum of the “Golden Fleece”

awards was eventually slowed when a behavioral

scientist who had received such an award filed suit

against Proxmire, arguing that, as a result of Proxmire’s actions, he had suffered a loss of respect

in his profession, was “held up to public scorn,

‘ ‘ Limits of Scientific [nquir}, ” Daedaius, spring 1~78, p. vli,

‘fiI>rice, op. cit., p. 80,

and suffered a loss of income and ability to earn

income in the future. ” A Federal district court in

Madison, Wisconsin, granted a summary judgment in Proxmire’s favor on the grounds that he

enjoyed absolute immunity under the Speech and

Debate Clause of the Constitution; but in 1979

the Supreme Court held that the researcher was

not a public figure simply by virtue of receiving

Federal funding, and that congressional immunity did not extend to statements made outside

Congress.

Despite a lessening of political criticism following the Supreme Court decision, the scientific

community reacted as if the integrity of all science

in general had been questioned. Many researchers seemed to be underestimating the demand for

accountability inherent in acceptance of public

funding .89 “Those [scientists] who came of age

during the fifties and sixties, ” Robert S. Morison

observed in the 1970s, “may never quite understand why they have suddenly become ‘accountable’ to a ‘participatory democracy’.“90

Insensitivity may not be the entire explanation,

however, for public perceptions of science in general were also changing. Only a decade before,

science had had unquestioned social authority in

the culture and its research funding was ample,

growing, and relatively easily acquired; by the

1970s, research was being conducted in a social

climate that admitted scientific authority to questioning and in which other demands were biting

into science’s portion of the Federal budget. Scientists who had been trained before the war probably also could not have imagined the extent of

regulation of the research process which had begun to occur.

Some scientists who took part in these discussions reacted negatively to the proposal of citizen participation in what were traditionally considered to be “scientific” matters.91 “How, ” one

commentator asked, “can public participation be

arranged without clashing with the very meaning of science as a consensual activity among

“9Robert S. Morison, “Commentary on ‘The Boundaries of Scientific Freedom ’,” Newsletter on Science, Technology. & Human

I’alues, June IQ77, pp. 22-24.

‘

L

’ Ibid., p. 2-I.

‘

]

’’ Limits of Scientific Inquiry, ” op. cit., p. viii
trained specialists?”92 Scientists who had previously assumed total control over their research

now talked about being at the “mercy of citizens’

groups” who were seeking input to the decisionmaking process .93

Despite this reaction—or perhaps because of

it—many leaders of the scientific community appear to have believed that public scrutiny inevitably implied restrictions. According to Dorothy

Nelkin, by the 1970s, it was no longer a question

of whether there would be public control, but of

who would participate, how control would be organized, and how much they would influence research decisions.94 The discussions then moved

to consideration of how the situation could be

shaped to “protect” basic science, and to when

and how much the public representatives would

actually be involved.95

The scientists, philosophers, and policy analysts

were not, however, always in agreement about

the question under debate. Some regarded it as

a debate over “limits to free scientific inquiry, ”

viewing proposed regulation as an attempt to inhibit researchers’ freedom to pursue intellectual

inquiry. Others began to frame the debate in terms

of funding priorities. Andre Hellegers once made

this point forcefully, arguing that freedom of inquiry was not under assault because science was,

in fact, “royally” funded.96 Hellegers cited the two

central issues for science as: 1) “Given finite resources, how much should the public invest in an

enterprise such as science?; and 2) “How far (if

at all) should any enterprises, in the name of freedom of inquiry, be allowed to infringe on the free-

——. .———

“Ibid., p. 232.

‘

3

1 bid., p, viii.

94 Dorothy Nelkin, “Intellectual Property: The Control of Scientific Infor,mation, ” Science, vol. 216, May 14, 1982, p. 207.

“Andre Hellegers, “The Ethical Dilemmas of Medical Research”

and Barry Casper “Value Conflicts in Restricting Scientific Inquiry, ”

l?egu~ation of Scientific Znquiry, Keith M. Wulff (cd. ) (Boulder, CO:

Westview Press, 1979).

“Ibid., p. 9.

dom of others?”97 Should low priority be given

to those activities that have adverse consequences?98

To Hellegers, the real topic of importance was

“the ordering of priorities in things which affect

both science and human values.’’”

Don K. Price has observed that in the 1970s

scientists were often inclined to blame their problems on politicians. This tendency was exacerbated by historic differences in the outlooks of

the two groups. Scientists and politicians operate in different time frames—Congress in the short

term and scientists in the long term. Conflicts

often arise from the imposition of a political paradigm onto the agenda of the scientific community.

But Price believes that the problems themselves

evolved from three other factors. First, the political strategy for the support of science was devised by scientists themselves and was based on

the experience of private philanthropy before

World War II. Second, the political authorities

had accepted science “as the dominant intellectual approach to public issues, which scientists

and other liberal intellectuals agree must therefore be regulated in the public interest.” And third,

the U.S. constitutional structure is “too decentralized to sustain the integrated and long-term view

of public policy which might justify the support

of science as an intellectual and educational enterprise. “100

The academic debate over “limits to scientific

inquiry” can be seen as a response to social pressures, to events and progress within science, and

to the scientists’ fear that public support for

science was declining. The academic scientific

community believed that it was necessary to defend the very core of science—which they perceived as under attack. They saw the humanists’

criticism and the attempts to regulate as threats

to the legitimacy of modern science.

“Ibid., p. II.

‘

s

Ibid., p. 22.

9gIbid., p. 29.

]~oprice, Op, cit., p. 76.
27

RECENT RESTRICTIONS ON SCIENTIFIC COMMUNICATION

From the earliest days of the Nation, Federal

policy has largely been supportive of open communication, free exchange of information, and

wide publication in scientific research.101 From

time to time, however, recognition has been given

in Federal law to “circumstances that constitute

what have been thought to be obvious and compelling reasons for imposing official secrecy on

research or restrictions on the dissemination of

certain kinds of research findings .’’102 For example, the first War Powers Act, signed 11 days after Pearl Harbor, gave the President the authority to censor all communications with foreign

countries. But the scientific community has also

made some attempts at voluntary control. In

1940, for example, editors of various professional

journals cooperated with a special committee of

the National Research Council to review papers

for possible defense information. ’”’ This combination of Federal support for open communication, defense-related restrictions imposed on a

case-by-case basis, and occasional voluntary cooperation by the scientific community continues

today.

Because of this history, it is noteworthy therefore that the most controversial regulatory issue

for science in the 1980s has been the imposition

of restrictions on the communication of basic science. In part, the new restrictions have resulted

from the changing nature of information, espeIL’i Harold C. Rel yea, “Shrouding the Endless Frontier—Scientific

Communication and National Security: The Search for Balance, ”

S&Aing a Balance: Nationa] Secufity and Scimtifjc Freedom, Harold

C Relyea (cd. ) (Washington, DC: American Association for the

Advancement of Science, 1985), p. 75.

‘L” Ibid,

I

L

’’ Harold C. Relyea, “Increased National Security Controls on

Scientific Communication, ” Government information Quarterly,

vol. 1, No, 2, 1984, pp. 187-188, See also Michael M. Sokal, “Restrictions on Scientific Publication, ” Science, vol. 215, Mar. 5, 1982,

p. 1182; and Michael M. Sokal and Janice F. Goldblum, “From the

Archives, ” Science, Technology, & Human Values, vol. 10, spring

1Q85, pp. 24-27.

cially its status as a valuable property or national

commodity, and from the growth in modes of dissemination of information. The decreasing distinction between basic and applied research added to

the difficulty of assigning national security classification according to the information’s potential for application. And, especially in the last few

years, there is an increased perception that the export of U.S. technology is weakening this country politically and economically on a worldwide

basis. 104

This series of disputes first arose in the late

1970s, when the National Security Agency (NSA)

and later the National Science Foundation attempted to prevent university-based cryptology

researchers from publishing their unclassified

work on encryption schemes. In these cases, the

Federal Government invoked the Invention Secrecy Act and the International Traffic in Arms

Regulations, regulations intended to control the

export of munitions and related technology. The

result of discussions between the universities and

the government was the adoption of a voluntary

prepublication review process, under which copies of manuscripts on cryptology are sent to NSA

at the same time they are circulated to colleagues

or submitted to journals.105 This system of voluntary prior restraint was endorsed in 1980 by the

American Council on Education, and in 1981,

NSF amended its policies on research grants to

require similar prior restraint on “potentially classifiable results .’’106

At about the same time, the Department of Defense—concerned especially about the leak of information on Very High Speed Integrated Cirl~ilnterjm Report ~)f the Committee on the Chanb~inA~ Nature of

Information (Cambridge, MA: Massachusetts Institute (>t Techn<~logy, Mar. 9, 1983).

l~SJohn C, Cherniavsky, “Case Study: Openness and Secrecy in

Computer Science Research, ” Science, Technology,, & Htlman

Values, vol. 10, spring 1985, pp. 99-104.

‘“’ See sec. 794 on National Security in the NSF Grant Policy

Manual.
28

cuits —began to use the Export Administration

Regulations to restrict public communication of

results and to control the access of foreign scholars to U.S. university research, ’07 The presidents

of five major universities objected to these restrictions and to the trend of increased control that

they represented. That protest and the prior debate over restrictions on cryptology research were

principal factors in the initiation of a special National Academy of Sciences-National Academy

— .

107 1 bid., p. 102.

of Engineering-Institute of Medicine panel, under

the direction of Dale Corson, which issued its

seminal report “Scientific Communication and

National Security” in 1982. 108 The Corson panel

report has been a touchstone for subsequent reaction to government actions to restrict scientific

and technical communication.

— —

‘O”Scientific Communication and National Security, report by the

Panel on Scientific Communication and National Security Committee on Science, Engineeringr and Public Policy (Washington, DC:

National Academy Press, 1982).

POLITICAL INFLUENCES ON REGULATION

The science policy developed over the last 40

years reflects certain assumptions about the nature of science, the character of scientists, and the

political management of science. There have been

important assumptions about the ability of scientists to govern their own affairs; often, discussion

of the peer review system will figure prominently

as evidence of whether or not this governance

“works.” Other assumptions are made about

whether, given the current structure of science,

effective and equitable regulation is possible; and

related to that are a host of assumptions about

the nature of expertise—especially the belief that,

on scientific matters (even those with heavy policy components), scientists alone can best identify promising projects and areas of research.

Historian Alex Roland, in his March 7, 1985, testimony to the Science Policy Task Force of the

House Committee on Science and Technology, articulated this perspective well when he observed

that “scientists understand nature’s laws better

than anyone else; they are in the best position to

see the potential applications of their undertaking. ”

Some assumptions relate to the conduct of research—such as where it is best performed—or

to the appropriate relationship between research

and university education. Other assumptions relate to the process of regulation. There are, for

example, strong opinions about how far government “interference” should extend in all aspects

of science policy and about who should participate in the development of policy about controls.

Assumptions about who should control research

and at what stage are also inextricably linked to

the question of who is the best judge of science,

who is the expert, and who evaluates science.

How are changes in these assumptions—and in

the social relations of science—affecting the intensity and extent of the regulatory environment

for research?

Without doubt, there is new pressure for a balance between the push for scientific and technical progress and the demand for regulation. Congressional management of science and technology

today may require special legislative effort to

reconcile the complexity and sophistication of new

technological challenges with society’s regulatory

capabilities.

Another important force shaping enforcement

of Federal regulation on scientific research is a national fear of failure, especially in international

technological competitiveness. Science policy

leaders argue for increased funding in order to

keep the United States from “falling behind” in

certain scientific fields. But these same arguments

are used by the executive branch to justify increased restrictions on scientific communication.

Such attitudes have repercussions on scientific research through the setting of national research priorities and through pressures to achieve competitive status (or to “maintain the lead”) in all areas

of science.

One of the most visible changes—to be discussed in chapter 4—is in the creation of specific

political or bureaucratic mechanisms for implementation of social controls on research. As a

handle for enforcing regulation, the requirement
29

—

for financial accountability inherent in the research system has been successful. The post-war

contract between scientists and government had

allowed the scientists, through the process of peer

review, to make decisions about the allocation of

government funds to specific projects but required

the universities to be accountable financially to

the government. Thus, regulatory requirements—

committees to review research for ethics, regulations on the disposal of hazardous materials—

could be tied to the award and management of

money.

Changes have also occurred in the amount and

type of public participation in decisionmaking on

issues related to science and technology. Changes

in public beliefs about the value of “expert” v. lay

opinions on political or social issues involving

science or technology have reinforced the trend

toward less autocratic control of science by scientists. Until the last decade or so, when policymakers turned to scientists for advice in making

decisions on technically-intensive public policy issues, the practice was to distinguish between the

technical and the political, or normative, aspects

of a problem. 109 Today, the involvement of more

laypersons in that decisionmaking process on reg-

‘

(

’’ I.(lren R. Graham, ‘Comparing L’ S. anci Soi’]et Experiences:

Science, Citizen>, and the Policy hlaklng Procms,” En\’ironrnent,

~ro] ~b, %ptembvr 1 Q84, p 8 ,

ulating research has not only shifted some control from the scientists but has introduced more

sensitivity to normative concerns,

These and other influences on U.S. research

have helped to change the nature and character

of the politics within which research is conducted,

When the Bush and Steelman reports outlined

their visions for how the Federal Government

should sponsor and finance a national structure

for scientific research, there was little reason to

believe that those same arrangements could become the vehicles through which research might

be regulated according to prevailing social or political attitudes. Science was to be managed with

loose reigns. It was not perceived as either requiring suspicious administration or warranting externally-imposed controls. The specific links between the events that stimulated much of the

current regulation and the concurrent shifts in

public attitudes are not well understood, but it

is clear that, in the 40 years since Bush, something

has changed. That shift is linked in some way to

the original assumption that guided the design of

the system as well as to the assumptions that now

underpin priority-setting and funding today.

Science is now clearly conducted within a regulatory environment that affects its agenda, its procedures, and its communications. The next four

chapters describe the existing situation—why regulation occurs, how it occurs, and where it occurs.
Chapter 3

Social and Political Rationales

for Controls on Research
Chapter 3

Social and Political Rationales

for Controls on Research

Harold Green has observed that, all things being equal, there is no question that “a scientist has

the freedom to think, to do calculations, to write,

to speak and to publish’’—as long as these activities remain within the area of abstractions.1 Research, of course, involves more than abstract

thinking. Scientists experiment, observe subjects,

record data, and describe their work to others.

These activities can be affected by social mores

and customs and can in turn affect society, the

environment, or the people and objects involved

in the research. When research violates the social

norms, or when society perceives risks or dangers

in the research process, then restrictions may be

implemented either by society or voluntarily by

the research community.

This chapter develops a typology of the various reasons used to justify either legally enforceable regulations or social restraints on scientific

activity. In most cases, the rationale described is

one that is used to explain why scientists should

not do research on a certain topic or in a certain

way, or should not describe their results to a particular group of people. In a few instances, the

justification may be used to discourage scientists

from pursuing one research line or encourage

them to pursue another, or to protect government

or commercial rights in scientific information, *

‘Harold I’. Green, “The Boundaries of Scientific Freedom, ” Regulation of Scientific Inquirj’, Keith hf. Wulff (cd. ) (Boulder, CO:

\\’e\tv]em I’res>, 1Q7QI, p. 140; reprinted from Newsletter on Science,

Technc)lc)g~’ & Human I’alues, June 1977, pp. 17-21.

‘Is>ues or events are described in this chapter as examples of when

a particular justlticatlon or rationale may have been employed. A

sclent itic topic or project may have been regulated for more than

one reason, but all these reasons are not necessarily listed for each

example.

This chapter describes the rationales or legal

justifications for two types of regulation of scientific research. One type includes legal barriers,

incentives, or other actions that have some binding or controlling effect. The other type of regulation includes forces or actions—ranging from

changes in funding to negative public opinion—

that do not have the force of law but may have

some important effects because of the way in

which science is funded and is dependent on political and social support for the continuation of

that funding.

Table 3-1 .–Justifications for Control of Research

Regulatory forces on the research agenda:

Ž To fuIfiII political objectives

● To avoid environmental damage

. To promote or avoid specific economic consequences

• To preserve moral values

Regulation of research procedures and protocols:

● To protect human health and safety

. To protect an i reals used in experimentation

. To protect the environment

Regulation of the dissemination of scientific knowledge:

. To uphold scientific standards

. To protect a professional or economic interest

. To protect the health, privacy, and safety of

individuals

● To protect the national miIitary or economic security

REGULATORY FORCES ON THE RESEARCH AGENDA

Attempts to control the research agenda of a are convinced that application of the research

field or laboratory may take one of two forms. could bring harm. Others may be unwilling to

Opponents of a research topic may wish to sup- grant legitimacy to a morally (or politically) obpress a project or a line of research because they jectionable idea by implying that it is worthy of

33
34

scientific attention. Proponents of a research topic

may seek to alter the research agenda to include

that topic.

For these reasons, justifications are likely to be

affected by beliefs about the probability and type

of any eventual application. The regulator is convinced that, should the research ever be done,

some imaginable (or predictable) result or finding would be unacceptable or undesirable. The

potential of research for application—and the regulator’s ability to envision such application—thus

can have considerable effect on the predisposition

to control. Harvey Brooks points out, “the regulatory climate for research which is influenced by

its potential applications will depend on the

uniqueness of the relation of these applications

to the substantive content of the research, since

the amount and richness of the applications vary

considerably among types of research.”2 Some observers, however, argue that all regulation occurs

because of the anticipation of some effect, although they may distinguish between attempts to

limit inquiry because of: 1) “anticipated deleterious consequences of the inquiry itself” (e. g., effects of the research procedure on experimental

subjects); and 2) “anticipated deleterious consequences of applications of knowledge obtained by

the inquiry.”3

The most common justifications for restraints

on research agenda are political, environmental,

economic, and moral concerns.

To Fulfill Political Objectives or

Avoid Political Effects

Political reasons may underlie both the encouragement and the suppression of research, when

society perceives that research could achieve a specific advantage or result in a negative effect. The

protection of national economic or military security, for example, may justify either the redirection of research toward military goals or the

inhibition, discouragement, or prohibition of

weapons development research outside of government control. Both justifications were used durIHarvey Brooks, Benjamin Peirce Professor of Technology and

Public Policy, Harvard University, personal communication, 1985.

3Barry M. Casper, “Value Conflicts in Regulating Scientific Inquiv, ” Regulation of Scientific Inquiry, Keith M. Wulff (cd. ) (Boulder, CO: Westview Press, 1979), p. 15.

ing the 1970s controversy over research on the

laser separation of isotopes of uranium. That research topic became an active area of controversy

in 1976, when experiments in both government

and private industry labs showed a promising new

approach to laser isotope separation. A few

months later, a private consortium, Jersey Nuclear-Avco Isotopes, Inc. (JNAI) applied to the

U.S. Nuclear Regulatory Commission for a license

to build a $15 million facility for large-scale experiments using one of these approaches.’ Because

laser isotope separation was believed to promise

a cheaper, easier way to obtain enriched uranium—for both nuclear powerplants and weapons—these new developments provoked both

considerable controversy and attempts to classify

the work. Many observers believed that existence

of a perfected process would increase the risk of

unintentional proliferation of nuclear weapons,

would undermine existing international safeguards, and could aid terrorists. In proposing a

moratorium on further research and development,

physicist Barry Casper argued that “there is still

time to stop and consider whether laser enrichment should be developed, in light of its broader

consequences.”5 Proponents of the research argued that laser isotope separation required sophisticated facilities and was not a “garage” technology adaptable by terrorists, and that therefore

those fears were groundless. *

At the international level, the nuclear nations

have tried to curb the proliferation of nuclear

weapons by preventing additional countries—and

especially countries considered to be politically

unstable—from doing nuclear research that could

produce weapons-grade plutonium. International

political objectives have also justified government

actions that discouraged or denied permission to

foreign students from certain countries who

wanted to study nuclear engineering in the United

States. By preventing access to advanced training in certain fields, the United States was effectively attempting to control the other country’s

research agenda.

4

Barry M, Casper, “Laser Enrichment: A New Path to Proliferation?” Bufletin 01 the Atomic Scientists, January 1977, p. 29.

‘Ibid.

*In fact a special panel of consultants appointed by JNAI concluded I hat the JNAI process was probably lms proliferation-prone

than th~ centrifuge process which was being commercialized, or than

the process being developed at Los Alamos.
35

National economic priorities and international sities should accept Department of Defense

standing may justify redirecting research toward funding. 8

topics related to technological competition. When

a country decides to shore up its prestige in the

international scientific community, it often concentrates on achieving or maintaining superiority

in some but not all scientific fields. Such justifications may be discerned in, for example, the current debate on funding high energy physics and

the superconducting supercollider. Belief that the

success of U.S. industry in competing in world

markets is increasingly tied to research has

prompted several regulatory actions in the field

of biotechnology. In 1984, for example, the Cabinet Council on Natural Resources and Environment asked 14 agencies to develop a framework

for the regulation of gene splicing. ’ George Keyworth, President Reagan’s Science Advisor, has

also suggested that the National Institutes of

Health should broaden its mission by paying more

attention to the needs of the biotechnology industry through more funding of generic applied work

in biotechnology, promotion of intellectual support for biotechnology companies, and training

of bioprocess engineers and other needed personnel. 7 International relations may also affect research when science and technology are used as

tools for political diplomacy, as in scientific exchange programs.

Government actions may also be directed at encouraging or discouraging research related to specific domestic political goals. During the Reagan

Administration, the regulatory system itself has

been used to influence the funding of research pertaining to specific regulatory issues. Executive Order 12485 (Jan. 4, 1985) instituted an office of

Management and Budget (OMB) review of regulation-related research proposed by executive

branch agencies. Through its power to approve

the appearance of any research on the regulatory

calendar, OMB can control the agencies’ research

agenda before funding. In the late 1960s, both domestic and international politics related to U.S.

involvement in the Vietnam War shaped a number of acrimonious debates over whether univer-

‘An Acfmlnl>tration official was quoted as saying that the framew.[)rk was aimed at avoiding “federal actions that could aitect the

lnd ust ry’s competitiveness. l?usiness J$’eek, May 21, 1984, p. 40,

‘Barbara Cull]ton, “NIH Role in Biotechnology Debated, ” Science

vo]. 22Q, July 12, 1~85, pp. 147-148.

Special difficulties arise when the justifications

for control are linked to a controversial social or

political issue. Various forms of research to detect XXY and XYY chromosomal aberrations,

such as the screening of male newborns to identify and study prospectively the development of

those with a XYY karyotype, combine basic epidemiological research with longitudinal followup

of “experimental” (XYY) and “control” groups,

including potential therapeutic intervention.9 In

the mid-1970s, at Harvard Medical School, objections by Harvard University faculty members

and by geneticists elsewhere in the Boston academic community resulted in the voluntary termination of a research project on XXY and XYY

children. 10 The project staff argued that research

should proceed because of its potential therapeutic

value to the patients. They were sincerely attempting to advance science and “to bring what they

perceived as the benefits of science to the resolution of a social problem.”11 Their opponents, with

equal sincerity, sought to expose and stop what

they perceived as a “misuse or abuse of scientific

hypotheses and techniques.”12 Scientists critical

of the research topic argued that there was no scientific evidence linking XYY and antisocial behavior, 13 and that the research should be stopped because its goals directly contradicted American

political beliefs about the rights of individuals.

Other critics believed that the research had the

potential of being just the first step in an attempt

to determine a genetic basis for antisocial behavior. Infants tagged as having such a trait might

be treated differently all their lives and therefore

identification might become a self-fulfilling pro-

‘Dorothy Nelhln, The llni~ersitj and hfilitar?’ Research: ,Jlc)ral

I’oiitlcs at ,IIIT (Ithaca, ,~}’ Cornell Uni\’ersit}r I>ress, 1 ~72 )

“Dorothy Nelkin and ludith A. Sw.ve}, ‘Science and St>c ial C(~ntrol: Controversies O\rer Research on L’io]ence, ” Report No 1970,

conference proceedings, Institute for Studie+ In Research and Higher

Education, Norwegian Research Council for Science and the Humanities, p, 5.

1OBarbara J, Cu]]iton, “XYY: Harvard Researcher Under Fire st(~ps

Newborn Screening, ” Science, VO]. 188, ]une 27, lQ75, pp. 1284-

1285; Frederick Hecht, “Biomedical Research Ethics and Right\, ”

Science, VC)I. 188, lC175r p, 502, and Loretta Kopelrnan, “Ethica[ Controversies in hledica] Research: The Case of XYY Screen ing, ” Perspecti~’es In I?mlogjr and ,Iledicine, winter 1978, pp. 1 %204.

I ]Ne]kln and Stvazeyr [~p. clt., p. 211.

“Ibid.

1’Culliton, “XYY,” op. cit., p, 1,284 .
36

phecy, ” And finally, some asserted that the research should be stopped because the benefits to

society were dubious .15 Defenders of the research

called this latter argument “a misplaced ideological approach. ”16 In this case, both proponents and

opponents had to weigh the importance of protecting the rights of individuals against the importance to society of predicting (and therefore

possibly preventing) criminal behavior, the importance to future generations of developing chromosome screening for the detection of genetically

linked illnesses, ’7 and the importance to current

patients should reliable therapy ever become

available.

Political concerns can also drive the research

agenda when an individual or a group of researchers attempt to redirect the agenda of an institution or a field away from one topic and toward

another considered to be more socially or politically acceptable. Most often, such actions occur

at the individual or personal level; but on occasion there have been loosely coordinated actions

by groups. In the 1950s, for example, the Society for Social Responsibility in Science and the

Committee for Social Responsibility in Engineering “required their members to take a pledge upon

joining the organization which stated that they

would not engage in research for destructive purposes.”18 In the 1960s and 1970s, many scientists

switched fields rather than work on topics connected to weapons or to the military. Some attempted to choose research topics that they considered to be more socially relevant or more

expressive of their own moral or political philosophy. Some rejected certain topics out of protest

(again, on moral or political grounds) to U.S. military action in Southeast Asia or because they espoused general pacifist objections to their country’s military research agenda. Decisions to reject

a line of research were, however, more often related to the proposed military sponsorship of the

research than to any specific application of the

particular investigation. In the late 1960s and early

1970s (as discussed in ch. 2), during controversy

liKope]man, op. cit,, notes 11 mcf 13.

“Ibid., p. 200.

“Ibid.

‘

7 Culliton, “XYY,” op. cit.; and Hecht, op. cit., p. 502.

)~Rosemary chalk, “Drawing the Line: Science and Military Ilesearch, ” unpublished manuscript, May 1983, p. 8.

over the presence of classified military research

on university campuses, for example, the organization Scientists and Engineers for Social and

Political Action actively attempted to persuade

researchers to forego participation in war research

or weapons production.19

Rejection of a research line by individuals or

groups can be a form of “conscientious objection

in science. “2° Individuals who “draw the line” in

this way may simply decide to have nothing to

do with research linked to the military or, more

specifically, with nuclear weapons or chemicalbiological warfare. Many physicists, whose line

of interest and expertise would fit them notably

for the scientific task involved, justify their refusal to work on nuclear weapons research on

moral grounds. More recently, a few graduate students in the field of artificial intelligence—where

the proportion of Department of Defense funding is increasing—are reported to have either

switched their thesis topic to one unrelated to military applications or, in an extreme case, left

school or switched fields altogether.

In the 1980s, social anxiety about the nuclear

arms race has had a direct effect not in inhibiting

but in stimulating research. Funding for—and researchers’ interest in—arms control research has

increased. * Physicians, psychiatrists, and other

medical professionals have encouraged and supported new research efforts on the medical consequences of nuclear war or the psychological effect of the nuclear arms race on children.

To Avoid Environmental Damage

Environmental concerns that provoke the imposition of regulation can trigger similar conflicts

in values. At issue here is the narrowness of the

relation of the potential application to the overall substance and goals of the research. Does regulation undertaken because of the fear of one particular application serve to deny the potential

benefits to society of other possible applications

perhaps not now clearly visible?21 This justifica-

—

l+lbid p, B: See also Colin Norman, “Classification Dispute Stalls

NOAA” Program, ” Science, vol. 227, Feb. 8, 1985, p. 155.

20 Chalk, op. cit.

*For example, the International Security Program of the John D.

and Catherine T. MacArthur Foundation.

“Brooks, op. cit.
37

tion underpins, for example, the legal action to

halt deliberate release of genetically altered organisms, In a suit discussed in more detail in appendix A, the Foundation on Economic Trends has

charged that the National Institutes of Health

failed to evaluate adequately the environmental

impact of experiments involving the release of genetically altered organisms into the environment.

The plaintiffs are seeking to halt the work altogether because they are convinced that the potential long-range benefits of such research are simply not worth the potential risks to the environment.

To Promote or Avoid Predictable

Economic Consequences

International competition in trade has been used

to justify suspending one line of research (or to

cut back on its funding) because another line appears more promising. Such a situation currently

exists in the field of silicon electronics; work in

that area has been so successful that research on

alternative technologies has been cut back.

In another recent case, predictions of adverse

economic effects alleged to result from the eventual application of research projects have stimulated protests that may yet lead to restraints. In

1980, California Rural Legal Assistance filed a

lawsuit on behalf of 19 farm workers, which

charged the University of California “with unlawfully spending public funds on mechanization research that displaced farm workers. “22 The plaintiffs believe that the research—intended to develop

large, more efficient agricultural machines and

new farm methods—would reduce the need for

human labor in agriculture. They are convinced

that such innovations would have an adverse economic effect on the workers displaced by machinery, on small farms, and on consumers, and therefore that public funds should not be used to

support such research. Defenders of this research

argue that mechanization research should continue “in order to create more desirable jobs and to

keep the American fruit and vegetable industry

competitive in the international economy.”23 (See

app. A for further discussion. )

‘lI)h]l]p I Llartln and Alan L. Olmstead, ‘The Agricultural hfechan i7a t i (ln C<) n tr(~ver~}’, Science, vol. 227, Feb. 8, 1Q85, p. bOl

1‘Ibid., p o(M.

To Preserve Moral

In some instances, a

Values

society or a group within

the society may perceive the very exploration of

a topic (or the legitimacy granted to the topic by

a serious research effort) as a threat to moral or

social beliefs. That is to say, the research hypothesis contradicts the social or political beliefs of the

opponents. Early 20th century attitudes to human

sexuality, for example, acted to inhibit all types

of research relating to sexuality, contraception,

and reproduction.24 Research was discouraged because of fear that it might encourage or condone

“immoral” behavior; religious and moral leaders

objected to laboratory consideration of what were

considered to be private, personal matters.

Such objections continue to be raised today. In

public opinion polls run in 1983, approximately

one-quarter of the adult population of the United

States were willing to endorse the statement that

one of the “bad effects of science” is that it breaks

down people’s ideas of “right and wrong.’’”

On occasion, therefore, opponents of a research

topic or hypothesis believe that any exploration

(however well-controlled) might endanger the social cohesion of the community. Such concerns

fuel contemporary objections to research that

would attempt to link human intelligence to genetic inheritance. American psychometrician Arthur R. Jensen sparked a controversy in 1966 when

he argued that IQ is genetically fixed. ” Jensen proposed that social intervention aimed at boosting

minority students’ IQ scores—e.g., Headstart and

other compensatory educational measures—were

a waste of time and money. Opponents of the Jensen research are convinced that even to consider

such research as scientifically legitimate and

morally acceptable would be a racist act. The

‘“For a brief review of this history, see Emily H. Mudd, “The Historical Background of Ethical Considerations in Sex Research and

Sex Therapy, ” Ethical Issues in Sex Therapy and Research, William

H. Masters, Virginia E. Johnson, and Robert C. Kolodny (eds. ) (Boston, MA: Little, Brown & Co., 1977), pp. 1-10.

“ion D. h!iller, A Nationaj Survey of Adult Attitudes To\\rard

Science anci Techno)oH’ in the United States (Philadelphia, I’A: Annenberg School [Jf C[)mm un icat i ens, Uni\ersit}’ of Pennsylvania,

1983).

‘pSee Richard l.e~vcmtin, “Race and Intelligence, ” l?u~letin of the

Atomic Scientist\, hlarch 1Q70. Also see Arthur R, lensen, “HO W

N!uch Can \$re Boost IQ and Scholastic Achie\’ement?” Har~rard

Educational l<e~ie~j’, VOI, 39, 1 %q, pp. 1-123.
38

mere existence of the research project was perceived as an insult to members of certain minority groups. The objections can also go beyond the

desire to avoid offending certain social groups.

“The critics of such research, ” Harvey Brooks

writes, “believe that the risks of political misuse

of the resulting knowledge outweigh any possible social benefits.”27 In some cases, then, the principal objection may be to undesirable application

of the research knowledge; the secondary objection, offense to a social or cultural minority

group.

On occasion, however, the very idea of doing

such research on a taboo subject has been sufficient to warrant social regulation. This justification plays a role in the regulations promulgated

1“Brooks, op. cit.

by the Department of Education (ED) to implement the 1978 Amendments to Section 439 of the

Federal Education Provisions Act, commonly referred to as the “Hatch Amendments” after their

originator, Senator Orrin Hatch. The ED language

aims to prevent specific subject matter, teaching

methods, psychological tests, or educational research from being utilized or conducted without

parental knowledge or consent. It would prohibit

“research” designed to “reveal” such things as: political affiliations; mental or psychological problems potentially embarrassing to a student or his

or her family; sex behavior and attitudes; illegal,

antisocial, self-incriminating, and demeaning behavior; critical appraisals of other individuals with

whom respondents have close family relationships; legally recognized privileged and analogous

relationships such as those of lawyers, physicians,

or ministers; or income.

REGULATION OF RESEARCH PROCEDURES AND PROTOCOLS

With the exception of protests over the use of

animals, social criticism in the early 20th century

was more likely to be directed at the topics than

at the procedures of research. The moral and ethical concerns expressed in attempts to control how

scientists conduct their research are not new, however. What is new is the raising of such concerns

to the level of government action or legally enforceable regulation.

In these cases, the rationale for external control is most often that the scientific community’s

own safety procedures have been or are predicted

to be inadequate or insufficient to prevent harm

to human beings, animals, or the environment.

The motivations for managing the risks inherent

in the research process are straightforward: to

comply with Federal, State and local laws and regulations and thereby to avoid enforcement actions

or civil or criminal sanctions for noncompliance;

and to comply with common law duties (e. g., to

act with due care) and thereby to avoid personal

injuries or environmental degradation, as well as

any liability or duty to provide compensation

which could arise from claims brought by the injured parties.

To Protect Human Health and Safety

By far the most visible and vocal science policy debates on regulation have been those surrounding how to protect human health and safety.

Although the preoccupation with safety is a recent phenomenon, “it has taken hold so universally and absolutely that this operation hardly recognizes the possibility of a different world.”28

Regulations set by local or Federal authorities to

protect the health and safety of workers (e.g., requirements for certain types and amounts of safety equipment for persons working with hazardous chemicals) apply with equal force to laboratories and, in some cases, may have been written

specifically to apply to laboratory workers. The

Occupational Health and Safety Act of 1970 (discussed in more detail in ch. 5) includes protections for research workers who might be subjected

to unnecessary hazards on the job.

28 Rc)[)ert L, Sproul], “Federal Regulation and the Natural Sciences, ”

Bureaucrats and Brainpower: Government Regulations of Universities, Pau] Seaburg (ed. ) (San Francisco, CA: Institute of Contemporary Studies, 1979), p. 86.
39

Emotional controversy has surrounded efforts

to extend special legal protections to the human

subjects of experimentation (see box in ch. 4 for

the specific regulations). Human subjects are used

in all parts of science. They are used to test new

forms of diagnostic procedures, treatments, or

medicines. Carefully controlled clinical trials in

drug research are necessary to prove effectiveness,

to set dosage, and to uncover unknown side effects before drugs may be licensed for general use.

Human subjects must be observed for research on

mental disorders. Private industry uses them to

test new consumer goods, or in research on how

to make products more useful.

The types of experimental situations involving

human subjects can be classified generally into

four

1.

2.

3.

4.

In

only

categories:

experiments done to test physiological states

and environmental manipulation, both internal and external, in “normal” subjects;

studies of human performance and process—

e.g., memory or vision;

the trial of new methods, procedures, or

drugs on persons who are ill; and

the use of terminally ill patients to test potentially dangerous drugs or procedures .2’

the latter case, research may be conducted

as a “compassionate” procedure not requiring the review of a local ethics board if it is an

“emergency” treatment with potential therapeutic value and involving a new or investigational

drug or device.

Historically, the impetus for controls on the use

of human subjects has been either the documentation of abuse of subjects or questions raised

about potentially risky research. In the 1960s and

1970s, studies such as the Milgram “psychology

of obedience” project (in which subjects were encouraged to act with increasing severity against

other subjects),30 or the Public Health Service

Tuskegee study experiments in which over 300

black prisoners with syphilis were examined and

tested but not treated for more than 40 years in

“R{~bert E. Hodges and \V]lliam B. Bean, “The Use of Prisoners

for hledlcal Research, ” The lournal of the American Afedical Assc)-

cidt][)n, v()], 202, N’ov. 6, 1967, p, 177,

‘OStanley Nlllgram, Obedience to Authoritj (New York: Harper

& Row, 1974).

order to observe the complications arising during terminal stages of the disease,31 served to

focus public and congressional attention on the

need for more formal governmental surveillance

of research on human subjects. In these and other

cases, critics were able to show that human beings were subjected, usually without their knowledgeable consent, to the risk of some potential

harm: death, physical abuse or injury; psychological abuse or injury; damage to interpersonal

relations (e. g., loss of trust in others); legal jeopardy (e.g., creating and revealing a record of criminal behavior); career damage; economic harm;

or invasions of privacy.32

Of all aspects of the human subjects debate perhaps the most sensitive has been the use of subjects with “limited civil freedom, ” a classification

that includes prisoners, residents of institutions

for the mentally ill and retarded, and children/

minors .33 As research institutions are often located

in large urban areas, subjects are frequently drawn

from the disadvantaged in those cities. Hospitalized or incarcerated subjects also provide a convenient, stable population that can be monitored

with ease.34 The large U.S. prison population, in

fact, makes it possible for a research project to

choose subjects with any necessary characteristic. Proponents of the use of such subjects argue

that, moreover, there are also considerable advantages to society: prisoners are provided with

a break from monotony, a feeling of altruism, and

some monetary reward; research on mental illness and retardation cannot proceed without access to such patients,

Foremost in the discussion of whether minors

or institutionalized subjects should be used is the

question of coercion; for these subjects’ peculiar

position renders their “consent” to participation

questionable and may also lead to subtle, and

often unintended, abuse by experimenters.35 Op-

‘

] James H. Jones, Bad Blood: The TusAegee Sjpbi/is E~perinlent

(New York: The Free Press, 1981 ).

“Donald P. Warwick, ‘Types of Harm in Social Research, ‘ Ethical

Issues in Social Science Research, Tom Beauchamp, et al. (eds. ) (Baltimore, MD: The Johns Hopkins University Press, 1982 ), Pp,

105-110.

‘

} Robert ]. Ilvine, Ethics anci Regulations of Cljnical Research

(Baltimore, hlD: Urban & Schwarzenberg, 1Q81 ),

“Ibid.

“Alexander Nl, Capron, “Nledical Research in Prisons, ” The Ffastjngs Center Report, June 1~73, p. 4,
40

ponents argue that because such research may be

carried out in prisons or mental hospitals, it does

not receive the scrutiny and criticism by colleagues

which may be routine or required in normal research settings.

Concern that special populations might not be

adequately covered by existing regulations led in

the 1970s to the suggestion of a moratorium on

research involving prisoners. In some countries—

e.g., England—prisoners may not be used as subjects of experiments. The World Medical Association’s Declaration of Helsinki (1964, revised in

1975) states that the only appropriate subjects are

those “in such a mental, physical, and legal state

as to be able to exercise fully [their] power[s] to

consent. ” Dissension over exactly how to treat

prisoners has apparently stymied recent Food and

Drug Administration efforts to finalize its regulations on such research.

Additional questions may be raised about how

human subjects are used in social science research.

Quite a bit of controversy arose in the 1960s and

1970s over deception that occurred in such research. Because they used stooges or engaged in

covert observation of unsuspecting people, some

social scientists appeared to be using “dubious

means to achieve questionable ends. ” The researchers insisted that deception was only used

to advance human understanding and thus was

beneficial to human welfare, that it helped in the

study of “underdog” social groups such as homosexuals, and that deception in research—just as

deception in muckraking journalism–could help

to expose the unethical conduct of the power elite.

Critics argued that any study that involved the

violation of moral norms could not advance the

human welfare, that “a chain of lies was not

morally justified, “36 and that no gain could offset the magnitude of potential discomfort to the

subject .37

The tremendous acceleration of medical research—e.g., in immunology, genetics, and biomedical engineering-has created new controversies for those fields. Many medical researchers

“Donald P. Warwick, “Social Scientists Ought to Stop Lying, ”

Psychology Today, February 1975, pp. 38-40, 105-106.

‘“See Tom L. Beauchamp, et al. (eds. ) Ethical Zssues in Social

Scjence Research (Baltimore, MD: The Johns Hopkins University

Press, 1982).

would like to use new techniques or technologies

on patients before they have been fully tested.

They believe that if a procedure could help a patient, then they have a responsibility to try it, even

if they are not sure it will work. Others believe

that the physician’s responsibility is to be certain

that a technique will result in some benefit. The

conflict between these two perspectives raises such

questions as: Who is or is not an experimental subject? What are the justifications for delay in using

a new technique? Ethicist Thomas Murray has

pointed out, in discussion of the “Baby Fae” baboon heart transplant, that even in a desperate

therapeutic situation, certain rules should be followed. He suggests that four questions should be

asked before an experimental treatment is used:

Is the scientific background right? Is the next experimental subject naturally a human being? Is

there no superior alternate therapy available? And

can the researcher get truly informed consent—

or informed consent from a guardian or parent?38

Similar questions are being raised for the use

of human somatic-cell gene therapy39 when opponents ask whether such research is playing with

the very essence of humanness, or when animal

rights groups object to the use of primates as a

substitute for human experimental subjects .40

Those arguing for proceeding with the research

cite the potential benefit to existing patients. The

“bottom line” for that debate—as with many

others—has become, as Alexander Capron has

writ ten, “when may a society, actively or by acquiescence, expose some of its members to harm

in order to seek benefits for them, for others, or

for society as a whole?”41 In some other contexts,

society has already answered Capron’s question

by putting some people in jeopardy to protect the

whole population. We select firemen and members of the military forces, sometimes by conscription, sometimes by lottery, sometimes by offering incentives. We have also used some of these

‘8’’The MacNeil ‘Lehrer News Hour: The Baby Fae Case, ” transcript 42385, Thirteen, Nov. 16, 1984, pp. 1-9.

3’See “Points to Consider in the Design and Submission of Human Somatic-Cell Gene Therapy Protocols, ” prepared by the Working Grc}up on Human Gene Therapy of the NIH, Ftderal Register,

vol. 50, No. 14, Jan. 22, 1985.

40Jud[th A. Johnson, “Human Gene Therapy, Updated 10/30 /84,”

Library of Congress, Congressional Research Service, Science Policy Research Division, Apr. 3, 1984.

i Ical)ron, op. cit. I P. 4‘
41

—

means—incentives and lotteries—to select subjects

for experiments .42

In the debates over experimentation on fetuses

(either still in the womb or newly aborted or miscarried), the emotionally charged issue of abortion—as a potential “source” of fetuses or fetal

tissue—has often been the implicit or explicit justification for controls. (See ch. 4 for discussion

of specific regulations on use of fetuses. ) Similar

debates are now raging in England. ’3

On occasion, objections to research have focused on accusations that a city or special population might be “experimented on. ” Concern that

research might jeopardize the health and safety

of the general public was, for example, expressed

during the 1970s’ recombinant DNA controversy

in Cambridge, Massachusetts (see ch. 7).44 The

argument was not that such research was intrinsically “bad” or that it might not result in positive gains for society, The argument was that the

safety of the research procedures was untested and

the consequences of an accident —even if only remotely possible—were potentially so negative that

the community might be unwilling to risk any

mistake. In such cases, until the procedures can

be proved to be reliable, the public and the legislative bodies have acted to suspend research temporarily—until public study and debate can take

place. The Catch-22 in this scenario is often that

the procedures cannot be proven to be safe without trying them in some way.

To Protect Animals Used

in Experimentation

The first attempts at social regulation to protect the welfare of animals (to obtain legal protection for members of nonhuman species) date

to 19th-century England, although social concern—in the form of cultural reverence for some

animals, and/or repulsion at cruel treatment of

animals—may be found in many countries for

hundreds of years.45

The controversy over the experimental use of

animals is characterized by certainty of moral position on both sides. Thomas H. Moss of Case

Western Reserve University observes that:

. . . those who are convinced that laboratory animals are cruelly or unnecessarily used have often

characterized the scientific establishment as insensitive to animal pain, and lacking in basic compassion toward living creatures. Those who are

convinced that animal experiments are natural

and appropriate tools to serve the advancement

of science . . . have often characterized the animal welfare movement as irrational and as blindly

myopic in the sense of moral outrage at animal

suffering but lack of recognition of human health

needs .46

In its attempt to abolish totally the use of animals

in experiments, the animal liberation movement

is saying:

. . . that animals and humans have similar interests . . , those interests are to be counted equally,

with no automatic discount just because one of

the beings is not human.

This argument extends to such similarities as

avoiding physical pain.47

The justifications for the various positions are

based on a number of philosophical arguments

related to perceptions of the appropriate relationship between humans and animals. Members of

the animal rights community believe that animals

possess a consciousness and certain attributes—

e.g., symbolic communication, self-awareness,

and anticipation of future events—which imbue

animals with rights as exercised by humans. They

see the animal rights movement as the progeny

of the “humanitarian” movement, as the logical

successor to the civil rights movement and the

feminist movement. In comparison, the animal

welfare movement, which includes some animal

“Dael Wolile, Emeritus Professor, Graduate School of Public Affairs, University of \4rashington, personal communciation, 1985.

~ 3See ~~ar~, ~j’arnoc~, A @estjon of life: The Warnock Report

on Human F’ertilizat~on and Embr}~ologJ (New York: Basil Blachwell, Inc., 1~851.

“Sheldon Krimsky, Genetic Alchemy: The Social History of the

Recombinant D,\rA Controversy (Cambridge, MA: The MIT Press,

19821.

“Harriet Ritvo, “PIus a Change: Anti-\ ’i\’isection Then and

~

Now, ” Science, Technology, & Human l~alues, VOI. ~, spring 1Q84,

pp. 57-66.

“Thomas H, hloss, “The Nlodern Politics of Laboratory Animal

Use, ” Science, Technology?’, & Human \’a/ues, vo]. ~, spring 1~84,

pp. 51-56.

“Peter Singer (cd. J, In Defense of Animals (New York: Basil Blackwell, Inc., 1~8.5 }, p. ~.
4 2

researchers, believes that as humans, in the words

of Arthur Caplan, we hold a certain “moral stewardship” over animals, which requires that we

treat them with respect even in the service of humans. The concept of moral stewardship infuses

a spectrum of regulatory activity, ranging from

outright bans on the use of certain animals (or

of any animal in certain types of research) to National Institutes of Health regulations governing

the treatment, handling, and use of animals in laboratories. (See ch. 4). *

To Protect the Environment

If research involves the use of toxic chemicals

or biological materials known or suspected of

causing some adverse effect on the environment

by altering the natural composition of air, water,

or soil, or by destroying or altering the ecologi-

‘Concern about this issue has also lead to a National Academy

of Sciences study of the numbers of animals used in the United States

in research and testing and to an OTA report on Alternatives tO

Animal Use in Research, Testing, and Education, OTA-BA-273, January 1986,

cal balance, then regulation of the research process may be implemented with the specific intention of protecting the environment.

The dangers in the introduction of new plant

or animal species or new genetic forms have been

obvious for decades in the destruction caused by,

for example, the introduction of such nonnative

species as kudzu vine and gypsy moths. Comparison of the effect of a current line of research to

the past adverse effects of nondeliberate alterations of the balance between species or environments forms the basis of many attempts to regulate research on environmental grounds .48 Because

it is virtually impossible to design tests to predict

the ecological risk from a nonnative species, these

concerns have been raised again and again and

have now reached the courts via legal action to

prevent agricultural research involving deliberate

release of genetically engineered bacteria.

48see fc)r examp]e, Winston J. Brill, “Safety Concerns and Genetic

Engineering in Agriculture, ” Science, vol. 227, Jan. 25, 1985, pp.

381-384.

REGULATION OF THE DISSEMINATION OF

SCIENTIFIC KNOWLEDGE

Open communication, through such things as

publications, symposia, and face-to-face meetings,

has always been an essential aspect of scientific

endeavor. Unrestricted interaction sets forth a

framework within which peer review, criticism,

and data sharing can occur; it provides the arena

for cross-fertilization of ideas, and helps avoid

duplication of effort .49 As the American Association for the Advancement of Science, Committee on Science in Promotion of Human Welfare,

stated in a 1965 report:

Each separate study of nature yields an approximate result and inevitably contains some errors

and omissions. Science gets at the truth by a continuous process of self-examination which remedies omissions and corrects errors. The process

requires free disclosure of results, general dissemination of findings, interpretations, conclusions,

~~NATO Science Committee, “open Communication in Science,

NATO Science & S<xiety, 1983.

and widespread verification and criticism of results and conclusions. 50

Because openness in science also encourages uninhibited dissemination of results outside of the

laboratory, the justifications for restraining such

communication center primarily around the potential effect of the information, the information’s

“value” (economic or otherwise), and who is perceived to “own” the information (e. g., the scientist or the organization that supported the scientist’s work).

Regulation of scientific communication is far

from simply a process of stamping a label on a

document, however; it involves restraints or controls on, for example: 1) who may know certain

‘“Harold C. Relyea, “Shrouding the Endless Frontier—Scientific

Communication and National Security: The Search for Balance, ”

Striking a Balance: National Security and Scientific Freedom, Harold

C, Relyea (cd. ) (Washington, DC: American Association for the

Advancement of Science, 1985), p. 76.
scientific data or information, 2) the dissemination of printed documents, 3) who has access to

an electronic communication system, 4) descriptions of processes or computer programs, and 5)

even who may share or receive certain cell lines

or biological strains. 5

1 Physicist Lee Grodzins has

pointed out that the appropriate point of classification often may not be a specific formula or instruction but the knowledge that a result can be

accomplished, for “once it is disclosed that something can be done, then someone will be able to

duplicate it. ”52 Joan Bromberg, a historian of

science, adds that “keeping secret that a research

program exists is one way to hold the edge in a

field, ” because such “revelations also give hints

at the correct direction for research.”53

Because of the differing values of the groups

involved in the communication of science, the information developed during research frequently

becomes the object of dispute or tension between

those who sponsor and those who conduct research. In general, this tension derives from conflicting desires to disseminate and to restrict

access to information, As each actor defines differently the areas of restriction, then the tension

grows.

This tension is particularly apparent in contemporary restraints on communications relating to

national security and commercial property rights

in such things as biological materials. In these

cases, a lack of consensus on boundary definitions

has resulted in increasingly large “gray areas” of

information perceived as possible candidates for

restriction in the future. The more that military

systems depend on advanced technology-including such things as large-scale integrated circuitry,

space technology, and microbiology54—the more

that basic research appears to have the potential

for military importance. For technology related

to international industrial competition, similar uncertainty about what may prove to be important

in the future has stimulated restrictions on the

“1’atrick D, Kelley and Ernest G. Jaworski, “Agreements Covering Exchanges 0[ Biological Materials, ” American Association for

the Advancement of Science, annual meeting, New York, May 1Q84.

““Openne\s and $ecrcc} in Scientific and Technical Communication, Sernlnar, [Xc, ] 1, I Q84, hlassachusetts Institute (}[ Technolo~}’, Cam bnd~c NIA

‘ ‘Ibid.

“NATC) Science C(~mmittcw, op. cit.

43

sharing of information with citizens of other countries and on the freedom of industrial scientists

or industry-supported university professors to

converse openly with their colleagues about their

work,

Four main rationales may underpin actions to

restrict communication:

to uphold scientific standards;

to protect a professional or economic interest;

to protect the health, privacy, or safety of

individuals; and

to protect national military and economic

security.

Uphold Scientific Standards

Within science, both traditions and good laboratory practice govern the flow of dissemination

of research results—who can communicate, who

will receive communications, and when and where

communication takes place. A junior member of

a research team may be restricted from discussing his or her own original work until the team’s

publication is ready, or scientists in one laboratory group may refrain from discussing their work

with colleagues elsewhere in the organization or

with journalists until a writeup is submitted to a

scientific journal. The ultimate justification for

most such controls—whether reinforced by laboratory “rules” or by the pressure of tradition—

is to uphold scientific standards, to assure that

only verifiable and replicable science is presented

as legitimate science.

The peer review system in scientific journals,

for example, seeks to filter out reports of scientific work that do not meet the highest standards

of research in the field, Readers must be able to

accept publication confidently as a seal of legitimacy and accuracy, thereby allowing them to

trust the author’s conclusions without replicating

the experiment or redoing the research. In theory,

the norms of good scientific practice justify acceptance or rejection of communications; in practice,

the current agenda and occasionally the biases of

the research field may determine which topics are

favored as well as which determine the mode of

presentation.
4 4

The goal of preserving the quality and integrity

of science, and the goal of protecting the public

are both used to justify an unusual but effective

restriction on the timing and, in a few cases, the

actual publication of articles in medicine. In 1969,

Franz J. Ingelfinger, editor of The New England

Journal of Medicine, began to worry that premature disclosure of unevaluated and unauthenticated medical research results before they were

published in a peer-reviewed medical journal (and

hence presumed to be evaluated and authenticated) could be dangerous to the public. He argued that such reports might contribute to false

expectations of unevaluated drugs or treatments

or, on occasion, might advocate treatments later

found to be useless or potentially harmful.55 Ingelfinger therefore instituted an editorial policy

that denied publication to an article if its conclusions or major data had appeared in a medical

news publication or similar unrefereed format.

This rule has been continued and reinforced by

the Joumal’s subsequent editor,56 and similar practices are followed by editors at other journals.

To Protect a Professional

or Economic Interest

Scientists have always exercised a form of selfregulation in publication in order to achieve personal or professional rewards. Timing and placement of publication, for example, can significantly

affect a scientist’s career success.

Protecting an economic advantage has also long

been accepted as a legitimate motive for communications restraint in commercial circles; businesses control publication to protect their economic rights in the material, to make a profit, or

to avoid a loss. Examples of such motivations for

restrictions may be the protection of patent rights,

the maintenance of competitive advantage, or the

protection of rights in biological materials.57 Industry, in fact, has cited the ability to protect in55 Barbara J. Culliton, “Dual Publication: ‘Ingelfinger Rule’ Debated by Scientists and Press, ” Scienm, VO]. 176, June 30, 1972, pp.

1403-1405,

s~Arno]d S. Relman, “The Ingelfinger Rule, ” The New England

journal of Medicine, vol. 305, 1981, pp. 824-826.

SYKelley and Jaworski, oP. cit.

tellectual property as a major determinant of

success:

There is a direct correlation between the security of patent rights and industry’s willingness to

commit large sums to the inherently risky efforts

needed to find and develop new technologies .58

In industrial research, the sponsor wants to protect the proprietary nature of the research and

may not want competitors to have access to the

information resulting from the sponsored research. This justification for secrecy now extends

widely as more and more universities enter into

research agreements with industrial sponsors. The

institutions’ naturally opposing views about the

value of information are often a subject of negotiation in university-industry relations, where the

traditional openness of the university could act

against the commercial interests. Most frequently,

the resolution is a contract provision that allows

a prespecified delay of publication in order to permit the sponsor to file a patent application. Some

university research projects will submit to a delay to allow an industrial sponsor to review a document for proprietary data.

A desire to secure or protect certain legal rights

of the generator or sponsor of the research may

also motivate restrictions. With respect to new

products or processes developed during research,

three outcomes are possible: it may be kept secret;

it may enter the public domain; or it may be

granted a patent. The patent laws grant an exclusive right, for a fixed period of time, to commercial exploitation of an innovative product or

process to the person who discloses the invention

to the U.S. Patent Office. Data or analyses collected during research may also receive protection via the copyright laws, which prevent plagiarism. The first U.S. regulation concerning the

use of research results was, in fact, stated in the

patent and copyright clause of the Constitution.59

Premature disclosure of patentable information

could endanger the legal rights of the inventor and

Se Alexander MacLachlan, testimony before the U.S. Congress,

Science Policy Task Force, House Committee on Science and Technology, Apr. 25, 1985.

S~Haro]d Relyea, Congressional Research service, personal communicat~on, 1985.
4 5

therefore restriction is chosen. In other cases, disclosure might be used to establish some such right.

An organization may take action to impede dissemination (or to hasten dissemination) in order

to preserve a corporate image or administrative

power. Similar action might be taken to support

the mission of a government agency. In a few reported cases, businesses have acted to impede the

dissemination of scientific data in order to protect the company’s legal position or to avoid adverse publicity. When studies of the toxic effects

of vinyl chloride on rats revealed cancer, one Italian researcher, for example, found that his industrial sponsor refused to let the evidence be released. It was some time after that suppression

occurred that cancers were found in workers in

the United States who had been exposed to vinyl

chloride. 60

To Protect the Health, Privacy,

or Safety of Individuals

Federal regulations as well as informal controls

on the publication of data from human subjects

research often seek to control dissemination in order to protect the privacy or safety of individuals

described in the reports, or to protect subjects who

participate in research on controversial topics or

illegal activity.”]

Some research information may have the potential of harm to the public welfare either because

of what is said or when it is said. In those cases,

dissemination is regulated (delayed or prohibited)

to protect the public health and safety. Announcements pertaining to some real or potential public

health problems could cause panic, and so restraint is used in the dissemination or publicity

prior to publication—a justification that has been

used for restricting communication of data on possible modes of transmittal of acquired immunodeficiency syndrome (AIDS). Dissemination of a

result may also be delayed or controlled to prevent a potential adverse economic, social, or political reaction. This justification is used to avoid

‘“John T. Edsall, “Scientific Freedom and Responsibility: Report

of the AAAS C<>mm ittee on Scient i tic Freedom and Responsibility, ” .%lence, vo], 188, .May 16, 1975, pp. 687-693, and \rol, 18Q,

July 18, 1~75, pp. 174-175.

“’Barr~’ Barnes, ;I’ho Shouid Knon’ ;l’h~t: Social Science, Pri\’ac>

and Ethics ( Cambridge, England: Cambridge University Press, 1979),

the panic or devaluation of property that might

follow publication of an earthquake prediction for

a specific area. The “Paigen” report, which analyzed the alleged health effects of the chemicals

dumped at Love Canal, was later criticized by a

panel of scientists for improper epidemiologic

methods that “fueled rather than resolved public

anxiety. “62 One of the most important questions

raised in such situations is how, in the face of great

scientific uncertainty, adverse economic effects

should be weighed against possible health risks

to individuals or the general public.

Opponents of such restrictions argue that they

inhibit free discussion in a democracy. The American public has a right to be told the technical information, even if the public policy decisions are

ultimately based on normative rather than technical grounds. In the laser isotope separation case

discussed earlier in this chapter, the argument was

made that severe classification of such research

might not, in the long run, prevent dissemination

of the scientific “trick” or secret of the laser isotope separation process to other countries, but

that it could discourage public discussion in the

United States on whether the work should continue. The “lid of secrecy” would “effectively preclude public scrutiny, ” one observer wrote.63

To Protect National Military

and Economic Security

Protection of national security has been used

for centuries as a justification for government regulation of technical information.64 During World

War II, American scientists and engineers accepted

two kinds of censorship or control of communications—voluntary (justified in the spirit of patriotism) and mandatory. Scientific journal editors

practiced extensive voluntary censorship during

the war—they believed that some type of censorship was necessary to prevent the leakage of

vital information to U.S. enemies.65 Scientific pub-

*’Lewis Regenstein, America the Poisoned (Washin~t(~n, DC:

Acropolis Books Ltd., 1982), p. 140.

* ~Casper, “Lasa Enrichment, ” op. cit., p. 38.

“Relyea, “Shrouding the Endless Frontier, ” op. cit., p. 80.

“hllchael Ivl, Sokal, “Restrictions on Scientific Publication, ”

Science, ~’o]. 215, hlar. 5, 1982, p. 1182; and Michael M. Sokal and

Janice F. Goldblum, ‘From the Archives, ” Science, Techno]og}, &

Human I’a]ues. ~’o]. 10, spring 1~85, pp. 24-27,
46

lications of all types were also subject to mandatory review by the Office of Censorship. And

scientists engaged in weapons research were, of

course, subject to the military’s restraints and controls on all their activities, including conversations

as well as written communications. In peacetime,

however, the “conflicting imperatives of national

security and open scientific communication” have

occasionally led to controversy and legal action

and are continually the subject of vigorous debate.” The tension between these two objectives

arises primarily in a clash between the justifications for restraint and openness. The government

wants to control all information that could be of

possible value to potential enemy states; the scientists stress that such measures could damage scientific progress and creativity and abridge traditional scientific freedom. ’7

The motives for restrictions justified by national

security can be both economic and military.

Often, the restriction is indicative of whether the

research has demonstrated application. * Although

“national security” is vaguely defined in the law

and the uses of the term range from “defense of

the United States” and “public peace and safety”

to “financial policies of the United States, ” there

is agreement among policy analysts that that policy concept does provide to the President a broad

grant of administrative discretion to justify all

sorts of policies.

Recently, the justifications for communications

restraints based on national security considerations have tended to relate to quite specific perceptions about the importance of science in an international context. First, those who believe that

the United States’ lead over the Soviet Union in

some important areas of military technologies is

diminishing attribute that situation to Soviet absorption of U.S. technologies. Second, the military systems themselves have become more dependent on sophisticated new technologies and

on the science that feeds them. Third, proponents

“Richard D. DeLauer, “Scientific Communication and National

Security, ” science, vol. 226, Oct. 5, 1984, p. 9.

“NATO Science Committee, op. cit.

*,, know-how is a precious commodity . . . leading to the commercial or military products that determine the fortunes of nations

in peace and in war. Yet sometimes it is hard to tell where scientific

knowledge leaves off and engineering know-how begins. ” DeLauer,

op. cit.

of restrictions believe that a steadily increasing

share of these technologies is dual-use in nature,

that is, that they can have both military and nonmilitary applications. ’a And fourth, such national

policies as East-West detente and scientific exchanges with the Chinese are perceived to have

increased the opportunities for leakage of technical information of all types. Such rationales

were clearly stated in the draft “National Policy

on the Transfer of Scientific and Technical Information, “ issued by the executive branch on June

15, 1984:

The acquisition of advanced technology from

the United States by Eastern Bloc nations for the

purpose of enhancing their military capabilities

poses a significant threat to our national security.

Intelligence studies indicate that a small but significant target of the Eastern Bloc intelligence

gathering effort is science and engineering research

performed at universities and federal laboratories.

At the same time, our leadership position in science and technology is an essential element in our

economic and physical security. The strength of

American science requires a research environment

conducive to creativity, an environment in which

the free exchange of ideas is a vital component .69

The government has recently justified the application of export control regulations to basic research as necessary to protect: 1) tangible goods,

including technical data, that relate to national

security; and 2) the domestic economy. The application limits “information of any kind that can

be used or adapted for use, in the design, production, manufacture, utilization, or reconstruction

of articles or materials.”70

The ensuing controversy over the wide-scale

application of these controls has led to a reaffirmation by the Department of Defense/University

Forum that: “No restriction may be placed upon

the conduct or reporting of fundamental research

that has not received national security classification.“ However, how the various participants in

such restrictions define what is or is not funbsPZ,nel ~jn Scientific Commmication and National Security ~’ommittec on Science, Engineering, and Public Po] icy, Scientific Communication andlVational Security (Washington, DC: National Academy Press, 1982), p, 11.

69U S. Congress, “Scientific Communication and National Security, ” hearings before the House Committee on Science and Technology, May 25, 1984.

7015 CFR 379. 1.a.
4 7

damental research can determine the extent of restriction. This window of uncertainty prompted

the Department of Defense (DOD) to state its definition of “fundamental research”:

For DOD purposes the decision whether a particular research activity is or is not fundamental

will be determined primarily by considering the

following easily identified characteristics: 1) performer (for example, university, industry, inhouse) 2) budget category (for example, 6.1, 6.2)

3) sponsoring DOD entity 4) special contract provisions. . . Unclassified contract research supported by 6.1 funding shall be considered ‘fundamental. Similarly, unclassified research

performed on campus at a university and supported by 6.2 funding shall with rare exceptions

be considered ‘fundamental.’71

In the disputes over restrictions on scientific

communication, DOD sees itself as “caught in a

dilemma. ” In the words of the Defense Science

Board:

If it vigorousl y attempts to regulate the flow

of scientific information in the scientific community, it could jeopardize the strength and vitality

of the very community it is seeking to revitalize

for the sake of national defense. On the other

“’I.e(l }’(lung, “( t~mrnentary The C(~ntr~>l of Government-Sponw~rcd Tec hn ica 1 I nt or ma ti on, Scienm, Technology >,, & Human \’alues, vol. 10, spr]n~ 1Q85, pp 82-80 .

SUMMARY

In 1979, Miller, Prewitt, and Pearson conducted

a public opinion poll for the National Science

Foundation in which they asked respondents

about specific types of scientific studies and

whether scientists should be “allowed” to conduct

those studies. Because the structure of the poll

questions implied regulation, the response can be

interpreted as one measure of the public’s willingness to restrain certain types of scientific inquiry. 75 The results indicate that a majority of the

respondents would have liked to prohibit research

dealing with the creation of new life forms and

with the gender of children, Opposition to genetic

“ion 11 Nllller, et J]., The Attitudes of the 11, S, Public To;\ard

Science and Ttt-hno)og},” ( ~f’ashln~ton, DC: Nat]ona] Science Fc~undation, 1 Q80 ), alw} J{~n D !vliller, The ,4nwrican People and Science

/’()/ic}, ( ~cw }’orh [)erg~m[,n I’ress, 1 Q83 ).

hand, if DOD abandons any attempt at regulation in the university context, it could seriously

compromise and, in certain cases, totally undercut other efforts to control the out-flow of militarily critical technology. The middle ground is a difficult one to establish. ”

The Corson panel of the National Academy of

Sciences, fearful that the government policy could

begin to endorse a form of “blanket justification”

for restricting some fields of basic research, attempted to clarify the limits of acceptable restraints. The Corson panel’s report73 stated that

communication restrictions should not be applied

to any area of university research, be it basic or

applied, unless they involve a technology meeting all the following criteria:

The technology is developing rapidly, and the

time from basic science to application is short;

The technology has identifiable direct military applications; or it is dual-use and involves process

or production-related techniques; Transfer of the

technology would give the U.S.S.R a significant

near-term military benefit; and the U.S. is the

only source of information about the technology,

or other friendly nations that could also be the

source have control systems as secure as ours.74

71 Report (~t the Detense Science Board Task F(>rce In Universit\r

Responsiveness t[> National Security I{equirements, )anuary 1982.

‘~[>anel On Sclentlflc COmmunicatlon, (~p. c]t,

‘i[bid,

engineering declined some when the question specified plants and animals rather than humans, but

there was still substantial disapproval of scientific

research in this area. In contrast, only one-quarter

of the population expressed opposition to studies that would involve weather modification or

the extension of the average human life span.

Such data tend to indicate that Americans, in

deciding whether research should be restricted or

prohibited, may make such decisions based on

whether they believe that the restriction would

respond to moral or social objections. The results

may also indicate that the public is more likely

to approve regulation for reasons relating to the

immediate protection of human health or safety

or to preservation of the moral order than for rea-
4 8

sons relating to potential long-term damage of the

environment or depletion of economic resources.

Although most Americans believe that the government has some control over the work of scientists, the public does not appear to be willing to

endorse more direct public control. A 1983 Annenberg study asked whether the government presently has any control over “what scientists do”

and 77 percent of the respondents indicated that

they thought that the government did have that

kind of control. ” When asked if the government

“should” have control over what scientists do, 67

percent of the public agreed that this kind of control was appropriate. In a 1979 study, respondents were asked whether “most citizens are well

enough informed” to help set goals for scientific

research or to decide which new technologies

should be developed .77 Approximately 85 percent

of the public indicated that they did not feel that

most citizens had the knowledge needed either to

set research goals or to select technologies.78 Contradictory evidence of such willingness to participate was found, however, in a pilot study conducted in 1979 by the Public Agenda Foundation,

which concluded that public participation in decisionmaking can extend to priority-setting based

7bMiller, The American People and Science Policy, op. cit.

7“Miller, et al., op. cit.

781bid.

on limiting or restraining certain areas of research .79

Available public opinion data suggest that the

public is not unwilling, based on a number of rationales, to restrict the scope of scientific inquiry,

especially in the area of human health and safety

such as genetic engineering. The data also suggest that a larger portion of the public would be

comfortable with the genetic modification of

plants and animals, but that there is substantial

concern about work involving changes in the human genetic structure. Other evidence, such as increased demonstrations, publicity, and legislative

initiatives, indicates that, in the eyes of the general public, some regulation of experimentation

on animals is supported.

It is possible that because the public appears

to place such high value on science’s contribution

to human health and to quality of life, and because usefulness and application play such a significant role in the public’s evaluation of scientific priorities, a willingness to regulate may

indicate that, in such instances, the perceived risk

is believed to outweigh perceived benefit, even

though there may be inadequate evidence to supTqpllbllc Agenda Fo~&tion, Scienm Poiicy Pn”on’ties and the pu~-

lic, a report to the National Science Foundation on a Pilot Project

to AS:CSS Public Attitudes About Priorities and Indicators of Quality for Scientific Research, New York, 1983.
Chapter 4

The Mechanisms for Direct

Control of Research
Chapter 4

The Mechanisms for Direct

Control of Research

At the laboratory bench level, each researcher

controls his or her own activities, deciding which

questions to answer and how to go about answering them. Controls are also part of the normal

procedures of a research field or discipline—for

example, the peer review system that governs the

contents of disciplinary journals. Other, more formal control takes place at the laboratory or institutional level, through set policies or such mechanisms as review committees. And finally, legal

and administrative regulation of research occurs

at all levels of government, most likely in response

to public opinion or public protest. This chapter

looks at the administrative mechanisms for control or influence at all stages of the research

process.

In an idealized model of scientific freedom, a

scientist sets his or her own research agenda, performs the research without fear of repercussion

or criticism, and describes the work to anyone and

everyone. Sissela Bok characterizes such freedom

as “freedom of limitless thought and unfettered

speech. “I For scientists in some fields, that freedom has traditionally been perceived to encompass autonomy of action as well as responsibility for how the work is conducted. Biologist

David Baltimore observes that contemporary research in molecular biology, for example:

. . . has grown up in an era of almost complete

permissiveness. Its practitioners have been allowed

to decide their own priorities and have met with

virtually no restraints on the types of work they

can do. z

In many research facilities and in many laboratories, open communication has been routine,

IS]\sela Bok, “Freedom and RIsL, ‘ l.{mifs of Scientltic lnqu)rj,

Gerald Ht)lt[)n and R[]bet-t 5 ~loris(~n leds ) INe\v }’c~rk. \$’ \lr N~~rt(~n & Cc) 1~7~ ~, p 110

‘David Baltimore, “A Biologist’s Perspective, ” Limits of Scientif~c inquiry, Gerald Holton and Robert S, Morlson (eds, ) (New

York: W,W. Norton & Co., 1979), p. 37,

Zoologist Alexander Faberge describes the “open

traditions” in one field:3

Not only is it normal to discuss one’s ongoing

research, but also to give away one’s research

material in the form of genetic stocks, with the

verbal understanding that the giver should be

given time to publish first. Such genetic stocks,

or cultures of organisms, sometimes take years

of work to prepare, and are placed in culture collections, freely available.

“It would bean unheard of matter, ”Faberge continues “to keep genetic stocks private . . .“ These

and similar aspects of the sharing of research data

are discussed in a 1985 report from the National

Academy of Sciences (NAS) which notes that, in

general, access helps in reanalysis and verification. 4 In fast-moving areas, the sharing of research

data may jeopardize a researcher’s patent rights

or the commercial return on a discovery, so there

are significant forces against openness. Nevertheless, the NAS committee concluded that without

data sharing, scientific understanding and progress would be impeded.

Even in early modern science, however, communication of ideas was not totally open. Inventors delayed or repressed publication out of fear

of ecclesiastical or political displeasure. Because

the community of science rewards priority, researchers have also delayed sharing data until

credit is assured, usually through publication. Historian David Hull attributes such secretiveness to

science’s “intrinsic competitive nature.”5 Technological skills and knowledge regarded as applied

have not always been tightly controlled by their

possessors; skills were assumed to be the prop-

‘A]exander C, Faberge~ “ Thoughts on the Clrlglns C}I Secrec } and

Openness in Science, ” American As%lclat](~n t or the Adiranccmcnt

ot Science, annual meeting, New York C i t}’, Nla}’ 1484.

‘National Academ}r ot Sciences, Committee on Nat]ona] Stat]+

t]cs, .$h.]rinX l{ew~r~h Data (llrashlngtt~n, DC National Acaclem}r

I)ress, 1Q851

‘Ila~’]d Hull, “Openness and Sccrec} in Sc]ence: Their Ori~ins

and I.irnitat ions, ” Science Techno/og~,,” & Human \ ‘alues, v[~]. 10,

~pring 1Q85, pp. 8-0

51
52

—

erty of those who exercised and developed them.6

Although unqualified sharing (especially before

publication) has never been the norm, until several decades ago, scientists exercised relatively few

restraints on their communications to others.

Contemporary attitudes to openness in university science are also influenced by the concept of

academic freedom in general. In the United States,

“academic freedom” has stood for personal freedom of the academic, rather than the collective

freedom of the Nation. Because of this emphasis

on the individual, some academics have regarded

regulation more as a limit to which they are

obliged to submit. Limits have been, therefore,

equated with “responsibilities.”7 But, Walter Metzger points out, “academic freedom and scientific

freedom are different species of freedom. . . .“8

The former is an ideology of a profession, across

the disciplines, with common duties; the latter is

the ideology of various professions in a discipline

(e.g., science). And the latter need not be connected to a university.

Historian Carroll Pursell takes a more pragmatic view. Science, he observes, is always “regulated” in the sense that it is given shape, direction, and impetus by something. There is, he

writes, “a tendency to take it simply as the working of some invisible hand until the public (in the

form of government, mobs, or whatever) takes

a more visible hand. This is, of course, nonsense.”9 Communities have, for example, never

tolerated (for very long) any researcher who

tackles topics outside the boundaries of accepted

moral behavior or social beliefs or who knowingly

OErnan Nlchfullln, “Openness and Secrecy In Science: S(>me Notes

on Early Hist(>ry, ” Science, TechniJ/(]~}’, & }fuman I’alues, ~r(~l. 10,

spring 1985, pp. 14-23,

‘Walter 1’, Metzger, “Academic Freedom and Scientific Freedom, ”

Limits of Scientific inquiry, Gerald Holton and Robert S. Morison

(eds. ) (New York: W.W. Norton & Co., 1979), p. 102.

‘Ibid , p. 107.

‘Carr[]ll I’ursell, [Department ~~t History, Universit} (lf Call[~~rnia, Santa Barb,] ra, perw}nal c (~m mu nlcat i [>n, 1 Q85.

puts the community at risk through hazardous,

dangerous procedures (e.g., experimenting with

explosives in Times Square). Such “moral regulations’’--enforced through social condemnation

or disapproval—have been the predominant controls on research for centuries, other than those

which arose in connection with military research.

Neither Federal nor local governments in the

United States had formal laws, rules, or policies

by which the subjects or procedures could be controlled.

This environment changed for American scientists in the 1940s. When the United States entered

World War II, the scientific community joined in

the war effort and, just like millions of other people, scientists relinquished to the Government

their personal autonomy over how they did their

work. They accepted government control over

agenda, over process, and—in the case of information considered to be of military importance—

over dissemination even to their colleagues. When

almost everyone in science was working behind

the secrecy fence, the communications restrictions

did not seem so onerous. There was a comraderie

and free exchange that participants recall as frequently greater than in the structure of university departments. Within the Manhattan Project,

for example, Robert Oppenheimer successfully

convinced General Leslie Groves not to implement

irrevocable application of “compartmentalization. ” Groves wanted to keep scientists from sharing information with their colleagues in other

parts of the project; Oppenheimer argued that

some decompartmentalization was necessary for

progress at both the laboratory and the individual level. The perspective argued by Oppenheimer

was that the scientists were the best judge of how

to get to their goal. He also believed that the creative scientist required intellectual “elbow room”

for the cross-fertilization that could be vital in a

new field. Each individual had to feel free to pursue research whatever way he or she wished.
53

MECHANISMS FOR INDIVIDUAL OR RESEARCH GROUP CONTROL

At the level of individual choice, then, researchers in a democratic system decide what line of research to pursue, how to test their hypotheses,

which data to gather and how to gather it, and

when and to whom to tell about their results. The

scientists simply seize on personal freedoms available to all citizens.

The amateur astronomer provides an excellent

example of how little externally imposed controls

can affect a researcher who is working outside

conventional institutional settings for research,

academic or otherwise. There are approximately

10,000 amateur astronomers in the United States,

many of them engaged in the search for new astronomical bodies, or in recording astronomical

phenomena. Almost all work at their own expense, in return for the reward of discovery, the

joy of creative activity. Such an individual can

decide what to do, can build his or her own equipment according to any schedule, and can elect to

tell everyone or no one* about the results. To

achieve recognition and acceptance by the community of professional astronomers, however, a

researcher must adhere to the standards and

norms that govern conduct in the field and must

subject that work to review by colleagues, usually through the journal peer review system.

Agenda Controls

In research groups, internal factors may not

only direct but also constrain research. At any

given point in the development of a scientific

speciality, for example, there exists some finite set

of research topics that are considered by the members of the speciality to be legitimate, interesting,

and feasible.10 If peers do not consider an area

to contain “interesting” questions and hence to be

intellectually stimulating or professionally rewarding, then researchers may suspend research out

of concern for their professional reputations. Influence on the researchers to control or restrain

their own work may also come from the social

environment, as when the public raises questions

about the morality of a project. Other research

topics may receive little attention and no funding because peers consider them to be outside the

boundaries of “legitimate” science; research on

parapsychology often falls into this category, Researchers working on new chemicals for introduction into commerce or on new pesticide formulations may tend to shape their investigations so that

the chemical will withstand scrutiny and secure

approval under such Federal environmental regulations as the Toxic Substances Control Act or

the Federal pesticide laws.

The cost of instrumentation and the internal allocation of resources can be devices for dramatically controlling the research agenda. The major

experimental facilities for high energy particle

physics research, for example, are few in number

and because the demand for time on the accelerators far exceeds the time available, laboratories

‘ ‘Darvl E. Chubin and Terence C(lnn(}ll} Rcwarc h Trail\ and

Science I’(~llcies: Local and ~xtr.~-l.(~ca] Nc~L~t iatl(~n (}i SC ltntlt IL

\\’ork, Scientific ~Sfdb/l\hl?lf’rI~\ .Ind }firrar( hit’s .S[l( J()/()g~ ()/ th(

Sciences I.TC)] b, Norbert Ella+, et al ~ vds } ( [ {Inxham \lA: I<cldc,l

H(~lland, 1Q82 ), p, 20.3 .
54

Box A.-NIH Study Sectbns as a Mechankm

for Control d A#?M48 , ,

Thepeerreview system, whereby scientists advise the Federal Government on huw to akeate

research funds, is rqxesentative of a twpronged mechanism for control of the ms@arch

-da: decisions an fundiq p&Wti4XdiW prop

S& both S@ the current &kr~ WUI

affect the direction of a field or discipline. The

rnuki4?vel process used by NM provides a god

example of such controls.

A research proposal submitted to NM is first

scanned by an OffiUer in the Division of RM?arCh

Grants, WhO refers the pro@wd to tk mostxeb

Vant of 4S chartered Study -sl?!etkns arid to @w

most appropriate Institute of NM4. Each study

section is composed of app+ximdy 1$ *ntis~s and a fulktime? nom- mwcwtk -

tary who is an NIH scientitk W exaathm *-

retary nominates memti of *- study aeetigw

for selection by thehJIHDimctcw. s&ldy&q&m

members serve a 40year tgrm andme43 tbxkes

a year to review mmr NM pFoposds pw Wmkm.

The study SeCtiOt@ assi@’k to @ach +@

priority score ba8ed @n sCMNiEi4 merits R@ikwers am not aware of the to@, bud@ary ratpwst

on the prqxwal. The relevant Mtut@ theh receives the falikedpmposak and pa$ses * Mx@”

kg decision on to itit advisory coWwilrWhkk’i*

composed of kth saientkt~ and publk &jgums.

BeC?#se h=titute$ with MJer bud@iets ,* abla

ta fired HM2* proje@#?, Solite CWq Ck@:thikt

high qualiky rAear&h ti’$o~

-%- ~ where social andWin i% lower priorfty-foi’

h?sser quality m?aearcfl may be ftmdd @ IW08e

“glamorous” di#ase eat@&rie& The st##@MN&

tiolts ako CCMMkt workah@ps to*rSp@?t Qlx’tha

status of the field, thereby prw!ding kqpterrn

P-~~● n to.tk

and sen~ S@als to the!@/ntihlR Commimiiy

dxxlt areas of potential Merest to *h”@’ailtinff

agency.

adopt specific criteria for selecting experiments

and assigning priorities to them. The International

Committee for Future Accelerators of the International Union of Pure and Applied Physics

recommends four criteria be used for selecting experiments and determining their priority: 1) scientific merit, 2) technical feasibility, 3) capability

of the experimental group, and 4) availability of

the resources required.

At the individual level, research may be restricted not only by mechanisms driven by political, economic, or professional concerns but also

by personal values. Especially when alternatives

are limited, individuals “feel forced to choose

among projects they would normally not consider, the moral questions . . . become more immediate and controversial.”11 The decision not to

participate in military-supported or weaponsrelated research, therefore, may be also a decision to alter one’s lifetime research agenda. This

decision is a personal one, an individual rather

than a collective control .12

In each of these instances, the regulatory force

may actually be outside the research group, but

the group or the individual chooses to suspend

a line of research in response to either moral or

economic pressure.

Controls on Procedures

Within each scientific field or research speciality, the social influence of tradition and “standard practice” also govern aspects of the research

process. Even though these practices are voluntary, they carry the authority of social norms. On

occasion, they may later form the basis for institutional or governmental regulation.

Many controls are linked to the formal principles and rules that govern admission to a profession. Since antiquity, the medical profession, for

example, “has formalized principles and rules of

conduct for its members in prayers, oaths, and

codes. ”13 Universal codes adopted by more than

one scientific field may relate basic ethical and

moral principles to research practice. The Nuremberg Code of 1947, for example, serves as the

model for many international and national codes

pertaining to clinical research in general and to

such topics as organ transplantation .14 Another

I IRc)~emary Chalk, “Drawing the Line: Science and hfilitary I~esearch, ” unpublished manuscript, May 1983, p. 24.

“Ibid,, p. 22,

“Judith P, Swazey, “Protecting the ‘Animal of Necessity’: Limits

to Inquiry in Clinical Investigation, ” Gerald Holton and Robert S.

Morison (eds. ) (New York: W.W. Norton & Co., 1979), p. 136.

“Ibid., p. 132.
important code has been the World Medical Association’s Declaration of Helsinki (1964, revised

1975).

In some research areas, laboratory groups have

not refrained from imposing voluntary clinical

moratoria—prohibiting researchers from, for example, using on patients a procedure still considered to be experimental. Such a moratorium can

last weeks, even years .15 It is linked to perceptions of the risks associated with premature use

of a procedure and to the incomplete nature of

the research process, however, not to the topic.

The most dramatic instance of a voluntary moratorium on basic research was, of course, that imposed by molecular biologists in the 1970s. Recombinant DNA regulation arose first in the form

of a moratorium called by researchers in the field.

What began in private discussions was dramatically brought to public attention when, as described in chapter 2, biologists proposed a voluntary suspension of certain types of genetic

research. This extraordinary step was followed

by the 1975 Asilomar meeting, when researchers

from the United States and elsewhere, discussed

the appropriateness of continuing the moratorium. After that meeting, action moved to the Federal Government level—to legislation and the formal development of National Institutes of Health

(NIH) guidelines for the research.

Communication Controls

Through the centuries, individuals have also exercised self-restraint in dissemination of research

ludlth I’ Sw~ze} and Rcnee C. Ft~x, “The Clinical \loratorium:

A (-ate clt hlltr~l L’alvc Surger}, E~perirnentat~on 1$’ith HunrarI

Suh/e~ts, J)dul A, Freunci (cd. ) (LA!e~v York: George Brazil]er, 1%Q ).

55

results, either by withholding the information altogether or by delaying dissemination for a short

period of time. British mathematician John Napier, who had experimented with a new form of

artillery around 1600, “took great pains to conceal the workings of his invention.”16 In 1947,

Massachusetts Institute of Technology professor

Norbert Weiner refused to supply a paper of his

to an industry scientist engaged in military research. 17 In the 1980s, many biologists assert that

researchers in certain areas are refraining from

sharing information and substances with colleagues, ’a

The science community as a whole may support an investigator’s desire to avoid premature

disclosure, especially when data are incomplete

or not yet published in a refereed journal. Such

delay may also be linked to the researcher’s desire to maintain professional security through temporary but exclusive control of knowledge. A dramatic example of group self-censorship occurred

before World War II when a group of physicists

tried to limit the publication of scientific research

relating to nuclear fission. By the middle of 1940,

most physics journals had agreed informally “to

delay the publication of any article that might help

a knowledgeable scientist build an atomi c

bomb.” 19

‘“Cited in Chalk, c~p. cit , p Q.

‘“Norbert Weiner, The At)ant~c .Ilc)nthl}’, letter t(\ the edltot-, ]anuary ICM7; reprinted in Science, Technolc)A~j, & Humdn I’alues, vol.

8, No. 3, summer 1Q83.

I H ~io](J~ist5 in[erJriem~e~ bv Sandra Pan em ‘unltt]rnll! agreed t h~t

there was more . free information exchange ]n the I Q~Os th~n

currently .“ Sandra Panern, “The Interfer(}n D]lemma Swrec} \F

Open Exchange, ” The Broohirrgs Re\iew’, winter 1 Q8?, p, ZO

‘*Michael hl. Sokal and Janice F. Goldblurn, “Fr<lnl tht’ Archi\’e\,

Science, Technology, & Human Values, vol. 10, spring IQ85, p. 24.

REGULATIONS IMPOSED BY INSTITUTIONS

The attitudes and policies of research organi- perimental protocols and safety procedures and

zations can regulate the agenda, procedures, and have policies on what subjects are not acceptable.

communication of a project, through both infor- A research group may decide deliberately to take

mal guidelines enforced by social pressure and for- up or drop a specific line of research for political

mal rules enforced by threat of dismissal or pen- or moral as well as scientific considerations. Those

alty. Although the extent and stringency of rules decisions—whether to pursue certain topics, or

may vary, most organizations have specific ex- how to disseminate results—can reflect such fac-
56

tors as: 1) fear of social criticism or protest, 2 )

accommodation to the pressures of the surrounding social or political climate, or 3) a desire to protect property rights (e.g., when a team delays publication until assured of patent protection or keeps

a project secret in order to assure first publication) .20

As a result of discussions from the Vietnam era,

some U.S. research laboratories or universities

decided not to allow classified research to be performed on their campuses. ” Ohio State University, which accepted over $5 million in defense

contracts research in 1982, now bans any campus

research on offensive weapons .22 Other universities impose procedural restrictions—e.g.,

whether classified work may be accepted with any

entailing restrictions on publication23—or have

placed such work off-campus and attempted to

insulate it from the research environment of undergraduate or graduate students.

To enforce such administrative policies on

acceptable research topics or procedures, organizations employ a variety of mechanisms, ranging from informal guidelines and review committees, to formal administrative rules. In most cases,

these controls are enforced through social pressure

or reprimand. Many universities have adopted

guidelines for the acceptance of externally sponsored research which govern, for example, the

terms of university-industry cooperative projects,

the use of human subjects in experiments, or the

handling of dangerous biological materials.” Such

policy documents may govern with a velvet glove,

however. As the Harvard University guidelines

note, “The pursuit of truth in the academic community is impossible without a measure of mutual

trust between its members, and no set of detailed

principles and criteria can be a substitute for this

‘“As described in, for example, lames D. Watson, The Double

Helix (New York: Atheneum, 1968).

‘ ‘Robert C. Cowan, “Degrees of Freedom, ” Technology Revie~\r,

August September 1985, p. 6; also see Dorothy Nelkin, The Llnit’erslt~r and ,$Iilitar}’ Resedrch: Lfc)rdl Politics at &flT f Ithaca, NY: Cornell University Press, 1972),

“Kansas Cit.v Times, Jan. 13, 1983, p. A-7.

“Chalk, op. cit., p. 13.

“AS described in, for example, Nicholas H. Steneck, “The Universit y and Research Ethics, ” Science, Technolog}r, & Human Values,

VO]. q, fa]] 1984, pp. 6-15.

trust .“25 The Harvard report further points out

that:

. . . the principal means by which the faculty exercises control over the quality of the scholarly

activities of its members is through its role in recommending the selection of its own members and

through the professional standards that it and the

University apply in the selection process.26

To administer such rules on a routine basis,

universities and private laboratories set up institutional committees to review safety procedures, to

decide which topics to pursue, or to review the

quality or process of publication. Committees are

dominated by members of the institution and are

appointed and funded by the institution. Many

exist as a direct result of Federal regulations tied

to grant or contract funds. Institutional Animal

Care and Use Committees, Institutional Review

Boards, and the Institutional Biosafety Committees, for example, are all required of institutions

receiving funds from the Public Health Service,

NIH, or other compliant agencies. Institutional

review boards, which are (administratively and

financially) local committees of the institution,

nevertheless must include both scientists and nonscientist members from the local community, all

of whom “examine and pass judgment on the risks

and benefits of a proposed study and on the adequacy of the consent proceeding as described in

the research protocol.”27

Some institutional committees govern the

administration of a specific research program. For

example, in 1977, the Monsanto Co. and Harvard

University set up a special independent advisory

committee to oversee aspects of their $23 million

research agreement. The five-person committee,

established out of concern for the public interest,

assures that “both sides honor their contractual

promises to protect academic freedom—namely,

the right to publish—and to develop any products that may emerge in a manner consistent with

the public good. ”28 The Health Effects Institute,

“Report of the Committee on Criteria for Acceptance of Sponsored Research in the Facult,v of Arts and Sciences (Cambridge, MA:

Harvard University Press, October 1983), p, 3.

“Ibid.

‘

7 Swazey, op. cit., p. 139.

“Barbara J. Culliton, “Harvard and Monsanto: The $23-Million

Alliance, ” Science, vol. 195, Feb. 25, 1977, p. 759.
57

a private research firm, insulates scientists from

pressure by using two independent committees,

one that creates the research agenda, another that

reviews finished work.29 In the national laboratories, visiting committees, composed of scientists

from other institutions, are used to evaluate the

quality of work in the lab.

Institutional restraints on communication may

result not just in suspension of publication but also

deliberate, albeit temporary delays. At a 1984

seminar on secrecy in science, many university

deans of research remarked that it was not unusual for them to receive requests to delay the submission of a Ph.D. dissertation to University

“Sc~nce, Feb. i5, 1985, p, 72Q.

Microfilms, Inc. (a general clearinghouse for U.S.

theses and dissertations) and that it was not unusual for graduate schools to cooperate—as a matter of policy—by granting l-year delays .’” Typical reasons for such requests were: 1) to allow the

student time to seek patent protection, 2) to allow time for first publication in a journal of record, 3) to provide a degree of protection for industrial sponsors of research, 4) to protect the

safety and welfare of informants used in the research, or 5) to protect militarily-sensitive information.

‘

L

’’’ Opennes~ and Secrecy in Scientific anci Tcchn]c.~1 Commun]-

cation, “ seminar, Jranderbilt

1Q84,

CONTROLS BY PROFESSIONAL ORGANIZATIONS

SCIENCE AND ENGINEERING

Professional codes or industry association

guidelines may act as a regulatory force on the

research conduct of members. These rules are

voluntary standards that reflect private consensus

on public matters. They are enforceable primarily through the social pressure of membership in

the association and hence are effective only when

such membership is useful or necessary to acquiring or maintaining employment in the field or in

acquiring a government grant or contract.

In some scientific fields these rules may form

the foundation for State licensing procedures—

as in the case of physicians or engineers. In other

fields, the codes may pertain to accepted procedures in the field or to testing. The American Psychological Association, for example, has issued

guidelines for research psychologists who use animals, as have such groups as the Society for Neuroscience, the Society of Toxicology, and the International Society for the Study of Pain.31 The

American Psychological Association has also developed a set of Ethical Principles in the Conduct

of Research with Human Participants. The American Anthropological Association and the American Sociological Association adopted new codes

of ethics for research in 1971. The Evaluation Re-

“Science, vo]. 228, May 17, 1985, p, 830

Universit}r, Nashville, Th’, Sept 24 ,

IN

search Society has established professional standards for evaluation research. The American Chemical Society developed the Chemists’ Creed and

Professional Employment Guidelines, which set

standards for practice in research settings. Most

scientific societies have, at minimum, guiding

principles for the conduct of research. Some have

extensive and detailed guidelines for agenda, procedures, and communication of research results.

Recent concern about the leakage of militarily

sensitive information to the Soviet Union from

the U.S. western allies has led the Federal Government to request the specific cooperation of the

scientific and technical societies in regulating communication. The Government has asked societies

to restrict access to certain meeting sessions—that

is, the session would be neither classified nor open

to all meeting participants. The American Association for the Advancement of Science Committee on Scientific Freedom and Responsibility has

identified examples of “self-imposed restrictions”

in a few professional societies that exclude nonU.S. citizens from meeting sessions dealing with

militarily sensitive topics .32 The Society for the

—-

“Robert L. Park, “Intimidation Leads to Seli-Censorship in

Science, ” Bulletin of the Atomic Scientists, IO]. 141, No. 3, spring

1985, pp. 22-25,
58

Advancement of Material and Process Engineer- At least half a dozen professional societies are eiing and the Society of Manufacturing Engineers, ther reconsidering or reformulating their policies

among others, have voluntarily censored them- eon restricted meetings. *

selves, limiting attendance at their meetings (or

at specific meeting sessions) to U.S. citizens only.33

“Janice R, Long, “Scientific Freedom: Focus of National Security Controls Shifting, r

’ Chemical & Engineering News, July 1, 1985, ‘The AAAS is distributing a survey to determine the extent and

p. 9. pervasiveness of this trend.

MECHANISMS FOR GOVERNMENT REGULATION

Federal, State, and local governments use leg- tional review of project applications.”36 Its prinislation, executive (e.g., Presidential) directives, cipal regulatory effects are felt in the university

agency rulemaking, and so forth, to exert con- research labs, although the regulations on molecutrol on the conduct and dissemination of research. lar biology research or on the use of human subSuch mechanisms differ from entity to entity. jects in experiments have also been applied to

A comparison of two Federal agencies that reg- some industry research.

ulate biomedical research demonstrates how dif- Because of the variety of mechanisms and enferent mechanisms can constrain research. The

Food and Drug Administration (FDA) closely

monitors drug research and applies its program

of control—e.g., in requiring the assurance of consent by subjects involved in clinical trials—

uniformly throughout the United States. Tighter

requirements for the use of human subjects were

instituted in 1962. This organizational approach

is tied to FDA’s principal mission of regulation

aimed at protecting the consuming public; its enforcement power to regulate research comes from

the fact that it must approve the marketing, advertising, and distribution of all drugs sold in the

United States. The principal regulatory efforts of

this agency are thus directed at research in the

pharmaceutical industry .34 In contrast, NIH, as

an organization that supports and conducts basic

research, applies a philosophy of encouraging academic freedom and imagination in the research

it supports through its extramural projects grants

program. 35 The NIH approach uses a system of

decentralized, institutional review committees that

operate under generalized ethical guidelines. NIH

also “takes direct responsibility for the protection

of research subjects under its own system of na-

“Alexander M. Schmidt, “The Politics of Drug Research and Development, ” The Social Context of Mecficaf Research, Henry Wechsler (cd. ) (Cambridge, MA: Ballinger Publishing Co., 1981), pp.

233-262.

35 William J. Curran, “The Approach of Two Federal Agencies, ”

Experimentation With Human Subjects, Paul A. Freund (cd. ) (New

York: George Braziller, 1969), p. 449.

forcement in the executive branch agencies, new

fields often face a thicket of duplicative or even

conflicting requirements. The December 31, 1984,

Proposal for a Coordinated Framework for Regulation of Biotechnology37 issued by the Office

of Management and Budget is evidence of increasing concern about this problem. In May 1984, the

White House Cabinet Council established a working group on biotechnology to review Federal regulatory rules and procedures relating to the biotechnology industry. All three affected agencies

(FDA, Environmental Protection Agency, and

U.S. Department of Agriculture) would review

biotechnology products and processes. Under the

Framework, review would proceed on a case-bycase basis, each with its own staff, consultants,

and expert scientific advisory committees. The Recombinant DNA Advisory Committee (RAC)

would continue to oversee rDNA experiments related to biomedical research and the National

Science Foundation (NSF) would form a review

committee to examine the potential environmental

effects of basic research experiments employing

rDNA. All five advisory committees would report to a parent committee, the Biotechnology

Science Board, which would receive summaries

of all recombinant DNA, recombinant RNA, or

cell fusion applications and may undertake itself,

“Ibid,

3749 Federal Register 50856-50907,
or request that the agency committee review, a

specific proposal. In addition, the Board would

evaluate review procedures and committee reports, conduct evaluations of broad scientific issues relating to this research, develop guidelines,

and provide “a forum for public concern. ” As of

this writing, NIH is in the process of reviewing

comments on the proposed regulations, and no

final rule has been issued.

Such coordination, is unusual, however. Normally, government regulation of research is administered through a number of uncoordinated

and therefore potentially conflicting mechanisms.

These include: national or local commissions to

review general procedures and policies; tax credits;

legislative review and veto; moratoria; controls

of acquisition or possession of materials needed

for research; interpretation of regulations; contract provisions; and publication or communication review or classification.

Agenda Controls

Governmental Review Commissions

The Government may set up a commission or

board to review research, either with an eye to

improving research procedures or to resolve some

dispute. An example at the local level is the Cambridge Experimentation Review Board, which

ruled on the safety of rDNA research in the 1970s

at the request of the Cambridge City Council. At

a national level, the NIH RAC approves experimental procedures and must consider any proposed changes in the NIH Guidelines for Research

Involving recombinant DNA Molecules. The NIH

committee, composed of both scientists and nonscientists, meets several times a year to examine

special cases of recombinant DNA research, petitions for examption, and proposals for changing the Guidelines. The Committee must also recommend to the Director of NIH any proposed

change in the guidelines.

National commissions have been used to formulate guidelines for research, but most have not

had any power to restrict or delay actual research —e.g., the National Commission for the

Protection of Human Subjects of Biomedical and

Behavioral Research, established by Congress in

1974 to develop guidelines for such research.

59

Tax Credits

Legislation offering tax credit or similar financial incentive to encourage and discourage research is passed usually to provide incentives for

private funding on designated topics (e. g., research on alternative energy sources). In 1980,

Congress gave small businesses and universities

the opportunity to obtain patent rights on inventions developed with Federal funds.38 In response

to the energy crisis of the 1970s, over 30 States

passed laws to promote solar energy. Most of

these laws provide tax incentives (income or property tax reductions) to stimulate private sector research, development, and commercialization of

solar systems .3” Congress has been similarly active in passing legislation that promotes research

on alternative energy systems. And the 98th Congress enacted the Orphan Drug Amendments to

the Food, Drug, and Cosmetic Act 40 in order to

stimulate privat e research and development

(R&D) of drugs for rare diseases.

The Internal Revenue Code also currently allows businesses the option of deducting or amortizing expenditures for research and experimentation over a period of 60 or more months. The

Economic Recovery Tax Act of 1981 (Public Law

97-34) provides a 25 percent tax credit for incremental research expenditures made after 1981.

That legislation reflects a deliberate attempt by

Congress to reduce tax burdens in order to stimulate research. It includes tax credits for laboratory equipment leases, and for portions of payments to universities to perform basic research.41

These provisions are set to expire at the end of

1985. To stimulate research by private industry,

Congress has tried to lower the cost of private

R&D through a combination of tax policy, direct

spending, and patent legislation.

Social science research was specifically excluded

from the areas of research spending for which a

tax credit is allowed. Bills introduced in the 98th
60

Congress, which would have created additional

incentives for corporate investment in research

and development, also excluded social science research from their definition of “qualified research”

for which a corporation may take a tax credit.

The Congressional Budget Office estimates that

the Federal Government gives the high-technology

research system approximately $1.5 billion in the

form of tax credits.42 There are currently three major tax-related mechanisms that high-tech research

industries may employ: 1) straight deductions,

year by year, of research expenses such as salaries and equipment [Internal Revenue Code, Section 174]; 2) the R&D tax credit, which expires

in 1985 and allows a company to deduct from its

taxes 25 percent of amounts that exceed the previous 3-year average of amounts the company

spent on research [Public Law 97-34]; and 3) the

funding of research through R&D limited partnerships, possible through several provisions of

the tax code.

Legislative Review

Congress has several times attempted to control specific research projects or types of projects

through legislative review of proposals or projects. In 1975, Representative Robert E. Bauman

of Maryland introduced an amendment to the

NSF authorization bill (H.R. 4723) which would

have allowed Congress to review all NSF proposals prior to the final awarding of the grants.

The Bauman amendment passed the House, but

was deleted in Senate Subcommittee and therefore not included in the final bill. The strongest

argument against the amendment was the burden

that would be placed on Congress to review thousands of grants. A second argument was that

Members of Congress are not scientists and therefore are not necessarily competent to judge specific research proposals. What might sound frivolous and inconsequential to a layperson can be

of major importance to scientific development.

A third argument was that consistency would require Congress to oversee the grants made by all

other agencies, including the Department of Defense (DOD). Other arguments included the added length of time to receive a grant, the politiciz-

‘2C;n~rewiclnal Budgyt Office, k(~eral Supptlrt for I{&[) 2nd ln -

no~r.]tion,” ilpri] 1Q84, pp. 7b-83.

ing of the award decisionmaking process, and the

possibility of making NSF more conservative (and

possibly less innovative) in its effort to please

Congress. In 1983, the Supreme Court effectively

ruled in INS v. Chadha (103 S. Ct. 2764) that

legislative vetoes, such as proposed in the Bauman amendment, were unconstitutional.

In the 99th Congress, Representative Robert G.

Torricelli of New Jersey introduced a bill entitled

the “Information Dissemination and Research Accountability Act” (H. R. 1145), which has similar

evaluative intent. The purpose of the bill is to

“promote the dissemination of biomedical information through modern methods of science and

technology and to prevent the duplication of experiments on live animals. ” It calls for a National

Center for Research Accountability, located

within the Library of Medicine, which would provide for a comprehensive, full-text literature

search before any research proposal involving the

use of live animals could be approved. Thus, all

animal research proposals would be funneled by

the potential granting agency through the Center prior to approval. The President would appoint 20 persons to serve as members of the Center. Critics of the bill claim that the process would

unnecessarily prolong the already extensive grants

review process and would duplicate the peer review process. In addition, the duplication of research that the bill intends to eliminate is often

an important and required aspect of research in

that it enhances validity and reliability, Proponents of the bill feel that it will prevent the unnecessary use of animals in research.

Moratoria

The most dramatic device used by government

to control research is the legally enforceable ban

or moratorium. Moratoria on science—or the proposal of same—are effective ways to focus attention on a serious issue or to express a political perspective that the researchers appear to have been

ignoring. The 1974 act prohibiting experimentation on human fetuses (see box B) is an example

of such a ban. In 1975, the Department of Health,

Education, and Welfare prohibited the funding of

research on in vitro fertilization without review

“h’[lchael Cold, “Research olt-limits, ” Sc)ence 8.5, vol. b, April

1985, p. 36.
61

Box B.—Fetal Research

The controversy over research on fetuses or fetal tissue illustrates the implementation and effect

of various mechanisms for government control of research.

Between 1970 and 1972, advisory groups within the National Institute of Child Health and Development debated NIH policies on the review and funding of human fetal research. Reports of abuses by

researchers in other countries had led to pressure on NIH to declare a moratorium on any research with

the living fetus before or after abortion, lest such abuses be repeated in the United States, Congressional

debate and legislation (National Research Act, Public Law 93-348, Section 2130) created the National

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which produced

recommendations that became the core of the Federal regulations. The Commission intended the existing independent, local institutional review boards (IRBs), with the addition of a national Ethics Advisory Board, as the means for control and consideration of fetal research. The fetal research guidelines

were adopted as Federal regulations on July 29, 1975, but an Ethics Advisory Board was not chartered

until 1977 or convened until 1978, so a de facto moratorium existed during this time on both fetal research and in vitro fertilization.

The Ethics Advisory Board was allowed to die in 1980 and its absence means that the privately

supported IRBs are still the only locus of practical control. Supplementing the Federal regulations are

25 State statutes and the Uniform Anatomical Gift Act (passed in all 50 States by 1973). That act governs

research on dead fetuses generally by including explicit language to that effect. Department of Health

and Human Services (DHHS) regulations cover only DHHS funded research or research institutions;

other research is governed by State statutes, when they exist. They range from strict (no research except

that of therapeutic value to mother or fetus) to those more liberal than the Federal regulations.l

In summer 1974, the National Commission for the Protection of Human Subjects declared a national moratorium on all fetal research, which remained in effect until the Commission issued interim

regulations in 1975.

In several cases in Boston in the 1970s, State-level protest also attempted to halt fetal research. Because the research in question used dead fetal tissue obtained from abortion procedures, antiabortion

groups charged that publication of findings based on research using such tissue was unethical. In response to the public protest, the 1974 session of the Massachusetts legislature passed “An Act Prohibiting Experimentation on Human Fetuses, ” which treated such research as a felony offense punishable by

up to 5 years in prison. The law (amended in 1976) applies only to fetal tissue and does not prohibit

experimentation on live fetuses in efforts that might be considered “beneficial” to the fetus. Many legal

scholars consider the law to be imprecise and, because of that imprecision, to have the potential for

producing a “chilling effect” on researchers. On the other hand, opponents of the research have pushed

for stronger legislation that would make violation a criminal offense. Controversy has continued with

the introduction of legislation in Congress proposing a national moratorium on research on live fetuses.

Rules restricting federally funded research on human fetuses, set in place in 1974, specify that individual research proposals must be reviewed by a federally appointed Ethics Advisory Board. When the

Ethics Advisory Board was allowed to lapse in 1980, the effect was a de facto ban. No research in this

area can be done until it is reinstated. Four succeeding Secretaries of DHHS have failed to limit the moratorium. In January 1984, the NIH sent a request to DHHS for reestablishment of the board, but as of this

writing, the Secretary has not acted on the request.

‘John C. Fletcher and Joseph D. Schulman, “Fetal Research: The State of the Question,” Hastings Center Report, vol. 15, April 1985, pp. 6-11.
62

A moratorium was proposed in 1976 on all

R&D surrounding laser isotope separation of uranium. The proposal was to suspend all projects

in the United States, “pending the results of efforts to achieve agreement with other industrialized nations to halt their work in this area. “44 The

proposers acknowledged the complexity of implementation (and improbability of success) of such

a moratorium, but used the proposal itself as a

way to further public discussion of the policy on

proceeding with the research. The LilienthalAcheson proposals in 1946 for regulation of

atomic energy would have entailed a similar ban

on research in certain sensitive fields .45

Controls on Procedures

Acquisition or Possession of

Materials Used in Research

Research may be regulated through controls on

the acquisition or possession of the chemicals or

other substances necessary to do the research. For

example, the Environmental Protection Agency

(EPA) is authorized by the Toxic Substances

Control Act (TSCA) to regulate the approximately 60,000 chemicals subject to the act, at all

stages of their development.46 TSCA recordkeeping and reporting requirements apply to research

on chemicals and additional regulatory requirements apply when the chemicals are introduced

into commerce .47

Federal regulations control the possession, use,

and disposal of radioactive substances, including

their use in research. Handling of nuclear and

radioactive materials is governed primarily by the

Nuclear Regulatory Commission (NRC), under

the Atomic Energy Act of 1954.4a The NRC has

regulatory power over any materials made in a

reactor. It does not have any jurisdiction over accelerator materials or over naturally occurring

radioactive materials, although some States do

regulate these substances. If the research institution is located within an “agreement” State, the

investigator must be licensed by the State radia-

“’Barry hf. Casper, “Laser Enrichment A New [’ath tt~ I’r[~liferatic)n?” Bulletin (Jl the Atomic Scientists, lanuar} 1477, pp. 28-41.

“The c(>mplete text of the plan was contained in a State Department dc~cument, I)uh[icatlc}n 2498 (1946),

‘“15 U.S, ~. Section 2(301

‘“15 U. SC. Section 2007

‘“!k’ especially Title 10 (~t the Act

tion control agency. If the institution is within a

“nonagreement” State, it must apply to NRC for

a license. All research must comply with Federal

and State OSHA regulations, which regulate exposure to toxic substances in laboratories.

For research using radioactive substances, then,

there are various degrees of licensing and permits,

depending upon what is done and the substance

in question. Regulatory jurisdiction varies from

State to State and between the Federal Government and the State. In addition, there is a tiered

system of control based on the quantity of material in question. (NRC has established categorical exemptions from certain regulatory requirements for certain low-level radioactive materials. )

The requirements for a license pertain to the personnel and their qualifications, the facility, uses

of the material, estimated human exposures, recordkeeping and reporting systems, and disposal

practice .4’ Large institutions conducting a lot of

research may apply for a broad license, which

delegates considerable decisionmaking power to

the institution’s Radiation Safety Committee. In

all cases, radiation safety officers must be approved by the licensing agency and NRC must

know and approve the qualifications of such individuals. Most research institutions have a radiation safety officer, even if they do not have

a radiation safety committee. Licenses can be very

precise, authorizing one investigator to use a specific material for a specific period of time.

There are also regulations for disposal of radioactive waste. All Federal institutions must comply with the Clean Air and Clean Water Act, if

applicable. In addition, the institution must apply for a discharge and disposal permit from the

State air pollution agency and/or the State water

pollution agency. Both Federal and local regulations may apply to disposal as well.

If an institution is found to be in violation of

the laws governing radioactive materials, civil

monetary penalties can be imposed, and its license

suspended or revoked; in addition, the organization would probably receive damaging press coverage. At large institutions, safety precautions

may ‘be emphasized, therefore, because of the consequences of a single mistake, primarily the sus-

’910 CFR Parts 30-32.
pension of all of the institution’s research using

radioactive materials.

Department of Transportation regulations enacted

under the Hazardous Materials Transportation

Act govern shipments of certain research materials (e. g., radioactive materials, etiologic agents,

poisons, corrosives, flammables) by requiring specific carriers, containers, or handling practices .50

Federal laws prohibiting the possession of narcotics act to restrict research in a number of fields,

Researchers who wish to use controlled or illegal

substances as a legitimate part of their research

must first register with the Department of Justice;

they are then investigated by the Drug Enforcement Administration and their research is validated by FDA. If approval is granted, the researcher must request the drug from the National

Institute of Drug Abuse. If the research also involves human subjects, additional reporting requirements must be fulfilled. According to the

Drug Abuse staff of FDA, the administration of

these regulations used to be very time-consuming,

but recent streamlining of the approval process

and an apparently diminished interest in research

involving controlled substances have reduced the

number of requests and the time required to

ess them.

Requirements for Procedural

Review Committees

Various Federal and State commissions

prochave

been given principal responsibility to implement

legal regulations that apply to research procedures—in the case of the rDNA commissions, requirements for physical containment of the biological materials used in the research. By focusing

on a very specific step in the research process, the

Federal Government was able to establish standards of protection for workers and the community and as well as to set criteria for researcher

(and institutional) accountability. 51 Once the

rDNA guidelines were set (with the aid of the

scientists), the discussion moved back to the

sphere of the policy makers and administration

officials, who were under political pressure from

environmental and public interest groups.

’049 U.S. C. Sections 1803 et seq. and 49 C.F. R. Parts 100-179,

“Dorothy N’elkin, “Threats and Promises: Negotiating the Control of Research, ” Holton and Morison, op. cit., p, 199.

63 —.

Regulation may also occur at the very end of

the research process, as in EPA regulation of field

testing of new insecticides or for agricultural research involving rDNA. In a recent case involving insecticide-producing soil bacteria, the EPA

has required the company to apply for an experimental use permit and to submit more research

data on various aspects of the bacteria (e.g., its

longevity in soil and its effect on nontarget species), an action that has the effect of restricting

or delaying the use and dissemination of results

from the project.

The Federal Government may also require that

an institution set up review committees to monitor, approve, and shut down projects. The three

principal types are Institutional Biosafety Committees (IBC), Institutional Review Boards (IRB),

and Institutional Animal Care and Use Committees.

IBCs are mandated by the NIH Guidelines for

Recombinant DNA Research and have served as

the major locus of responsibility for oversight of

that research since 1978. The latest NIH

regulations 52 stipulate that an IBC must have “no

fewer than five members so selected that they collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of recombinant DNA research

experiments and any potential risk to public health

or the environment. ” At least two members must

have no affiliation with the institution apart from

their membership on the IBC and should be chosen to represent the interest of the surrounding

community with respect to health and protection

of the environment. Unless exempt from review

under the Guidelines, all rDNA research must receive IBC approval. Certain categories of research

considered to be of questionable or high risk must

be referred to the NIH Recombinant DNA Advisory Committee for approval before work can be

initiated. There are currently 301 IBCs registered

with the Office of Recombinant DNA Activity of

NIH. Approximately 250 are academic IBCs; the

rest are industrial. Compliance by industry is

voluntary.

“Basic DHHS Policy for Protection of Human

Research Subjects”53 requires that all research in-

“49 Federal Register 227, Nov. 23, 1984.

5’CFR 46,
64

volving human subjects conducted by the Department of Health and Human Services (DHHS) or

funded in whole or part by a Department grant,

contract, cooperative agreement or fellowship,

undergo review by an IRB. (See box C.) As with

an IBC, IRB membership is specified in the Federal regulations. The IRB must have five members and, per the Guidelines, “be sufficiently qualified through experience and expertise of its

members, and the diversity of the members’ backgrounds including consideration of the racial and

cultural backgrounds of members and sensitivity

to such issues as community attitudes, to promote

respect for its advice and counsel in safeguarding the rights and welfare of human subjects. ”

According to the Office for Protection from Research Risks, the office responsible for the implementation of the IRB regulations, there are currently over 5,000 operating IRBs in the United

States. A 1979 study by Jeffrey M. Cohen and

William B. Hedberg determined that, in 1 year,

a typical IRB was in session 41 times and reviewed

278 proposals, involving approximately 80,000

potential research subjects.54 That IRB cost the

university $36,000 during the year, or about $130

per proposal.

Institutional Animal Care and Use Committees

(IUCAC) are required of all institutions that receive Public Health Service (PHS) funds for research involving animals. Under revised PHS policies released May 1, 1985, those committees,

which must have lay members, will have the responsibility for reviewing research plans and monitoring compliance. Prior to the establishment of

these guidelines, nearly 1,000 institutions already

had animal assurances through PHS. It is not

known how many new committees will have to

be established once the guidelines take effect. The

new guidelines also require that all animal facilities must also be accredited by the American

Association for the Accreditation of Laboratory

Animal Care, a voluntary association that certifies animal handling facilities, or must conduct

an assessment based on the NIH Guidelines for

the Care and Use of Laboratory Animals. Accreditation is a necessary condition if an institution

wants to receive PHS funds for research involvsiJ~ffr~Y M, Cohen and William B. Hedberg, “The Annual Activity

of a University IRB, ” ZRB, May 1980, pp. 5-6.

ing animals. By January 1, 1986, each institution

receiving PHS funds must submit an “assurance

of compliance” (containing such documents as

descriptions of the facilities and membership and

procedure of the local IUCAC) to the NIH Office for Protection from Research Risks.

Contract Provisions

The provisions of research grants and contracts

are used to enforce such things as limitations on

spending, allocations of funds among budget categories, requirements that organizations be accredited or meet certain accreditation standards,

and requirements that research designs or procedures be approved by the monitoring committees

described in the previous section.

In the case of recombinant DNA research, the

Asilomar recommendations were adopted by

NIH, which then issued a set of guidelines covering research in designated categories. It applied

to all recombinant DNA research funded by NIH.

Today, the amended NIH Guidelines for Recombinant DNA Research set forth the generic requirements for safety in recombinant DNA research. These safety requirements apply through

contract provisions to all recombinant DNA research in the United States which is conducted at

or sponsored by an institution that receives any

support for rDNA research from NIH.55 Failure

to comply can lead to termination of NIH funding or other NIH sanctions. Although limited to

institutions funded by NIH, the Guidelines have

been adopted or followed by virtually all Federal

agencies, State and local agencies, and private

organizations.

Communication Controls

Reporting requirements in contracts can include

regulations on the “deliverables” of a project, usually through prepublication review. Such contractual provisions are currently being invoked in order to restrict the flow of information believed

to be linked to national military security or related to the Nation’s ability to compete in world

markets. Contract provisions have been used, for

example, to prohibit foreign nationals from be-

~~er~l Register 77384, Nov. 21, 1980, and 77409.
65

Box C.—Research on Human Subjects

Until the 1960s—with the exception of the Nuremburg Code (1947)—there were no legal decisions

from the courts and no Federal or State laws concerned directly with how humans were used in experiments (again, with the exception of violations of criminal law). NIH and PHS first began in 1953 to

develop formal standards for human experimentation, but these efforts were not productive. The turning point was the increased volume of clinical investigations funded by the Federal Government (the

shift in research performer) and government regulation of experimental drugs (manufacturing, distribution, and safety) in interstate commerce through FDA. Another factor was the thalidomide tragedy abroad,

which triggered the 1962 Kefauver-Harris Amendments to the U.S. Food and Drug Act. Congress, in

debate and not in the original bill, added the requirement to the law that subjects or patients be informed

that they were to receive an experimental drug not fully licensed by the Federal Government and that

their consent be obtained prior to receiving it. In 1966, the U.S. Surgeon General issued the first PHS

Policy and Procedure Order for extramural research on human subjects.1 This Order required all institutions receiving PHS funds to review projects for the potential of abuse and it led to the formalization

of the current system of IRBs.2

At present, most categories of human subjects research funded by Federal money or conducted at

institutions that receive Federal subsidies are subject to some form of review or regulation. Federal agencies with oversight in this area specifically list those categories that are exempt or not subject to regulation; but, research conducted without direct or indirect Federal funding is not subject to human subjects

regulations. In addition, some populations may not be adequately protected by existing regulations.

All research funded in whole or in part through DHHS by direct award, cooperative agreement,

or fellowship, then, is subject to human subjects regulations [45 C.F.R. 46, Section 46.101]. Indirectly,

all research conducted at or sponsored by institutions which do not receive DHHS funds are not legally

required to comply, but according to Charles McKay, of the NIH Office for Protection from Research

Risks, 96 percent of the 500 major institutions conducting research apply DHHS regulations to research

not funded by DHHS. Compliance is indicated through a statement of assurance. Regulations of FDA

cover clinical investigations with regard to products specified in the Food, Drug, and Cosmetic Act for

marketing. These include drugs, biological, blood and blood products, devices, and food additives.

In addition, the U.S. Department of Agriculture (USDA) regulates clinical investigations of food additives. For the Department of Defense, the Veterans Administration, and 20 other agencies, varying degrees

of regulations are tied to direct or indirect use of their funds. All use IRBs and informed consent practices. There is an effort underway by the Office of Science and Technology Policy-and near completion—

to have cross-agency uniform regulations very similar to the existing DHHS regulations.

Despite these efforts, research on human subjects does take place under conditions or in institutions

exempt from DHHS regulation. DHHS itself exempts educational research, test development, interview

and observation research, and research involving specimens and/or medical records, as long as the information taken from these sources is recorded in such a manner that subjects cannot be identified or

that the information revealed would place the subject at risk. The Department of Justice has exemptions

in their coverage of prison research, and has legal prohibitions against regulation of research on recidivism and probation. The Department of Defense exempts epidemiological research from regulation. Industrially related research (e.g., academics doing consultative work designing systems to improve worker

efficiency) is not subject to regulation. All product marketing research (testing of products not FDA or

USDA regulated) is exempt from DHHS regulations; some of it is covered by consumer safety laws,

but those only apply after the product is on the market. Moreover, the regulatory intent is to protect

the public rather than the subjects.

‘Judith P. Swazey, “Protecting the ‘Animal of Necessity’: Limits to Injury in ClinicaJ Investigation, ” Limits of scientific Inquiry, Gerald Holton

and Robert S. Morison (eds. ) (New York: W.W. Norton & Co., 1979), p. 138.

William J. Curran, “The Approach of TWO Federal Agencies, ” Experimentation With Human Subjects, Paul A. Freund (cd. ) (New York: George

Braziller, 1969).
66

One of the solutions to criticism has been to sharpen the procedures for ensuring that subjects have

knowingly and willingly consented to participate in an experiment. There is now an extensive body of

law and regulatory controls, and literature, debating the social and moral aspects surrounding the question of informed consent to human experimentation. Today, the United States regulates research to protect the physical or psychological health or the privacy of the human subjects used in research under

guidelines established by the National Commission for the Protection of Human Subjects of Biomedical

and Behavioral Research. The National Research Act of 1974 instructs the Commission to: I) “identify

the basic ethical principles which should govern research involving human subjects and to recommend

guidelines and mechanisms for assuring that such principles are observed; 2) “to clarify the requirements

of informed consent to research in the cases of children, prisoners, and the institutionalized mentally

infirm;” and 3) “to investigate the use of psychosurgery and recommend policies for its regulation.”

ing employed on a research project.56 More recently, the Federal Government has used grant

and contract terms as a means of directly controlling dissemination of research results, 57 by requiring that the researcher or institution allow prepublication review by the sponsoring or interested

Federal agency. Contracts for classified work, of

course, routinely include such provisions but some

agencies have begun to invoke prior approval provisions previously considered to be pro forma (or

have considered revising their standard contracts

to include such provisions). The purpose of requested delays or review is to allow the opportunity for either classification or alteration (editing

and censorship).

In one such case in 1980, NSF refused to fund

parts of a cryptology proposal submitted by a

computer scientist because of the national security implications of his work. A later decision

awarded the funds to the researcher with the stipulation that he take responsibility for seeking prior

constraint as required by the content of his work.

NSF eventually drafted new language for all its

contracts to require that a grantee take responsibility for notifying the cognizant NSF Program

Director if data, information, or materials developed in the course of research appear to require

classification. NSF retains the option—after review of the information—to defer dissemination,

distribution, or publication.

“Scientific Freedom and National Securjty, Issue 5 (Washington,

DC: American Association for the Advancement of Science, March

1985), p. 7,

“interim Report of the Committee on the Changing Nature O;

Inlorrnation (Cambridge, MA: Massachusetts Institute of Technology, Mar. Q, 1983), Section 4.5,

The mechanism of classification (or the threat

of the possibility of classification) can also be used

to delay publication. This tactic has been used by

the National Security Agency to delay journal

publication of a number of scientific articles on

cryptography. 58 From 1982 to 1985, Federal regulations on the export of technical information

have been used to bar certain foreign nationals

from attending otherwise open society meetings

and have been used to require researchers to withdraw unclassified technical papers scheduled for

presentation at professional society meetings because foreign nationals might attend those meetings. 59

In addition to contract provisions, there are

nine major legal mechanisms by which the U.S.

Government can restrict formal and certain informal communication of scientific and technical

information.

1. The Arms Export Control Act of 1976 and

the resulting International Traffic in Arms Regulations and U.S. Munitions List, administered by

the Department of State, authorize control of the

export and import of defense articles and defense

services, including export of technical data related

to defense articles.

2. The Export Administration Act of 1979, implemented through the Export Administration

Regulations, Commodity Control List (CCL), and

Militarily Critical Technologies List (MCTL), and

administered by the Department of Commerce,

581bid.

“Free Trade in Ideas: A Constitutional Imperative (Washingtonr

DC: American Civil Liberties Union, May 1984); Long, op. cit., see

especially the table of meetings that have been restricted.
— -—

authorizes control of the export of tangible goods,

including technical data, in the interest of national

security and foreign policy and, to a lesser extent,

to protect the domestic economy. MCTL designates arrays of technical information, expertise,

or equipment that DOD believes would make a

significant contribution to the military potential

of another country if exported. The unclassified

version of this list is over 200 pages long; the classified is reported to be over 700. 60 Both the CCL

and the MCTL were not intended to be control

documents, but rather to be reference lists of the

sensitive technologies,

3. Executive Order 12356 of 1982 authorizes

classification of information, including that pertaining to “scientific, technological, or economic

matters, ” that is “owned by, produced by or for,

or is under control of U.S. government” for national security purposes. The order contains a specific exemption for “basic scientific research information not clearly related to national security,”

4. The Atomic Energy Act of 1954, as amended,

places explicit controls on scientific information

and defines restricted data. The act is not limited

to nuclear physics nor even to activities of the Federal Government; its language is sufficiently broad

to allow the extension to “privately generated”

knowledge as well. A 1981 amendment allows the

Secretary of Energy to adopt regulations on the

dissemination of unclassified information regarding either the design of facilities or their security

measures. 61

5. The Invention Secrecy Act of 1951 authorizes the defense agencies to review applications

submitted to the Patent and Trademark Office

‘

c

’ Long, op. cit.

*

] Harold C. Relyea, “Shrouding the Endless Frontier—Scientific

Communication and Natlona] Security: The Search for Balance, ”

Striking a Balance: NatIonaI Secunt-t and Scientific Freedom, Harold

C. Relyea (ed I (Washington, DC: American Association for the

Advancement of Science, 1985), p. 85

6 7

and, if publication of the patent is deemed harmful to national security, to declare the invention

secret for a period of 1 year (with restriction annually renewable). The justifications for the Invention Secrecy Act (1951) are to allow defense

agencies to review applications for patents submitted to the Patent and Trademark Office, with

the goal of catching inadvertent violations. If publication of a patent is judged to be potentially

harmful to national security, then a 1-year, renewable secrecy order is issued .02

6. The Freedom of Information Act contains

provisions allowing but not requiring agencies to

exempt certain types of information from mandatory disclosure.

7. Executive Order 12333 on Intelligence, issued

December 4, 1981, allows for the covert collection of information by agents posing as academics.

8. A number of DOD directives on national

security and classification based on 10 U.S. C. 140c

allow that agency to restrict information developed by scientists under DOD contract. Directive

5230.25 outlines the conditions under which DOD

can withhold classified data from general public

dissemination in accord with export control laws.

An October 1984 memorandum on “Publication

of the Results of DOD sponsored Fundamental

Research” sets forth policies on publications. And

Directive 5230.24 (November 1984) requires all

newly created technical documents in DOD to

carry statements defining distribution and indicating how requests for the document should be

handled.

9. The Immigration and Nationality Act may

be used to refuse admission to or deport foreign

scholars from U.S. research activities.

b21bid.

THE ROLE OF THE COURTS IN THE REGULATION OF RESEARCH

Statutory law governs the role that the judicial Congress or regulatory actions taken under Fedbranch may play in the regulation of research: the eral, State, or local statutes.

courts respond to and interpret existing government action. The Federal courts have no jurisdic- The courts have frequently been used, however,

tion other than to interpret the laws enacted by in environmental disputes to require Federal agen-
6 8

cies to perform, commission, or use research to

support environmental policy decisions. The

intent—through lawsuit—has been to force the

agencies to increase or, in some cases, to improve

their use of research. The effect, at least in the

1970s, was to strengthen the quality and increase

the amount of environmental science research.

Environmental lawsuits are, however, just part

of a general shift in the use of the judicial system

to affect social policy.63 More dramatic use of the

courts occurs when, after a plaintiff has filed suit,

the court issues an injunction that prohibits the

research from going forward at all. In the case

study presented in chapter 7, the Supreme Judicial Court of the Commonwealth of Massachusetts at first issued a temporary restraining order

against a municipal public health order that had

attempted to stop research at a local laboratory;

that court later ruled to uphold the city’s right to

impose such a ban.

In May 1984, Federal District Judge John Sirica,

in effect, put a moratorium on all field tests of

genetically modified microbes being conducted by

the University of California.64 The experiments

in question involved tests of genetically engineered

bacteria (Pseudomonas syringae) designed to prevent frost formation on plants. In September

1983, a group of plaintiffs led by Jeremy Rifkin

and the Foundation on Economic Trends claimed

that NIH was violating National Environmental

Protection Act (NEPA) requirements for an envi-

“Donald L. Horowitz, The Courts and Social Policy (Washington, DC: The Brookings Institution, 1977),

b’Marjorie Sun, “Rifkin and NIH Win in Court Ruling, ” science,

vo]. 227, Mar. 15, 1985, p. 1,321.

ronmental impact statement. NIH claimed that its

approval process more than satisfied the NEPA

requirements. 65 On April 12, 1984, Rifkin filed a

motion for injunction to prevent the researchers

from proceeding with a field test experiment

scheduled for May. On May 16, Judge Sirica

granted the motion for a preliminary injunction

and ordered that: 1) NIH be enjoined from approving experiments involving the intentional release of recombinant DNA, and 2) that the University of California be enjoined from proceeding

with the experiment until final resolution on the

case. In subsequent court action, the U.S. Court

of Appeals for the District of Columbia ruled (February 27, 1985) that experiments could proceed

if their potential environmental effects were properly evaluated. NIH must now prepare environmental assessments.

Recently, an additional legal action has introduced controversy into what has usually been a

quiet region of the scientific community, agricultural research. In 1979, attorneys filed a lawsuit,

on behalf of 17 farm workers and the California

Agrarian Action Project, that charged the University of California with unlawfully spending public funds on mechanization research that displaced

farm workers.66 (For a full description of the case,

see app. A,)

‘5Judith A. Johnson, “Recombinant DNA: Legal Challenges to Deliberate Release Experiments, ” U.S. Congress, Library of Congress,

Congressional Research Service, Science Policy Research Division,

report No. 85-502, Jan. 7, 1985.

~bphi]ip L, Martin and Alan L. Olmstead, “The Agricultural

Mechanization Controversy, ” Science, vol. 227, Feb. 8, 1985, pp.

601-606.

MECHANISMS FOR SOCIAL CONTROL OUTSIDE OF GOVERNMENT

Public opinion can be a potent force for pressuring government to enact regulation or enforce

more stringently existing rules. It is most often

expressed through the mechanisms of public meetings, picketing, protest, violence, or political action organizations. For example, recent activities

by animal rights organizations have included

break-ins, vandalism, and theft of animals, data

and equipment from laboratories using animals

in their research; in some cases, direct threats have

been made to the lives and safety of investigators

and their staff. More moderate groups have used

the traditional policy arena to seek change, lobbying Congress and State legislators for stricter

laws. In summer 1985, DHHS Secretary Margaret

Heckler suspended funding for a head trauma

study utilizing anesthetized baboons at the University of Pennsylvania after members of the Animal Liberation Front (ALF) illegally raided the

University lab, stealing videotapes and destroy-
6 9

ing equipment. DHHS officials contend that while

the research protocol was considered to be scientifically justifiable, the laboratory had violated

its animal welfare assurance to NIH, and that the

decision to suspend funds was unconnected to the

sit-in conducted by ALF at the NIH Bethesda

Campus.

A number of church groups, in the United

States and abroad, have recently provided an additional mechanism for expression of social control on research. Through conferences, newsletters, and “pastoral letters, ” religious organizations

have attempted to educate their members, raise

public awareness about the theological and ethical dilemmas posed by research, or to sway public action concerning regulation of specific areas

of research. In 1979, for example, the World

Council of Churches sponsored a World Conference on Science, Faith, and the Future at which

scientists, theologians, trade unionists, businessmen, and politicians met to discuss the nature of

science and of faith. More recently, the Episcopal

Diocese of Massachusetts convened a BiotechnolSUMMARY

There have always been measures of control

imposed on the scientific community. Most often

the controls have been in the form of self-restraint,

imposed by the scientific community through peer

review and peer pressure. These controls have

been shaped by scientific and technological criteria as well as by the social values and norms

apparent in the ethical codes and standards

adopted by most scientific societies. It is only recently in the history of science that so many institutions and social forces have influenced in so

many ways the conduct of science.

As described in this chapter, research can be

directly controlled at all stages of the scientific

process. Forces can affect the agenda, the process, and the dissemination of results. These forces

ogy Study Group to develop a study guide for

use in churches. The guide addresses the implications of new developments in gene therapy,

genetic engineering, and fetal research, Theologians have also taken more direct approaches in

registering their concern, such as the 1983 “Theological Letter Concerning the Moral Arguments

Against the Genetic Engineering of the Human

Germline Cells, ” a letter signed by representatives

of virtually every major church organization in

the United States. Most recently, the House of

Bishops of the Episcopal Church adoped an official position on genetic engineering that “encourages . . . research directed to an increase in human understanding of vital processes, recognizing

that human DNA is a great gift of God . . .”67 In

addition, the Bishops asked that Congress ensure

that FDA or an appropriate agency seek advice

from ethicists and the lay public to assure that

use of genetic engineering is ethically acceptable.68

‘-cited in Science, vol. 230, No. 4724, oct. 25, 1985, p. 423.

‘*Ibid.

can be exerted informally, through professional

and peer pressure; formally, through institutional

mechanisms; or legally, through Executive orders,

legislation, and agency rulemaking. Finally, the

courts can be used as a mechanism for interpretation of legal controls.

The value of this “cobweb” of direct control lies

in its democratic and pluralistic nature. The danger of this system, however, lies in the potential

for uncoordinated and potentially conflicting

mechanisms for direct control. The potential complexity of this approach to regulation may be exacerbated when compounded by the many levels

and forms of indirect control of research, to be

examined in chapter 5.
Chapter 5

Mechanisms for Indirect

Control of Research

Photo credit: National Institutes of Health
Chapter 5

Mechanisms for Indirect

Control of Research

Research can often be as effectively restrained

by the secondary or tertiary impacts of laws or

policies intended to do something else as by deliberate imposition of regulatory law or policy.

Governmental activity can control the nature and

direction of science even when regulations would

seem to have very little to do with regulating the

scientific enterprise.1

In fact, many of the constraints that have been most burdensome to research institutions—both financially and administratively—were not intended to affect the

substance of scientific work. Such constraints as

the clerical and managerial burdens of social security taxes, equal opportunity and affirmative action requirements, environmental protection, or

occupational health and safety “limit the autonomy of administrators and the freedom of research workers.”2 Research institutions that do not

question the importance of such general domestic policy actions may nevertheless question the

use of research grants or contracts and in particular the withholding of Federal funds in order to

force an institution to comply. They argue that

constraints are imposed not to sustain or ensure

the quality of research but in an effort to secure

“short-term practical results, regional distribution

of funds, and other criteria more or less irrelevant to scientific excellence.”3 In these cases,

science has not been so much singled out for regulation as caught up in society’s growing willing-

‘Melvln Kranzberg, Georgia Institute of Technology, personal

comrnunlcation, 1985.

‘Don K. Price, “Endless Frontier or Bureaucratic Morass?” The

Limits of Scientific Inquir>,, Gerald Holton and Robert S. Morison

(eds. 1 ~New York: W. M’. N’orton & Co., 1979), pp. 75-92.

‘Ibid,, pp. 75 and 81.

ness to regulate all kinds of specialized institutions

and activities.4

The most pervasive control on the scientific

agenda is, of course, the supply of money, but

that control is uncoordinated. Such influences are

more likely to result in what historian Melvin

Kranzberg terms a “shotgun approach” to regulation via funding. This situation occurs when,

in response to a new government program directed at a narrow topic (e. g., some form of cancer), researchers alter their research descriptions

in order to obtain funding for basic or arcane research they are already pursuing.

This chapter looks at some examples of government laws or actions that, without so intending, appear to be exerting some regulatory influence on research. They can be distinguished from

the forces discussed in chapter 4 by the fact that

they are not intended to restrain or inhibit the

process of scientific research. This chapter addresses first those forces that act both at the

project and the institutional level through the

grant and contract funding mechanisms of the

Federal Government. Such restraints were among

those most frequently mentioned in OTA’s survey of university administrators and laboratory

directors. A second type of restraint results from

the implementation of legislation or rulemaking

related to social programs, such as antidiscrimination statutes or privacy legislation, and from

occupational and public health and safety legislation.

4Harvey Brooks, Benjamin Peirce Professor of Technology and

Public Policy, Harvard University, personal communication, 1Q85.

ADMINISTRATIVE REQUIREMENTS ON UNIVERSITIES THAT

ACCEPT FEDERAL GRANTS OR CONTRACTS

In the last 40 years, rules governing the research and legal requirements on the universities.5 These

grant system, the procedures for assuring account- requirements have stimulated considerable anability in the administration of such grants, and tagonism and hostility because many university

the system of Federal support to higher education 5David Dickson provides some discussion of the larger issues in

in general have placed ever more administrative The New Politics of Science (New York: Pantheon Press, 1984).

73
74

administrators have seen it as an intrusion into

their autonomy. In the 1970s, Steven Muller expressed these feelings during congressional testimony when he called for universities to:

. . . resist the tendency of the federal government

to attach a growing body of regulations and conditions to its measures of support for higher education. . . . At stake is the essential need of the

university to maintain the unfettered freedom of

the human mind to apply its powers and methods of reason. b

To many observers, relations between the government and the universities appear to have deteriorated over the last decade; they attribute this

change to policies and practices inherent in Federal support of research. These policies act as a

form of indirect regulation on research. Under

most conditions, Robert Sproull observes:

. . . the principal investigator does not feel the

weight of this pyramid on his back. Although no

one has ever calculated how much more research

could be supported if this towering apparatus was

made leaner, the investigator can frequently ignore it all. There is a growing intrusion, however,

into the control of an investigator’s research.7

A major change in public control of science—

and a handle for enforcing regulation—has been

the increased requirement for financial accountability imposed by the Federal Government. The

post-war “contract” between government and

science allowed scientists, through the process of

peer review, to make decisions about the allocation of government funds to specific projects, but

required that universities be accountable fiscally

to the government. The universities do not argue

over the need for accountability, rather about

how it can be accomplished. This indirect regulation derives in part from the retroactive application of increased standards and from the interpretations applied to key principles contained in

indirect cost calculation, and Office of Management and Budget (OMB) Circulars A-21 and

A-110.

%teven Muller, “A New American University, ” testimony before

the U.S. Congress, House Committee on Science and Technology,

published as National Science and Technology Policy Issues, 1979.

7Robert L. Sproull, “Federal Regulation and the Natural Sciences, ”

Bureaucrats and Brainpower: Government Regulations of Universities, Paul Seaburg (ed, ) (San Francisco, CA: Institute of Contemporary Studies, 1979), p. 72.

Indirect costs. Donald Kennedy, President of

Stanford University, has referred to the university-government indirect cost reimbursement system as “the basic fabric of understanding and trust

that has supported science for 30 years.”8 During those decades, “government policy has held

indirect costs to be an entirely legitimate part of

total research costs, ” but as these cost rates have

increased, and the resources for research at the

Federal level have become more constrained, the

rates-–and the accounting necessary to calculate

them-–have become an increasing source of tension, Many university administrators and scientists argue that the process of including an indirect

cost rate in a research proposal significantly affects research because it can act to array a principal investigator and his/her sponsor or granting agency against the institution—a polarization

that is “damaging to morale and, ultimately, to

research.”9

Indirect costs are paid as grant overhead to institutions to cover maintenance, administrators’

salaries, and other operating expenses. A 1984

General Accounting Office (GAO) Report calculated that, in the last decade, indirect costs have

increased so much that they now account for

about 30 percent of all National Institutes of

Health (NIH) extramural grant expenditures (up

from 21 percent in 1972) .10 Each institution receiving a grant negotiates its rate. The Department

of Health and Human Services (DHHS) may audit an institution to determine whether indirect

cost claims are valid. OMB’s Circular A-21 “Cost

Principles for Educational Institutions” lists allowable categories of indirect costs. Government rules

allow for the varying circumstances of institutions, but they do require that methods used for

calculations be consistent with sound accounting

principles. The disagreement over the reality of

indirect costs, and what the costs of research

should include, form a major part of the problems surrounding this topic.

Indirect cost rates are based on the most recent

actual expenditures for indirect costs. The costs

‘Donald Kennedy, “Government Policies and the Cost of Doing

Research, ” Science, vol. 227, Feb. 1, 1985, p. 482.

‘Sproull, op. cit.

10National Academy of Sciences, Strengthening the GOvernmentUniversjty Partnership in Science (Washington, DC: NAS, 1983),

p. 129.
75

rates are recomputed annually and submitted to

a granting agency for evaluation, which uses one

of two main systems for determining and reimbursing indirect costs. The NIH requires that principal investigators submit proposals that specify

only the direct costs of the research proposed, Peer

reviewers see only the direct cost budget. A separate award is made to the institution for indirect

costs. Other agencies, such as the National Science

Foundation (NSF), the Department of Defense

(DOD), and the National Aeronautics and Space

Administration (NASA), require that proposals

include both direct and indirect costs, and

reviewers see the complete budget. If an award

is made, the approved budget must be based on

the last negotiated indirect costs rate for the institution on the grant. If this rate is out of date

(as can occur), then rising indirect cost rates can

limit the funds available to a researcher on a project-by-project basis.

As indirect cost rates rise, research budgets buy

less. Some researchers “consider payment of indirect costs a subsidy for higher education and

a diversion of support for research.”11 University

administrators, however, see indirect cost recovery as essential to maintaining the research infrastructure.

Budget Circulars A-21 and A-110. Relations between the universities and the Federal Government were strained considerably in 1979 as a result of revisions to OMB Circular A-21 (Cost

Principles for Educational Institutions). In order

to allocate indirect costs, the universities were required to institute “time and effort” reporting for

employees whose salaries were charged in any

part to the research grant. The rule required

faculty to account for 100 percent of the time for

which they were compensated, regardless of the

fraction devoted to federally supported work. Although the OMB believed these procedures to be

necessary to determine if research funds were being used for the purposes designated by Congress,

academic scientists considered them a violation

of their autonomy. Emotions ran high. A. Bartlett Giametti, President of Yale, proclaimed:

I I u S Genera] Accounting office, Assuring Reasonableness @f ,.

Rising Indirect Costs on NIH Research Grants—A Difficult Problem (Washington, DC: 1984).

“Never have I seen the lash of federal regulations

applied to a crucial area of the nation’s intellectual life with such seeming indifference to financial and human consequences.“12 The stringency

of these OMB requirements has since been relaxed

somewhat. In fall 1982, for example, DHHS

awarded 22 contracts to large universities to test

a procedure whereby coordination audits would

be carried out by public accounting firms and

university auditing staff. For research administrators, this change meant added responsibility and

the imposition of a cost previously borne by the

Federal granting agency, but it allowed the independent auditors to conduct an audit that better

reflects the research environment in the institution under investigation. This single-audit concept, now allowable for all grantee institutions under 1982 revisions to Circular A-21, provides for

greater flexibility in university reporting of time

and effort, Some universities, Yale University and

Stanford University, in particular, have negotiated agreements with OMB that allow them to

eliminate time and effort reporting for the time

being. ’3

Concerns about the regulatory nature of the

Federal grant relationship date back to the 1960s.

A U.S. Commission on Government Procurement—set up in response to widespread concern

about grants and contracts administration rules—

found that procurement-type Federal controls

were being inappropriately applied to grant-type

assistance relationships. The Commission’s recommendations to deal with this problem were implemented eventually in the Federal Grant and Cooperative Agreement Act of 1977 (Public Law

95-224), which distinguished Federal assistance

from Federal procurement and required that grant

relationships entail minimal government involvement in grantee affairs. However, OMB guidance

issued to implement the act failed to require that

Federal agencies use the grant in the fashion envisioned by the act, thereby vitiating its regulatory-reducing effect .14

“See discussion of these agreements in Report o} the Workshop

on the Effort Reporting Requirements of OMB Circular A-21 (Washington, DC: Nat ional Academy of Sciences, 1984).

“Quoted in Dickson, op. cit., p. ~8.

I JI Robert NeW~ton, Nationa] Science Foundation, persona] communication, 1~85.
76

In the late 1970s, the National Commission on

Research concluded that the administrative and

fiscal controls used by Federal agencies in the support of academic research interfered with the conduct of research. During the same period, NSF

and the Association of American Universities conducted an experiment in grant administration that

resulted in NSF delegating to grantees the responsibility for administering most Federal controls.

More recent discussions have focused on problems caused by discrepancies between Federal

rules, and so there are proposals now for a simplified and standardized Federal approach to the

support of academic research. Such an approach

might reverse or remedy the fragmentation of research programs caused by multiple sources of

Federal support, might reduce overall research

costs, and might increase research productivity.

Federal administrative and accounting rules might

begin to match the realities of how research is conducted. One way would be to recognize the researcher’s program of research as the administrative and accounting unit. Under the aegis of the

National Academy of Sciences Government-University-Industry Research Roundtable, a Federal

effort is being undertaken to demonstrate such a

simplified arrangement, including a demonstration project for the Federal support of academic

research in Florida.

 

PROTECTIVE LEGISLATION AND AGENCY RULEMAKING

Antidiscrimination Statutes

Several statutes bar recipients of Federal financial assistance from excluding persons, because

of their color, race, sex, or national origin, from

participation in federally supported activities.

These antidiscrimination statutes apply to recipients of NSF and NIH grants and compliance must

be assured prior to receipt of funds.

Section 602 of the Civil Rights Act of 1964 requires Federal agencies and programs to issue regulations implementing Title VI of the Civil Rights

Act. The act provides that no person shall, on the

grounds of color or national origin, be excluded

from participation in, be denied the benefits of,

or be otherwise subjected to discrimination under any program or activity receiving Federal financial assistance. These regulations are also

applicable to sub-grantees, contractors, and subcontractors of a grantee. Grant applicants must

issue an “Assurance of Compliance” to be filed

with the agency. * Similar assurances must be filed

by the grantee to assure compliance with the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975.

Title 1X of the Education Amendments of 1972

prohibits the exclusion of persons on the basis of

sex from any education program or activity re-

*See National Science Foundation and National Institutes of

Health Grant Policy Manuals.

ceiving Federal financial assistance. NSF interprets

this to apply to grants under their Science Education Programs but not to grants for scientific

research. Public Health Service (PHS) grantees,

however, are required to submit an assurance to

the Office for Civil Rights, Office of the Secretary, DHHS, before a grant, sub-grant, or contract under a grant maybe made. In addition, all

PHS grantees are encouraged to “adopt practices

that will eliminate sex discrimination and encourage sex fairness, including but not limited to, using

language that represents both genders, avoiding

sex stereotyping, and representing women equitably in leadership and policymaking positions. ”

Small Business Innovation Research

Programs and Use of Services

Regulations

Federal research funding and how the grantees

use those funds are subject to laws and guidelines

that are intended to promote opportunities for

small businesses and minority-owned businesses,

and to favor American businesses over foreign interests. Under Public Law 97-219 (the Small Business Innovation Development Act) each agency

with a qualifying research and development (R&D)

budget in excess of $100 million must establish

a Small Business Innovation Research Program

(SBIR). Each agency must set aside 1.25 percent

of its extramural R&D obligations for its SBIR
77

— —

program. The SBIR program is intended to provide a mechanism for opening up Federal R&D

opportunities for small high-technology firms.

The Departments of Agriculture, Energy, Transportation, and Interior; the National Research

Council; the Environmental Protection Agency

(EPA); DOD; DHHS; NASA; and NSF are all required to participate in this program. In addition,

funds flow indirectly to small firms through the

subcontracting requirements of Public Law 95-

507, which requires that large prime contractors

must subcontract part of their Federal work to

small firms.

Executive Order 12138 of 1979 establishes a national program to foster the role of women in business, by encouraging preference in procurement

and the deposit of Federal funds. Executive Order 11625 of 1971 strives for the same goals for

minority-owned businesses. Recipients of NSF

grants are also encouraged, but not required, to

use banks owned at least 50 percent by minority

groups or women. In addition, according to the

International Air Transportation Fair Competitive Act of 1974, grantees must use a certified U.S.

flag carrier for foreign transportation of persons

or property, for purposes of the research, unless

not available.

Privacy Legislation

The Privacy Act of 1974 (Public Law 93-579)

provides certain safeguards for individuals against

ENVIRONMENTAL LEGISLATION

Until the end of 1984, EPA regulations for the

control of hazardous wastes under the Resource

Conservation and Recovery Act (RCRA)17 had

limited influence on some research activities, because they established regulatory exemptions for

“small quantity” generators18 but held all other

generators subject to the full range of regulatory

requirements. To avoid regulatory costs and other

burdens, many research institutions sought to stay

within EPA’s limit for small quantity generators.

Chemical associations also promoted the concept

1-42 U.S, ~. Sections 6901 et seq

‘“40 cFR part 261 ,

invasions of personal privacy. These include: 1)

the right of individuals to determine what information about them is maintained in Federal agencies’ files and to know how that information is

used; and 2) the right of individuals to have access to such records and to correct, amend, or request deletion of information in their records that

is inaccurate, irrelevant, or outdated .15

The act imposes requirements on Federal agencies with respect to the manner in which they

collect, use, disseminate, and maintain records

containing information pertaining to specific individuals. Thus, information obtained for one

purpose cannot be used for other purposes without the consent of the concerned individual. This

regulation applies to records maintained by PHS

with respect to grant applications, grant awards,

and the administration of grants, as outlined in

DHHS regulations that implement the Privacy

Act. 16 Records maintained by grantees, however,

are not subject to these regulations.

“Public Health Service, “Grants Policy Statement, ” December

1982, p. 15.

’045 CFR 5b,

and practice of waste stream reduction in process industries and laboratories. 19 In November

1984, amendments to RCRA severely limited these

exemptions by requiring EPA to regulate generators of as little as 100 kilograms a month .20 It will

be more difficult for research facilities to avoid

RCRA regulations in the future.

Other laws administered by EPA have led to

further unintentional regulations of research activities. Research laboratories that emit air and water

1 gsee L,ess IS L?etter: LabOrafOV Chemical Management for Waste

Reduction (Washington, DC: American Chemical Society, 1985).

2042 U, S.C. Sections 6931(D), added by Public Law 98-616 (1984).
78

pollutants are subject to EPA regulations under nificantly, especially when the research involves

the Clean Air Act21 and the Clean Water Act,22 highly toxic substances.

as well as corresponding State statutes. Research- Laboratory research in industry, universities, ers will have to secure permits and comply with

EPA and State permit restrictions on the discharge and government may also be affected by such

things as EPA regulations on disposal of hazard- of these pollutants. These “end-of-pipe” emission

restrictions can influence the research process sig- ous waste, health regulations set by the State or

city in which the laboratory is located, and regulations on handling nuclear and other hazardous ~ 142 LJ .s. c. Sections 7401 et seq.

2233 U.S. C. Sections 1251 et seq. substances .

OCCUPATIONAL AND PUBLIC HEALTH

AND SAFETY REGULATIONS

As will be illustrated chapter 6, government regulations intended for business and industry can

have quite different effects when applied to

laboratory-based, university research activities.

Richard W. Lyman has observed that “universities are not quite the uniquely subtle and complex organisms they like to consider themselves,

but they do possess a good many characteristics

that make regulations suitable to a steel mill not

always relevant or appropriate [to a university].“23

Most of these regulations are of two types: regulations designed to apply to production, or pilot

plant activities and regulations aimed at achieving some social goal.

Some observers propose that, in principle, the

cost imposed on various economic or research

activities by regulation should be proportionate

to the potential environmental, health, or safety

impact of these activities; but others disagree

sharply with the argument that such regulation

takes industrial financial resources away from research, and cite a lack of evidence for those effects. 24

The protection of worker health is required by

such legislation as the Occupational Safety and

z ~Richard Lyman, quoted in Seaburg, op. cit.

Z~Brooks, Op. cit.; for a general discussion of the effect of health

and safety regulation on R&D, see, for example, Nicholas Ashford

and George Heaton, “Regulation and Technological Innovation in

the Chemical Industry, ” Law & Contemporary Problems, vol. 46,

No. 3, summer 1983, pp. 109-137; also see Nicholas Ashford, et

al., “Using Regulations to Change the Market for Innovation, ” klarvard Environmental Law Review, vol. 9, No. 2, 1985.

Health Act,25 by the Occupational Safety and

Health Administration (OSHA), and by other regulations. 26 The act concerns the general duty of

employers to provide safe working conditions for

their employees and for employer compliance

with OSHA regulations. The regulations limit

worker exposure to various physical, chemical,

and other agents and hazards to health and safety,

such as noise, radiation, or toxic chemicals. In

addition to requirements for recordkeeping, medical surveillance, and monitoring, the regulations

also set forth, on a generic basis, employee rights

to request OSHA inspections and to obtain access to medical records, exposure records, and

labels on hazardous chemical containers.

Right- To-Know Legislation

The need for people to obtain information on

the risks they run by working with hazardous

chemicals has recently prompted more specific legislation, which could have a significant unintended regulatory impact on research laboratories,

especially those based in universities. Although

current Federal regulations in this area do not apply to such laboratories, the recent State and proposed Federal “right-to-know” legislation could

have the secondary effect of creating new controls

on university laboratories. These laboratories

work with hundreds of chemicals in an experimental situation or do research on hazardous

chemicals.

2529 IJ. S. C. Sections 651 et Seq.

ZbL~ CFR part 1900.
79

— — —

In November 1983, OSHA issued a “hazard

communication” rule, 27 which establishes that

workers in the manufacturing industry have a

right to know about the chemical and physical

hazards in their workplaces. Manufacturers and

importers of hazardous chemicals, and their customers who use the chemicals in subsequent manufacturing activities, thus have disclosure duties

under the rule.

The rule initially requires that manufacturers

and importers of chemicals provide their customers with labeled containers and a Material Safety

Data Sheet (MSDS) for each purchased chemical

that has been determined to be hazardous. It also

requires that all firms in the manufacturing sector—both “downstream” customers and chemical manufacturers themselves—institute hazard

communications programs to provide information

to and train workers who could potentially be exposed to the chemicals.

The rights created by the OSHA rule do not

currently extend to workers in research laboratories that are not within the manufacturing sector. For research laboratories within the manufacturing sector, however, employers must:

●

●

●

ensure that labels on incoming containers of

hazardous chemicals are not removed or

defaced;

maintain any MSDSs that are received with

incoming shipments of hazardous chemicals,

and ensure that they are readily accessible to

laboratory workers; and

provide laboratory workers with information

and training on hazardous chemicals in their

work areas at the time of their initial assignment, and when a new hazard is introduced

into their work area.

Chemical manufacturers must comply with its

labeling and MSDS requirements by November

25, 1985. Employers, thereafter, must meet the

worker communication requirements by May 25,

1986.

The rule provides that it is intended to preempt

any state law pertaining to this subject, although

the OSHA administrator has indicated that

‘“29 CFR SectIons IQ IO. 1200

OSHA would not assert preemption over any

State rules until the effective date of the Federal

standard (Nov. 25, 1985). Nevertheless, in the past

3 years, numerous State and local governments

have enacted right-to-know laws and ordinances.

These enactments can be classified as follows:

1.

2.

3

Worker right-to-know laws are designed to

expand the rights created by OSHA by giving workers in other sectors access to technical information concerning the hazardous

substances to which they are exposed, and

by increasing the list of hazardous substances

to which such access rights apply.

Comprehensive community right-to-know

laws are designed to give local officials

and/or residents access to technical information concerning hazardous substances at facilities within a community, without regard

to the use to be made of that information.

Limited community right-to-know laws are

designed to give specified local officials access to technical information concerning

hazardous substances at facilities within a

community, for the purpose of facilitating

appropriate responses in the event of emergency and/or protecting emergency response

personnel.

Such laws are likely to face a legal challenge

on the grounds that right-to-know requirements

have been preempted by the OSHA rule.28 Like

the OSHA rule, typical State right-to-know laws

are limited in their application to a specific list

of hazardous substances, rather than to hazardous substances generally. For example, the Massachusetts law29 directs its Commissioner of Public

Health to compile a substance list. The initial list

included approximately 2,000 substances.

New Jersey’s law30 has been challenged, and

found invalid by a U.S. District Court, in its application to the manufacturing sector, due to

OSHA preemption. 31 It is still in effect for other

zsse~ for example, New Jersey Chamber of Commerce v. Hu~he~r.

12 OSHC 1121 (t). N.1,, Jan, 3, 1Q85), which invalidates New Jersey’s right-to-know law insofar as it applied to manufacturing industries.

‘*Massachusetts General Laws c 11 IF.

j~chapter 315 of the Acts of 1983,

1

‘New lerse?’ Chamber of Commerce v. Hughe?, op. cit.
80

industries, however, and requires State agencies

to compile three sets of lists: a short list of “Environmental Hazardous Substances” (now approximately 154 substances); a more comprehensive

list of “Workplace Hazardous Substances” subject to less thorough reporting requirements

(about 800-1,000 substances); and a “Special

Health Hazard” list of substances that pose special hazards because of their known carcinogenicity, mutagenicity, teratogenicity, flammability,

explosiveness, corrosivity, or reactivity.

The New Jersey law, as still valid, applies to

research laboratories that are part of facilities engaged in:

●

●

●

●

●

●

●

pipelines, transportation, communications,

electric, gas, and sanitary services;

wholesale trade, nondurable goods;

automotive repair, services, and garages;

miscellaneous repair services;

health services;

educational services; and

museums, art galleries, botanical, and zoological services.

The law also applies to State and local governmental laboratories. By exclusion, therefore, the

law does not apply to retail trades, the professions, most service industries, and R&D laboratories that are not part of a covered facility.

The Massachusetts law, as yet unchallenged

and now being implemented, exempts research

laboratories not involved in the production or

manufacture of goods for direct commercial sale.

Comprehensive right-to-know laws, of course,

are far less restrictive. Massachusetts, for example, requires that an MSDS for each substance at

an installation be filed with the Department of

Environmental Quality Engineering (DEQE) and,

on request, with a designated municipal coordinator from the community in which the installation is located. Thereafter, any community resident who has reason to believe that a hazardous

substance may be endangering public health or

safety may request an investigation by the municipal coordinator. If an investigation is deemed

necessary, DEQE can provide relevant MSDSs to

the petitioning resident in appropriate cases. The

investigation is intended to ascertain what, if any,

State or local action is necessary to protect the

health or safety.

The New Jersey law is even less restrictive. It

requires employers to submit environmental surveys to the Department of Environmental Protection (DEP) and the health department of the

county in which the facility is located, as well as

pertinent parts of the survey to local fire and police departments. Any person making a written

request would obtain a copy of the survey from

the DEP. In addition, a list of workplace hazardous substances at each installation and the MSDS

for each one were to be maintained by the Department of Health and made available on request

to any person.

In the 99th Congress, a number of legislative

proposals have sought to extend community rightto-know and accident control provisions. H.R.

963, introduced February 6, 1985, by Representative James Florio (D-NJ), would amend the Occupational Health and Safety Act of 1970 to permit States to adopt more stringent right-to-know

provisions for access to information. The “Chemical Manufacturing Safety Act of 1985, ” H.R. 965,

also introduced on February 6, 1985, by Representative Florio, amends the Toxic Substance

Control Act to add provisions concerning a community’s right to know of the risks, emergency

planning, and liability for hazardous substances

releases. Research laboratories and hospitals are

exempt, if the substance is used under the direct

supervision of a technically qualified person.

H. Con. Res. 53, introduced by Representative

Bob Edgar (D-PA), is a concurrent resolution expressing the sense of the Congress that all persons

have a fundamental right to know when they are

exposed to hazardous substances that may be dangerous to their health. In part it declares that the

Assistant Secretary for Occupational Safety and

Health should immediately revise the hazard communication standards to extend right-to-know

protection to employees in any service or industry that employs hazardous substances and that

the Federal right-to-know standards should set

only the minimum requirements that the States

must follow. On March 6, 1985, Senator Alfonse

D’Amato (R-NY) introduced S. 606, the “Community Right to Know Act of 1985 .“ It provides
81

for the annual notification to a city or county of

the presence of hazardous substances in or near

such city or county (within a lo-mile radius) by

the owner or operator of such a facility.

On March 21, 1985, Representative Robert

Wise (D-WV) introduced H.R. 1660, the “Hazardous Materials Manufacturing Safety Act of

1985.” Similar to H.R. 965, the bill would amend

the Toxic Substance Control Act to add provisions concerning a community’s right to know of

the risks, emergency planning, and liability for

hazardous substances releases. And finally, H.J.

Res. 225, “The Hazardous Substances ‘Right-toknow’ Resolution, ” introduced by Representative

Bruce Vento (D-MN) on April 4, 1985, mirrors

the H. Con. Res. 53 expression of a person’s fundamental right to know when they are handling

or are exposed to a hazardous substance that may

threaten their health and well-being. It also

declares that OSHA should immediately revise its

Hazardous Communication Standard to extend

“right-to-know” protection to all workers in industries and services and that the Federal standards should only be minimum requirements that

the States must follow. *

*These legislative initiatives contrast sharply with the political

assumptions directing similar European efforts, where public disclosure is limited, In 1979, the European Community adopted a

Directive, commonly called the Sixth Amendment, containing provisions for the testing of chemicals to be placed on the market, and

for the notification to governments of the results of such tests, as

well as for chemical classification, packaging, and labeling. The Sixth

Amendment requires an importer or manufacturer proposing to place

a new chemical on the market to submit a premarket notification

to the appropriate regulatory body of the member nation where the

substance is produced or imported. The notice must contain health,

environmental, and physio-chemical test data on the substance, estimated volume and uses, and recommended precautions. On the basis

of the data submitted, packaging and labeling requirements may

be imposed, Exempted are substances subject to other regulatory

programs, such as medicinal and radioactive substances, waste substances and pesticides, research substances for evaluation, and substances marketed in quantities less than 1 metric ton per year per

manufacturer.

The most important European Community enactment on risk communicant ion for the control of chemical accident hazards is the

“Seveso Directive. ” This Directive is named for the town in Italy

where explosions at a Hoffman-LaRoche plant in 1976 spewed dioxin into the community, necessitating removal and testing of its

inhabitants.

Adopted in 1982, the Seveso Directive is to be fully implemented

by the member nations in 1989. Under the directive, a manufacturer who conducts activities which involve one or more of 178 designated substances must provide to the competent national authority: information on the substances and the processes used,

information on the installation (facility), information on possible

major accident situations, new information relevant to safety and

hazard assessment on a periodic basis, and special information on

multiple installations close to dangerous substances.

Each member nation is required to designate a competent authority

who will be responsible for receiving the information from the manufacturer, examining it, requesting additional information, developing an off-site emergency plan, organizing inspections, and determining that the manufacturer takes the most appropriate steps

to prevent major accidents and limit accident consequences. The

directive thus represents the most complete and integrated approach

taken to date to prevent chemical accident hazards. The directive

reflects European values in vesting full responsibility for public safety

in public officials, in restricting the flow of risk information to protect industrial secrecy, and in affording citizens and interest groups

no access to the risk communication process or to the information

outputs of the process.
Chapter 6

Institutional Differences
Chapter 6

Institutional Differences*

Research in the United States is performed in

a number of different institutional settings—in

university laboratories, in industry, in nonprofit

institutions, and in government laboratories. The

following profiles give examples of how some of

the mechanisms described in chapter 4 apply in

three different institutional settings. The profiles

are based on interviews and data gathered in actual laboratories.

PROFILE OF A REPRESENTATIVE INDUSTRIAL LABORATORY

After acquisition in 1981 by a major international chemical firm, this laboratory was made

part of a newly formed pharmaceutical products

division. One of the largest U.S. producers of

radioactive chemical compounds for life science

research and radiopharmaceuticals, the pharmaceutical products division’s research activities are

principally aimed at new product development,

at improving production efficiencies, and at developing radioisotope marking procedures for the

fields of radiopharmacology, life science chemistry, and biotechnology. In addition, the division

conducts research on industrial health and safety

improvement techniques.

Because the Laboratory’s primary function is to

develop and supply radioactive materials, a large

portion of the research is conducted to accomplish

this corporate marketing or production objective.

Some research is aimed at developing a marketable pharmaceutical that will receive U.S. Food and

Drug Administration (FDA) approval. Other research seeks to improve the efficiency or safety

of production processes. A small portion of the

division’s research is conducted under contract to

other industrial firms, principally to develop

product-specific radioisotope marking procedures

usable in their own research.

Control of the Research Agenda

Because the laboratory is a commercial facility, its research decisions are strongly influenced

by such considerations as the potential profit to

*This chapter is based on the regulations in force in three different laboratories. Interviews and data collection were performed by

Michael Baram and Raymond Miyares, Bracken & Baram, Boston,

MA, under contract to the Office of Technology Assessment.

be earned from new product sales, or the savings

to be anticipated from production efficiencies and

safety improvements. Funds for research are

deemed an investment and, as such, are expected

to pay dividends. The laboratory’s research

agenda therefore depends on corporate judgments

concerning the potential of research to yield

dividends.

In this regard, U.S. tax policy has, in recent

years, promoted research investments by granting business deductions or credits for research

expenditures—for example through the Internal

Revenue Code and the 1981 Economic Recovery

Tax Act (see ch. 4). The effect of these provisions

is to lower the effective cost of research to businesses and thereby to make the research more

likely to be profitable. To the extent that tax

breaks are given without regard for the content

of research, all forms of research are stimulated.

Virtually all of this laboratory’s research falls

within the categories eligible for preferential tax

treatment under current law.

The most important regulatory impacts on the

selection of research opportunities at this laboratory, however, are the result of policies or regulations of FDA. By specifying the evidence of

safety and efficacy it will require for new drug

approval, the FDA sets forth much of the research

agenda for product development. The FDA regulations also control the activities that may be undertaken with investigational new drugs. By specifying the protocols to be followed for each step

of such research, including toxicology and pharmacology procedures for animal testing and use

of human subjects, the FDA regulations chart the

course of new drug development research.

85
86

Outside of FDA requirements, the principal indirect impacts on the selection of research opportunities are higher costs resulting from compliance

with health, safety, and environmental regulations. Sometimes firms engage in research in order to control and reduce these costs. For example, the high cost of hazardous and low-level

radioactive waste disposal at licensed facilities

stimulates interest in development, production,

and recycling processes that produce less waste.

At this laboratory, decisions to undertake research

on ways to recover waste carbon isotopes and to

reduce the curies of tritium used to produce

tritium-marked products are attributable, in part,

to waste disposal cost increases.

Regulations can also raise the cost of the research itself and thereby deter a firm from undertaking it. This firm, for example, has thus far

declined to use P-3 level (high hazard) microorganisms in its biotechnology laboratory because

of the elaborate substance approval process required by National Institutes of Health (NIH)

guidelines. In interviews, company officials supplied other examples of research that they abandoned because of high regulatory compliance

costs :

●

●

●

The cost of establishing and maintaining a

laboratory “closed box” acceptable under

NIH guidelines and emission controls adequate to meet State air pollution requirements

was deemed so substantial that planned research utilizing aflatoxins was abandoned.

Similarly, the cost of obtaining an antidote

for the venom of an African poisonous

snake, in compliance with NIH guidelines,

was considered prohibitive and research utilizing the venom was dropped.

The Occupational Safety and Health Administration (OSHA) xylene and toluene exposure standards (to protect workers) were

considered too costly to comply with in research on liquid scintillation cocktails, so that

research was redirected to find scintillators

with less toxic components.

Controls on the Research Process

The protocols specified in FDA regulations dictate not only the type of research necessary to support a new drug but also the research procedures

to be utilized. Thus, to satisfy FDA, research must

meet regulatory requirements for a “scientifically

well controlled” study. Some of these steps are

undertaken for no other reason than FDA requirements; in the absence of FDA regulation, the research might be designed in a more streamlined

fashion.

For other types of research, regulatory requirements play a far less pervasive role. Research is

designed so as to be most likely to yield the desired

information. Because regulatory agencies have little interest in production efficiencies, much of the

research conducted in this area, for example, is

designed to suit the objectives of the researcher.

Management of Risks

Much of the division’s research is undertaken

by a permanent staff of scientists and technicians

who expect a long-term career with the company.

The long-term consequences of radiation and toxic

chemical exposure are as important to them as immediate health and safety effects.

Since its acquisition by an international corporation, this laboratory has undertaken to conform

its occupational and environmental health and

safety practices to those of its parent company,

which enjoys a national reputation for responsibility in this area. The laboratory has a safety executive committee of senior managers, with subcommittees on safety awareness, process hazards,

equipment safety, chemical safety, and radiation

safety. Every employee is required to attend a

monthly safety seminar, and regular inspections

are made, not only of the obvious hazards of

chemical storage areas, radiation shielding, and

electrical wiring, but also of the more mundane,

such as chair hazards. On-the-job injuries, lost

work time, restricted work time, medical treatment, and off-the-job injuries are reported

monthly to corporate headquarters.

The laboratory workers are protected by several

Federal and State regulatory programs. OSHA

regulations, the most comprehensive of these, set

general safety standards as well as exposure standards for toxic chemicals. Nuclear Regulator y

Commission (NRC) regulations specifically gov-
87

ern the safety of laboratory work on radioactive

materials and require dissemination of information to workers on any materials used in the laboratory and reporting of any incident involving

radiation exposure. NIH guidelines govern the

containment and security of micro-organisms used

in biotechnology research.

The firm’s preoccupation with safety also extends to environmental and community hazard

concerns. The laboratory conducts annual emergency training programs for local fire officials, police, and hospitals. In addition, it complies with

a panoply of Federal and State requirements for

construction and operation of industrial facilities.

The State plumbing code, for example, requires

separate piping in the biotechnology lab for human contact and contact with organisms. The Resource Conservation and Recovery Act and corresponding State requirements, as well as NRC

regulations, govern the disposal of hazardous and

radioactive waste. Federal and State air quality

regulations limit emission of radionuclides into

the air. And, in addition, regulations under the

Clean Water Act restrict the disposal of waste into

publicly owned treatment facilities as well as the

discharge of such waste into surface and groundwater. Under the Clean Water Act, even de

minimis spills of hazardous substances must be

reported.

Beyond these specific regulatory programs, the

potential for liability under the Federal Superfund

law, corresponding State laws, and the common

law influences the management of laboratory

risks. Such potential for liability provides an incentive for due care in the management and disposal of wastes and the emission of pollutants into

the environment. However, the incentive operates further to cause the company to reduce waste

generation so as to avoid strict liability even where

due care has been exercised.

Restrictions on Communication

of Information

As a manufacturer, the company is subject to

both the OSHA hazard communication standard

and the State’s right-to-know law, notwithstanding that law’s research laboratory component. Under both provisions, it must label—and supply its

customers with Material Safety Data Sheets

(MSDSs) on–all hazardous products sold. Company practice is to compile a notebook of MSDSs

for all its products sold and to disseminate the

same notebook to all customers with a printout

listing which products they purchased during the

previous 18 months.

The laboratory was in virtual compliance with

the OSHA standard prior to its issuance and is

encountering no significant difficulty in adapting

its prior community liaison activities to the State’s

right-to-know requirements. For laboratory workers, it is required, under the OSHA standard, to:

Ž ensure that labels on incoming containers of

hazardous chemicals are not removed or

defaced;

● maintain any MSDSs that are received with

incoming shipments of hazardous chemicals,

and ensure that they are readily accessible to

laboratory workers; and

● provide laboratory workers with information

and training on hazardous chemicals in their

work areas at the time of their initial assignments, and when a new hazard is introduced

into their work area.

The State has required further that the company

supply a list of the hazardous substances that it

uses, and an MSDS for each one, to local officials in both the State Capital and the town in

which the lab is located. Neither the OSHA nor

the State list of hazardous substances, however,

includes radioactive materials.

Although the laboratory often seeks to disseminate a product developed in its research laboratories, corporate policy necessarily restricts dissemination of information about its research or

about research results. Such information may be

legally patentable or protectable as a trade secret,

and corporate policy is to control dissemination

or publication of research data, especially on process refinements or improvements, unless there is

a valid business reason for dissemination. On the

other hand, the parent company’s policy is to disseminate fully any proven safety improvements

developed by corporate research laboratories.

Again, the potential for liability affects the

availability of information on research. The laboratory has a “document retention program” that
88

requires disposal of all documents not required

to be retained for a business purpose or by regulation, the objective of which is to avoid a paper

trail that could be used in enforcement or liability proceedings against the company. This proPROFILE OF A REPRESENTATIVE

INDEPENDENT LABORATORY

This cancer research center is one of several

teaching hospitals affiliated with a major medical school, although its Board of Trustees is fully

independent of the school. The center is involved

in cancer research of virtually all types, from cell

biology to clinical trials, with a special emphasis

on childhood cancers. Its research divisions include specialities in: biostatistics and epidemiology; cancer control, genetics, and pharmacology;

cell growth and regulation; immunogenetics; medical and pediatric oncology; medicine; and tumor

immunology and virology.

The center administers an annual budget which,

in 1984, exceeded $55 million. Of this amount,

approximately 45 percent was for patient care and

services and the remainder was for research. The

center maintains a 57-bed inpatient facility and

provided care through nearly 24,000 outpatient

visits in 1984. Approximately 50 percent of the

center’s patients participate in some form of clinical study, however, and the line between research

and patient care is not always precise.

Approximately 80 to 85 percent of the center’s

research is funded by Federal grants from NIH

and the National Science Foundation (NSF). Of

this amount, about 70 percent comes from the National Cancer Institute (NCI). Of the remainder,

most comes from private granting organizations

such as the American Cancer Society and the National Leukemia Foundation (principally for student fellowships). Approximatelys percent of research funds come from other private sources.

The center’s therapeutic research often involves

highly toxic chemical agents or radiation, and, of

course, the use of human subjects. The hazards

of the research may be concentrated on these subjects in some circumstances, and human subjects

must be informed of, and consent to, acceptance

gram can be seen as a prudent response to the

liberal discovery rights afforded litigants in the

courts today, but it may also cause information

on prior research to be lost to researchers within

the company.

NONPROFIT

of the related risks before participating in a clinical study in the hope of achieving therapeutic

benefits.

The center’s research staff of 600 includes approximately 350 with doctoral degrees. Much laboratory research is conducted by technicians. Such

technicians typically have a high turnover rate,

so that long-term exposure to laboratory chemicals and radiation is unusual. Nevertheless, some

research personnel, both professional and nonprofessional, perform research over a period of

several years.

Control of the Research Agenda

The center has a fairly formal administrative

hierarchy that sets the general theme of the research to be undertaken. Because the center is itself mission-oriented (i. e., devoted to cancer research), and its principal funding sources share

nearly the identical research mission, the center’s

broad outlines of research are not generally affected by considerations of funding availability.

To be sure, the work of an individual researcher

or laboratory might be terminated if funding were

withdrawn. Much of the research staff is dependent on continuing funding for their employment.

Further, if NCI were abolished or fundamentally

redirected, the center’s research agenda might be

substantially affected. The importance of cancer

research in American public health policy, however, makes the possibility of a major redirection

remote.

Indeed, it is this public policy commitment,

rather than the mission of funding sources, that

appears to affect the center’s selection of research

opportunities. For example, the center has thus

far declined to undertake a large amount of epi-
89

Box A.—An Assessment of Regulatory Forces by Lab Directors and Research Administrators

In March 1985, OTA sent questionnaires to 32 university research administrators (deans and vice

presidents) and 112 laboratory directors around the United States. The two groups were selected because of their varying roles in the university research process; administrators tend to be intimately

involved in the research administration policies established and followed within the university and the

lab directors are more involved with concerns linked to their particular field. The laboratory director

group was selected from the Gale 1984-85 Research Centers Directory. Out of the 7,427 entries for the

United States and Canada, at least two were chosen from every State and from the disciplinary divisions

according to the following proportions: agricultural and nutrition sciences, s percent; astronomy, 5 percent; engineering (research), 20 percent; life sciences, 20 percent; mathematics and computer sciences,

20 percent; physics, 25 percent; and social sciences, 5 percent. Laboratories of all sizes were chosen randomly within the above parameters. The response rate for this group was 23 percent.

The research administrators were chosen from the top 32 research universities in the country based

on the level of Federal funding for research, according to the NSF Academic Science R&D Funds: Fiscal

Year 1980, Surveys of Science Resources Series. Forty-four percent of the research administrators responded to the survey. The aggregate response rate was 27.7 percent.

Participants were asked to identify major regulatory forces in their research institutions, trends in

regulation of research, and channels or forums for discussing solutions to potential problems. In general, there were few differences in the forces listed between the responses of the two groups.

Major Regulatory Forces.—The regulatory forces listed by the respondents can be classified into

four major areas: controls on substance, whereby nonscientific forces are setting or influencing the research agenda; controls on process, whereby the nature of the research is not under consideration, but

the means and methods used to accomplish the research goals are regulated; administrative constraints

(including the funding process); and restrictions on dissemination of research results.

Clearly, the regulatory forces that are most keenly felt by both groups are the Federal guidelines

for the protection of human participants and animals in research. But following closely in the ranking

are many unintentional regulatory forces, such as environmental, health, and safety legislation intended

to protect the general public; or radiation safety regulations, environmental and worker protection laws,

and Good Laboratory Practice Standards intended to protect labor.

Administrative constraints were listed as a major area of concern by 37.5 percent of all respondents. Perhaps predictably, university administrators saw the financial accounting requirements as most

pernicious. When the responses are disaggregate, 64 percent of the administrators v. 23 percent of the

lab directors, listed financial accounting requirements as a major force.

Both groups found “social regulations” to play a major role, Social regulations include laws to encourage small business and minority business subcontracting, Fair Labor Standards, and Equal Employment Opportunity Commission and Affirmative Action requirements. Because respondents were not asked

to rank their answers, it is not clear how much of a force they feel these regulations present. The frequency of responses, however, indicate that they are not as significant a force as the administrative and

accounting requirements.

There was not a strong indication that either group feels that there are major regulatory forces affecting

the research agenda, although a few respondents from each group indicated that national priority setting is increasingly affecting the research agenda, particularly as a result of increased defense spending

and concern about industrial competitiveness. Only 17.5 percent of the respondents listed controls on

dissemination of research results as a major force.

When asked whether they believed that the controls they had listed were any different from controls experienced by other universities, 86 percent of the administrators responded that they did not feel

“singled out.” The major regulatory forces affecting them are most likely the same for other research

institutions.
90

demiological research in the area of cancer prevention because of its doubts about the long-term

commitment of NCI to such research. A cancer

prevention epidemiological study would require

a commitment to long-term funding without any

important intermediate benefits to be derived from

the research. National policy, in contrast, focuses

on research with measurable output within a short

time span, and the center has rot been satisfied

that funding for cancer prevention or epidemiological studies would not be terminated before usable results could be achieved.

With this exception, the principal factor governing the choice of research activities is the individual strategy of the principal investigator. Because

staff investigators are selected on the basis of the

congruence of their expertise and interests with

the center’s research mission, the focus of its effort is maintained without any formal structure

to review research proposals for consistency with

the center’s objectives.

Virtually all of the research conducted at the

center is investigator-initiated, and very little is

contract work. NIH and NSF proposals—as well

as others—are peer reviewed, and this review, in

some instances, may tend to discourage funding

of highly innovative research projects in favor of

more conventional undertakings. However, the

vagaries of peer review are regarded as less influential on an organization such as this center

than they might be for another research facility

of lesser reputation.

The impact of all types of government regulation on the selection of research opportunities is

also fairly minor. The cost of compliance with regulatory requirements is incorporated into grant

applications and is rarely so significant that funding is jeopardized. Moreover, the very properties

that make a substance or procedure a candidate

for regulation often also make it attractive as a

subject for research.

Control of the Research Process

Because NIH funding is so important to the

center’s research, the protocols established by that

agency strongly influence the conduct of that research. Moreover, NIH guidelines have become,

in many instances, the industry custom for laboratory research, and thus are followed even beyond the jurisdiction of NIH. NIH has published

guidelines for animal testing, for the use of human subjects, for recombinant DNA research, and

for the use of investigational drugs. The latter

guidelines apply when NCI provides a pharmaceutical on which research is to be conducted; if

an investigational drug were applied by a private

firm, the firm would have to obtain FDA approval

and meet FDA requirements established for such

drugs. In general, the center attempts to relieve

its researchers from the nonsubstantive burdens

of these guidelines and to assign to administrative staff the responsibility for paperwork and

managerial burdens.

A more fundamental effect on the conduct of

research is perhaps caused by the structure of the

usual grant agreement. Although NIH is authorized to make research grants for up to 7 years,

the typical grant is generally for 3 to 5 years and

never longer. On the average, an NIH grant provides 31⁄2 years of funding. This limit is set, not

so much by policy considerations, which arguably favor longer grants that are relatively easy to

administer and require burdensome administrative procedures less frequently, as by the demands

of peer review. Often reviewers recommend funding for less than the total period of time requested

in order to allow for thorough review at frequent

intervals. A possible impact of such temporal

limits, however, is to promote research protocols

that permit tangible work products in shorter time

periods.

A principal limitation of NIH funding is that

it does not fully cover experimental patient care.

This is not a reflection of any NIH judgment that

it is not responsible for experimental patient care,

but rather a dictate of the limitations of available

funds. Third-party procedures (e.g., Medicaid and

Blue Cross/Blue Shield), in contrast, do not assume responsibility for experimental clinical procedures. Thus, a gap exists, at least in theory, between NIH funding and third-party procedures.

In practice, the gap is less significant than it appears, in part because the line between clinical research (nonreimbursable) and “best patient care”

(reimbursable) is not precisely drawn. However,

as pressure to control medical costs increases,

third-party providers are likely to draw a more

restrictive line of distinction and more experi-
91

mental patient care may have to be funded by

NIH.

Management of Risks

The center is subject to OSHA, the Environmental Protection Agency, and NRC regulations

governing work place safety, environmental protection, and radiological health. The center’s Division and Laboratory Chiefs are responsible for

assuring compliance with such regulations by

those they supervise. In addition, the center is subject to the Joint Committee on Hospital Accreditation, a hospital self-regulating organization that

approves radiation, chemical, and biological

safety programs. The State and city in which the

laboratory is located further regulate aspects of

health, safety, and environmental hazards, including fire and chemical hazards and the biohazards

of recombinant DNA.

As noted, NIH guidelines govern the use of human subjects in research, and these guidelines generally require the approval of the research protocol by an Institutional Review Board and the

informed consent of the human subject or legal

representative. Typically, the center has found,

its patients are relatively sophisticated about the

nature of their disease, the hazards of research,

and the potential for harm. The center is a tertiary care facility, and the majority of its patients

have substantial experience with medical procedures and treatments. Therefore, the content of

its informed consent form can sometimes be relatively more technical than corresponding documents at other facilities such as at a primary care

hospital.

The informed consent form states the center has

“no formal policy” with regard to compensation

of research subjects who are injured in the course

of research. In practice, medical cost incurred as

a result of such injury might be paid by the thirdparty provider. In particular circumstances, however, the center might seek to assume or divide

these costs.

Controls on

Information

Communication of

Because the center regards its staff to be both

intelligent and well-educated, it relies on the provision of chemical and radioactive hazard information as the principal instrument for managing

risk hazard. The center employs one half-time

chemical safety information officer whose exclusive responsibility is to provide relevant information about substance hazards and appropriate

precautions and responses, as well as to perform

laboratory inspections.

The center, however, is not subject to either the

OSHA hazard communication standard or the

State right-to-know law. The OSHA standard, as

noted, applies only to workers within the manufacturing sector. The State law exempts research

laboratories not involved in the production or

manufacture of goods for direct commercial sale.

The regulations issued under the law require an

application for an exemption to be filed by each

laboratory. The center has filed such an application and, while that application is pending before

the State department of public health, the center

is exempt from right-to-know requirements.

A principal objective of the research conducted

at the center is the dissemination of user results.

Dissemination serves the interests of the center’s

mission by advancing the state of knowledge

about cancer and also enhances the reputation and

standing of the center and its staff. Therefore, the

center will not accept research funding that requires secrecy. Nevertheless, some limits on dissemination are accepted. Grant agreements may

specify, for example, that publication of research

results might be delayed for up to 3 months in

order to allow for review by the sponsor. Such

limits do not generally appear in NIH or NSF

grant agreements. Indeed, the policy of Federal

funding organizations is to stimulate the dissemination of research results, and failure to publish

may be considered negatively in evaluation of new

grant proposals.
92

A theoretical restriction may also derive from suits seemingly adverse to private clients. Such

the practice of some center staff to consult pri- an impact may be completely unconscious and imvately for industry. In such circumstances, the possible to demonstrate, but the restriction may

staff member could feel disinclined to publish re- nevertheless operate.

PROFILE OF A REPRESENTATIVE

The Department of Chemical Engineering at

this major research university engages in a range

of research projects and activities in support of

the academic development and advancement of

its students and faculty. Although much of this

research is funded from outside sources, the department does not principally engage in client

services, but rather seeks grant support for research into chemical transformation and separation processes, and energy intensive functions of

relevance to the interests of its members. The principal areas of interest include coal conversion,

synfuels developments, utilization of micro-organisms in chemical processes, and polymer production. Approximately 30 to 40 percent of the department’s research funds come from private

sources (e. g., one international corporation contributes $1 million annually); the remainder are

Federal grants, principally from the departments

of Energy and Defense (DOE and DOD) and NSF.

Much of the department’s research is conducted

at a very small scale, utilizing small quantities

(often less than a gram) of chemicals in any particular step. However, a great variety of chemicals

are involved in the department’s research programs so that the cumulative hazard of the research is highly variable. An exception to this pattern of low volume and high variety is in the area

of combustion engineering, in which substantial

volumes of petroleum products are burned in the

course of research.

In many instances, laboratory research is conducted by students rather than by staff technicians. Because the turnover rate for both students

and technicians is fairly high, most of the people

who work in the department’s labs are not subject to long-term exposure to laboratory chemicals. The students, however, may be more vulnerable to risks because they are relatively naive

and untrained in laboratory safety procedures and

may be somewhat less cognizant than career

UNIVERSITY LABORATORY

workers of the hazards of their research. This situation influences the amount and type of safety

measures taken by the university.

Controls on the Research Agenda

Because the university lacks the formal hierarchical administrative structure of a commercial

enterprise, decisions to undertake research are

relatively individual and idiosyncratic, rather than

directed by an overall institutional strategy.

Clearly, the availability of funding affects the research agenda, but this financial incentive differs

from that of an industrial laboratory, which must

make its research choices based, in part, on an

estimate of the market impact of the anticipated

results. Further, because of its stature in academic

circles, the department carries considerable weight

in negotiations with potential sponsors over the

content and conduct of its research activities.

This is not to say that research sponsors have

no influence over the manner in which their funds

are utilized. Many Federal sponsors and some

foundations, as well as virtually all commercial

sponsors, are mission-oriented. Such sponsors

make their grant awards based on whether they

perceive the research to promote their particular

mission objectives. Approximately 75 to 80 percent of the department’s research funds come from

such mission-oriented sponsors, which include

DOD and DOE, the petroleum and chemical manufacturing industries, integrated circuit manufacturers, and pharmaceutical companies. The remainder comes from sponsors seeking to support

“basic” research–some DOE programs, NSF, and

private foundations.

The impact of regulation on the selection of research opportunities is, by contrast, fairly minor

compared to the academic interests of the faculty

and the mission objectives of sponsors. Because

the department’s research seeks to be at the cut-
93

ting edge, regulation addressing the specific substances or processes under investigation may not

yet have been developed. The cost of complying

with health, safety, and environmental regulations

is rarely so significant that research is foreclosed.

To the extent that such regulation raises the cost

of certain lines of inquiry and thus may divert attention to other research activities, this effect is

countered somewhat by intellectual interest in

studying “problem” chemicals and process—those

that may be the subject of extensive regulatory

attention.

Because combustion engineering research has

different characteristics from other research conducted in the department, the effect of regulation

of this research is also somewhat different. In particular, research into the emissions produced by

combustion processes requires the use of substantial volumes of fuel. Often, from a purely research

perspective the fuel of choice would be benzene,

but benzene is the subject of such intense regulatory scrutiny that researchers are reluctant to use

it if a relatively less problematic alternative such

as toluene is available. This reluctance stems both

from current regulatory activities (principally by

OSHA) and from the concern that department researchers share with regulators over the hazards

of the substance.

A similar effect may be discerned with respect

to the use of radioisotopes in research. Because

of the regulatory burden of becoming licensed to

handle radioisotopes and the cost of their disposal

under NRC regulations, their use is discouraged

if alternative research procedures are available.

Again, the effect may be to skew the allocation

of research resources.

Controls on the Research Process

Most research grant agreements specify how research activities are to be conducted; but the level

of specification varies considerably with the sponsor. Sponsors of basic research typically require

a proposal that sets forth the research protocol

in sufficient detail to allow reviewers to judge the

technical adequacy of the research. Such protocols

are often thereafter incorporated by reference into

grant agreements, but most sponsors do little supervision or monitoring of performance under

these agreements.

Industrial sponsors may provide “foundation”

grants intended to support the department’s general research activities, rather than any particular project. Such broad grants are less likely to

constrain the specific conduct of research. When

industrial sponsors underwrite a particular research project, however, the grant agreement may

include specification of the research protocol. Surveillance of the department research, however,

is somewhat more extensive in that reporting requirements are more often imposed and site visits

more frequent.

Mission-oriented Federal agencies, such as

DOD and DOE, tend to specify research protocols

in the greatest detail. Such protocols are drafted,

not only to assure the technical adequacy of the

research, but also to assure that research results

will be usable by the sponsor in achieving its objectives. Commonly specified details include performance requirements, cost allocations, equipment, milestones, and personnel. This greater

specification is typically accompanied by greater

supervision and monitoring of the research. The

Department of Defense is especially strict in its

surveillance of the research it sponsors; however,

this university does not automatically comply

with DOD’s (or any other sponsor’s) requests for

secrecy in the conduct of research. Because it is

an academic institution principally devoted to

education, the university laboratories are widely

open to students and faculty. Classified or weapons-related research is deemed an inappropriate

activity for an academic institution, although it

may be conducted at university affiliated laboratories off campus.

Management of Risks

The university maintains a Safety Officer and

an Office of Environmental Medical Services

which are intended as a resource to consult in the

design of laboratory risk management activities

and to facilitate compliance with environmental,

health, and safety regulations. In addition, the

university faculty maintains nine standing committees that develop risk management procedures

to be used in research:

● Council on Environmental Health and

Safety,

• Committee on Assessment of Biohazards,
94

●

●

●

●

●

●

●

Committee on Radiation Protection,

Committee on Safety,

Committee on Animal Care,

Committee on the Use of Humans as Experimental Subjects,

Committee on Toxic Chemicals,

Committee on Radiation Exposure to Human

Subjects, and

Committee on Reactor Safeguards.

The university will not approve a grant agreement

or research contract that has not been approved

by the committee having jurisdiction over such

research.

In general, the safety practices established by

these offices and committees are equivalent to, or

more stringent than, corresponding regulatory requirements. Often, the faculty have been involved

in the development of Federal regulatory requirements and their influence is reflected in the requirements adopted. Nevertheless, researchers are

always alert to proposals for regulatory requirements that specify unachievable standards or unworkable administrative burdens, For example,

a new State plumbing code originally would have

required that no micro-organisms be disposed of

in the wastewater of laboratories where biotechnological research was being conducted, even

though there are safe and acceptable levels of

micro-organisms commonly allowable in wastewater generated by nonresearch facilities.

The department’s laboratories are subject to a

range of environmental and occupational safety

and health requirements that typically include: 1)

safety or health standards for emissions of, or exposure to, a particular substance; and 2)

documentation of compliance with such standards. Many of these regulations specify the chemical substance as the unit of regulatory attention,

and the paperwork burden of reporting requirements varies with the number of chemical substances used in research. Because department research typically utilizes tiny quantities of a

multitude of chemical substances, the paperwork

burden is substantial even though the exposure

and emission standards may be fairly easy to

achieve.

An example is provided by the regulations under the Resource Conservation and Recovery Act

(RCRA) for hazardous waste disposal. These regulations essentially prohibit the disposal of substances on the hazardous waste list by conventional means (emission standard =0) and instead

require that licensed hazardous waste transporters

and disposal facilities be utilized. The regulations

further specify the packaging and paperwork requirements to be followed in the disposal of hazardous wastes. At this university, hazardous

waste from chemical engineering laboratories is

sent to the safety office where such waste is collected from all parts of the university. Much of

this waste is unique and packaged in tiny vials.

Traditional practice has been to combine vials of

compatible wastes in “laboratory packs’’—conventional drums lined with absorbent material—

before shipping them off for disposal. The regulatory manifest, however, requires that the contents of each vial in the lab pack be separately

identified, and monthly and annual generator reports required under RCRA also must include information on each vial. Because the waste in each

vial may be unique, the information necessary to

complete the manifest may not be routinely available, and the safety officer may encounter some

difficulty in preparing the waste for shipment. A

barrel of industrial waste, in contrast, is likely to

contain only one waste type that is routinely generated. The paperwork burden for this barrel is

correspondingly light: Only one substance needs

to be identified on the manifest and the information to be provided is the same day after day.

Similarly, the State’s Clean Air regulations require an individual permit for each vent through

which air pollution emissions are made. The

university has approximately 20 such permits for

the Department of Chemical Engineering and each

one is supposed to include a specification of the

substances being emitted as well as the technology being employed to reduce those emissions.

Because laboratory work varies over time, however, any specification of substances in the permit is necessarily uncertain. Moreover, if an

honest effort is made to specify all of the substances likely to be utilized in the laboratory, the

permit application must then demonstrate that the

technology is in place to reduce emissions of the

full list of substances. Nothing in this State law

exempts from the permit requirement substances

that are being emitted in de minimis quantities.
95

Essentially, these two environmental regulatory

programs were devised with a different model of

facility in mind; it is increasingly apparent that

regulations devised for industrial facilities may be

poorly suited for application to research laboratories. RCRA regulations do include a partial exemption for small quantity generators, but this

is of no use to the university, which clearly does

not qualify as a small generator because of its substantial total volume of waste. If paperwork burdens are to be more closely related to the hazards

of the regulated activity, new efforts are required

to tailor regulatory requirements to the type of

enterprises being regulated.

One such effort is suggested by the statement

of projected rulemaking issued by OSHA on April

29, 1985, concerning health hazards of chemicals

in laboratories. In that statement, OSHA observed:

Existing OSHA standards are designed to protect employees who are engaged in work involving exposure to only a few toxic chemicals during relatively standardized, continuous or

repetitive processes. In contrast, laboratory

workers are exposed to a multitude of toxic substances under frequently changing or unpredictable conditions. OSHA will examine whether

prudent work practices and protective equipment, chosen for the specific facility and task,

are more effective, feasible and economical for

laboratory work than adhering to OSHA’s current substance specific exposure standards.

Such a proposal appears to be better suited to

achievement of the goals of environmental, health,

and safety regulations than the traditional ap -

proaches. The effect of traditional regulations, in

many instances, is to consume the time of safety

personnel in the documentation of compliance

rather than to stimulate such people to devote

their time to analyzing problems for which routinized solutions are not readily achievable.

Restrictions on Communication

of Information

It is the formal written policy of the university

that people who may be exposed to hazards

should be informed about the nature of these hazards and how to protect themselves and others

who also may be exposed. Faculty, administration, and research supervisory personnel are responsible for promoting safe practices and for informing individuals working in laboratories about

safety in connection with the work being conducted.

This policy derives from the university’s assessment of its own responsibility under ethical and

general liability principles rather than from a particular hazard disclosure regulation or statutory

requirement. For example, the OSHA hazard

communication standard applies only to workers within the manufacturing sector. Therefore,

no university laboratory is subject to its requirements.

Similarly, the State right-to-know law exempts

research laboratories not involved in the production or manufacture of goods for direct commercial sale. The regulations issued under the law require an application for exemption to be filed by

each laboratory. The Department of Chemical

Engineering has filed such an application for its

laboratories, which is presently pending before

the State Department of Public Health (DPH). Under the regulation, the department is exempt until DPH rules on the application.

Nevertheless, the State law does affect university operations in other ways. A number of vendors have terminated all business in the State in

response to the law, so that alternative vendors

have had to be found in some instances. In addition, MSDSs being supplied with chemical products sometimes appear to have been prepared by

lawyers to achieve minimal compliance with regulatory standards and to provide the least incriminating information possible, rather than by

persons desirous of promoting proper management of substance hazards. For this reason, when

the university is establishing safety procedures,

it frequently uses MSDSs prepared by an independent service, rather than those supplied by

manufacturers.

Clearly, a principal objective of academic research is publication and dissemination of research

results both to advance the state of knowledge in

the research field and to advance the reputation

and study of the department and its faculty. As

noted, therefore, the university will not approve
9 6

funding arrangements that require secrecy in the

conduct of research and the dissemination of

results.

Nevertheless, some limits on dissemination are

common. Grant agreements may specify, for example, that publication of research results must

await a release by the sponsor. In some circumstances—for example, where proprietary information has been licensed to the department for the

conduct of research—the sponsor may require

that articles proposed for publication be submitted

for review in advance to assure that inappropriate disclosures of patentable material or trade

secrets are not made.

The department’s agreement with the corporation cited above, for example, illustrates how

these provisions operate. Under that agreement,

the university will hold the patent on any discovery made in the course of the research funded by

the corporation, subject to the corporation’s

royalty-free license. If the university does not develop its patent, then the rights will revert to the

corporation. The corporation is also given 10 days

to review articles proposed for publication and

to make any objections. Of course, the principal

restraint on publication under this arrangement

may not be the final restrictions of the grant agreement but the desire to maintain a harmonious relationship with a major source of research funding.
Chapter 7

Community Control of

Research: Two Case Studies

Photo credit: National Institutes of Health
Chapter 7

Community Control of

Research: Two Case Studies*

This chapter describes two cases involving

precedent-setting interventions into scientific inquiry by a local government in Massachusetts.

The first describes the city’s two-phase regulation

of recombinant DNA molecule technology—in

1977, passage of the country’s first law regulating rDNA research, and in 1981, a revised law,

enacted in response to research and development

(R&D) activities of newly established biotechnology firms. The second case describes the city’s efforts to proscribe the handling and testing of certain chemical warfare agents by a consulting firm

under contract with the Department of Defense

(DOD). The public controversy over the second

case was kindled in October 1983 and has been

the subject of litigation since March 1984 when

the city promulgated its first regulation.

The case studies that follow describe the events

leading up to the respective regulations, discuss

the possible national impacts of these types of

cases, and survey the arguments presented in favor of and opposed to local regulation of research.

The report also examines the general policy implications of these cases on the issue of freedom

and accountability in the conduct of scientific research.

RESEARCH INVOLVING RECOMBINANT DNA MOLECULES

The controversy in Cambridge, Massachusetts,

over research involving the use of recombinant

DNA molecules began in Spring 1976. At that

time, the administration of Harvard University

was considering a proposal for the renovation of

one of its biological laboratories. The purpose of

the renovation was to construct a facility that

would conform to requirements of the National

Institutes of Health (NIH) for performing certain

classes of rDNA experiments, designated at the

time as “moderate risk.” NIH was also in the process of issuing guidelines that defined six classes

of gene-splicing experiments: research exempted

under the guidelines; P-1; P-2; P-3; P-4; and research prohibited under the guidelines. The planned

Harvard laboratory was expected to meet the performance and physical containment specifications

*This chapter was prepared by OTA staff, based largely on work

performed under contract for OTA by Sheldon Krimsky and on

reviewer comments thereon. Dr. Krimsky is Associate Professor in

Urban and Environmental Policy, Tufts University, and in 1984 was

appointed Chairman of the Cambridge Scientific Advisory Committee that played a major role in the Arthur D. Little controversy

detailed in this chapter. Professor Krimsky’s contract report was

reviewed by numerous experts, both within and outside of OTA,

includlng Arthur D, Little, Inc. , and other participants in the controversy.

of a P-3 facility, designed to provide a protective

barrier against the release of experimental organisms. A laboratory of this type required several

hundred thousand dollars in equipment and special construction techniques.

When plans for the $380,000 research laboratory were being discussed by the university

administration, several Harvard scientists questioned having an rDNA facility in a densely populated area close to other research and teaching

activities. The issue was taken up by Harvard’s

university-wide Committee on Research Policy.

The Committee responded by holding an open

meeting for the Harvard community which was

also attended by a member of the Cambridge city

council and a reporter from a weekly newspaper,

The Boston Phoenix. A news story on the meeting, “Biohazards at Harvard’ ’-the first media report of the controversy surrounding the new

laboratory—appeared in the Phoenix on June 8,

1976.1 Troubled by the story, Cambridge Mayor

Alfred Vellucci decided to hold hearings on rDNA

‘Charles Gottlieb and Ross Jerome, “Biohazards at Harvard, ” l?osfo~ Phoenix, ]une 8, 1976,

9 9
100

research at Harvard. Mayor Vellucci was supported and advised by several scientists in the city,

including some of Harvard’s own faculty. 2 When

the city council held hearings on June 23 and July

7, 1976, scientists and physicians affiliated with

Boston-area universities and hospitals were among

those who testified. Academic and biomedical research centers outside of Cambridge, contemplating rDNA research at the P-3 level, were concerned that the imposition of a city-wide ban on

certain rDNA experiments would eventually affect their own institutions.

Harvard’s Committee on Research Policy

agreed unanimously that the research should proceed despite its potential hazards. According to

the Committee, the new facility provided a sufficient margin of safety. Harvard set up a parallel

review committee comprised exclusively of scientists. Known by the name of its chairman, the

Branton Committee also issued a favorable response to the proposed rDNA facility. On June

14, 1976, a week prior to the first Cambridge hearing, the Harvard Corporation authorized construction of the P-3 laboratory.3

Subsequent to the public hearings, the city

council, frustrated by the technical complexity of

the issues and perplexed by the polarization of

viewpoints, voted on the recommendation of one

of its members to establish the Cambridge Experimentation Review Board (CERB). The city

council order contained no specifications about

the composition of the citizen board, leaving the

appointments to the discretion of the city manager. The city council also requested that Harvard

and the Massachusetts Institute of Technology

(MIT) accept a 3-month, good-faith moratorium

on any P-3 level rDNA research. Both universities accepted the moratorium, thus giving the

newly established review board an opportunity

to evaluate the risks. Since the new laboratory

was expected to be completed by the spring of

1977, the city’s moratorium on research did not

‘For a detailed account of Cambridge, MA’s involvement in the

rDNA controversy, see ch. 22, Sheldon Krimsky, “Local Initiatives

for Regulation, ” Genetic Alchemy: The Soa”al History of the Recombinant DNA Controversy (Cambridge, MA: The MIT Press,

1982).

‘Marc M. Sadowsky, “Rosovsky Approves DNA Research Lab, ”

Harvard Crimson, June 15, 1976. Also, Richard Knox, “Harvard

and Genetics Controversy, ” Boston Globe, June 22, 1976.

postpone any work. However, Harvard proceeded with the laboratory’s construction without assurances that an occupancy permit would

be issued.

Members of CERB were appointed by the city

manager in late August 1976. The manager consciously avoided the appointment of any biologists

to the nine-member committee on the grounds

that they were already divided on the question.

(Initially appointed as a full member, the Commissioner of Health and Hospitals subsequently

became ex officio. )

CERB met over a period of 4 months between

September and December 1976. Harvard and MIT

agreed to a 3-month extension to the good-faith

moratorium on P-3 experiments otherwise scheduled to elapse in September, The citizens’ committee issued its report to the city manager and

the Commissioner of Health and Hospitals in January 1977. The report stated that P-3 rDNA research may be permitted on the stipulation that

additional safeguards be added to the requirements of the NIH guidelines. CERB also recommended passage of a new ordinance that included

the creation of a Cambridge Biohazards Committee (CBC) to oversee all rDNA research in the city.

The committee’s recommendations were enacted

into law on February 7, 1977. The law was not

subjected to legal challenge by any of the affected

parties. Overall, public reaction to the outcome

was favorable and controversy subsided quickly.

A second debate over rDNA activities erupted

in Cambridge during 1980. This time the issue was

over R&D activities in genetics. Biogen, a newly

formed Swiss biotechnology firm, seeking its commercial and management headquarters in the

United States, chose a site in an area of Cambridge

zoned for manufacturing and light industry. Undaunted by the city’s reaction to rDNA experiments 4 years earlier, Biogen officials notified the

city manager and the health commissioner of the

firm’s interest in selecting a site and its willingness to conform to all Federal and local regulations.

CBC called a public hearing on October 28,

1980. Unlike the first rDNA debate, public opposition was mild. No biologists testified against

siting the new biotechnology facility or spoke in

support of additional local controls. Furthermore,
beyond those employed by Biogen, Boston-area

scientists were not present at the hearing. Public

reaction centered around the release of genetically

modified biological agents into the air and water,

particularly when cultures of rDNA molecules

were prepared in large scale.

In response to public anxieties over commercial gene splicing, the city manager once again

called on the Cambridge Experimentation Review

Board to respond. Since CBC was responsible for

implementing the rDNA ordinance, CERB considered it wise to involve this body in any decisions

on revising the law. Thus, CERB chose to hold

its hearings in collaboration with CBC. The joint

committee developed a consultative relationship

with representatives of Biogen, Harvard, and

MIT. After several months of hearings and deliberations, the CERB-CBC review panel issued

recommendations emphasizing safeguards against

the promiscuous release of genetically modified

organisms and, to a somewhat lesser degree,

against occupational hazards. The Cambridge city

council voted the recommendations into law on

April 23, 1981. In contrast to the extensive publicity surrounding the passage of the first rDNA

law, this new enactment was accompanied by little public discussion, and was only mildly acknowledged by the national media.

The new law established a permit system for

all institutions intending to use recombinant DNA

molecule technology. The ordinance distinguishes

101 — .

between small scale and large scale permits, the

latter being required for cultures of genetically

modified organisms in volumes greater than 10

liters. The deliberate release into the sewers,

drains, or the air of any organism containing

rDNA molecules is prohibited. For fermentation

processes, the law also requires effective sterilization of spent organisms before they are released

into the waste stream.4

During the second rDNA debate, the city convened a citizen review process while Biogen was

in the planning stages of siting and constructing

its new facility. None of the firm’s research was

held up as a consequence of the city’s deliberations. Similarly, Harvard’s P-3 laboratory was

scheduled for completion in the spring of 1977,

several months after the city’s moratorium on P3 experiments was terminated. Neither of the two

Cambridge rDNA laws was subjected to a legal

challenge. The universities considered that option

but favored a negotiated settlement that avoided

litigation. The 1981 Cambridge rDNA law is still

in effect and is administered by the Commissioner

of Health and Hospitals, who currently heads the

Cambridge Biohazards Committee.

‘A brief history of the passage of rIINA legislation in nine cities

and towns (including Cambridge, LIA ) and two States is presented

in Sheldon Krimsky, et al., ,~lunicipal and State Rec[lmbinant DNA

Lams (hledfor-d, LIA: Tufts University, lune 1Q82)

TESTING CHEMICAL WARFARE AGENTS

The second case centers around Arthur D. Little, Inc. (ADL), a multi-faceted management and

technology consulting firm with its world headquarters in Cambridge, Massachusetts. The firm,

which has been operating in Cambridge since the

early part of the century, has offices in Europe,

Canada, and South America, and a work force

of 2,500.

Around June 1982, ADL decided to renovate

an existing chemical laboratory with state-of-theart safety features that would enable the firm to

take on work with highly toxic chemicals. The

renovated laboratory was designed to meet the

specifications of DOD for working with “chemical surety materials, ”—chemical warfare agents—

consisting mainly of nerve and blister agents.

The company’s investment in the laboratory exceeded $750,000. The Philip L. Levins Laboratory

was planned to occupy 1,300 square feet in ADL’s

Acorn Park, a 40-acre complex located at the

northern boundary of Cambridge, near the adjoining towns of Arlington and Belmont. Because

of the extensive renovation required, ADL applied

for and was issued a building permit on December 10, 1982. Approximately a month later, ADL

personnel met with the Cambridge city manager,
102

the fire chief, and officials of the police department to inform them about the new testing facility. Notification of the police was in conformity

with DOD stipulations; surface shipments of the

chemical nerve and blister agents require a police escort. ADL disclosed the general nature of

the facility and indicated that, among its functions, it would be used for testing chemical agents

supplied by the army. According to an official of

ADL, the company was not requested to provide

“specific names and toxicities of the materials it

was planning to test in the new laboratory.”5

ADL requested that city officials keep confidential the location of the laboratory and the type

of work to be undertaken there. Public safety considerations were given by the firm as the reason

it requested nondisclosure. The firm maintained

that its policy of confidentiality would reduce the

chances that the laboratory would be a target for

vandalism or terrorism. The city manager, police,

and fire chiefs complied with the request. ADL

filed for an occupancy permit on May 18, 1983.

The certificate of occupancy was issued on May

25. The laboratory was approved for operation

by DOD on September 19, 1983.

Responding to the cooperative arrangement

that existed between the fire departments of Cambridge and its neighboring towns, ADL also contacted officials of Arlington and Belmont in September 1983 to inform them of the new facility.

At a meeting with Arlington’s town manager, officials of the police and fire department, and the

town’s civil defense officer, ADL continued its policy of requesting confidentiality about the nature

of its facility.

Arlington’s town manager, however, informed

ADL that he planned to introduce the issue of the

laboratory at the upcoming meeting of the town

selectmen. On that same day, October 14, 1983,

ADL issued a press release announcing the establishment of a laboratory to be used for “advanced

chemical analysis of toxic and hazardous chemicals so as to develop improved methods for detecting, identifying, and detoxifying such materials and new means of protecting people from

5Reid Weedon, Vice President of Arthur D. Little (ADL), comments made on Mar. 7, 1985, during a community debate between

ADL and the North Cambridge Toxic Alert.

them. ” The news release omitted any mention of

chemical nerve or blister agents. On October 20,

1983, the story of the laboratory was reported in

the Arlington Advocate and the Boston Globe.

The Globe speculated that chemical warfare

agents may be among the agents handled at the

facility. On October 17 and 24, 1983, respectively,

the Arlington selectmen and the Cambridge city

council held public meetings at which the ADL

matter was discussed.

At the October 24 Cambridge council meeting,

the nature of the chemical warfare agents supplied

to ADL under DOD contract was disclosed by

company officials. By that time, the company had

begun work on the DOD contract. The council

also heard residents of the North Cambridge community voice a strong protest against ADL’s testing of chemical nerve and blister agents adjacent

to a densely populated area. In response to public concerns, at the same meeting the city council

voted to establish a “citizens’ scientific advisory

board” to review the risks associated with the

ADL laboratory. Individual councillors requested

that ADL accept a moratorium on its tests of

chemical warfare agents until the city completed

its risk assessment. ADL, having to contend with

its DOD contract requirements, did not accept a

moratorium.

By early winter, the Scientific Advisory Committee (SAC) had still not been appointed, although responsibility for implementing the orders

passed by the city council had passed to the city

manager. Long delays between council orders and

their implementation are not unusual in Cambridge. As the city’s principal fiscal agent, the

manager must consider the financial impacts of

council orders and the practical consequences of

its policies. In this instance, however, the hiatus

between the time the SAC was created by the

council and the time its members were appointed

is indicative of the city manager’s hope that the

controversy could be resolved quickly. In late

winter, however, the conflict intensified when the

Cambridge Commissioner of Health and Hospitals issued an emergency regulation (March 13,

1984) that prohibited “testing, storage, transportation and disposal of five specified nerve and blister agents within Cambridge, until SAC and an

independent hazard assessment has been com-
103

pleted and these recommendations have been reviewed by the Commissioner’s office.”6

Three days later, ADL received a temporary restraining order against enforcement of the regulation from a Massachusetts superior court judge.

On March 27, 1984, the temporary restraining order was converted into a preliminary injunction.

The injunction against enforcement of the city regulation remained in effect until February 27, 1985,

after a decision was issued by the Superior Court.

The city manager appointed the membership

to the Cambridge SAC on March 26, 1984. Following established tradition, the manager accepted recommendations from the council. The

committee was comprised of 16 members, including scientists, individuals in the fields of public

and occupational health, and residents from

North Cambridge.

SAC completed its inquiry and issued a report

in September 1984. The cornerstone of its decision was a series of worst-case scenarios in which

different volumes of nerve agent are hypothetically released into the environment. The analytical calculations for the worst-case scenarios were

developed by a risk assessment consultant hired

by the city. Building on those calculations, SAC

concluded:

. . . the benefits of research with these chemicals

do not justify lethal risks to the general public.

For this reason, the SAC believed that storage

and testing of these chemical warfare agents

within the densely populated city of Cambridge

in the quantities and concentrations used by ADL

is inappropriate.

‘Melvin Chalfen, Commissioner of Health and Hospitals, City

of Cambridge, “Order on the Testing, Storage and Transportation

of Chemical Nerve and Blister Agents, ” Mar. 13, 1984.

COMPARISON OF THE CASES

Origins of Local Regulations

The city’s involvement in both rDNA research

and chemical weapons testing started with citizen concerns over the research slated for a renovated Laboratory facility. Harvard’s P-3 laboraThe majority of the SAC members judged the

risks associated with any such work to be unacceptable. 7

On receipt of the SAC report, the Commissioner of Health and Hospitals made his interim

order—prohibiting any person from testing and

handling three nerve agents and two blister

agents—into a permanent regulation on September 18, 1984. Hearings before the Massachusetts

Superior Court resumed, The judge severed the

issues into the questions of Federal supremacy and

the reasonableness of the Cambridge order. On

December 14, 1984, the Court ruled in favor of

the city on the supremacy issue. The decision on

whether the Cambridge regulation was reasonable

or not and whether it conformed to State law was

rendered on February 26, 1985. Once again the

ruling favored the city. On the following day, the

Superior Court judge proclaimed the September

1985 order of the city “valid and enforceable.” The

injunction, which had been in effect for 11

months, was removed by the court order.

ADL appealed the case to the Massachusetts

Appeals Court on March 12, 1984. The court gave

ADL immediate relief by reinstating the injunction against the order, pending the outcome of

the appeal. In response, the city petitioned the Supreme Judical Court (SJC) of the State and asked

that it take the case over from the Appeals Court.

The SJC agreed and heard the case on April 4,

1985. In a four to one decision issued on August

1, 1985, the SJC upheld the Cambridge regulation banning the testing, storage, transportation,

and disposal within the city of the five chemical

warfare agents.

‘Scientific Advisory Committee for the City of Cambridge, Report to the Cib hfanager on the Use of Chemical If’arfare Agents

at Arthur D, L“ttie Levins L.aborator}r (Cambridge, hlA: September IQ84),

tory, designed to conform to NIH specifications

for working with rDNA molecules, was in its

planning stages when the city council learned of

its prospective use. In contrast, Arthur D. Little’s

testing laboratory for chemical toxins was completed and set for operation by the time its use
104

became known to the Cambridge citizens. In both

instances, existing facilities owned by the respective institutions were significantly renovated.

Building permits were obtained and several hundred thousand dollars in renovation costs were

allocated. The planned P-3 laboratory was reported in the media after information was obtained at a university hearing attended by several

outsiders. Harvard neither attempted to keep the

laboratory’s presence confidential nor sought to

inform city officials and the public of its intentions to construct the facility. Funding for the

renovated moderate containment P-3 laboratory

and for the research for which it was designed

came from science funding agencies of the Federal Government.

ADL’s Levins Laboratory was paid for entirely

out of company funds. The laboratory was

planned specifically for the testing of toxic substances. It was anticipated that one major source

of funding for recouping the investment in the laboratory was DOD. Other potential clients were

Federal and State environmental agencies and

those segments of the private sector that, increasingly, have become responsible for the control of

toxic substances. ADL sought to have the laboratory’s purpose and function known only to a select number of local officials in Cambridge, Arlington, and Belmont, Massachusetts. Public

safety was the company’s reason for nondisclosure

of the laboratory’s purpose to the general public. ADL’s efforts to preserve the confidentiality

of the lab and the chemical warfare agents it was

testing was thwarted when a local official from

the neighboring town of Arlington, informed

about the facility, filed a report with the town

selectmen.

Types of Local Interventions

When the Cambridge city council learned of

Harvard’s plans for a new laboratory, it requested

both Harvard and MIT to accept a good-faith

moratorium on rDNA experiments classified as

P-3 or greater under the 1976 NIH guidelines, until

CERB issued its recommendations. Harvard and

MIT complied. No other intervention was taken

by the city until the release of CERB’s report.

In contrast, ADL was unwilling to accept a general moratorium on its testing of chemical nerve

and blister agents pending investigation by a

citizens’ committee. However, on February 16,

1984 ADL did agree to a 30-day moratorium on

performing any work on new contracts involving chemical warfare agents.

In neither of the two cases did the city attempt

to withhold building permits or change the zoning regulations. ADL obtained its building permit in December 1983, long before the city council became involved in the issue, Neither of the

voluntary moratoria affected any ongoing research projects. The ADL voluntary moratorium

was short-lived and probably not disruptive. The

rDNA moratorium was targeted to research that

awaited completion of the new laboratory. There

were several months between the end of the rDNA

moratorium (January 1977) and the opening of

the P-3 facility at Harvard (spring 1977).

In response to ADL’s unwillingness to accept

a general testing moratorium, an action that might

have threatened its contract with DOD, the city

council urged the Commissioner of Health and

Hospitals to act. After several months of discussion and consultation, the commissioner issued

an interim public health order that prohibited the

testing of five chemical warfare agents. A court

injunction kept the order from being enforced during the entire period of litigation. As of the writing of this report, the commissioner’s order was

the sole nature of the city’s intervention into

ADL’s testing program. SAC did recommend an

ordinance that, if passed, potentially could affect

research at universities and other R&D firms. To

date, the proposed supertoxin ordinance has not

been acted on by the city.

One month after CERB issued its report on

rDNA research, the city council passed an ordinance incorporating the principal elements of

the recommendations. The rDNA law, amended

in 1981, requires that all individuals or institutions undertaking experiments involving the production of recombinant DNA molecules must be

licensed. Except for minor differences, the requirements for research are ostensibly equivalent to the

guidelines issued and periodically amended by
105

NIH. The law sets additional requirements for a

large scale permit for which there is no counterpart in the NIH guidelines.

In conclusion, the Cambridge rDNA ordinance

followed the general framework of the Federal

NIH guidelines. It permitted academic and commercial research to continue while incorporating

additional safeguards. The city’s intervention in

the testing of chemical warfare agents involved

a specific, local prohibition against the use of five

chemicals. This was the first stage in a long-term

plan supported by some city officials to regulate

all highly toxic chemical agents in research and

commerce. In May 1984, Health Commissioner

Murray Chalfen issued a report that included a

proposed ordinance on toxic chemicals and hazardous materials. The proposal, along with the

SAC’s recommendations, is currently under review by the city.

Stage of the Scientific Enterprise

Affected

The first rDNA ordinance in Cambridge had

its direct impact on university research, particularly the field of molecular genetics. The regulatory

intervention was directed at a specific technique

of scientific inquiry, namely, plasmid-mediated

gene transfer, which is of fundamental significance

to genetics research. Any scientific discipline that

planned to use the technique was ipso facto under

local regulation, however.

The revised rDNA law of 1981 was a direct response to the emergence of commercial biotechnology. Its principal effect was on R&D applications of gene splicing. Special attention was given

to large volumes of genetically modified organisms, The utilization of large cultures represents

a stage beyond basic science. Organisms genetically modified to produce a desired product are

tested in pilot plant bioreactors with capacities of

a hundred to several hundred liters, a stage in

product development prior to manufacturing and

production. The Cambridge law sets environmental and occupational safety requirements specifically for large cultures of rDNA-generated

organisms.

ADL contracted with DOD to develop detection kits for nerve agents, to study the means by

which fabrics may be made impermeable to them,

and to investigate methods of detoxification. The

firm’s R&D work incorporated the expertise of

analytical chemists, product development

chemists, and electronics specialists. The order issued by the city on chemical warfare agents was

not targeted to a particular research technique or

methodology, as in the rDNA case; instead, it prohibited the use of five substances cited in an ADLDOD contract. The regulation was, therefore,

directed at the application of science and technology for solving targeted problems. In distinction

to the rDNA case, ADL’s research was not designed to generate new science. The purpose of

the research was to supply the army with new information on the handling, detection, and detoxification of chemical warfare agents.

Social Risk Assessment

The two cases illustrate different approaches to

social risk assessment. This is particularly evident

in the composition, goals, and functions of the

two citizens’ committees. CERB was a committee comprised of nonexperts in the subject matter under consideration, namely molecular

genetics. Out of eight members, the one who came

closest in expertise to the field was a physician,

board-certified in infectious diseases. The membership of the committee was chosen to reflect racial, ethnic, and neighborhood diversity. It was

divided equally between men and women. In an

internal memo, one member likened CERB’s function to that of a jury in a legal proceeding.8 This

memo clarified the role of nonexperts in a technical controversy. CERB was asked to review the

debate among scientists on the safety of rDNA

research; but it was not asked nor was it equipped

or prepared to undertake a risk assessment. After receiving testimony from experts, CERB members weighed the strengths of the arguments and

on that basis made their decisions.

6A detailed account of CERB’S decisionmaking process is contained

in Sheldon Krimsky, “A Citizen Court in the Recombinant DNA

Controversy, “ Bulletin of the Atomic Scientists, vol. 34, No. 8, October 1978, pp. 37-43.
106

In contrast, the Cambridge Scientific Advisory

Committee was comprised of experts and nonexperts with respect to the problems of highly

toxic agents. Of the 16 members, 10 had advanced

degrees in one or more of the relevant fields:

physics, chemistry/biochemistry, chemical engineering, biology, and public health. SAC was presented with three tasks: 1) to undertake a risk

assessment of ADL’s use of chemical warfare

agents, 2) to make a determination about acceptable risks, and 3) to advise the city council on a

risk management plan.

Although the structures and goals of the two

social risk assessment processes differed, both

SAC and CERB were given the charge of determining whether the respective research activities

should be prohibited, unconditionally permitted,

or conditionally permitted. Also, both processes

resulted in a proposed framework of risk management involving the creation of a new institutional structure for the city.

Parties Affected by the Proposed or

Actual Regulations

The first Cambridge rDNA law had a direct impact on biomedical scientists, including biochemists and molecular geneticists who study gene

structure and function. The revised law primarily affected R&D firms that were investigating

commercial and medical applications for genetically modified organisms. In the former case,

scientists responded as a community to the prospect of being regulated and opposed differential

standards of research between Cambridge and

other parts of the country. In the latter case, Harvard and MIT joined with Biogen to ascertain the

impacts of licensure on rDNA research in their

respective institutions. The revised law created

new formal requirements for academic and commercial institutions but the actual requirements

for individual investigators in academe remained

unchanged.

The Cambridge emergency order on nerve and

blister agents did not single out the names of any

institutions. However, no institution other than

ADL is known to have been directly affected. The

agents prohibited for use were taken directly from

an ADL-DOD contract. For all practical purposes,

therefore, the order was directed at ADL. The regulations covering the use of supertoxins recommended by SAC were, however, much broader

in scope and, if passed, probably would affect research at other institutions. For example, SAC

proposed that certain designated hazardous materials proposed for testing, use, storage, or disposal within the city must be reported to the Commissioner of Health and Hospitals at least 3

months prior to the date of planned entry into

the city. The substances designated for reporting

inclucle: chemical warfare agents (as provided in

a list), other nerve agents of different chemical

structure to those listed when used in chemical

weapons R&D, biological warfare agents, and

other highly toxic agents as the Commissioner

may designate. SAC also proposed that each use

of the regulated agents be reviewed by the Commissioner and given a site evaluation in writing

after appropriate information is provided. Should

the Commissioner find that the use of the regulated chemical presented an unacceptable hazard

to public health or safety, then a site assignment

could not be given and the commissioner could

prohibit the use of the materials. And, finally,

SAC recommended that in addition to chemical

warfare agents, the City of Cambridge develop

policies to regulate other supertoxins.

To date, the city has not acted on these recommendations, which, if adopted, could significantly

affect university research. At the least, the proposed regulations would apply to any experimental uses of substances designated by DOD as

chemical warfare agents. Most broadly interpreted, the rules might regulate research employing any highly toxic chemical such as dioxins,

chemotherapy agents, or potent mutagens. In the

former case, the impact to academic scientists

would be minimal for chemical warfare agents are

not widely used in university laboratories (although analogs and close derivatives of them may

be more readily found). In the latter case, many

chemical and biomedical facilities would be affected because it is not uncommon to find some

quantities of highly toxic agents in most wellequipped laboratories.
107

Legal Issues

The authority of cities and towns to enact

health and safety regulations is firmly established

under State laws. Both the rDNA law and the order on chemical warfare agents are examples of

such powers exercised by the city of Cambridge.

Three generic legal questions arise when the city

regulates an activity under public health and

safety statutes: 1) Are there any procedural errors in the process of issuing regulations? 2) Is the

regulatory action arbitrary or capricious? 3) Is the

regulation preempted by or does it conflict with

Federal and/or State laws or authority?

No legal challenges were directed to either of

the Cambridge rDNA laws. Similarly, laws of

other cities and towns were also enacted and implemented without challenge.9 Because no Federal

rDNA laws were passed and because Congress has

yet to express a policy on whether it occupies the

field of regulations for gene-splicing, the issue of

preemption in either of the rDNA cases is generally considered weak. NIH guidelines may have

the force of law to those who receive Federal

funds, but the agency lacks legislative authority

to preempt other political jurisdictions from passing more stringent rules.

Harvard and MIT were prepared to challenge

the legality of the rDNA laws if they had prohibited or substantially inhibited scientific research. As it turned out, the universities avoided

litigation and accepted rDNA standards somewhat stricter than those which were required of

other academic institutions in the country. The

“Balkanization” of standards for scientific research

was a great concern to researchers during the

Cambridge debate and for years thereafter as Congress considered Federal legislation; but the predicted adverse consequences on scientific research

from local rDNA laws never materialized. None

of the 13 communities that passed rDNA legisla-

‘Sheldon Krimsky, “Local Monitoring of Biotechnology: The Second Wave of rDNA Laws, ” Recombinant DNA Technical Bulletin<

vol. 5, No. 2, June 1982, pp. 79-85. To date, the following cities

and towns have passed ordinances on recombinant DNA research.

In Massachusetts: Amherst; Belmont; Boston; Cambridge; Canton;

Lexington; Newton; Shrewsbury; Somerville; Waltham, In other

States: Berkeley, CA; Princeton, NJ; Emery vine, CA.

tion have placed undue burdens on scientific research, and scientists have adapted easily to the

additional local requirements.

Cambridge’s public health regulation on chemical warfare agents took a different legal course.

ADL challenged the order immediately after it was

issued. Counsel for ADL argued that the regulation was invalid on all three grounds cited above.

The legal question with the widest implications

was whether DOD-sponsored research performed

at a private facility was protected against local

regulations. Is this a case where Federal supremacy

over local authority applies?

ADL offered the following arguments:

1.

2.

3.

4.

Congress authorized DOD to establish a

chemical warfare program and this includes

the authority to issue requirements for handling and disposing of chemical warfare

agents.

The framers of the U.S. Constitution as well

as Congress intended the Federal Government to have exclusive responsibility for national defense. The city’s regulation prohibiting ADL from conducting defense-related

testing of chemical warfare agents is tantamount to interference with government functions and represents a clear conflict with the

Federal interest.

If Cambridge is free to prohibit such work

by a duly contracted agent of the Federal

Government, then so too is any other community. If all jurisdictions followed Cambridge, Federal programs in chemical warfare research would be frustrated.

Because ADL is a contractor of the government, the firm is invested with “derivative

sovereign immunity, ” which allows the

supremacy clause of the Constitution to apply to it with equal force to that of the Federal Government.

Counsel for the city argued that two conditions

must be satisfied for Federal supremacy to hold.

Either the Federal Government has explicitly

preempted the field of toxic substances regulation

or a fundamental conflict exists between the Federal and local governments on the regulation of
108

these substances. According to the city, Congress

never stipulated that testing of toxic substances

would be exclusively regulated by the Federal

Government. Moreover, on the question of jurisdictional conflict, the city maintained that the Federal Government possesses other facilities at which

to carry out such tests. The facts do not demonstrate that prohibition of such tests in Cambridge

represents a fundamental conflict between local

and Federal purpose.

On December 14, 1984, a State Superior Court

judge ruled that Federal supremacy was not in effect for this case. Subsequently, on February 26,

1985 after reviewing arguments on the reasonableness of the regulation and its legality with respect

to State law, the same court found the regulation

“valid and enforceable. ” The city’s arguments

prevailed on all the legal points.

The Massachusetts Supreme Judicial Court also

upheld the regulation, stating in its decision on

August 1, 1985, that the regulation constituted a

permissible attempt by the city to protect its inhabitants under local police powers derived from

State statutes. The court rejected arguments by

ADL that the ruling violated the firm’s right to

due process or constituted an unjustified interference in its contract with DOD, The court also

ruled that the regulation is not invalid under the

Supremacy Clause of the U.S. Constitution. The

SJC failed to find within Federal statutes congressional intent to preempt local communities from

passing health and safety regulations for chemical warfare agents. The court affirmed the right

of local health authorities to prohibit activities as

long as the regulations are not “unreasonable,

arbitrary, whimsical, or capricious. ”

The context of legal similitude for the rDNA

and the chemical weapons issues is very narrow.

In both cases there are Federal guidelines or regulations for certain experimental activities. In both

cases, the city chose to augment or supersede the

role of a Federal agency. But from that point, the

legal issues evolved quite differently.

IMPACTS OF THE CITY’S INTERVENTIONS BEYOND ITS BORDERS

The 1976 rDNA debate was covered extensively

by the national and international media. Little research has been done on the impact of the debate

outside the United States, but within this country

there is documentation about direct and indirect

effects on other municipalities and on national

policies. Nearly two dozen city/town governments and State legislatures considered passing

laws that would have extended coverage of the

NIH guidelines to privately funded institutions.

In response to the first Cambridge debate, two

States and four local governments enacted rDNA

legislation. Several communities modeled their citizen review process closely on that of Cambridge.

The City of Berkeley passed an rDNA law that

incorporated verbatim sections of the Cambridge

ordinance. By 1978, however, the ripple effect of

the first Cambridge rDNA controversy had taken

its course and was affecting only a handful of

university communities. The national debate subsided and so did the involvement of town and municipal bodies.

A second wave of community responses broke

after Cambridge passed its 1981 law. An additional seven communities in the greater Boston

area, including the City of Boston, passed similar laws directed at commercial biotechnology but

also applicable to scientific research. In an unusual

case, a law passed in the City of Waltham, Massachusetts, prohibited the use of human experimental subjects in recombinant DNA research.

This is, perhaps, the first U.S. law prohibiting human genetic engineering.

The rDNA events in Cambridge also had reverberations in Congress. The publicity surrounding

the Cambridge controversy was one of the key

factors influencing some Members of Congress to

file bills that would place gene-splicing under Federal regulation. Of the two leading bills, the Senate version, sponsored by Edward Kennedy (DMA), paid close attention to the events in Cambridge, ’” The Kennedy bill contained weak

preemption language, signifying a respect for the

rights of communities like Cambridge to establish standards of safety for rDNA research in exl~The lt~ding congressional bills were introduced by Representative Paul Rogers (D-FL), H.R. 4759, on Mar. 9, 1977, and Senator

Edward Kennedy (D-MA), S. 1217, on Apr. 1, 1977.
109

cess of those required by the Federal Government.

Despite considerable congressional activity, however, no legislation emerged during the years of

peak public interest between 1977 and 1980.

The extensive publicity around the citizen participation process in the Cambridge rDNA affair

probably did have some influence in the reorganization of the Recombinant DNA Advisory Committee (RAC) in 1978. Department of Health,

Education, and Welfare (HEW) Secretary Joseph

Califano expanded the size of the RAC from 16

to 25 members to accommodate more public participation. Cambridge became a model for environmental groups like Friends of the Earth and

the Sierra Club which lobbied Congress and HEW

for broadening public involvement in the decisionmaking process. One of the members of the Cambridge citizens’ committee was appointed to an

expanded RAC in 1979 when 30 percent of its

membership was drawn from the fields of public

health and public interest.

ARGUMENTS FOR

The ADL debate over the testing of chemical

warfare agents is over a year old. It has been accompanied by a limited amount of national publicity. Lower court decisions were picked up by

three national television news networks. The ABC

TV news magazine program “20/20” produced a

segment on the debate. National Public Radio also

broadcast a program on “Morning Edition, ” October 3, 1984, describing the Cambridge-ADL

debate.

Cambridge is one of at least 12 cities in the

United States containing firms that have contracted with DOD to conduct research with chemical warfare agents. This list became public as a

consequence of the “20/20” broadcast. There have

been no reported actions taken by any of these

communities in response to the Cambridge prohibition, but it is too early in the legal process to

speculate whether the case might serve as a precedent for local regulation of research involving

highly toxic chemicals.

AND AGAINST REGULATIONS

Recombinant DNA Controversy

For Regulation

NIH released its first set of guidelines for rDNA

research on the same day the city of Cambridge

held public hearings to discuss Harvard’s planned

P-3 laboratory. The guidelines were issued in response to concerns by molecular biologists that

gene splicing might result in the unexpected creation of a new epidemic pathogen, toxin-producing bacteria, or a coliform bacteria harboring a

human cancer virus. In Cambridge, the debate

centered on whether the research should be done

at all and whether the NIH guidelines provided

a sufficient margin of safety against an accident

or unintended outcome.

Scientists spoke forcefully on both sides of the

issue. Those against the use of a P-3 facility at

Harvard for rDNA experiments cited three deficiencies in NIH’s role as the overseer of the research. First, they argued that the guidelines were

constructed from untested a priori hypotheses and

they placed little confidence in the regulation’s effectiveness as a containment strategy. Second, it

was pointed out that the NIH guidelines had no

force over R&D activities that were not funded

by the Department of Health and Human Services. At the time, biotechnology firms had not

sought entry into the city, but that was thought

not to be far off. Third, opponents argued that

NIH had not enlisted sufficient participation from

the general public and other segments of the scientific community. Some scientists maintained that

rDNA molecule technology was an unknown and

uncharted area of research with unpredictable

risks. They felt it should not be done in proximity

to classrooms and other research activities.

When the city was approached by the first of

several biotechnology firms planning to locate in

Cambridge, a new set of public anxieties arose.

By that time the city’s rDNA law had been in effect for 3 years. The principal rationale for passage of the revised law was the concern over large

volumes (over 10 liters of culture) of genetically

modified organisms, and the potential hazards
110

associated with occupational exposure and environmental release.

The citizens’ committee was not aware of any

regulatory body at the Federal or State level which

set standards for large-scale work involving rDNA

molecules. After consultation with experts in fermentation engineering and the sterilization of

spent organisms in large vessels, the citizens’ committee proposed revisions in the 1977 law. Among

the restrictions cited in the revised law was:

There shall be no deliberate release into the environment, that is the sewers, drains, or the air, of

any organism containing recombinant DNA and

further that any accidental release shall be reported to the Commissioner of Health and Hospitals within five days. ”

The new law created a system of accountability

according to which biotechnology firms were required to have special licenses for large scale

work. The system included periodic inspections

to ensure that the environmental release provision was respected by the technology and practiced by the institution.

Against Regulation

The principal opposition to local regulation of

rDNA research in 1976 came from scientists, graduate students, and university administrators. They

emphasized the confidence that the vast majority

of scientists had in the NIH guidelines. RAC was

cited as an exemplary system of oversight and one

that a local community could not duplicate. The

importance of uniform national guidelines was

stressed. Science, it was said, cannot flourish in

a patchwork of regulations. If Cambridge enacts

restrictive rDNA regulations, scientists will find

it necessary to move away from the city to other

areas more conducive to their research. The

universality of the scientific method requires uniformity in the social context within which research

is carried out. This norm would be violated if each

community passed its own research guidelines.

Opponents of regulation also stressed the benefits of rDNA research. These benefits might be

delayed significantly if restrictive local regulations

1 IKri~~kY, et ~1,, Munjcjpa] and State Recombinant DNA Laws.

op. cit.

were established. Those critical of local regulation emphasized that the risks of rDNA research

were at best hypothetical and quite likely nonexistent, while the benefits were real. Not a single case of illness was linked to an agent of an

rDNA experiment. In their view, a significant

margin of safety was already provided by the NIH

guidelines.

The Case of Chemical Weapons

Research

For Regulation

The arguments for regulating chemical warfare

agents centered around the potential adverse public health consequences associated with their accidental or intentional release. The Cambridge

Scientific Advisory Committee examined several

worst-case scenarios in which quantities of 10,

100, and 500 ml. of nerve agent were hypothetically released from the testing facility. SAC concluded that such an accident was unlikely but not

impossible; in the event of a 100 ml. release, members of the general public might be located within

range of lethal doses of such agents .12 The committee cited an independent consultant report that

estimated between 10 to 30 members of the general public might be located within range of lethal

levels of such agents in one of several worst-case

scenarios. The case in question involved a sudden release of 100 ml. of sarin in the form of a

gaseous cloud. ’3

The SAC report stated that there were no satisfactory regulatory mechanisms for managing the

use of supertoxic agents in the city. Having concluded that even relatively small quantities of

chemical warfare agents used in R&D could pose

a risk to the public, the committee proposed a municipal ordinance for regulating such agents in particular and supertoxins in general. SAC made no

distinctions in its regulatory program between

R&D or between university and nonuniversity

uses of supertoxins.

lzscientific Advisory Committee for the City of Cambridge, oP.

cit., p. 2.

13TR(: Environmental Consultants, Inc., Community Risks from

Experiments w“th Chemicaf Warfare Agents at ArthurD. Little (Hartford, CT: 1984).
111

More than half the members of the committee

favored a ban on any research involving chemical warfare agents on the grounds that the “risks

associated with any such work [are] unacceptable. ” A smaller number of members expressed

opposition to the research on ethical grounds—

that any work on chemical weapons is morally

reprehensible. They believed that no clear distinction can be drawn between offensive and defensive research. The city’s legal arguments for its

regulation, however, focused exclusively on issues of public health and safety. City council debates also centered on public health issues in contrast to the rDNA episode when some councillors

questioned the morality of genetic engineering.

To some degree, the psychological impact of the

term “chemical warfare agents” was a relevant factor, however, in the public’s sensibility to the

issue.

Against Regulation

Arthur D. Little’s case against the city’s ban can

be classified according to the following categories: 1) safety of the facilities; 2) errors and deficiencies of the SAC report; 3) discriminatory nature of the action; 4) misunderstood goals of the

research; 5) compliance by ADL to all Federal,

State, and local laws and regulations; and 6) violation of Federal supremacy.

1. The company maintained that its laboratory

is among the safest that exists for the work intended. The laboratory satisfied DOD specifications for handling chemical warfare agents. ADL

was also in compliance with Federal and State

environmental regulations. The firm argued that

its laboratory advances the state of the art for the

safe handling of hazardous substances. To further

increase the margin of safety, ADL agreed not to

store more than certain minimum volumes of the

chemical agents.

2. ADL also argued that the committee’s technical analysis was flawed. According to company

spokespersons, the report drew conclusions from

assumptions that do not reflect ADL’s operations.

One of the risk scenarios developed by SAC assumed greater quantities of chemicals than ADL

claimed it would ever have on hand. Furthermore,

SAC did not determine the probability of its

worst-case accidents. It did not describe how

chemicals stored in secure containers could be released into the environment from some accident.

The SAC report did not take account of the many

barriers there are to the kind of accident it postulated. In fact, if there were an accident, the company held, the effects would not be felt beyond

ADL. According to the company, the city’s attempt to ban the five chemicals was unreasonable and invalid because it was not shown that the

research posed any potential health hazard.

3. The company also believed that the city’s action was discriminatory. Selected city officials,

including the city manager, were first informed

about ADL’s plans for the laboratory in January

1983, but it was more than a year later, and after

an occupancy permit was issued, that ADL was

ordered to cease its testing. In its letter to the public, ADL wrote: “We worked closely with the

Cambridge City Manager and the relevant public safety officials throughout the planning and

construction of the facility, and they expressed

complete confidence in its safety and security. We

hired outside consultants to check our findings

and designs. ”

ADL also faulted the city for not allowing the

company to remedy any defects that may have

been found in its safety program. As a result, the

city’s prohibition imposed upon ADL nearly a

million-dollar loss in the cost of the laboratory

in addition to substantial losses in present and future DOD contracts.

ADL also argued that it had been selected out

for regulation. According to the company, there

are many risks to the people of the city that are

far greater than its testing program, yet the city

focused attention on a state-of-the-art testing laboratory that uses small quantities of chemicals.

If the city wishes to regulate toxic substances,

ADL proposed, it should treat all institutions and

all substances on a comparable basis. The determination to regulate should not depend on

whether the research is done at a profit or nonprofit institution, involves basic or applied

science, or is carried out under contract from

DOD or under a grant from NIH.

4. ADL correctly surmised that some of the

public concern over its research was motivated
112 —

by concerns over the morality of chemical weapons research. In a letter to the public, ADL clarified the ethical basis of its contract with DOD:

We believe something must be done to control

the threat of uncontrolled toxic chemicals in the

environment. We have the professional capabilities and the resources to help solve some of the

inherent problems. That is why we went to the

expense of constructing a safe, secure, facility for

research designed to find better ways of protecting people from the effects of uncontrolled environmental hazards, ”

The firm assured the citizenry that its research on

chemical and nerve agents is exclusively for “defensive and protective purposes.”

We are using existing substances in analytic

tests in order to develop better methods of detecting minute quantities of these agents in the

environment and safer, more effective means of

destroying them on a large scale. We are also

working to develop better protection, including

clothing for people who might be exposed to

these substances .14

5. All Federal, State, and local regulations had

been met before ADL’s lab went into operation.

The facility had been inspected by DOD, State

agencies, and city officials. The company received

an occupancy permit. The city’s ban thus was perceived by the company as an afterthought to all

regulations that were in effect prior to and during the time the laboratory was under construction.

14John F. Magee, President of Arthur D. Little,

lie, Jan. 28, 1985,

Letter to the PubGENERAL POLICY IMPLICATIONS

The central issue underlying both case studies

is the extent to which local communities are justified in regulating research. Beyond this similarity,

there is considerable variation in how these cases

relate to issues of scientific freedom and social accountability. The rDNA case involves a welldefined scientific population, a Federal funding

agency, local universities, and a city government.

The case of chemical weapons testing is about private contract research. It too involves city gov6. The supremacy arguments have been outlined in detail in the section of this report comparing the rDNA research and chemical weapons

testing. In summary, ADL contended that the city

has no authority to interfere with a contract of

the Federal Government when all Federal and

State safety standards are met. The city’s ban on

the testing and storage of the agents is argued to

conflict with the Federal authority governing national defense and is therefore unconstitutional.

If other municipalities passed similar prohibitions,

there would be a direct conflict between the policies of the U.S. Government and the actions of

local communities. Under such conditions, the

policies of the Federal Government are preemptory, the company stated.

Although the principal opposition to the city’s

action banning the testing and storing of five

chemical warfare agents came from ADL, there

was some criticism expressed by university representatives about the proposed regulations for

supertoxins contained in the SAC report. MIT

officials argued that SAC’s approach to chemical regulation would have a “harsh and adverse

effect on the conduct of research in chemistry, biology, nutrition and food science” at universities.

Because SAC made no provisions for volume exclusions in its proposed regulations of chemical

warfare agents or closely related chemicals, many

substances used in the course of research would

fall under the proposed criteria. According to the

MIT officials, if enacted, these criteria would be

an obstacle to scientific research without offering any additional protection to public health.

ernment, and a Federal funding agency. But a

well-defined scientific constituency is absent.

Three policy issues stand out in the rDNA episode. First, should science be self-regulated and

therefore insulated from State and local laws? Second, does NIH oversight of rDNA experiments

provide a legal basis for Federal supremacy and,

if not, should Congress establish legislation

toward that purpose? Third, to what extent, if at
113

all, is scientific research a right granted under the

First Amendment?

NIH has been the de facto regulator of federally funded rDNA experiments. Scientists, however, have had an influential role in the establishment and implementation of guidelines. Through

the NIH structure, the molecular geneticists have

had what has been ostensibly a self-governing

apparatus somewhat analogous to a peer review

process. The Cambridge debate threatened this

tradition of self-governance which began at Asilomar and evolved into the formation of the Recombinant DNA Advisory Committee. The city

also challenged the idea of uniform safety standards for experiments in molecular genetics.

Although Cambridge scientists were the only

ones directly affected by the city’s intervention,

the possibility of multiple sets of guidelines for

rDNA technology, based in part on local standards, troubled scientists throughout the country,

Many biologists who opposed congressional intervention, preferred it over a patchwork of regulations. According to Rockefeller University biologist Norton Zinder, the uniformity of scientific

practice transcends local interests:

The proliferation of local options with different guidelines in different states and different cities can only lead to a situation of chaos, confusion, and ultimately to hypocrisy amongst the

scientists involved. 15

Most legal scholars agreed that the NIH guidelines did not provide a-basis for preempting the

Cambridge law. No judicial challenge was made

on the reasonableness of the Cambridge rDNA

law in the context of the Federal guidelines. Perhaps because the Cambridge rDNA laws (first and

second) added very little to the substance of the

NIH guidelines, a legal challenge was avoided.

Had the city banned rDNA research, the question of preemption most certainly would have

been addressed in litigation, if not through congressional action.

Preemption was not the only legal question

raised in the early rDNA debate. Facing the prospect of Federal regulation, some scientists argued

that rDNA legislation would infringe on their

1’National Academy of Sciences, Research 1}’ith Recombinant

DNA: Academy Forum (Washington, DC: December 1977).

rights to engage in research. Prompted by several

inquiries, in 1977 the American Civil Liberties

Union (ACLU) began a task of formulating a policy on whether, or to what extent, scientific inquiry is a civil liberty protected under the first

amendment. Special committees of the ACLU began drafting policy statements that provided a

civil liberties perspective on scientific research.

Thus far, the Board of Directors of ACLU has not

reached a consensus on the wording of such a

policy.

ADL’s legal battle with Cambridge did not attract sympathetic support from other scientists.

Most university-affiliated scientists did not view

the possible restriction on specific contract research as a conflict between the local community

and freedom of scientific inquiry. The applied nature of the testing work and the fact that the results would probably be classified contributed to

this attitude.

The policy dilemma is best interpreted as a conflict between the rights of a firm to accept Federal contract research under Federal guidelines and

the rights of a city to set its own standards of public health and safety including a prohibition of research it deems hazardous. The outcome of the

ADL case has implications for any federally contracted research on nongovernmental property

that involves hazardous or potentially hazardous

procedures or materials. For example, a community might decide to establish prohibitions against

certain animal experiments. As a consequence,

contract research and basic science would be affected adversely. Cases of this nature have not

been widespread; but they are appearing. In

Washington Grove, Maryland, residents have expressed opposition to the testing of chemical nerve

agents in the vicinity of a school. Morris Township, New Jersey, has been the site of a controversy involving Bell Communications Research

(Bellcore), an AT&T spin-off company. At issue

has been the use and storage of highly toxic gases,

such as arsine, commonly used in semiconductor

research (see discussion in app. C). Neither congressional policies nor case law has settled the debate over Federal supremacy in these cases. If the

ADL litigation continues beyond the Massachusetts courts, Federal judicial interpretation may

set some explicit parameters for local control of

private sector research.
Chapter 8

Research Policy Issues That

May Warrant Congressional

Attention in the Future

Photo credit: National Institutes of Health
Chapter 8

Research Policy Issues That

May Warrant Congressional

Attention in the Future

In OTA’s brief survey of laboratory directors

and research administrators, * the respondents

were asked to reflect on how things have changed

from when they were just starting out in science

and to list the major constraints then as opposed

to now, The trend most noted by both groups is

understandably the increase in administrative and

“bureaucratic” requirements of grant procurement

and administration. Fifty percent of the university administrators and 32 percent of the lab directors noted that administrative requirements for

the investigator have increased substantially.

Time spent on detailed administrative work means

less time and money spent on research.

Other changes in the regulatory environment

noted by the respondents were the greater chance

of litigation and the appearance of more actors

involved in the scope and definition of research.

Respondents see this latter trend as a result of increased Federal funding for research, which necessarily involves more political actors, and increased media coverage, which attracts more

public attention to the research process. Many

also mentioned increased controls on dissemination of research results as being a significant differ-

‘~c~r ~c(;fi~, ~~~ ~c~x in ch. b .

ence between the climate of, say, 30 years ago and

today.

About one-third of the respondents stated that

they were not aware of any research areas where

the trend is toward fewer rather than more controls. Of those laboratory directors who did cite

an area where controls have eased, 16 percent felt

that changes in the National Science Foundation

(NSF) procurement and granting procedures have

helped to ease the administrative controls resulting from grants arrangements with that agency.

Recombinant DNA research was also listed as an

area where the trend has been toward more relaxed regulations, Other areas mentioned were human subjects research (where expedited review

processes and exemptions have made the approval

process less difficult) and a tendency toward decreased controls at the Federal level with simultaneous increase in controls at the State, local,

and institutional levels.

If these research policy issues which have dominated the discussions for the last decade appear

to be either resolving or, at least, not creating major controversies among the research community,

then what issues do appear to be emerging for

congressional attention?

WHO BEARS THE BURDEN OF PROOF?

The burden of proof for control of research ap- ample, cryptology researchers were asked to carry

pears to be changing. Increasingly, the individ- the burden of deciding which papers to submit

ual researcher or research facility must prove that to the National Security Agency for review.1 A

the research is safe rather than the regulator prove similar shift in the burden of responsibility

that it is unsafe. occurred in 1980 changes in NSF grant policy,

A shift in responsibility is clearly occurring in which made the grantee responsible for notifying

the case of restrictions on scientific and technical .

communication. Under schemes proposed in 1980 I Massachusetts Institute of Technology, Interim Report of the

by the American Council on Education, for exCommittee on the Changing Nature of Information (Cambridge,

MA: Mar. 9, 1983), Section 4.5.

117
118

NSF if, in the course of an NSF supported project, the burden of proof on the government to show

“information or materials are developed which a compelling need to infringe. But some legal schomay affect the defense and security of the United lars argue that the situation is now muddied beStates.”2

cause it is increasingly difficult to distinguish beIf a fundamental constitutional right is in- tween pure speech and “impure” special action.

volved, then in the past the courts have placed

‘National Science Foundation, Grant Policy Manual, Section 794c.

THE SCIENTIST’S ROLE IN ASSURING SAFE RESEARCH

One of the principal unresolved issues is that

of who should be involved in the regulatory process. What is an appropriate role for the individual scientist, for a professional science or engineering society, or for the public?

To what degree should the scientific community itself take central responsibility for both policing its own safety procedures and participating

in the broadscale development of regulation?

There are differing views on the extent to which

scientists should be involved. Do scientists have

some special right to be exempted from consideration of these issues? Or is it as John Edsall

wrote in 1975:3

The responsibilities are primary; scientists can

claim no special rights, other than those possessed by every citizen, except those necessary

to fulfill the responsibilities that arise from the

possession of special knowledge and of the insight arising from that knowledge.

The conflict between these varying interests is

made clear in the specific provisions of the Export Administration Act, for example, where

scientists, whether employed by academic institutions or industry, are expected to comply with

the requirements of the Act and other “applicable provisions of law” when communicating research findings “by means of publication, teaching, conferences, and other forms of scholarly

exchange.” 4

‘John T. Edsall, Scientific Freedom and Responsibility, report of

the American ksociation for the Advancement of Science, Committee on Scientific Freedom and Responsibility (Washington, DC:

American Association for the Advancement of Science, 1975), p. 5.

4Harold C. Relyea, “The Export Administration Act of 1985: Implications for Scientific Communication, ” memorandum to the Committee on Scientific Freedom and Responsibility, American Association for the Advancement of Science, June 8, 1985, p. 9.

Many agencies have reached out to the affected

research community, asking scientists to review

proposed regulations, both formally and informally, and thereby hoping to assure that the regulations are written in such a way that they are

enforceable and can and will be complied with

(i.e., are not far-fetched). Such an approach tests

those scientists’ belief that the regulations are necessary to protect society. For example, some

. . . social scientists argue that in the case of recombinant DNA the process was flawed, precisely

because the political authorities put too much reliance in the judgement of the researchers themselves” and that this situation led to “the capture

of a regulatory agency by those it is supposed to

regulate.” 5 Others argue that the recombinant

DNA case was “a model of responsible public policy decisionmaking for science and technology.’”

How much should research be controlled by legal regulation, how much by institutional rules,

and how much left to informal practice or to the

codes or guidelines of professional societies?

Strong arguments can be made that, when restraint is desirable, it should not involve the government. Regulatory enforcement, court cases, or

congressional legislation may be inappropriate settings in which to make social decisions about the

dangers and risks of research. Neither the current

regulatory laws nor the agencies that enforce them

are geared to address social or ethical issues. For

many of the recent regulatory debates involving

‘Susan Hadden, as quoted in Sanford A. Lakoff, “Moral Responsibility and the Galilean Imperative, “ Ethics, vol. 191, October 1980,

pp. 110-116.

“Harold P. Green, “The Boundaries of Scientific Freedom, ” Regulation of Scientific Inquiry, Keith M. Wulff (cd. ) (Boulder, CO:

Westview Press, 1979); reprinted from Newsletter on Science, Technolog~’, & Human Values, June 1977, p. 118.
119

science, Congress has legislated solutions to fit one

particular situation or crisis, While these procedures or rules may work well to adjudicate among

differing scientific or legal aspects of problems,

they are not always constructed in such a way

as to resolve or negotiate compromise easily on

moral or ethical points. Critics of a new line of

research may be left to feel that they have no real

forum from which to effect change.

How extensive and complete should regulatory

legislation be? If the decision is to rely on selfregulation, what criteria will be used? The philosophy behind both the Institutional Review

Board (IRB) system and the Institutional Biosafety

Committees is a form of “monitored self-regulation, ”7

in which the process of regulation is subject to review and monitoring by government authorities. The extensive use in the U.S. regulatory

‘Harvey Brooks, Ben]amin Peirce Professor of Technology and

Public Policy, Harvard University, personal communication, 1985,

system of consensual voluntary codes and standards* is in this tradition, but this self-regulation

for certain forms of research appears to have been

questioned in many recent cases (e.g., animal experimentation). Should sanctions be imposed on

professional communities or institutions that fail

in their self-regulation? Or shall the disciplinary

action continue to be directed at individuals?

One alternative to increased regulation might

be better education of the young scientists in the

rationale for and the ethical aspects of regulation.

Today, such education occurs primarily through

apprenticeship, through informal learning. Congress might be asked to consider encouraging—

e.g., through fellowships—education in the ethics

or procedures of regulation.

*See discussion in ch. 4.

EX POST FACTO RESTRICTIONS ON RESEARCH COMMUNICATION

An individual researcher and the Federal Government often can have overlapping but not identical interests in suppressing or disseminating

scientific and technical information. In this respect, controls on research resemble government

controls in all parts of society. “Most decisions

about regulation involve decisions among competing societal ‘goods, ’ not decisions between

‘goods’ and ‘bads’.”8

To achieve greater benefits,

society may be inclined to accept greater risks;

but in some situations the risks are experienced

differentially by particular groups or individuals.

The Department of Commerce has, for example,

interpreted such normal scientific activities as presenting papers and talking with colleagues as a

potential “export” of technology, which could be

construed as requiring a scientist to obtain an export license before participating in such activities.

In the opinion of some observers, this interpretation constitutes a prior restraint on speech, a

“governmental intrusion on the scholarly exchange of ideas.”9

‘Ibid.

‘American Civil Liberties Union, Free Trade in ideas: A Constitutional Imperative (Washington, DC: May 1984), p. 18,

These interests have been placed in especially

sharp contrast when the Government has attempted to restrict communication about research

undertaken independently and without Federal

support, or when the Government classifies

retrospectively research that was not conducted

under classification or even with military funding. Similar issues are raised when there are attempts to control the dissemination of militarily

or internationally “sensitive” but previously unclassified information or to control access to facilities. 10 In the decision to classify or control

scientific information, the risks to national security must be weighed against the long-term value

of free flow of information among a nation’s scientists and against principles of scientific and academic freedom.

One consequence of U.S. restrictions may be

the inhibition of U.S. scientists’ access to information abroad. Several European members of the

l~Haro]d C, Re]yea, IVatjonaj Secun’tv Contro)s and sCkntifJ’C information (updated 09 ’11 84), issue brief IB 82083, Library of Congress, Congressional Research Service, Government Division, Washington, DC, 1984.
120

North Atlantic Treaty Organization (NATO) are

reported to be considering the establishment of

a new technology transfer agency to coordinate

their political response to the controls placed by

the United States on the flow of advanced technology.” The NATO Science Committee recently

wrote that, around the world, “certain important

research institutions are . . . already being overcautious” in communication of research results. 12

“NATO Science Committee, “Open Communication in Science, ”

NATO Science & Society, 1983.

‘

z

Ibid.

The Committee expressed fear that the combination of an increasing amount of classification—

for reasons relating both to national military and

economic security—and increased international

industrial competition could impede cooperation

between the scientific communities of friendly nations, They also emphasized that restrictions will

make it more difficult for small nations to obtain

access to much-needed research results and that

more classification may lead to more costly duplication.

“GRAY AREAS” OF SENSITIVE INFORMATION AND

BROADER CLASSIFICATION

“Significant attempts have been made to restrict

the flow of information in cases where it has been

felt that, though unclassified, it was of such sensitive nature that our ‘enemies’ could use it to their

advantage.” 13 For example, Executive Order

12356, a classification order issued by President

Reagan, “appears to allow classification to be imposed at any stage of a research project and to

be maintained for as long as government officials

deem prudent.”14 John Shattuck, of Harvard

University, observes that that order “could inhibit

academic researchers from making long-term intellectual investments in nonclassified projects

“Alan McGowan, Scientists’ Institute for Public Information, New

York, NY, personal communication, 1985,

IdJohn w. Shattuck, Feder~ Restrictions on the Free F1OW of Academic Information and Ideas (Cambridge, MA: Harvard University, Januar y 1985).

with features that make them likely subjects for

classification at a later date.”15

As discussed in chapters 3 and 4, the use of Export Administration Regulations and International

Traffic in Arms Regulations to identify and control “gray areas” of research previously unclassified and usually not considered covered by those

regulations has raised a number of questions

about the potential of long-term adverse effects

on the U.S. scientific base. Increasing the areas

of unclassified but severely restricted information

not only inhibits communication among colleagues who could benefit from interaction but

may also point out to opponents those scientific

areas of potential fast progress.

‘51bid.

IMPACT OF NEW COMMUNICATION TECHNOLOGIES

The information revolution creates new opportunities or methods for delaying or classifying information as well as opportunities for more open

dissemination. “As long as there were significant

delays in publication of new scientific results, the

review process for commercially sponsored research offered only modest impediments to scientific openness.”16

‘“Brooks, op. cit,

If recognized by the scientific community as a

legitimate publication that signifies a claim to priority, publication on electronic networks could

provide a new channel for scientific interaction.

It could also have the effect of increasing the

amount of classification of scientific information

if, because of the speed of publication on such networks, the Government feels compelled to act

quickly to classify without adequate information

to justify such classification.
121 —

New technologies also give rise to questions

about how much control an originator/creator

has over the research project’s results or data, its

PATENTS

Many observers propose the need for revision

of the patent system because they believe that the

existing policy inhibits the progress of science and

stifles invention and innovation. Federal Government policy has been to retain title and rights to

inventions resulting from federally funded research and development (R&D) made either by

government contractors or grantees or by inhouse government employees.17 However, only

about 5 percent of the 25,000 to 26,000 patents

currently held by the government have been used.

A related issue is whether there is a need for

a uniform government-wide patent policy. Several pharmaceutical firms have also begun to use

the patent law to restrict research uses of patented

products and procedures, even for experimental

use (heretofore regarded as exempt).18 Such ac-

‘

-William C. Boesman, “Government Patent Policy: The Ownership of In\’cnt ions Resulting From Federally-Funded R& D,” issue

briet ]B78057, Library ot Congress, Congressional Re\earch Set-w

ice, Science Policy Research Division, 1985.

‘

5 Jeffrey L. Fox, “Patents Encroaching on Research Freedom, ”

Sc~ence, vol. 224, lune 3, 1Q84, p. 1080.

intellectual property. This issue is discussed in

OTA’s forthcoming report on intellectual property.

tion raises new questions about the interpretation

of current law when there is competition in a fastmoving field and where the language of the law

may be at variance with contemporary research

practices.

An Organisation for Economic Co-Operation

and Development (OECD) task force has recently

recommended that OECD countries adopt the

U.S. policy of making the date of conception,

rather than the date of filing, the legal date of a

patent. If this were followed, then pressure to keep

data confidential pending patent filing would be

much reduced because there would be a grace

period of 12 months after publication for filing

of a patent application. The main reason for delay of publication in most university-industry

agreements is to allow time for filing for foreign

patents. Revisions in the patent laws could therefore result in significant long-term effects on research.

PUBLIC EDUCATION ON THE BASIS AND

PROCEDURE FOR REGULATION

Understanding of and education in science play

a vital role in the public’s willingness to support

the regulation of research. If the public understands the inadvertent and unintended effects of

government regulations, then it may be more

likely to support changes in policy which more

accurately implement the intent of the law. Many

observers have described to OTA a growing disassociation between what the public believes

should be controlled and what the government

actions are controlling. The government is presumed to be acting on behalf of the public, but,

for example, is there evidence of public support

for the increased controls being placed on scientific communication?

As the case studies presented in chapter 7 and

appendix C show, how the public perceives or calculates the risks of research may greatly influence

its willingness to control research and may similarly influence public beliefs about when controls

or legal regulation should be imposed.
122

SHIFT IN THE JURISDICTION FOR REGULATION

The discussions of such actions as the right-toknow legislation, the Arthur D. Little and Bellcore cases (chapter 7 and appendix C), and the

animal experimentation controversy show that the

public—through either community protest or referendum—can act to control, direct, or influence

the topic choice, experimental procedures, or

communication of science. Although the evidence

is limited, such cases hint at the beginning of a

jurisdictional shift in the regulatory arena for

science, especially from the Federal to the State

and local. This change may be a reaction to either real or perceived laxity in Federal regulations

for health and safety protection, it may relate to

broader issues of the exertion of local control over

land use and community activity, or, in some

cases, it does relate to the larger agenda of national political groups—e.g., protests linked to nationwide efforts to stop all nuclear power, abortions, or the use of animals in research.

This jurisdictional shift raises the spectre of a

number of negative effects on research caused by

GENERAL ISSUES

Underlying many of these issues are questions

not resolvable through legislative activity but to

which the Science Policy Task Force of the House

Committee on Science and Technology, in its deliberations, should attend. Once societal constraints may be imposed, a fundamental question

is that of what constitutes “research. ” For example, does there exist some constitutional protection for research, and if so what does the legal

definition of “research” include? Does it include

not only thinking about a problem or talking to

other scientists but also experimentation? The definition of what is or is not basic research currently

plays a role in the dissemination of Department

of Defense (DOD) -sponsored research results. Defining a project as falling within Federal budgetary

category 6.1 (fundamental research), for example, can determine whether or how it is classified

by DOD. ’9 The definition of what is or is not re- ——.— .

19 Janice R. Long, “Scientific Freedom: Focus of National Security Controls Shifting,” Chemical & Engineering News, July 1, 1985,

pp. 7-11.

inconsistencies or variations in the strictness of

Federal and local regulations. As Allen G. Marr,

Dean of the Graduate Division of the University

of California, argued in a letter to OTA:

Regulations promulgated uniformly on the basis of federal law are far superior to patchwork

regulation by state law or local ordinance. Codes

of ethical professional practice are art important

complement but not a full substitute.

An issue raised by participants in the Arthur

D. Little case (see ch. 7), was that protests over

research involving hazardous chemicals might

have the unintended result of segregating such research. States without the resources for developing comprehensive regulations (or for assuring

compliance) might become dumping grounds for

research no other States want.

Is there a need for a new jurisdictional framework by which Congress can deal with these issues, or are they best resolved at State and local

levels”!

search also plays a role in regulation of biomedicine. Experimental surgical procedures, for example, may be justified as therapeutic and not be

subjected to review by an ethics committee. A

medical researcher who refers to a project as a

“pilot study” or as “innovation” can keep it

outside such regulatory control mechanisms as

IRBs. 20 Better understanding of these and other

definitional questions will be essential to future

attempts to resolve many of the issues mentioned

above.

In setting an agenda for science, should policymakers look only to the potential benefits of the

research proposed or should equal consideration

be given, before funding, to the risk posed by the

research? If so, what parameters should be used

to make those determinations? Andre ́ Hellegers

once said that he, for example, would “assign a

ZOArthur Cap]an, T~ Hastings Center, Hastings-on-Hudson, NY,

persona] communication, 1985.
123

-.

very low priority” to any inquiry that “does not,

in the inquiry, harm nature, but which may be

dangerous in its consequence. . .“.21 Ruth Macklin

made a similar point in her essay “On the Ethics

of Not Doing Scientific Research” when she wrote:

There is surely some disutility attached to an

outcome that fails to benefit people who might

otherwise have been helped by research. But unless we subscribe to a research imperative that

places freedom of scientific inquiry above all other

values when potential danger lurks, we need to

examine closely the value dimensions of each instance of decisionmaking under certainty. ’z

To approach full understanding of this question,

one must also consider what consequences—e.g.,

only the most probable or only the most negative—are to be included in such a determination

and also what relative weights should be assigned

to various potential outcomes. Is there not just

one but a spectrum of possible ways in which society might use the results, and what relative

weights can be assigned to the better or worse consequences? 23

In setting funding priorities, Congress may increasingly have to confront determinations of

‘iAndre’HeIlegers, Regulation of Scientific Inqul~’, Keith hf. Wu]ff

(cd. J (Boulder, CO: Westview Press, 1979).

“Ruth Macklin, “On the Ethics of Not Doing Scientific Research, ”

Hastings Center Report r vol. 7, December 1977, pp. 11-15.

2

‘Brooksf op. cit.

what are the boundaries of control of science’s

overall agenda. Such questions have been raised

in connection with the current shift toward military dominance of basic research funding and with

the increased numbers of arrangements between

universities and industry. Will such shifts result

in increased, long-term restrictions on communication, and in controls on procedures as well as

on agenda-setting? How might such changes

affect—positively and negatively—the research

process and the openness of scientific communication?

And, finally, as the case studies and many of

the examples show, the flow of public information plays a significant role in the regulatory environment for science. There is, of course, an urgent need for truly sensitive information to be

protected by the classification system, whether for

reasons of military security or economic protectionism, and such arguments are equally valid for

industrial or academic protection of intellectual

property. Arbitrary and capricious use of secrecy

and classification, however, may inadvertently

damage the progress of science by inhibiting the

free flow of information among researchers and

the flow of information to the public. In the latter case, inadequate or incomplete information

could, in fact, increase the probability of arbitrary

regulation at the local level and, on matters relating to national policy debates, inhibit free political discourse.
Appendixes
Appendix A

The Regulatory Environment for Science

Regulatory Forces on Specific

Fields—Two Case Studies

These case studies illustrate the regulatory forces at

work on two different research areas—agricultural research and research on acquired immunodeficiency

syndrome (AIDS). The first area, agricultural research,

is highly organized and highly controlled. Regional

needs largely determine the substance and agenda of

research, even though the actors who set the agenda

may be part of centralized government or in a multinational corporation. Recently, two well-publicized

legal actions have had a dramatic influence on the research process in agriculture, attempting to prohibit

research from progressing on certain topics or in a certain manner. The second area, research on AIDS,

offers an interesting contrast in the types of forces regulating a “hot” research field. Here, the methodological traditions of science and some significant liability

and privacy issues may be colliding with the push by

advocacy groups for acceleration of the research.

Regulatory Forces on

Agricultural Research1

In April 1863, the U.S. Department of Agriculture

(USDA) was given authority to use about 40 acres of

land at the west end of the Capitol Mall in Washington, DC, as an experimental farm. Since then, food

and agricultural research in the United States has expanded and now includes three major performers: the

USDA; the State agricultural experimental stations

(SAES), and private industry, all of which do both

mission-oriented research and basic research.

For its research activities, USDA maintains three

separate operating agencies—Agricultural Research,

Cooperative Research, and Extension Service-and an

Office of Science and Education, which sets broad agricultural research policies. The Agricultural Research

Agency is responsible for most of USDA’s in-house

agricultural research and is accountable and responsive to Congress and the executive branch for broad

regional, national, and international concerns. The

Cooperative Research Agency administers Federal

funds that go to States for agricultural research. The

Extension Service disseminates research results

through, for example, publications, public meetings,

‘This section summarizes material In U.S Congress, Off Ice of Technology

Assessment, Lln~ted States Food and Agricultural Research System (Washington, DC U S Goverment Pr]ntlng OftIce, December 1981)

and demonstrations. The four SAES geographical regions are each headed by a deputy administrator and

typically include a central station located often on the

campus of a State’s land-grant university, and a number of branch stations throughout the State. Major private performers in agricultural research include such

companies as General Foods Corp., Ralston Purina

Co., and Campbell Soup Co..

In general, public sector agricultural research focuses

on biological technologies, while the private sector

sponsors research on mechanical and chemical technologies. In 1978, total Federal expenditures for all research and development (R&D) were $26.2 billion.

USDA’s expenditures were $381 million, or only 1.5

percent of the total U.S. R&D budget. The total private sector agricultural R&D budget is about threefourths of the total USDA contribution.

A multiplicity of actors—consumers, producers, investors, in-house scientists, scientific societies, the regulatory agencies, the executive branch and Congress—

thus determine research priority setting in agricultural

research. Within the SAES system, for example, line

item administrators and scientists set specific project

priorities according to their assumptions about what

is the greatest need in their field and what would be

of greatest value to the State. Traditionally, federally

sponsored research has been managed through a classification system based on geography, type of research

(i.e., basic or applied), the problem area, and program

structure. A less direct, but no less influential determinant of research direction has been Federal environmental and safety regulations, such as regulations on

chemical residues or additives in food.

Recently, two separate legal actions have introduced

controversy into what has usually been a quiet region

of the scientific community. In 1979, attorneys filed

a lawsuit, on behalf of 17 farm workers and the California Agrarian Action Project, which charged the

University of California with unlawfully spending public funds on mechanization research that displaced

farm workers. That suit is still in litigation.

Mechanization research includes the development

of machinery, crop varieties, chemical herbicides,

growth regulators, and laborsaving methods of handling, transporting, and processing crops. Lawyers for

the farm workers allege that such research displaces

farm workers, eliminates small farms, harms consumers, impairs the quality of rural life, and impedes

collective bargaining, thereby failing to satisfy the government’s obligation to consider the needs of small and

family farmers, as specified in various Land-Grant

127
128

Acts and the Hatch Act of 1877, which authorizes

Agricultural Experiment Stations.

The plaintiffs are demanding that all mechanization

research at the University of California be halted until a fund is created to be used to assist and retrain farm

workers. z Their supporters feel that Federal funding

for research on laborsaving devices is an improper use

of Federal money; it is best supported by the marketplace because agribusiness is the primary group that

stands to gain most from the benefits of such research.

Opponents see it as a battle between consumerism and

good science at best, and the imposition of Federal controls on research and a violation of academic freedom

at worst. They cite many cases where mechanization

research has resulted in lower prices for the consumer

and more humane working conditions for the farm

worker. The case, as yet unresolved, raises issues

about: 1) the social costs of innovation through agricultural research, and 2) the legal and social responsibilities of those who conduct research that might adversely affect certain populations. In the legal sense,

the case raises questions about the propriety of Federal expenditures for research activities that might primarily benefit private interests.

The other legal action and public protest, launched

by activist Jeremy Rifkin and the Council on Economic

Trends, has attempted to halt the deliberate release of

genetically engineered products into the environment,

a technology of potential use to the agricultural industry as a means of increasing and improving crop production. A Federal appeals court has ruled that experiments involving the release of genetically altered

organisms into the environment can proceed, provided

that their potential ecological effects have been properly evaluated. Rifkin’s group has also filed suit along

with the Humane Societies of the United States and

the Minor Breeds Conservancy against the Department

of Agriculture on the issue of transferring genes between species, such as injecting genes for human

growth hormone into livestock to promote more rapid

and exaggerated growth, As of September 1985, a

hearing date had not been scheduled,

These actions demonstrate that even the most highly

controlled of research fields may be disrupted by new

regulatory forces.

Research on AIDS3

Much of what we know about the biology of acquired immunodeficiency syndrome (AIDS) is also a

‘Calitornja Agrarian Action Project (CAAP) et al v The Regents of the

University of California, Case 516427-5, Superior Court of the State ot Callforn,a, Oakland (filed Sept. 4, 1979)

‘This section summarizes material m U.S. Congress, Ottlce d Technology

Assessment, RevJew, of the Public Health .%vice’$ Re3ponse to AIDS (Washington, DC U.S. Government Printing Ofhce, February 1985)

result of federally sponsored research activities; for example, Public Health Service (PHS) grantees “discovered” AIDS as a syndrome, PHS has conducted surveillance of AIDS, and PHS investigators and others

have made significant scientific advances, including the

discovery of the probable etiologic agent for AIDS.

Furthermore, PHS investigators-are extensively involved in collaborations with non-Federal researchers,

both nationally and internationally. Thus, the environment in which AIDS research is funded, conducted,

and reported is influenced not only by the politics of

the disease (i. e., the special populations which it effects), but also by the traditional funding mechanisms,

the grants review process, and the way in which commercial interest turns basic research results into vaccines. In the case of AIDS, these forces appear to have

both contributed to and impeded the research.

Although AIDS funding increased substantially in

fiscal years 1984 and 1985, the history of specific funding for AIDS has been marked by tension among the

individual PHS agencies, Department of Health and

Human Services (DHHS), and Congress. Through the

Assistant Secretary for Health, individual PHS agencies have consistently asked DHHS to request specific

sums from Congress; DHHS has submitted requests

for amounts smaller than those suggested by the agencies; and Congress typically has appropriated amounts

greater than those requested by the Department, Except when prodded by Congress, DHHS has maintained that PHS agencies should be able to conduct

AIDS research without extra funds. However, threatened cuts in overall funding and personnel levels have

restricted the ability of affected agencies to redirect resources.

An additional indirect influence on the research has

been the uncertainty of project staff levels. At critical

times in the planning stages”, the number of personnel

needed to conduct and support the research-has actually been reduced in several of the PHS agencies. As

a result, the PHS agencies have been unable to plan

their activities adequately because they have not

known how much funding and staff will be available

to them, Now that an etiologic agent for AIDS has

been discovered and the research could move into

areas where several agencies have overlapping expertise, the jurisdictional uncertainty—because of the uncertain}’ in resource allocation—has intensified competition.

The question of whether AIDS funds should come

out of existing PHS agency budgets, or whether such

funds should augment agency budgets, also reflects

concern about the perceived appropriateness of PHS

funding of AIDS-related research and the perceived

magnitude and importance of the AIDS epidemic.

Some scientists have expressed concern that ‘research

on other diseases will suffer because funds are being
129

—

transferred from these areas to AIDS-related research;

other observers believe that AIDS-related research

may be delayed because of wrangling over such

transfers.

In AIDS research, some sharing of information has

taken place through the informal networks that exist

among PHS agencies and among their researchers, but

tensions also surround formal communication, Since

the National Cancer Institute’s work on HTLV-III was

announced in April 1984, formal information-sharing

on a management level has increased substantially, and

centralized coordination of activities is also on the increase. Members of the PHS Epidemiology and Prevention Task Force have agreed to distribute articles

prior to publication, and to discuss studies at the planning stage in order to avoid unnecessary redundancies and to ensure that all the necessary areas are being covered. Many of these sharing and coordinating

activities would have taken place regardless of any

directive from PHS central management, but in other

instances, earlier PHS guidance might have led to better coordination —e.g., PHS might have directed the

National Cancer Institute (NCI) to share AIDS virus

culture with the Centers for Disease Control, an action which was not taken.

Another factor that may have impeded the generation and dissemination of information is the Federal

grants application and approval process for extramural

research. National Institutes of Health (NIH) research

grants take about 16 months from conceptualization

to awards; contracts, about 14 months. The first round

of extramural grants awarded by NIH for AIDS research took 14 months to be processed, in part because

of negotiations with the Office of Management and

Budget over the specific language used in the agreements. Since that time, some steps have been taken

to speed up the process, such as mail balloting instead

of face-to-face meetings by reviewers. Shortening the

process, however, may only increase concerns about

the quality of the research activities funded.

Federal regulations covering commercial development of drugs, biologics, and devices have also

impeded open communication. In the United States,

Federal policy tends to leave commercial development

of technologies, including technologies derived from

Federal biomedical research, to the private sector.

Once under commercial sponsorship, R&D activities

are considered proprietary and will not be made public unless voluntarily released. The Food and Drug

Administration (FDA), therefore, cannot even divulge

the protocols being used by the five companies under

license from NCI to develop AIDS screening tests to

Federal researchers who are not directly involved in

these activities. Yet the Federal researchers will generally share their research, including their research materials; their primary concerns are the qualifications

of the private researchers and the quality control processes they have established. In the case of AIDS, the

sharing of information developed by commercial firms

was enhanced in small part because PHS selected the

companies that would get the HTLV-III culture developed by the NCI laboratory. Other laboratories, however, have now cultured the virus and sold or given

it to companies other than those selected by PHS, and

the status of those companies’ activities is formally unknown to any Federal researcher at FDA.

Finally, AIDS has been described as a “legal emergency” as well as a medical crisis. Much of the concern centers on social discrimination experienced by

members of the groups at risk to contract the disease,

especially homosexual men and intravenous drug

users. Two sections of the Public Health Service Act,

therefore, have been used to protect confidentiality in

federally sponsored research. Section 242a authorizes

the Secretary of DHHS to protect the privacy of individuals participating in research on mental health, including research on the use and effect of alcohol and

other psychoactive drugs, by: 1) withholding from all

persons not connected with the conduct of such research the names or other identifying characteristics

of such individuals; and 2) prohibiting persons authorized to protect the privacy of such individuals from

being compelled to identify them in any Federal, State,

or local civil, criminal, administrative, legislative, or

other proceedings. Section 242m(d) provides that information may not be used for any purpose other than

the purpose for which it was supplied unless consent

has been given.

As more is known about the relationship between

HTLV-III and AIDS, or as other diagnostic tests are

developed, confidentiality safeguards will have to be

implemented without sacrificing the surveillance needs

of public health officials or data sharing among researchers. Informed consent will be an especially difficult issue, for example, because the first test to be

applied will detect exposure to HTLV-III only through

the presence or absence of antibodies and persons who

test positive may actually be carriers of HTLV-III, may

develop AIDS, or may remain well. Regulatory decisions, therefore, will have to balance the public health

concerns surrounding the transmissibility of AIDS

with the social stigma or employment discrimination

that may accompany identification as a potential carrier or potential victim.
Appendix B

Public Attitudes Toward Science*

The attitudinal environment for science includes the

attitudes of the public toward science and technology

in general or institutional terms. These attitudes may

be usefully grouped as hopes and expectations, reservations and concerns, and confidence in the leadership of the scientific community. This appendix will

examine both the literature and the data relevant to

each of these three sets of attitudes.1

Hopes and Expectations

In broad strokes, the literature and the publication

data from the 4 decades since 1945 portray a public

that has a high regard for the past achievements of

science and technology and high hopes for even more

*This appendix is based on an OTA contractor report written by Jon D.

Miller, Northern Illinois University.

‘The following data sources were utilized in secondary analyses. The 1957

National Association of Science Writers study was based on personal in-home

interviews with a national probability sample of 1,919 Americans. The interviews were conducted by the Survey Research Center at the University

of Michigan. The field work for this survey was completed just prior (about

2 weeks) to the launch of Sputnik 1 by the Soviet Union and is the last measurement of American attitudes toward science and technology prior to the

Space Age For a full description of the study and results, see R.C. Davis,

The Public Impact of Science in the Mass Media, Survey Research Center

monograph No. 25 (Ann Arbor, MI: University of Michigan, 1958).

The 1979 survey of public attitudes toward science and technology was

based on personal In-home interviews of a national probability sample of

1,635 adults. Sponsored by the National Science Foundation (C-SRS78-16839),

the field work was conducted by the Institute for Survey Research at Temple

University. For a description of the design and results of the study, see Jon

D Miller, et al , The Attitudes of the US. Public Toward Science and Technology (Washington, DC. The National Science Foundation, 1980)

The 1981 survey of public attitudes toward science and technology was

based on telephone interviews with a national probability sample of 3,195

adults The study was sponsored by a grant from the National Science Foundation (NSF 8105662) and was conducted by the Public Opinion Laboratory

at Northern Illinois University. For a description of the sample and results,

see Jon D Miller, A National Survey of Public Attitudes Toward Science

and Technology (DeKalb, IL Northern Illinois University, 1982).

The 1983 survey of public attitudes toward science and scientists was based

on telephone Interviews with a national probability sample of 1,630 adults,

Sponsored by the Annenberg School of Communications at the University

of Pennsylvania, the survey was conducted by the Public Opinion Laboratory at Northern Illinois University. For a description of the design and results of the study, see Jon D. Miller, A National Survey of Adult Attitudes

Toward Science and Technology in the United States (Philadelphia, PA:

University of Pennsylvania, Annenburg School of Communications, 1983),

The 1985 data on attentiveness to science policy were taken from a telephone survey of a national probability sample of 1,514 adults. The study

was sponsored by Family Circle magazine and conducted by the Public Opinion Laboratory at Northern Illinois University, A technical report on this study

will be released by the Public Opinion Laboratory in the fall of 1985,

The 1981-82 study of the attitudes of science policy leaders was based on

telephone interviews with a national sample of 282 individuals, Sponsored

b y a grant from the National Science Foundation (NSF 8105662), the survey

was conducted by the Public Opinion Laboratory at Northern Illinois University. For a description of the study design and the methods used to identify

and sample science policy leaders, see Jon D, Miller and Kenneth Prewitt,

“National Survey of the Non-Governmental Leadership of American Science

and Technology, ” a report to the National Science Foundation, 1982,

spectacular results in the future. Even though most

Americans still see science as a magic black box, ’ the

evidence is clear that they also believe that their current standard of living is in large part the result of modern science and technology. The substantial gains in

medical science, for example, symbolize the achievements of science for most Americans.

The first national study of public attitudes toward

science in the post-war years was conducted in 1957

by the Survey Research Center of the University of

Michigan. Sponsored by the National Association of

Science Writers (NASW) and the Rockefeller Foundation, the study was designed to assess the public’s interest in and knowledge about science and technology,

the major sources of information on current science

issues, and the appetite of the public for science news.

The study included personal interviews with a national

probability sample of 1,919 adults and the field work

was completed in early October 1957, just 2 weeks

prior to the launching of Sputnik I. Inadvertently, the

1957 NASW study became the only existing set of

measures of the attitudes of the American public

toward science prior to the beginning of what is often

termed the Space Age. The study offers, therefore, a

unique opportunity to look back to the calm of the

mid-1950s.

The 1957 NASW study found a public that believed

that science and technology had won the war, created

“miracle” drugs, and would continue to produce a cornucopia of benefits for American society.3 Almost 90

percent of the American adults polled said that the

world was “better off because of science. ” When asked

why they thought so, slightly more than half cited

medical advances and about 40 percent pointed to the

American standard of living. When asked to name

some potential “bad effects” of science, 90 percent of

the adults in the study could not think of a single possible negative effect. Ninety-four percent of the population were willing to agree that science was making

their lives “healthier, easier, and more comfortable. ”

Ninety percent agreed that “most scientists want to

work on things that will make life better for the average person” and 88 percent felt that science was “the

main reason for our rapid progress. ” It would be hard

to imagine a more supportive public,

Despite the influence of the space race and the continued growth of post-war science and technology,

‘Jon D. Miller, “Scientific Literacy: A Conceptual and Empirical Review, ”

Daedalus vol. 112, No. 2, 1983, pp. 29-48,

‘Davis, op. cit.

130
131

there were few efforts made in the 1960s to measure

public attitudes toward science. The next systematic

effort to assess the attitudes of the American people

toward science and technology was initiated by the

National Science Board (NSB) in 1972. As a part of

its new Science Indicators series, the NSB decided to

include a chapter on public attitudes toward science.

The NSB staff prepared a set of questions and used

the Opinion Research Corporation to collect national

data sets in 1972, 1974, and 1976.

These NSB surveys found a public that still held

science and technology in high regard, although less

so than in 1957. In contrast to the almost 90 percent

of the public that thought in 1957 that the world was

“better off” because of science, only 70 percent of the

public held the same view in 1972. ’ Similar results were

obtained in the 1974 and 1976 studies.5 While the absolute level was down somewhat, a substantial majority

of the total public held very positive views of the contributions of science to American society.

In a 1979 national study of public attitudes toward

science and technology, also sponsored by NSB, several of the 1957 questions were repeated, offering an

opportunity for comparison across 2 decades. In 1979,

81 percent of the public still agreed that scientific discoveries were making their lives “healthier, easier, and

more comfortable” and 86 percent expressed the view

that scientific discoveries were “largely responsible”

for the standard of living in the United States. ’ In a

comparable national study in 1983, Miller found that

85 per cent of American adults continued to agree that

science made their lives healthier, easier, and more

comfortable. 7

Although the material gains attributable to science

have undoubtedly influenced public attitudes toward

science, there is evidence that Americans also have a

commitment to the value of science per se. In a 1983

national survey, Louis Harris found that 82 percent

of American adults agreed that scientific research

“which advanced the frontiers of knowledge” was

worth supporting “even if it brings no immediate benefits.’” Only 14 percent of Americans rejected this idea.

Evidence from the European Barometer indicates

that western Europeans hold very similar views about

the positive contributions of science and technology

to their standard of living.9 (See table B-l. ) Approxi-

‘National Science Board, Science Indicators—lQ72 (h’ashington, DC

1973 )

‘N’atlonal Science Board, .%-)errct= [ndicators—lvd (Washington, DC.

1975 ), and Nat]onal Science Board, .Sc]ence IrrdJcatom — 2976 (Washington,

DC IQ77)

‘Miller, et al , op c]t

“Miller, A Nat]ona/ Surve}, of Adult AttJ/udes To~\ard Sc]ence and Technology In the Lrrf/ted States r op clt

“Louis Harris ‘The Road After 1984. The Impact ot Technology on Society, a report prepared tor the SOu them New England Telephone Cornpan>’,

1Q84

9Jacques-Rene Rabler Euro-baromefer I(?a .%-~entlf]c F’rlorjtie, in the Furopean Commurrlty octoher-,~f”~remher,” 1978 ( Ann Arbor MI. InterUnlvers]ty Consort] urn for Pol]tlca] and Soc]al Research 1981)

Table B-1 .—European Attitudes Toward Science, 1978

Country Percent agree

Northern Ireland . . . . . . . . . . . . . . . . . . . . . . 800/0

United Kingdom . . . . . . . . . . . . . . . . . . . . . 79

Italy. ., ., . . . . . . . . . . . . . . . . . . . . . . . . ., 76

France ., . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

West Germany . . . . . . . . . . . . . . . . . . . . . . . 71

Luxembourg . . . . . . . . . . . . . . . . . . . . ., ... 70

Denmark. . . . . . . . . . . . . . . . . . . . . . . . . ... 67

Belgium . . . . . . . . . . . . . . . . . . . . ... ... . 66

Netherlands . . . . . . . . . . . . . . . . . . . . . . . . . . 65 —

“Science will continue in the future as it has

done in the past to be one of the most important factors in improving our lives. ”

—

mately threequarters of western Europeans were willing to agree with a statement that science had been and

would continue to be a major factor in improving their

lives. There was a high degree of consensus among

countries, ranging from 80 percent in Northern Ireland

to 65 percent in the Netherlands.

Another facet of the attitudinal environment for

science is reflected by the public’s expectations for future achievements. The belief that science has contributed to the health and comfort of the society is, of

course, inherently retrospective; and so it is important

to inquire whether the public expects similar achievement from science in the future, or whether the public thinks that the frontiers of science have been explored thoroughly. Beginning with the 1979 study for

NSB, one series of questions have asked respondents

to assess how likely it is that science will achieve certain results in the next 25 years. The results indicate

that a large segment of the public holds high expectations for future outcomes from science and technology. By 1983, a majority of the public thought that

it was “very likely” that within the next 25 years

science would find a cure for the common forms of

cancer, have people working in a space station, and

find efficient sources of cheap energy (see table B-2).

In contrast, a substantial portion of the public indicated that they did not expect science to be able to cure

mental retardation, communicate with alien beings,

or put whole communities of people into outer space.

These results indicate that the public does have some

ability to differentiate between likely and less likely

outcomes and that the optimism found in several previous responses is not a simple yea-saying reaction.

From these aggregate results, it would appear that

a significant portion of the American people hold some

positive general attitudes toward science. It is also important to inquire whether the attentive public* for

‘ln brle~, the basic dimensions of an ‘attentive public” tor science pollcy

are h]gh level of Interest in the topic, comb]ned with the perception of be]ng

adequately lntormed For a discussion of th]s concept In more depth, see l(~n

D Miller, I’ubl]c Attitudes Toward the Regulation of Research, c{~ntra~-

tor report prepared for the U S Congress, OttIce of Techno]og}, Assessment
132

Table B-2.—Expectations for Future Scientific Achievements, 1979-83

Percent saying that the following results will Possible, but Not likely Number of

be achieved in the next 25 years: Year Very likely not too likely at all people surveyed

A cure for the common forms of cancer. . . . 1979 46 44 -

8 1,635

1983 57 36 6 1,630

A cure for mental retardation . . . . . . . . . . . . 1983 11 40 47 1,630

A way to put communities of people in

outer space . . . . . . . . . . . . . . . . . . 1979 17 38 42 1,635

People working in a space station . . . . . . . . . . 1983 52 34 12 1,630

Humans communicating with alien beings . 1983 1 4 33 51 1,630

More efficient sources of cheap energy . . . . . 1979 57 34 7 1,635

A safe method of disposing of

nuclear wastes . . . . . . . . . . 1983 29 41 26 1,630

“NOW let me ask you to think about the long-term future. I am going to read you a list of possible scientific

results and ask you how likely you think it is that each of these will be achieved in the next 25 years or so. ”

science policy shares these same positive views of the

past and future results of science. Fortunately, the national data sets collected in 1957, 1979, 1981, and 1983

are available for retabulation for this purpose .

The one question relevant to this section of the analysis that has been asked repeatedly throughout the last

3 decades has been the agree-disagree statement concerning the contribution of science to making our lives

“healthier, easier, and more comfortable. ” A retabulation of three previous studies indicates that there has

been some decline in the proportion of both the attentive public and other citizens willing to agree with

the statement, but 9 of 10 members of the attentive

public for science policy and 8 of 10 other Americans

still hold that belief (see table B-3). At all three measurement points, at least 10 percent more of the attentive public were willing to agree with this view than

were other citizens.

Some of the more recent data sets allow an examination of the difference in expectations between those

who follow science policy matters and those who do

not. In general, people who were attentive to science

policy issues were more optimistic about the future

achievements of science and technology than were

those who were nonattentive (see table B-4). The general pattern of expectations by the attentive public and

by the others did not differ significantly.

In summary, both the existing literature and selected

retabulation of available data indicate that most

Americans have a positive image of science and/or

Table B.3.—Attitude Toward Contribution

scientific research. Those who have a high level of interest in science and who feel reasonably well informed

about it tend to hold even more positive views about

the past and future benefits of science.

Reservations and Concerns

Throughout the post-war years, there has been some

level of wariness about some of the possible negative

effects of science among a substantial minority of the

American people. On balance, these reservations have

not offset the high levels of positive affect and expectation described above, but it is necessary to review

and understand the magnitude and substance of these

attitudes.

The 1957 NASW study found some reservations

about the effects of science, but it was muted and most

often accepted as the price of gaining good things from

science. Slightly over 40 percent of the public were

willing to agree that science “makes our way of life

change too fast” and 23 percent agreed with the statement that “one of the bad effects of science is that it

breaks down people’s ideas of right and wrong. ” Although 70 percent of the adults in the 1957 study

agreed that “the things that happen in this world are

mostly controlled by God” and about half felt that

“one of our big troubles is that we depend too much

on science and not enough on faith, ” when asked to

assess the net effect, 9 out of 10 concluded that the

world was better off because of science. There was

of Science, by Attentiveness, 1957.83

Attentive Not Number surveyed

Year public attentive Attentive Not attentive

Percent agreeing that science makes our 1957 980/o 930/0 183 1,736

lives healthier, easier, and more 1979 89 79 232 1,313

comfortable — 1983 92 82 398 1,232
133

Table B-4.–Expectation for Future Achievements, by Attentiveness, 1979-83

Percent saying it is “very Iikely’’ that the following results wiII be

achieved in the next 25 years: Year Attentive public Not attentive —

Ž A cure for the common forms of cancer, . . . . . . . . .

●

●

●

●

●

●

A cure for mental retardation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A way to put communities of people in outer space . . . . . . . .

People working in a space station . . . . . . . . . . . . . . . . . . . . . . .

Humans communicating with alien beings. . . . . . . . . . . . . . . . . . . .

More efficient sources of cheap energy . . . . . . . . . . . . . . . . . . . . .

A safe method of disposing of nuclear wastes . . . . . . . . . . . . . . . .

N (1979) =

N (1983) =

1979 55 “/0

1983 68

1983 13

1979 13

1983 62

1983 17

1979 76

1983 35

307

398

44

54

10

10

49

13

53

27

 1,328 

 1,232

“Now let me ask you to think about the long-term future. I am going to read you a list of possible scientific

results and ask you how likely you think It is that each of these will be achieved in the next 25 years or so.

some wariness, but not enough to offset the desire for

increased health and comfort.

Karen Oppenheim repeated some of the 1957 NASW

items in a national survey conducted by the National

Opinion Research Center in 1964 and found that the

level of public wariness or concern was increasing .’”

The NSB-sponsored studies in the early 1970s found

the same trend.

Four of the items originally used in the 1957 NASW

study were replicated in a 1983 survey sponsored by

the Annenberg School of Communication at the

University of Pennsylvania. ” A comparison of the results indicates that the reservations expressed by those

citizens included in the 1957 study have remained

largely unchanged over the last quarter century.

The concern over the impact of science on the pace

of change in society has also continued at virtually the

same level. In both years, about 4 in 10 Americans expressed some concern that science was causing our

lives to “change too fast” (see table B-5).

—

‘Karen [)ppenhelm Acceptance and [)lstrust Att]tudes C)I Amerlcdn

Adults Toward Science, ma~ter s the~]s Llnlversi t}. ot C hlcagc), I WJO

I I hfllier .-i ,\’a IIorIa/ $ur~’e~ (): .A(fult .IftItUdCS T(JH ard SC 1~’nce .?n~j ~e~ hrr(llo~~’ /n the ( ‘n)tml .5tJ(es OF ( it

Table B-5.— Public Concerns About Science, 1957.83

Year

1957 1983

● We depend too much on science

and not enough on faith . . . . . . . 500/0 500/0

• One trouble with science IS that

it makes our way of life change

too fast . . ... . . . . . . . . . . 43 44

• The growth of science means that a

few people could control our lives . 3 2 35

. One of the bad effects of science is

that it breaks down people’s ideas of

right and wrong . . . . . . . . . 23 29

Number. . . . . . . . . . . . . . . . 1,919 1,630 —

Finally, these data indicated a persistent public concern about the potential for a few people to control

the lives of the total society, using the power of science.

In both years, about one-third of the adult population

was willing to agree with the statement that the

“growth of science” meant that a few people could

“control our lives. ”

Recent studies indicate a renewed concern about the

tie between science and weapons. A 1983 national survey by Harris found that 74 percent of adults in the

United States were willing to agree with the statement

that “with the development of nuclear, chemical, and

biological weapons, science and technology may end

up destroying the human race.“12 Another 1983 study

found that one-quarter of the adult population thought

that it was very likely that “wars in space” would occur in the next 25 years and an additional 36 percent

of the American people thought that space wars were

“possible.’’”

Do people who pay more attention to science (the

“attentive public” ) have the same kinds of reservations

as those reviewed above? A retabulation of the 1957

and 1983 data indicated that the attentive public holds

many of the same reservations found in the previous

data, but that the proportion of persons holding those

reservations is slightly lower among the attentive public than other people (see table B-6). Although 4 in 10

members of the attentive public were concerned that

society depends too much on science and not enough

on faith, only 2 in 10 felt that science tended to break

down people’s ideas of right and wrong. The proportion of the attentive public concerned about changes

in the pace of life and in the loss of the control of their

lives to science did not differ significantly from the

proportion for the nonattentive public.

“}iarrl~ op clt

I ~Nll]]er ,,1 ,\.<ltlOn<l/ ,sLirL,(,} ~)f ,Adu/( .A ttjtudtx T( )L* ,~rd .% Ien( c’ .Ind Te( b

nt)lo~}r in the Z ‘nl(td Stales t)~ c]t
134

Table B-6.—Concerns About Science,

by Attentiveness, 1957-83

Year

Not

Attentive attentive

Percent agreeing that . . . . . 1957 1983 1957 1983

●

●

●

●

We depend too much on

science and not enough

on faith . . . . . . . . . . . . . . . 440/0 430/0 50% 53 ”/0

One trouble with

science is that it makes

our way of life change

too fast . . . . . . . . . . . . . . . 34 36 44 48

The growth of science

means that a few people

could control our lives . . 31 31 32 38

One of the bad effects

of science is that it

breaks down people’s

ideas of right and

wrong . . . . . . . . . . . 16 24 24 32

Number . . . . . . . . . . . 183 321 1,736 1,309

In summary, from the literature and from selective

retabulation of previous data, it appears that a substantial portion of the American people hold some reservations about the impact of science on society. In

the context of the very positive views found in the

preceding section, it would appear that a significant

portion of the American people recognize and understand that science involves both the potential for substantial benefits and the possibility of damage or

misuse.

Confidence in Science

Given the combination of positive hopes and expectations and the simultaneous level of concern, how

does the public reconcile these attitudes? Is there an

overall view of science? In general terms, the attitude

research data from the last three decades suggest that

people have concluded that the benefits outweigh the

potential harms from organized science in the United

States.

As noted earlier, 88 percent of the adults studied in

1957 reported that they felt that the world was better

off because of science, 14 The preceding analyses hav e

demonstrated that the level of concern was as high in

1957 and in the early 1980s. The conclusion that the

world was still better off for the contributions of

science could be interpreted, therefore, as an assessment that the benefits outweighed the past and prospective risks.

“Ibid,

Beginning in the 1970s, the surveys sponsored by

the NSB asked each respondent to make an assessment

of the relative benefits and harms and to weigh the

two. Similar questions have been asked since that time

by Cambridge Reports. ’s

The data from the last 15 years indicate that a solid

majority of Americans believe that science does more

good than harm (see table B-7). Only about 1 in 20

Americans believe that science does more harm than

good, but about one-third of U.S. adults are unsure

as to where the balance falls. Some of this uncertainty

may reflect a lack of interest or information. About

5 percent of current respondents are simply unable to

answer the question.

Although the exact items discussed above have not

been used in a survey that would allow the separation

of attentive and nonattentives for analysis purposes,

the 1983 Annenberg study did include two items that

reflect the same attitude. Each respondent was asked

to agree or disagree with the statement that “the benefits of science outweigh whatever harm it does. ” Twothirds of the attentive public agreed with the statement

in comparison to 55 percent of nonattentives.16 The

same sentiment was measured with a paired statement

worded in the other direction. When asked to agree

or disagree with the statement that “science is likely

to cause more problems than to find solutions, ” only

16 percent of the attentive public and 27 percent of

the nonattentive public agreed. These results suggest

that those who are interested in science issues and who

follow science policy matters believe that the benefits

of science outweigh its potential harm. This same view

is reflected in the larger public, but it is not likely to

be as solidly rooted in the larger population as it would

be in the attentive public.

A second approach to reconciling the potential for

good and harm. from science is reflected in measures

of confidence in the leadership of organized science.

Most Americans have considerable pressure on their

time and do not normally set aside a significant portion of time to consider the flow of issues in areas like

science policy. If people (especially those attentive to

science) have confidence in the leadership of major

scientific organizations and corporations, then the

leaders can be relied on to monitor the process and

the public can wait until a real controversy emerges

before becoming concerned about the issue.

The evidence from the General Social Survey17 indicates that the leadership of the scientific community

I sNatlon,~cience bard, Science Indicators— 1984 (Washington, IX.

1985).

lbM1]]er A Natjona] Survev of Adult Attitudes Toward Science and Technology in (he United States, op. cit,

“J. A D,IVIS and T. Smith, General Soc]al Surveys 1972-1984: Cumulatit,e Code Book (Chicago, 11.: National Opinion Research Center, 1984).
135

has been and continues to be held in high esteem (see

table B-8). The only major institution in American society that has consistently claimed a high level of confidence from more Americans has been medicine,

which may be viewed as at least closely related to the

scientific community.

In summary, the literature and the reanalysis of previous data can be interpreted to indicate that most

Americans see the benefits of science as greater than

any potential harms or risks. This view is apparently

held even more firmly by the attentive public for

science policy. The evidence may also be interpreted

to indicate that the leadership of the scientific community is held in high regard, implying a degree of

trust in their monitoring of the work of organized

science. But it should be noted that no major survey

to date has specifically addressed the philosophical and

political issue of direct regulation of scientific research.

Episodes such as those discussed in chapter 7—and the

existence of considerable congressional legislative

activity resulting in regulation—can be interpreted just

as strongly as indicators of, if not a lack of trust, at

least a wariness on the part of some communities and

constituencies.

Table B-7.— Public Assessment of the Risks and Benefits of Science, 1972-85

Science and technology . . . . . do about the

do more good do more harm same amount dent know/

Year than harm than good of each not sure Number

1972 ...., . . . . . . . . . . . . . . . . . . . 54 4 31 11 2,209

1974 ..., . . . . . . . . . . . . . . . . 57 2 31 10 2,074

1976 .., . . . . . . . . . . . . . . . . 52 4 37 7 2,108

1983. , . . . . . . . . . . . . . . . . . 73 3 21 3 1,466

1984. , ... . . . . . . . . . . . . . . . . . 63 5 27 5 1,864

1985. , ... . . . . . . . . . . . . . . . . 58 5 32 5 1,866

“Overall, would you say that science and technology do more good than harm, more harm than good,

or about the same amount of each?”

SOURCES Opinion Research Corp. (1972 1974 1976), Cambridge Reports (1963, 1984, 1985)

Table B-8.– Public Confidence in Science and Selected Other Institutions, 1973-84

Have a “great deal of confidence” in: 1973 1974 1975 1976 1978 1980 1982 1984

Medicine ., . . . . . . . . . . . . . . . . . . . . 54 60

Scientific community . . . . . . . . . . . . . 37 45

Education . . . . . . . . . . . . . . . . . . . . . . 37 49

Organized religion . . . . . . . . . . . . . . . . . 35 44

Military . . . . . . . . . . . . . . . . . . . . . . 32 40

Major companies . . . . . . . . . . . . . . . 29 31

Press . . . . . . . . . . . . . . . . . . . . . . . . . 23 26

Television ... . . . . . . . . . . . . . . . . . . . . 19 23

Organized labor . . . . . . . . . . . . . . . . . . 15 18

Executive branch . . . . . . . . . . . . . . . . . 29 14

Congress . . . . . . . . . . . . . . . . . . . . . . . . 23 17

Supreme Court. . . . . . . . . . . . . . . . . . . . 31 33

N = 1,504 1,484

50 56 46

38 43 36

31 37 28

24 30 31

35 39 29

19 22 22

24 28 20

18 19 14

10 12 11

13 13 12

13 14 13

31 35 28

1,490 1,499 1,532

52

41

30

35

28

27

22

16

15

12

9

25

46

38

33

32

31

23

18

14

12

19

13

30

52

47

29

32

37

32

17

13

9

19

13

35

1,469 1,506 943

“I am going to name some institutions in this country. As far as the people running these institutions

are concerned, would you say you have a great deal of confidence, only some confidence, or hardly any

confidence at all in them ?“

SOURCE James A. Davis and Tom W Smith General Social Surveys Cumulative File, 1972-1984 (Ann Arbor Inter-University Consortium for Political and Social Research,

1984), p 152
Appendix C

Environmental Concerns

and Laboratory Siting:

The Morris Township-Bellcore Case*

From February 1984 to May 1985, Morris Township, New Jersey, was embroiled in a controversy over

the siting of a new research facility for Bell Communications Research, Inc. (Bellcore). The site plan of the

proposed telecommunications research complex was

debated extensively before the township planning

board. At issue was the storage, use, and disposal of

highly toxic and flammable gases. A group of residents

formed the Concerned Citizens of Morris Township

(CCMT)—an organization that spearheaded opposition to the research facility on the grounds that the

work being planned there was potentially hazardous

to public health and environmental quality. The Morris Township-Bellcore case draws attention to the efforts by citizens to set community standards of acceptable risk for privately financed research that requires

the use of toxic materials. This brief case study summarizes the key events of the controversy, examines

the legal basis of local regulation for the proposed

research, reviews the justifications for and against siting the research facility, and finally, casts some preliminary comparisons to the two Cambridge, Massachusetts, cases discussed in chapter 7, in which

recombinant DNA research and chemical warfare

agents were regulated.

Historical Background

This case began like many land use decisions in communities throughout the United States. In the late

1970s, residents of a suburban neighborhood in Morris

Township, New Jersey, raised concern over the development of a parcel of land adjacent to single-family

subdivisions and a recreational area. The issues expressed during this period were predominantly those

of traffic, noise, density, and aesthetics. In February

1980, after 15 public hearings over a 12-month period,

the Morris Township planning board approved a plan

submitted by the Southgate Corporation, developer

of the site. The 58-acre parcel, called the Southgate

Office Park Complex (Southgate Complex), was designated exclusively for office use.

‘This case study was prepared for OTA by Sheldon Krimsky, Tufts

University.

Three years later, during the summer of 1983, with

three office buildings under partial completion, the

Southgate Corporation leased the site to Bell Communications Research, Inc. (Bellcore), a research organization owned by seven regional telephone companies.

Bellcore is a by-product of AT&T’s court-ordered

divestiture of the Bell System. The Bell System Plan

of Reorganization stipulated that the regional telephone companies create a central services organization to provide them with research and technical

services.

On behalf of its tenant, the Southgate Corporation

submitted an amended site plan on December 1983,

which included the construction of an additional building devoted to research, and the use, as a laboratory,

of two floors of a building previously approved as office space. Bellcore had planned to locate its Morris

Research and Engineering Center at the Southgate location. A. number of AT&T employees at Bell Labs facilities in Murray Hill, New Jersey, and Whippany,

New Jersey, were expected to be transferred to the new

center.

The proposed facility was devoted to advanced research in semi-conductors and fiber optics. This type

of research commonly employs toxic gases such as arsine, phosphine, and diborane as well as liquified

hydrogen.

Residential abutters to the site had attended a planning board meeting in February 1984 to discuss traffic patterns when they learned that toxic and flammable gases would be used under the amended site plan.

Within a month, a core group of residents organized

themselves into CCMT.

The citizens framed their opposition to the research

facility on two principal grounds: 1) the health effects

of an accidental release of toxic gases into their neighborhooods, and 2) a potential release of untreated or

partial] y treated toxic effluent from the research facility into Loantaka Brook—a major tributary of the

Great Swamp National Wildlife Refuge.

CCMT’s main effort to prevent construction of the

research facility was directed at the Morris Township

Planning Board, a body consisting of nine appointed

members legally responsible for land use decisions.

Over two dozen public hearings were held by the plan136
137

ning board on the Bellcore case between December

1983 and May 1985. CCMT brought in paid consultants, some from outside the State, to testify in its behalf on the potential hazards to the community of the

proposed facility. Eventually, CCMT drew support

from a broad range of constituencies covering Morris

Township and neighboring communities. Included

among these were: Harding Township Environmental

Commission; over 50 Harding residents; the Great

Swamp Watershed Association; 14 civic associations

with a putative representation of 2,000 households in

Morris Township and neighboring communities; and

an official of the U.S. Fish and Wildlife Service.

A letter signed by 14 representatives of civic associations expresses the intensity of public opposition:

We question the need for Bellcore to impose the laboratory on a community that does not want it . . .

We emphatically state that the Bellcore laboratory is

not welcome and that we will pursue every means available to expose and publicize the fact that, in this instance, Bellcore has failed to fulfill its role as a responsible corporate citizen . .1

What started out as a controversy involving abutters to an industrial site, soon evolved into a regional

conflict over a proposed research and engineering center. As community pressure grew, so did Bellcore’s impatience with the uncertainty of locating its new research home. The company made serious attempts to

communicate its position that “the small quantities of

chemicals that [the company] plans to use and the

‘state-of-the-art’ safety systems and procedures that it

plans to employ will make the Southgate facility safe

beyond any reasonable question whatsoever.’”

In May 1984, Bellcore submitted an environmental

information document to the planning board, describing its prospective laboratory operations, providing

a representative chemical inventory for the new complex, and outlining safety procedures for the storage

and handling of toxic materials. The company also

hired risk assessment consultants to present its case before the planning board. Bellcore scientists provided

an additional source of technical assistance to the company during the protracted debate.

In the 18-month period during which the planning

board held public hearings on Bellcore’s proposed research complex, proponents and opponents of the

amended site plan were assigned scheduled sessions at

which to present their respective arguments. On May

3, 1985, the planning board prepared for a final vote

on the site plan. However, at the outset of the session

prior to the vote, Bellcore made an unexpected anIThc,ma\ Fuschett[> Ir , Bel]core [’r{)test Cont]nucs t{) Build ObserLrerTr/hunf, Nlar 28, 1Q8.5

h’ Nllchael (;rt)ve, LrICe President and General C<)unse], Ije[[cc)re, ]etter

to lames $tenger Concerned Cltlzens ot Morris Township, Nlar 11, 1 Q85

nouncement that it was withdrawing several controversial elements of its site plan including the new

laboratory building, and the use of certain toxic and

flammable gases. The planning board hastily accepted

the modified proposal by a vote of 9-O. Realizing that

even a vote in its favor would not end the controversy

or the delay in construction, the company appears to

have capitulated to the concerns of the citizen protestors. In response, the citizen’s group chose not to appeal the final decision of the planning board—despite

some uneasiness among CCMT members that they had

not seen a completed version of the adopted site plan.

This decision brought to a close an 18-month controversy over potentially hazardous research in

telecommunications.

The Legal Dimension

Local planning boards derive their authority to exercise land use controls from State statutes. In New

Jersey, Chapter 57 of the State Land Development Ordinance sets forth principles of municipal land use controls that include the promotion of public health and

safety and protection against man-made and natural

disasters. In the written opinion of the Morris Township counsel, “both municipal land use law as well as

the Morris Township ordinances provide sufficient legal basis to deny the [Bellcore] application if the Board

feels it would present an unacceptable risk. ” The key

to the planning board’s authority to proscribe research

is in the interpretation of “unacceptable risk” —a vague

and elusive term that was the centerpoint of much of

the public debate.

The Southgate Complex is on land zoned for office

and laboratory use, a point emphasized by Bellcore

in its repeated contention that the amended site plan

was in conformity with zoning requirements for the

parcel. CCMT claimed that it was within the purview

of the planning board to restrict research activities that

pose a threat to human health, public safety, or environmental quality, even though the parcel is zoned for

laboratory use. It argued that the zoning classification

“research” is only a guide. Each activity must be carefully examined under this broad category (which includes everything from pencil and paper operations to

the storage and use of hazardous chemicals) to determine whether it conforms to community standards of

acceptable risk.

Acting in a quasi-legal manner but without strict

rules of evidence, the planning board heard testimony

from both sides, cross-examined witnesses, and permitted adversaries to question one another. A decision by the planning board is subject to an appeal in

the State courts if the petitioner files the appeal in

accordance with accepted guidelines.
138

Citizen opposition to the facility was not directed

at a particular research program per se, but rather at

the chemical substances that were a critical part of the

research activities.

Arguments For and Against a

Research Ban

In its presentation before the planning board, Bellcore maintained that the site plan was in conformity

to the zoning requirements of the parcel, Moreover,

the proposed laboratory facility was designed to meet

or exceed all Federal, State, and local laws on handling

toxic materials. Company officials argued that “their

plans are a logical extension of work done safely since

1941 at Bell Labs in Murray Hill where Bellcore scientists are working now until their company opens a

home for them.’”

Bellcore cited results of its commissioned risk assessment studies that examined the case of a worst-credible

arsine leak. The conditions defining the worst-credible

case are a failure in the mechanical scrubber (a device

that filters out unwanted gases) resulting in a slow leak

of arsine, or an accidental release of arsine as a result

of a tube fracture, According to those studies, the maximum exposure of any citizen in the community would

be about one fortieth of the safe arsine levels permissible for workers.

The risk assessment consultant to CCMT developed

a worst-case scenario that differed considerably from

cases cited by Bellcore. The storage of 1,500 gallons

of liquid hydrogen on the roof of the laboratory building was the basis of one potential worst-case accident.

A CCMT consultant cited as a plausible event a large

hydrogen leak that could cause an explosion that

would rupture the arsine tank and send toxic gases out

toward the neighborhood.

CCMT was uncompromising on the matter of storing toxic gases on the roof of the proposed facility.

The citizens group was not persuaded by company statistics on the low probability of hydrogen explosions,

or the gas detection and monitoring systems planned

for the new facility. Opponents of the facility fixed

their attention on the worst-case explosive release of

toxic gases. That became the standard against which

they would judge acceptable risk.

An article in Technology Review which was distributed widely among members of CCMT fueled the citizens’ resolve against accepting a compromise on the

storage of toxic gases. Passages of the article read:4

‘Timothy Mullaney, “Neighbors, Firm Struggle Over Chemical Risk, ” Dail.v

Record, Apr. 22, 1985.

‘Joseph La Dou, “The Not-So-Clean Bus]ness of Mak]ng Chips, ” Technology Review, May June 1984, pp. 23-25, 32, 36

Acute inhalation [of arsine gas] can cause rapid destruction of red blood cells, followed by severe kidney damage, and if the patient is not immediately

treated-death. Given sufficient low-level exposure

over time, arsine also may be carcinogenic. The accidental release of the contents of a 20-pound cylinder of 100 percent phosphine would have to be spread

over 1,792 acres—or 276 city blocks—before being

diluted to the permissible exposure level of 0.3 ppm.

A second argument, which evolved somewhat later

in the controversy, centered around the environmental

protection of the Great Swamp National Wildlife Refuge. The proposed laboratory facility borders on Loantaka Brook, which flows into the Great Swamp. In response to the prospect of having pretreated emissions

from the research facility flush into Loantaka Brook,

a spokesperson for the Great Swamp Watershed Association said:

[A]ny accidental discharge of hazardous materials

from the Bellcore facility could impair the Woodland

Treatment plant operation and seriously degrade water

quality in the brook and further downstream in the

Great Swamp. ’

Environmentalists also expressed concerns about

seepage of toxic materials into the groundwater from

accidental spillage or a gas cylinder rupture. It was

stressed that two streams running through Southgate

--feed a major drinking water source for 600,000 people. By dramatizing the potential environmental impacts, CCMT was able to build a broad coalition of

supporters, consisting of civic associations and environmental protection groups, to oppose the Southgate

site of the research facility.

A key difference between Bellcore and CCMT on

the conceptualization of risk is exemplified by the

terms “worst-credible case” and “worst-possible case”

as applied to an accidental release of hazardous substances, In emphasizing the former phrase, Bellcore

urged the community, in evaluating the risks, to consider plausible accidents and not extremely remote or

unrealistic events. However, CCMT fixed on the worst

event that was conceivable, without considerations of

probability. Neither side introduced a quantitative

assessment of the likelihood that any accident could

take place. Each party argued its case within a preferred model of risk assessment, the choice of which

is more a question of culture than of science. This

difference made a negotiated settlement between adversary groups extremely difficult.

The Morris Township case is thus not one of a community regulating a form of objectionable research.

Barely any interest was expressed by citizens about the

nature of the semi-conductor and fiber optic research

‘Sally Dudley, letter to the ed]tor, Observer-Tribune, Mar. 21, 1985
139

planned for the site. The entire focus of the debate was

on the types of chemicals on site and the possibilities

of their release into the environment. Had the planning board ruled against Bellcore, the decision would

also not have established a legal precedent for similar

cases that might arise elsewhere in the township. Planning board decisions are rendered for specific circumstances and do not accumulate as in case law. However, had such a decision been made, it is likely to have

created for the township an informal regulatory precedent against similar proposals involving research with

highly toxic gases. Although the company withdrew

the proposal before a planning board vote was taken,

a mood has been created in Morris Township that,

while not codified into law, may be no less effective

in proscribing such activities should they arise in a future site plan.

Comparisons With Two Cambridge,

Massachusetts Cases

Table C-1 illustrates some comparisons and contrasts between the Morris Township case and the two

Cambridge controversies. Notably, both the Arthur

D. Little (ADL) and Bellcore cases involve private sector research for which highly toxic chemicals are required. Citizens of both communities cast their opposition to the respective research activities on public

health grounds emphasizing worst-case scenarios. Opponents of the research in both cases were not persuaded by comparative risk analysis and arguments

that they consider the probability of a worst-case accident. Environmental factors became important in the

Morris Township debate, but were of little significance

in the issue of chemical warfare research. However,

the morality of research was discussed, to some degree, in both the debate over rDNA molecules and

chemical warfare agents. Moral discourse about the

nature of the research program did not arise among

Morris Township citizens.

Bellcore’s research program is a mixture of basic and

applied science/engineering. The character of its research is a blend of what we would find at a university and what might be carried out at ADL. In Morris

Township, the restraints on research came prior to the

construction of a laboratory; that compares favorably with the rDNA case. In contrast, ADL had initiated its research before local restraints were imposed.

The social instruments for regulating research are

markedly different between the Cambridge and Morris

Township cases. The Cambridge city council and the

health commissioner played key roles in the control

of rDNA molecules and chemical nerve agents. In contrast, the township planning board acted as the exclusive social instrument for regulating Bellcore’s research

program. The public health officials of the township

did not have a visible role in the controversy.

Whereas codification of research restrictions

emerged in both the Cambridge cases, no formal restrictions on research were imposed in the Morris

Township situation. In the latter case, withdrawal by

Bellcore of its proposed solid state laboratory revealed

the importance of a local cultural barrier to specific

types of research. The barrier, although informal and

unmodified, may have the persistence and efficacy of

a law.
140

-.

Table C-1 .—Comparison of Three Cases Involving Local Control of Research

Category of comparison rDNA—Cambridge

Type of research . . . . . . . . . . . . . Basic science

Nature of institutions . . . . . . . . Academic/nonprofit

Stage of the research at outset

of local intervention . . . . . . Not yet begun

Source of research funding . . . . NIH and NSF primarily

Origins of controversy . . . . . . . . National and within

scientific community

Stimulus of local

involvement . . . . . . . . . . Newspaper story on

Harvard’s plan to build

P-3 genetics lab

Primary regulatory agent . . . . . . City council

Time period of controversy . . . . Stage 1: 7 months

Stage 2: 5 months

Codification of ruling . . . . . . . . . Municipal ordinance

regulating rDNA

activities

Institutional response to

community reaction . . . . Universities accept

temporary moratorium

Actual interference with

research. . . . . . . . . . . . . No appreciable delay

Judicial action . . . . . . . . . . . . . . No legal test of moratorium

or rDNA ordinance

Nature of community

involvement. . . . . . . . Primarily from academic

sector; no grass roots

organizations

Perceived community risk . . . . Unspecified speculative

scenario of creation and

release of disease-carrying

organisms

aSclentific Advisory Commfttee

Arthur D. Little

(ADL)–Cambridge Bellcore—Morris Township

Applied chemical and

engineering

Consultant/for profit

7 months ongoing

DOD

Local and centered on a

city and two towns

Newspaper story on ADL’s

new lab for testing

chemical warfare agents

Public health commissioner

20 months as of July 1985

Public health order banning

uses of certain chemical

warfare agents

ADL rejects moratorium;

litigates public health

order

Not prevented or

appreciably delayed to

date

Litigation taken on research

ban

No organized opposition at

the early stages; intense

community organizing

after release of SACa

report

Explosive release of nerve

agents exposing resident s

Basic and applied science

and engineering

Private sector/for profit

Not yet begun

Private sector: regional

telephone companies

Local and centered on a

township

Planning board hearing on

site plan for commercial

development

Township planning board

18 months

None; withdrawal of planned

research by firm

Followed process through

planning board; finally

withdrew proposal, no

Iitigation

Research was delayed and

finally prevented at site

No litigation

Organized opposition at the

outset; coalition-building

with other townships and

regional groups

Explosion of hydrogen tank

and release of arsine gas;

also release of toxic

chemicals into fragile

preservation area and

groundwater —.
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