Enhancing Responsible Science

Considerations for the Development and Dissemination of
Codes of Conduct for Dual Use Research

Report of the
National Science Advisory Board on Biosecurity

CONTENTS
Abbreviations and Acronyms
Executive Summary
Introduction
Part I: The Activities and Accomplishments of the First NSABB Working Group on
Codes of Conduct
Part II: The Activities and Accomplishments of the Second NSABB Working
Group on Codes of Conduct
Appendices Appendix A: A Code of Conduct Toolkit
 Appendix B: An Educational Module Appendix C: NSABB Codes of Conduct Workgroup Charge
 Appendix D: NSABB Roster Appendix E: Roundtable Agenda: Promoting Awareness and Responsibility in Dual
Use Research: A Critical Assessment of the Role of Codes of Conduct
 Appendix F: Roundtable Participants’ Biographies Appendix G: Bibliography of Literature Review
 Appendix H: Survey of Professional Societies - Codes of Conduct
 Appendix I: Considerations in Developing a Code of Conduct for Dual Use
Research in the Life Sciences

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Abbreviations and Acronyms

CCWG

Codes of Conduct Working Group

DUR

Dual Use Research

DURC

Dual Use Research of Concern

HHS

Department of Health and Human Services

IACUC

Institutional Animal Care and Use Committee

IBC

Institutional Biosafety Committee

IRB

Institutional Review Board

NIH

National Institutes of HealthNSABB

National Science Advisory Board for Biosecurity

OBA

Office of Biotechnology Activities

PI

Principal Investigator

RCR

Responsible Conduct of Research

USG

United States Government

iii

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Executive Summary
The National Science Advisory Board for Biosecurity (NSABB) was established by the U.S.
Government to provide advice, guidance, and leadership regarding the oversight of dual use life
sciences research—that is, research with a legitimate scientific purpose that yields informationor technologies that may be misused to pose a threat to public health or other aspects ofnational security. According to the Board’s current charter, one key function of the NSABB is to“advise on the development, utilization and promotion of codes of conduct to interdisciplinary
life scientists, and relevant professional groups.”1 In the performance of this function, NSABB
has formed two Working Groups on codes of conduct in dual use research. This report provides
a summation of the activities of both Working Groups with a focus on the second Working
Group and on the principal outcomes of its work—a toolkit for individuals and groupsinterested in formulating codes of conduct for dual use research and an educational module ondual use research.
Codes of conduct for dual use research exemplify a long tradition in morality. For millennia,
individuals and groups have used codes, along with oaths, as tools for several interrelated aims:
to prevent or encourage certain morally significant behaviors and to form and solidify the moral
identity of a group. The Oath of Hippocrates and the American Medical Association’s Code of
Ethics (first formulated in 1847) are statements of moral precepts that have been, and continue
to be, central to the moral and professional identity of physicians. Many scientific societies
have also adopted codes in an effort to promote certain ethical principles in such activities as
research and publication.
In recent years, interest in codes of conduct has intensified within and beyond the global“community” of scientists, mainly in response to concerns spawned by 9/11 and thesubsequent anthrax attacks. The latter incidents revealed both the risks and the vulnerabilities
associated with life sciences research of dual use potential. Given the risks, many within thescientific community have argued that scientists themselves must lead the way in developing
and instituting measures to raise awareness about—and inculcate responsibility for—dual use
research. Among these measures are codes of conduct. Although codes, whether of ethics orof conduct, have been utilized in differing domains, in the context of dual use research, theyoften raise questions of what, why, and how: in what should a code of conduct consist, why arecodes of conduct useful in dual use research, and how might a code of conduct in the context
be formulated, disseminated, and sustained?
The first NSABB Working Group on codes of conduct, established in 2005, produced a set of“considerations in developing a code of conduct,” presented as Appendix 3 to the NSABB’s June2007 Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for

1

NSABB, Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential
Misuse of Research Information (National Institutes of Health, June 2007),
oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf.

1Minimizing the Potential Misuse of Research Information.2 With these considerations, NSABB
sought to spell out the potential content for any given code of conduct by identifying key
individual, group, and institutional responsibilities at each phase of the research process; itthereby addressed the questions of what a code of conduct might consist in and why a code isjustified as a tool in cultivating awareness and responsibility for dual use research amongscientists. The Working Group activities that led to the development of the considerations aredescribed and summarized in Part I of this report.
Created in March 2010, the second Working Group on codes of conduct has sought to address
the question of how a code of conduct can be formulated, disseminated, and sustained as aliving document and force in the promotion of awareness and responsibility. The activities theWorking Group has undertaken in this effort—a survey, a literature review, and a roundtable—
are described in Part II.
Parts III and IV present the culmination and chief outcomes of these activities: a code of
conduct toolkit and an educational module. In assembling the toolkit and the module, theWorking Group set out from two basic assumptions about codes of conduct: first, developing
and implementing a code of conduct is ideally a voluntary, grass roots activity, freely
undertaken by scientists in any context, be it a professional society, an industrial entity, or an
academic institution; and second, a code of conduct is optimally used for the purposes of
educating and raising awareness among scientists. With these assumptions as its conceptual
foundation, the toolkit goes on to provide a series of tools that are adaptable to different
settings, including background on the dual use issue and tools for getting started, forformulating a code, for disseminating a code and for evaluating a code within the broader
context of initiatives aimed at the creation of cultures of responsibility in dual use research.

2

NSABB, Appendix 3, Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the
Potential Misuse of Research Information (National Institutes of Health, June 2007),
oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf.

2

Introduction
The scientific community, governmental authorities, and the public have raised the concernthat life sciences research conducted for legitimate scientific purposes could be misused for
harmful purposes. This type of research is known as dual use research (DUR). To help addressconcerns regarding DUR, certain scientific and professional societies have advocated the use ofcodes of conduct as a way to guide scientists’ work.
The United States Government established the National Science Advisory Board for Biosecurity(NSABB) to provide advice on oversight of dual use life science research. According to theBoard’s current charter, one key function of the NSABB is to “advise on the development,utilization and promotion of codes of conduct to interdisciplinary life scientists, and relevant
professional groups.”3
In its Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for
Minimizing the Potential Misuse of Research Information (June 2007), the NSABB articulated“considerations in developing a code of conduct for dual use research in the life sciences,”
which includes a set of core responsibilities regarding dual use research of concern and acomprehensive delineation of responsibilities in the research process.4
Building on these accomplishments, and in response to the Board’s charter in 2010, the NSABB
established a Working Group, the Codes of Conduct Workgroup (CCWG). The CCWG’s task is topromote the dissemination, awareness, and adoption of codes of conduct by academic
institutions as well as by professional societies and individuals engaged in dual use research.
To fulfill the requirements of this task, the CCWG undertook several objective-driven initiatives:
1) In order to provide an assessment of “the state of the issue,” that is, the extent to which
professional societies and institutions have adopted—or are considering the adoption of—codes of conduct, the CCWG, with support from National Institutes of Health’s (NIH) Officeof Biotechnology Activities (OBA) staff, surveyed scientific associations and academic
institutions.
2) In order to identify barriers to the formulation and dissemination of codes, along withstrategies for the effective accomplishment of these ends, the CCWG, with support from
NIH/OBA staff, reviewed the scholarly literature. In addition, and with the same objective in
mind, the Working Group convened a roundtable in which representatives of professionalsocieties, academic institutions, and industry discussed the problems with and potential forcodes of conduct in dual use research.
3

NSABB, Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential
Misuse of Research Information (National Institutes of Health, June 2007),
oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf.
4
NSABB, Appendix 3, Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the
Potential Misuse of Research Information (National Institutes of Health, June 2007),
oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf.

3

The Purpose of this Report
This report describes the activities of the NSABB’s two Working Groups on Codes of Conduct
and the second Working Group’s principal outcomes, i.e., a code of conduct toolkit and an
educational module for use by institutions and scientific associations with an interest informulating and disseminating codes of conduct.
Early on in its deliberations, the second NSABB Working Group on Codes of Conduct reachedagreement on two basic assumptions that then informed the remainder of its work, especiallythe content and objectives of the toolkit and the educational module: first, developing andimplementing a code of conduct is ideally a voluntary, grass roots activity, freely undertaken byscientists in any context, be it a professional society, an industrial entity, or an academic
institution; and second, a code of conduct is optimally used for the purposes of educating andraising awareness among scientists.
In the course of its deliberations, research, and consultations, the Working Group reached anumber of conclusions and findings about codes of conduct—conclusions and findings thathave been incorporated into the toolkit presented in Part III. These conclusions and findingsare:
1. Codes of conduct can be effective in raising awareness about dual use research.
2. The very process of formulating and developing a code of conduct is rich in opportunities
for educating and raising awareness about dual use research.
3. As such, that process should be designed to engage as many stakeholders as possible.
4. Disseminating a code of conduct is not simply a process of distributing the code to affectedparties; it is also a process of ensuring that the code will be a “living” document and, assuch, a vital force in shaping the day-to-day moral behavior of scientists in a given context.
To achieve this aim, the following points should be considered: To make a code effective, strong institutional commitment is needed. This entails thatsufficient resources would need to be allocated for developing and disseminating thecode.
 A successful code also depends on a strong commitment by individuals who undertakethe responsibility for “championing” the code and for disseminating it throughout theinstitution. Institutions should identify such individuals.
 Allocation of time for discussing the code is required. Multiple existing venues can beused, for example, student orientation sessions, faculty meetings, lab meetings, RCR
courses, conferences, and workshops, etc.
5. The advantage of utilizing codes in an educational setting is that in these settings a code
could be used as a guide for addressing real life case studies.

46. To maintain their effectiveness and relevance over time, codes should be revised andupdated on an ongoing basis.
These findings and conclusions have relevance in any organization, i.e., academic institutions,scientific associations, and industry. In any one setting or context, however, they should be“applied” with care and sensitivity, especially to the particular needs and features of that
context. An obvious example is this: academic institutions and scientific associations aredifferent in many respects and strategies for developing and disseminating a code of conduct
should be designed accordingly.

Part I: The Activities and Accomplishments of the First NSABB Working
Group on Codes of Conduct
The first NSABB Working Group on Codes of Conduct (i.e., the CCWG) invested significant effort
in evaluating the status of codes of conduct in general, their utility, and how best to formulate
them. Its activities and the outcomes of those activities have provided the foundation for thesubsequent efforts of the second Working Group on Codes of Conduct.
The charge and objectives of the first Working Group were two-fold. First, the Board’s initialcharter specifically stated that NSABB will “provide recommendations on the development of acode of conduct for scientists and laboratory workers that can be adopted by professionalorganizations and institutions engaged in the performance of life science research.”5 Second,the Working Group will develop standards and principles that can be incorporated into a formal
educational and training program to cultivate awareness and appreciation for codes of conduct
in the life sciences disciplines.
To fulfill the charge, the Working Group pursued three key activities: (1) it conducted a surveyof codes of conduct; (2) it formed and consulted with focus groups of ethicists, scientists, andothers, especially with the aim of identifying elements of a code; and (3) it formulated a set of
considerations in the development of codes of conduct.
A.

The survey:

Before formulating its recommendation on the utility of codes of conduct, the Working Groupembarked on an extensive survey on existing codes with the aim of clarifying the kinds of codesof conduct then in use, their components, their differing uses, and the types of organizations
that have adopted them. The survey gathered the necessary background knowledge to informthe Working Group’s development of a template code of conduct.

5

Department of Health and Human Services, National Science Advisory Board for Biosecurity Charter — Revised, March 16,
2006.

5

Seventy codes were selected for analysis and inclusion, on the basis of content, type oforganization, and applicability to the scope of biosecurity in the life sciences. Preference wasgiven to codes with well defined elements, and to organizations with large or national
memberships. The intent was to include a sufficient number of domestic and international
codes of comparable scope originating from a variety of disciplines and professions.
Notable Elements: During the analysis, certain elements were identified in the codes that areconsidered noteworthy in terms of preparing a code of conduct for dual use research in the life
sciences. These elements included: National Security: Three codes addressed national security concerns.
 Resources: Several of the codes included requirements for the proper use of funding or
institutional resources, such as equipment, supplies, laboratory, or office facilities.
 Training: Although, only one of the codes specified that a mentor must be identified for all
trainees and provided specific expectations for that mentor’s role, many of the codes
addressed the education of future generations, with some specifically requiring ethicaltraining.
 Dual Use: Two codes specifically contained text that alluded to dual use dilemmas within
particular fields of study.
 Communication: Many of the codes surveyed contained statements requiring members to
be truthful when communicating with the public about the organization or the field ofstudy, and even more contained statements regarding a responsibility to inform andeducate the public on matters fundamental to the field or organization.
 Review Practices: Many of the codes described a process for convening an ethical review
body to review and arbitrate violations of the code, and several acknowledged that thecode is a “living document” that is subject to revision and “adaptable and relevant to newsituations as they occur.”
Basic Considerations in Code Development: Based on the survey results, it appears that
although the mere existence of a code of conduct may lay the foundation for ethical standards
within an organization, it does not guarantee compliance. The content of the code, the degree
to which leadership is committed to the code, and the degree to which it becomes embeddedin the organization’s standard operations are all critical to the effectiveness of the code in
reducing unethical behavior. It is also important to recognize that codes are not intended to bestatic documents and should be developed with sufficient flexibility to encourage review andrevision by the sponsoring group as responsibilities, expectations, and biotechnologies evolve.
The survey helped the Working Group crystallize some findings with regard to developing anddisseminating codes of conduct, including: Code language should be simple, concise, and readily understood by all persons affected.
 The code should state expected behaviors and avoid a legalistic tone, unless legal
restrictions apply. Codes do not supersede existing regulations or ordinances, but they may
elevate the ethical norms beyond the minimum expectations outlined by law.
 The code should be sufficiently general and global in scope.

6







In recognition that a single issue may have multiple perspectives and consequences, thecode should be written, reviewed, and edited by a multidisciplinary team, including
members of the public, to ensure consistency with other communications and policies that
may be in effect and to facilitate acceptance by the affected constituents.
Although it is difficult to fully anticipate all the consequences of an activity, all relevant risk
areas with appropriate plans for abatement should be considered prior to initiation.
Codes should be revised and updated to reflect changes in professional values and advancesin technology.
When considering the development of a code, an evaluation component and objective
criteria should be included.

Content Considerations: The survey also helped in identifying appropriate content for codes ofconduct. Although the specific content of a code varies according to the purpose, intended
audience, and sponsoring organization, almost every code should include some standard
components:
 An introductory section that sets a tone and emphasizes the importance of ethics andcompliance.
 Guiding principles that articulate the profession’s underlying core values and guiding
principles to the highest degree possible.
 Models for decision making to assist an individual in making the right choice about apossible course of action. Such constructs can contain straightforward examples or adecision framework to guide the individual in making a decision.
 Provisions for dissemination of the code to appropriate audiences and recommendations
for the proper education and training of these individuals.
 Procedures for reporting suspected misconduct and advice on mechanisms for theprotection from retribution of those who report violations.
 Implementation mechanisms to establish individual and organizational accountability andenforcement procedures to censure unethical behavior.
 A listing of any additional ethics and compliance resources with applicable supplementarypolicies and procedures.
 A list of available educational and training resources.
The survey and its lessons remain a valuable resource that can be consulted when deciding topursue a code of conduct for dual use research. These lessons were incorporated into theSecond Working Group’s efforts.
B.

Focus Groups:

The second task the first Working Group undertook was to solicit input from focus groups forthe purpose of developing a draft code. Participants in these focus groups included practicing
scientists, administrators, leaders of scientific and professional organizations, local oversight
personnel, and ethicists. General attitudes towards codes and dual use research concerns were
sampled.

7

Most participants had experience with codes and found that they had a positive impact
personally. One issue of particular relevance to the current context is the mixed views about
the level of detail that is helpful in a code of conduct. In general, codes that are detailed mightprovide concrete guidance but would fail to apply when new circumstances arise. Moregeneral codes have the advantage of leaving room for interpretation as they direct attention to
the major concerns. However, such codes do not give specific guidance which is often needed.
Opinions of participants also varied regarding the ability of codes to influence behavior. There
was a general agreement that those who intend to do wrong will not be deterred by a code.
For others, one of the main contributions of a code is that it can be helpful in clarifying or
reinforcing behavioral principles, particularly for those inexperienced in research or in contexts
where the standards may not be obvious. Moreover, participants expressed the view that acode can make good people better.
Many participants agreed that a code would be an effective tool to raise awareness about “Dualuse” research concerns in the life sciences. Three specific benefits were mentioned: a code cancatalyze discussion in the community about dual use, it can serve as an educational tool for
individuals, and it can enhance sensitivity to the possible misuse of research results.
Focus Groups were also asked about what a code should include, they suggested that ingeneral, a code of conduct should:
 include principles unified by a clear underlying philosophy regarding the dual use researchconcern; add value and not redundancy to the body of existing codes in the life sciences; have a clear scope, including specific target audiences; be concise and compelling; articulate realistic expectations;
 have a peer-oriented voice, speaking to scientists as professionals; and be positive in tone and convey the value of the scientific endeavor.
Based on the results of the survey and the focus groups, the Working Group formulated a set of
considerations in developing a code of conduct.
C.

Considerations in Developing a Code of Conduct

A pivotal challenge in formulating a code of conduct for dual use research is determining thespecific content of the document. To help interested individuals and groups meet thischallenge, the first NSABB Working Group sought to catalog and delineate all of the
responsibilities inherent in every phase of the process of scientific research. The results of thiseffort were presented as Appendix 3 to the NSABB’s June 2007 report, entitled Proposed8

Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the
Potential Misuse of Research Information.6
In addition to describing the utility and potential applications of a code of conduct, theconsiderations articulate a set of core responsibilities related to dual use research, along withan additional responsibilities specific to the various phases of the research process and research
related activities. The core set of responsibilities and delineation of specific responsibilities
offer interested individuals and groups several potential uses: they may be adopted verbatim,
modified, or used as the basis for a code of conduct in dual use research.
CORE RESPONSIBILITIES OF LIFE SCIENTISTS IN REGARD TO DUAL USE RESEARCH OF CONCERN
Life sciences research is a critically important endeavor that has benefited society by advancing
our understanding of living systems. Critical to the future of scientific progress and freedom isthe preservation of public trust and support, which scientists have earned through theirattention to responsible research practice. Despite a scientist’s conscientious approach toresearch conduct, the knowledge, products, or technologies derived from some life sciences
research may be misused to pose a threat to public health, agriculture, plants, animals, theenvironment, or materiel. Research with this potential is known as “dual use research ofconcern.”

Individuals involved in any stage of life sciences research have an ethical obligation to
avoid or minimize the risks and harm that could result from malevolent use of researchoutcomes.
Toward that end, scientists should:
 assess their own research efforts for dual use potential and report as appropriate; seek to stay informed of literature, guidance, and requirements related to dual use
research; train others to identify dual use research of concern, manage it appropriately, andcommunicate it responsibly; serve as role models of responsible behavior, especially when involved in research thatmeets the criteria for dual use research of concern; and be alert to potential misuse of research.

RESPONSIBILITIES IN THE RESEARCH PROCESS
Research is a complex, iterative process, and the potential for dual use may be recognized atmany junctures and through different activities. Consequently, while it is valuable to be
mindful of the core responsibilities articulated above, those involved in life sciences research
6

NSABB, Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential
Misuse of Research Information (National Institutes of Health, June 2007),
oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf.

9may also benefit from a more specific review of their responsibilities in regard to dual use
research of concern.
Proposing Research
When designing and proposing research, the ethical responsibilities of life scientists include:
1. Considering whether the knowledge, products, or technology resulting from the research
could be deliberately misused to endanger public health, agriculture, plants, animals, theenvironment, or materiel;
2. Striving to design research that promotes beneficial scientific advances, while avoiding or
minimizing elements of study design that raise concerns about dual use;
3. Weighing carefully the benefits of study elements presenting dual use concerns that cannot
be completely eliminated against the harm that could occur through their deliberate
misuse; and4. Considering ways to modify the research design to manage and mitigate potential misuse
when it is clear that the benefits of the research with dual use potential outweigh thepotential harm.
Managing Research
The ethical responsibilities of persons who manage research programs, whether within the
public or private sector, include:
1. Promoting awareness of dual use research of concern and the ethical responsibilities it
entails;
2. Developing and maintaining systems, policies, and training to ensure that dual use researchof concern is identified and managed appropriately; and3. Implementing federal, state, and other appropriate guidelines specific to dual use researchof concern.
Reviewing Research
The ethical responsibilities of those responsible for establishing and managing thereview process (e.g., funding agencies) include the following:
1. Ensuring that when research proposals are reviewed, appropriate systems are in place toidentify the possibility of dual use research of concern and to address related issues.
Examples of common means of reviewing research proposals include Institutional Animal
Care and Use Committees (IACUCs), Institutional Biosafety Committees (IBCs), Institutional
Review Boards (IRBs), and peer review groups.
2. Ensuring that both researchers and reviewers are knowledgeable of, and adhere to, all
ethical, institutional, and legal requirements that apply to the review of possible dual use
research of concern.
3. Reconsidering institutional review systems periodically to ensure that they reflect current
criteria defining dual use research of concern and are consistent with applicable federal andstate guidelines.

10

The ethical responsibilities of individuals serving on peer review groups or otherwise engaged inresearch review include:
1. Becoming well educated about dual use research of concern and related ethical, legal, andinstitutional requirements, as well as applicable federal and state guidelines;
2. Being mindful during the review process of whether the research could meet the criteria fordual use research of concern; and3. Using methods in keeping with the reviewer’s charge and context to make appropriate
people aware that the research being reviewed meets the criteria for dual use research ofconcern.
Conducting Research
The ethical responsibilities of life scientists engaged in research include:
1. Observing safe practices7 and ethical behaviors in the laboratory, clinic, field, and classroom
and ensuring that subordinate personnel do so as well;
2. Using appropriate security measures and continually reassessing their adequacy as concerns
about potential misuse evolve;
3. Observing applicable guidelines for the responsible conduct of dual use research of concern;
4. Being attentive to the dual use potential of the knowledge, products, or technology
resulting from research activities as they emerge; and5. Alerting responsible institutional officials when dual use research of concern is identified
and when decisions must be made to manage associated risks.
Collaborating on Research
Research endeavors frequently involve the participation and cooperation of multiple
laboratories and disciplines, which can be subject to different management, codes of conduct,
cultural values, or operating procedures. Besides the ethical responsibilities associated with
conducting research, scientists involved in such collaborations have the additional obligationsof:
1. Engaging in open dialog regarding whether knowledge, products, or technology resulting
from the research could be considered dual use research of concern; when such research ispursued, ensuring that all parties are aware of their ethical responsibilities.
2. Agreeing on specifically assigned responsibilities to ensure ethical oversight of all aspects ofresearch with dual research potential, including its outcomes.
3. Considering and respecting expressions of concern regarding the possible dual use ofknowledge, products, or technology resulting from the research and ensuring that theseconcerns are raised with those charged with responsibility for research oversight.
4. Considering appropriate measures to reduce or eliminate risks to public health, agriculture,
plants, animals, the environment, or materiel resulting from the research project.
5.
Maintaining a current awareness of national and international standards and policies
regarding dual use research of concern.
7

Safe laboratory practices are embodied in such documents as CDC-NIH Biosafety in Microbiological and Biomedical
Laboratories (www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm), NIH Guidelines for Research Involving Recombinant DNA
Molecules (www4.od.nih.gov/oba/rac/guidelines/guidelines.html), and Biological Safety: Principles and Practices (ASM
Press, www.asm.org/), and applicable occupational and safety regulations and standards.

11

Communicating the Results of Dual Use Research of Concern
Regardless of the stage of the research process and the form of the communication,
those involved in communications regarding knowledge, products, or technology thatcan be considered dual use research of concern have the following ethicalresponsibilities:
1. Being aware of ethical and legal considerations relevant to communications regardingknowledge, products, or technology that can be considered dual use research of concern.
2. Analyzing potential risks to public health, agriculture, plants, animals, the environment, ormateriel that could result from research-related communications, balancing them against
the potential benefits.
3. Considering options for communication that may reduce or eliminate risks whencommunicating information with dual use potential is clearly warranted by its benefits.
Examples of mitigating strategies may include a delay in releasing the information, theaddition of appropriate contextual information, or communicating the information to amore limited audience.
Scientific Education and Mentorship
Practicing scientists who serve as role models to developing scientists (e.g., theirtrainees, students, and staff) have the following ethical responsibilities:
1. Raising developing scientists’ awareness of what constitutes dual use research of concern
and why it matters;
2. Informing developing scientists of their ethical, legal, and institutional responsibilities whenengaged in dual use research of concern, as well as applicable federal and state guidelines;
and
3. Encouraging open and respectful discussion of issues related to dual use research ofconcern, including whether or not a particular project could be considered dual use
research of concern.

12Part II:
The Activities and Accomplishments of the Second NSABB Working
Group on Codes of Conduct
A.

Working Group Charge

In its current charter, the NSABB charge included the provision to, “advise on the development,utilization and promotion of codes of conduct to life scientists and relevant professionalgroups."8 This basic charge was expanded by the Codes of Conduct Working Group to include
specific tasks that are intended to promote the dissemination, awareness, and adoption ofcodes of conduct in specific venues such as in academic institutions or professional societies,
and among individuals engaged in dual use research.
Specifically, the Working Group’s tasks are to:1) Advise on ways to promote the adoption of Codes by academic institutions and scientificsocieties; and2) Provide guidance on how to maintain Codes’ effectiveness and relevance over time.

To achieve these tasks, the Working Group reviewed previous NSABB work addressing codes ofconduct (see Part I), and conducted a survey of existing codes among professional societies andinstitutions and a literature review. Based on the findings of the previous Working Group, andthe 2010 survey and literature review, a Roundtable was held in October 2010. The
Roundtable’s goal was to gather input from relevant Working Group members, researchers in
the life sciences, and representatives of the Office of Research Integrity’s Responsible Conductof Research (RCR) programs regarding best practices for promoting and adopting codes ofconduct by academic institutions and scientific societies.
B.

Survey of Professional Societies

To prepare for the October 2010 Roundtable, NSABB staff conducted an online survey in 2010
to identify organizations with DUR-related codes. The survey was intended to update the 2006
list of existing society and institutional codes of conduct, ascertain how many relate specificallyto DUR, and to help identify questions for exploration at the Roundtable of the barriers orchallenges the societies or institutions experienced in the process of adopting codes of conduct.
The survey was conducted as an environmental assessment of scientific societies andprofessional organizations and, initially, did not involve direct contact with any of theorganizations surveyed. However, several of the organizations with codes of conduct were

8

Department of Health and Human Services, National Science Advisory Board for Biosecurity Charter, March 10, 2010, available
at oba.od.nih.gov/biosecurity/PDF/NSABB%202010%20Charter_Renewal%20.pdf.

13subsequently invited to participate in the Roundtable to provide additional information about
their code and the process of its development.
Organizations were surveyed based on the 2006 survey and also included societies identified
through the activities of the first Working Group. However, there are limitations to the amountof information the survey provides as it did not involve follow up questions or other directcontact with societies or associations, was conducted online, and it did not include academic
institutional codes of conduct, where much of the dual use research is conducted. In addition,
the survey did not reveal how scientific societies promote, disseminate or use their codes,
whether there are sanctions for members, or whether society members even know about thesecodes or use them.
The survey included 50 associations and found that 20 societies had either a general code of
conduct or statements related to ethics, and 14 had either a specific code devoted to dual use
research, statements on social responsibility or bio-security, or statements indicating theirintention to develop a code (see Appendix H). Those with specific codes relating to dual use
research include the American Society of Microbiology (ASM), the American PhytopathologicalSociety (APS), and the American Medical Association (AMA). ASM, for example, adopted a
Code of Ethics in 1988 that was revised in 2000 and that contains sections that specifically “seekto discourage ASM members from activities that involve misuse of microbiology."9 Following
the terrorist incidents of 2001, ASM made further revisions to its code and, by 2005, hadadopted specific policies and procedures establishing “that it is the responsibility of
microbiologists to conduct research that is beneficial to humankind and that openness of
research activities provides the transparency necessary to help prevent activities that could
result in the misuse of microorganisms as biological weapons.”10
Those with a statement of social responsibility include the Society of Toxicology and the
Biotechnology Industry Organization (BIO). The BIO’s statement is of particular note, as it
represents the international biotechnology industry’s response to the issue of dual use
research, and the commitment of an important partner with academia and professionalsocieties in promoting awareness of DUR. Although not designated as a code of conduct, theirstatement notes the organization’s commitment to “the socially responsible use of
biotechnology to save or improve lives, improve the quality and abundance of food, and protect
our environment.”11 The BIO board of directors adopted this Statement of Ethical Principles,
established a standing committee on bioethics in 2006, and continues to refine “acomprehensive vision of ways to ensure biotechnology is used for the betterment of
humankind and not abused.”129American Society for Microbiology, Code of Ethics, 2005, available atwww.asm.org/ccLibraryFiles/FILENAME/000000001596/ASMCodeofEthics05.pdf.
10
Ibid
11
Biotechnology Industry Organization (BIO), Ethics - BIO is committed to the socially responsible use of biotechnology, availableat www.bio.org/articles/ethics.
12
Ibid.

14

In addition to the 14 associations with codes or statements, 3 societies (the Institute ofMedicine, the American Association for the Advancement of Science, and the Federation ofAmerican Scientists) have organized conferences, created resources, or initiated projects on
dual use research. The FAS, for example, has developed educational tools on its website(www.fas.org/biosecurity/education/dualuse/) that include case studies in dual use forbiological research. These case studies are provided in three languages and “help define theissues associated with “dual-use” research and security in the research lab” and “include
interviews with researchers whose legitimate scientific work could potentially be used forquestionable or harmful endeavors, as well as a historical perspective on their research,bioterrorism, and research regulations."13 The AAAS has also actively engaged its members on
the topic of DUR; this includes organizing symposia, such as the 2010 forum on Minimizing theRisks of Synthetic DNA,14 developing an online database of existing resources and programs foreducating practicing scientists about dual use life sciences research,15 and the dissemination of
professional and graduate-level programs on DUR and biosecurity through its Center for
Science, Technology and Security Policy for scientists working in the biological sciences(cstsp.aaas.org/dualuse.html). In addition, the AAAS participated in 2007 in a collaborative
effort with the National Research Council to survey attitudes and actions on DUR in the life
sciences.16 The survey yielded some of the first empirical data on US life scientists’ views about
the potential misuse of legitimate scientific research and also explored actions scientists might
support to reduce the risk of misuse of research.
The findings of the 2010 survey demonstrate a heightened interest among many scientificsocieties and associations about DUR and a broader commitment to address members’
responsibilities for dual use potential throughout the research process. As compared to theresults from the 2006 survey, which identified only 5 societies with codes on DUR, by 2010
there had been a notable increase in the development of codes and resources focused on DUR
related issues. In addition, since 2006 there has been an increase in the number ofconferences, workshops and symposia focused on this topic. These fora have served as
effective venues for disseminating the message about DUR among life scientists andbioengineers, and provided opportunities to reach out to related disciplines, such as non-lifescientists and do-it-yourself biologists, whose activities also have a dual use potential.
Analysis of the survey results led to the development of topics and questions for theRoundtable. In addition, since the survey had focused on professional societies andassociations and some understanding of the state of codes among those groups had beenobtained, the Roundtable invitees included academic representatives and those who teach13

Federation of American Scientists, Case Studies in Dual Use biological Research,www.fas.org/biosecurity/education/dualuse/index.html
14
The American Association for the Advancement of Science, Minimizing the Risks of Synthetic DNA, available at
http://cstsp.aaas.org/content.html?contentid=2299
15
The American Association for the Advancement of Science, Educational Programs for Scientists on the dual use dilemma,
available at: http://cstsp.aaas.org/dualuse.html
16
Committee on Assessing Fundamental Attitudes of Life Scientists as a Basis for Biosecurity Education, National ResearchCouncil, A Survey of Attitudes and Actions on Dual Use Research in the Life Sciences: A Collaborative Effort of the National
Research Council and the American Association for the Advancement of Science (National Academies Press, 2009).

15

Responsible Conduct of Research (RCR). By including individuals responsible for training
academic personnel in RCR, the Working Group charge to promote development of codes ofconduct among societies as well as in academia would be fulfilled, as would the charge todevelop standards and principles for incorporation in formal education and training programs.
C.

Literature Review

Aims and Methodology: A review was conducted in PubMed of peer-reviewed articles,
professional society and governmental websites, and scientific news articles to identify relevant
information on the history and implementation of codes of conduct. This included a review ofarticles describing the specific development of a code of conduct for dual use research, thelegal, cultural and behavioral aspects affecting implementation of a code for dual use researchin the United States, and case studies of how codes were implemented in other countries andthe lessons learned from those experiences. The information obtained through the review was
intended to help identify relevant topics for further exploration at the Roundtable and to
inform Working Group members of historical and recent activities related to code of conduct
development. Forty articles were chosen and reviewed to ascertain relevant themes and topics
pertinent to current NSABB efforts to promote the adoption of codes of conduct for dual use
research (see Appendix A – Bibliography of Selected Articles).
Themes and Topics: Major themes that emerged from the review included the historicalcontext and justification for why codes were first developed, the types and utility of various
codes and their intended purposes, the relation of codes to the conduct of science and to theregulatory and cultural context in different countries, the identification of gaps in existing codesand best practices, and, most importantly in terms of the NSABB aims, how to implement codesin various venues. Examples and details of these themes include:Historical background: Many of the articles situated codes of conduct in the context of thedevelopment of the scientific process and as a manifestation of science as a self-regulating
culture with implicit notions of professional behavior. Atlas proposes that “from theinception of modern science, the community of scientists acknowledged that it needed toact responsibly to protect the public against potentially dangerous scientific information,”17and cites Sir Francis Bacon (1626) as one historical example of the philosophical basis for acode of conduct,
And this we do also: we have consultations, which of the inventions andexperiences which we have discovered shall be published, and which not;and take all an oath of secrecy for the concealing of those which we think fit
to keep secret; though some of those we do reveal sometime to the State,and some not.18

17
18

Atlas RM “Responsible conduct by life scientists in an age of terrorism,” Sci Eng Ethics. 2009 Sep;15(3):293-301.
Ibid.

16

These articles note other precedents and historical codes of ethics and conduct, such as the
Nuremberg Code, and the emergence of formalized bioethical considerations of scientificactivities, particularly in the U.S., as other essential contextual elements leading to current
efforts to develop codes of conduct.
Justification for development of a code for dual use research: The historical context
leading to a heightened interest in code development is explored in several articles, all ofwhich mention the impetus of recent events such as 9/11 and anthrax-laced letters, or cite
examples of dual use research, such as adapting pathogens to be drug-resistant.
“While emerging technologies have the potential for many benefits, they also tend to bedual-use, capable of both good and pernicious applications….[and] the progress ofscientific research may reach a point where the results could have devastatingconsequences (so called “existential” or “catastrophic” risks). Such catastrophic risks
have only become apparent in recent decades, and create a new and compelling casefor restricting some types of scientific research.”19
These articles justify code development as one mechanism to increase awareness of thepotential for bioterrorist threats, and as a non-traditional tool to regulate problematicscientific research. One article situates the development of codes within “the context of thebasic conflict between the freedom of science and the duty to avoid causing harm” and as
an ethical problem wherein the “freedom of science conflicts with other values”.20 Many ofthese articles provide a timeline of the recent activities that underlie code development,
including the formation of the Biological and Toxic Weapon Convention (BTWC), theBiological Weapons Anti-Terrorism Act of 1989, the National Research Council 2004 reporton Biotechnology Research in an Age of Terrorism, establishment of NSABB, theInteracademy Panel on International Issues (IAP), and other governmental responses tothreats of terrorism, biological weapons, and the potential for dual use research.

Types of Codes/Utility of Codes: Several articles delineate codes by type. Three basic
types of codes are proposed by Brian Rappert as serving specific purposes and functions.21
This includes aspirational codes that propose principles, educational codes that provide
guidelines, and enforceable codes that are embedded within wider systems of professional
and legal regulations. Rappert distinguishes between and among advocacy codes thatprovide general life science principles, adopted codes with “elements specific to matters ofbiosecurity and biological weapons,” and advisory codes which is language that isdeveloped by international scientific societies for inclusion into other existing codes.22

Types of Codes

Purpose19

Marchant GE, Pope LL, “The problems with forbidding science,” Sci Eng Ethics, 2009 Sep;15(3):375-94.
Ehni H-J, “Dual use and the ethical responsibility of scientists,” Arch. Immunol. Ther. Exp. 2008, 56:147-152.
21
Rappert B, “Responsibility in the life sciences: assessing the role of professional codes,” Biosecur Bioterror. 2004;2(3):164-74.
Rappert B, “Coding ethical behaviour: the challenges of biological weapons,” Sci Eng Ethics. 2003 Oct;9(4):453-70.
22Rappert B, “Codes of conduct and biological weapons: an in-process assessment,” Biosecur Bioterror. 2007 Jun;5(2):145-54.
20

17

Aspirational codes
Educational codes
Enforceable codes

Philosophical – set out ideals that practitioners should uphold
Awareness raising – provide guidelines suggesting how to act
appropriately
Regulating - seek to codify what counts as acceptable behavior
and delineate illegal or sanctionable behavior

Advocacy codes

Principles for the life sciences

Adopted codes

Principles specifically related to biosecurity and biologicalweapons

Advisory codes

Language for inclusion into existing codes

Several other authors reference Rappert’s categories and explore the relation between theintended goal of a code and the specific functions they are supposed to fill, and provide
useful information for how to design and implement an effective code.
“If the primary goal is to educate new as well as current members of a discipline about
what is expected in a societal role or professional capacity, then an ethics code shouldhave practical use. In other words, it should be capable of providing researchers or
professionals with guidance on the correct course of action in particular cases. If a
professional code is intended to be enforceable, it should include procedures forhandling allegations of misconduct or unethical behavior.23
The articles also explore the general utility of codes and the advantages of the different
approaches to “presenting ethical principles in different formats….the less detailed codes ofconduct can articulate the profession’s most important ethical precepts, while the moredetailed codes can provide the context and detail needed to apply ethical standards to reallife circumstances.”24 Ultimately, the utility of a specific code may be whether it addresses“questions about who needs to do what and how to reduce security concerns.”25Relation of codes to conduct of science: Codes of conduct for scientific research areproposed as an analogue to the Hippocratic Oath for physicians, and “send importantsignals to scientists about professionalism in the practice of a discipline; codes make explicit
many tacit assumptions about scientific practice; and codes convey a rejection of improper
research behavior”.26 Articles propose implementing codes as Standard Operating
Procedures in laboratories, discuss the culture of mentorship in science, and the influenceof this type of relationship on the adoption of new guidelines. Several articles provide
arguments that address some of the perceived barriers to developing or implementing

23

Bullock M, Panicker S, “Ethics for all: differences across scientific society codes,” Sci Eng Ethics. 2003 Apr;9(2):159-70.
Iverson M, Frankel MS, Siang S, “Scientific societies and research integrity: what are they doing and how well are they doingit?” Sci Eng Ethics. 2003 Apr;9(2):141-58.
25
Rappert B, “Codes of conduct and biological weapons: an in-process assessment,” Biosecur Bioterror. 2007 Jun;5(2):145-54.
26
Association of American Medical Colleges, Developing a Code of Ethics in Research: A Guide for Scientific Societies, 1997.
24

18

codes, such as their lack of enforcement. For example, Frankel and Bird, propose that whendeveloped by scientific societies, a code becomes a part of the….hidden curriculum, i.e., what individuals learn implicitly from observing the actions ofothers and reflects the recognition that professional societies are the ideal setting inwhich peers can clarify their professional standards and values, make explicit their
expectations regarding colleague’s behavior, and influence each other to conform.27
The articles delineate the structural components of scientific institutions within which codes
operate. These structural components include the inter-related responsibilities for dual use
research among individuals (researchers, lab technicians, and administrative staff) andacademic units, and the larger framework provided by Federal, State, and local regulations,certification and licensing requirements of funding entities, professional society standards,
and international conventions. The development of codes is envisioned by these authors as
one means of establishing “a discipline’s norms and traditions” and for “codifying thecommunity’s conventions and standards." In addition,…the research community [could] demonstrate, through its various professional andscientific associations, a clear and tangible concern about the integrity of federallyfunded research programs. Codes…..are an important embodiment of this concern and,apart from leading to more responsible behavior, they may offer convincing evidence ofthe research community’s intent to use federal resources responsibly.28


Relation of codes to legal/regulatory frameworks: Several of the articles explored howeven non-enforceable codes have become ‘codified’ in law, and often represent the only
written guidance on a particular topic.
A court’s inclusion of a professional standard or guideline in its analysis may result in theprofessional norm’s becoming the legally accepted standard of care; particularly in cases
where “clinical practice guidelines help courts discern whether professional conduct was
reasonable and consistent with accepted practices." In such cases, “ethics codes [may]guide their assessment of the moral underpinnings of professional choices andbehaviour.”29
Other articles examined codes in an international context under the premise that “researchin the life sciences is a global endeavor”.30 These articles identified barriers to harmonizingor standardizing codes internationally and the specific cultural differences, or differences in

27

Frankel MS, Bird SJ, “The role of scientific societies in promoting research integrity,” Sci Eng Ethics. 2003 Apr;9(2):139-40.
Association of American Medical Colleges, Developing a Code of Ethics in Research: A Guide for Scientific Societies, 1997.
29
Campbell A, Glass KC, “The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research,”
McGill Law J. 2001 Feb;46(2):473-89.
30
Atlas RM, “Responsible conduct by life scientists in an age of terrorism,” Sci Eng Ethics. 2009 Sep;15(3):293-301.
28

19

the historical context for concerns that will require a “dialogue across cultural, religious andphilosophical perspectives that [can] shape ethical decisions and professional behaviour”.31
Best practices: A sub-set of articles expounded on what has worked and what has notworked in the development and implementation of codes. Although, this literature is not
focused exclusively on codes for dual use research, it includes case studies from The
Netherlands and Australia that may be applicable to the challenges faced by the NSABB in
its development of a toolkit. In Australia, for example, a proposed medical practice code…aims to define ‘clear, nationally consistent standards of practice’ that can be applied toregulate standards of practice…and used in the assessment of complaints andallegations of unprofessional conduct. The Code is not a mere statement of principles, a
discussion document, or a hortatory guide for practitioners seeking to respond to thecomplexities of daily practice; it is a comprehensive statement of how doctors must
behave.32
Although, the Australian code’s immediate relevance is for medical practice, the principles it
embodies are applicable to code development for dual use research in terms of codifying
norms of professional behavior. The case study from Netherlands focused on the utility ofcodes which the authors propose is not self-evident in influencing scientific practice. For
these authors, the utility of a code “largely depends on the implementation phase following
their establishment – a phase which often receives little attention”. 33 This article is basedon interviews among researchers about a newly established code of conduct.
…although researchers perceive the principles within the code to be almost self-evident,
the application of these principles in practice may lead to morally complex situations”
and the researchers “did not see how the principles were meant to guide conduct inpractice. They considered the code too general to apply.34
Examples of the limitations of codes might prove useful guidance to the NSABB, or provide
clues to what should and should not be included as necessary elements of a flexible,
adaptive, and effective ‘living’ code. For, if codes are too prescriptive they may have theunintended consequence of lowering awareness rather than providing a framework forresearchers to learn how to recognize the potential for dual uses in their research.
Codes of conduct can foster and reinforce the strength and effectiveness of professional
communities and moral norms and processes. However, they can also provide a vehicle
for oversimplifying the moral world, stripping ethics of its context and supporting an

31

Komesaroff PA, Kerridge IH, “The Australian Medical Council draft code of professional conduct: good practice or creeping
authoritarianism?” Med J Aust. 2009 Feb 16;190(4):204-5.
32
Ibid.
33
Schuurbiers D, Osseweijer P, Kinderlerer J, “Implementing the Netherlands code of conduct for scientific practice-a casestudy,” Sci Eng Ethics. 2009 Jun;15(2):213-31.
34
Ibid.

20

excessively rigid, restrictive and narrow moral regime. They can either expand theability of individuals to make their own decisions and maximize their opportunities for
ethical action, or they can claim authority beyond their capacity and encourage thebelief that good practice simply involves following a formula or applying rules.35
Moreover, this attention to the potential limitations of codes is of particular importance inthe development of a code for dual use research, as many of the potentially negative usesof biological materials and technologies are difficult if not impossible to foresee. A ‘living’
code would be most effective if it provided ways to evaluate and respond to the potential
for dual use, rather than establish a set of fixed rules for known select agents or identifiablemisuses of technology. Other articles provide suggestions for the promotion of codes byscientific societies or by (senior) scientific leaders in academia as proven best practices for
implementation.


Gaps in existing policies and codes: A particularly useful theme that emerged in the review
was identification of gaps in existing codes. Examples of such gaps include not having aprocess in place for protecting whistleblowers, the need for guidance on theimplementation of codes in settings with limited resources, the undue emphasis onindividual rather than organizational (shared and inter-related) responsibilities, and theneed to resolve contradictory, overlapping, or confusing sets of guidelines. Sutton notes inher commentary on the document “Responsible Conduct by Life scientists in an Age ofTerrorism” that
“In the U.S. regulatory framework for ensuring biosafety and biosecurity, the focus onlife scientists has left a number of gaps in the framework…In fact, the goals of biosafety
and biosecurity may not be sufficiently met because researchers are the target of theregulation almost exclusively.”36
As other authors have done, Sutton notes the range of stakeholders and institutional
entities that are involved in dual use research, and the layers of local, national andinternational laws and policies that regulate scientific research of select agents. Her strong
warnings against putting a “disproportionate burden on the individual researcher” reflects
her understanding of the complexity of the scientific enterprise; as does her injunctions to“rethink the regulatory framework for the nation’s biodefense research” and de-emphasize
timely filing of reports and filling out forms as the primary means of complying with acode.37
Additional important omissions in existing codes were related to the lack of enforceability,
the need to maintain the relevance of codes within rapidly changing biotechnologies and35

Komesaroff PA, Kerridge IH, “The Australian Medical Council draft code of professional conduct: good practice or creeping
authoritarianism?” Med J Aust. 2009 Feb 16;190(4):204-5.
36
Sutton V, “Smarter regulations: commentary on "Responsible conduct by life scientists in an age of terrorism",” Sci Eng Ethics.
2009 Sep;15(3):303-9.
37
Ibid.

21

ever novel potentials for misuse, and the need to identify metrics for evaluating codes, as“little is known about their effectiveness in practice”.38 This literature strongly suggests theneed for further research to evaluate best practices in designing and implementing codes;
and particular areas that should be addressed when developing or disseminating codes ofconduct.
Implementation of Codes: Several articles examined the issues involved in institutional
enhancement of the culture of research ethics and provided strategies for initiating
institutional change. Topics explored in these articles included the barriers to the full
uptake of codes of conduct; how the introduction of a new code may disrupt traditional
norms by providing an alternative counter-norm; and the process of effective selfregulation. Ferguson et al. (2007) note the shift in terminology in discussions about
research behaviors from detecting and punishing undesirable behaviors to “promoting
desirable behaviors."39 These authors propose that cultural change in the academic setting
is an obtainable goal,…if we assume that the usual and/or collective beliefs and behavior of the majority of
the individuals in an institution reflect institutional culture, then an institution’s ethicalculture for research is reflected in what is perceived to be appropriate ethical behavior
and the manner in which the majority of its members deal with ethical issues (Ferguson
et al., 2007).40
Anderson’s analysis of data from two national surveys of 4,000 faculty and doctoral
students in scientific disciplines showed the “significant effects of departmental climate on
normative orientations."41 For Anderson, an institution’s norms “are generally viewed as
critically important to the group and are communicated as such to newcomers through thesocialization process. Norms are not specific rules or regulations but fundamental principles
that support appropriate behavior and relationships within the group, which views
violations of the norms as serious offenses.”42 All of these articles suggest the efficacy of
promulgating codes of conduct through academic and society leadership, i.e., seniorscientists and professional society leaders acting in a mentoring capacity to disseminate
new norms and guidelines for behavior.

Analysis: The literature review provided an understanding of the contextual influences on thedevelopment of codes of conduct, the inter-relations of stakeholders in the process and theiroverlapping areas of responsibility, notable gaps in existing codes, and the challenges ofidentifying time, resources, and the expertise needed to develop and implement codes at the
local level. The themes identified through the literature review were used to inform
38

Rappert B, “Responsibility in the life sciences: assessing the role of professional codes,” Biosecur Bioterror. 2004;2(3):164-74.
Ferguson, K, et al, “Enhancing the Culture of Research Ethics on University Campuses,” Journal of Academic Ethics, 2007; 5:
189-198.
40
Ibid.
41
Anderson, MS, “Normative orientations of university faculty and doctoral students,” Science and Engineering Ethics, 2000; 6,
443–461.
42
Ibid.
39

22

organization of the Roundtable and helped to identify specific challenges that, although
discussed in the literature, may yet require creative thinking and coordinated efforts to resolve.
Two such matters that emerged in the literature review must be emphasized:
1. the need to gather more information and data on what makes a code effective, and whatmakes it evolve and remain a vital source of moral inspiration; and2. how to identify best practices for implementing codes, integrating them into the culture,and keeping them relevant.
It was anticipated that participants at the Roundtable might offer specific recommendations for
how to make codes effective, provide suggestions for how to integrate codes into academic
culture, and help in the identification of best practices based on their experiences.
D.

The Roundtable

The NSABB Code of Conduct Roundtable was organized to involve relevant individuals within
academic institutions and professional societies who have the respective authority and reach todisseminate codes. The Roundtable also included the participation of instructors in the
Responsible Conduct of Research who represent the front line of outreach and education formany institutions.
The aims of the Roundtable were to provide advice on ways to engage these individuals on theissue of Codes, identify barriers to awareness and adoption of codes of conduct in thesesettings and ways to overcome these barriers, and identify strategies for realizing the potentialof codes in shaping behaviors and practices.
The Roundtable explored considerations for developing codes of conduct that had been
advanced as part of an NSABB recommended oversight framework for dual use research in2007. One key consideration was to identify the essential “raw material” that any
comprehensive code should include. Other considerations included the formulation of realistic
strategies for promoting codes of conduct in the settings of professional societies, academic
institutions, and industry and the identification of relevant individuals who might best promote
adoption of a code of conduct by an institution or professional association.
The Roundtable presentations and discussions explored the general utility of codes for changing
behavior, the need for national guidelines on how to develop and implement codes, the keyrole academic leadership and scientific mentors play in promoting codes as the new norms oflife science research, and the advantages and disadvantages of top-down vs. bottom-up
development of codes. Discussions also touched upon the resources needed at the local level
to develop, implement, and regularly update codes, whether academia or scientific society
meetings are the most appropriate venues for disseminating codes, and the challenges ofidentifying what disciplines to include, and at what stage in the career or educational path tofocus on when promoting codes of conduct.
23

Although, the presentations and discussions at the Roundtable covered a wide range of topics
and opinions, a consensus on several key points emerged. First, codes should be aspirationaland educational in purpose, rather than enforceable or compliance oriented. Second, codesshould be dynamic rather than static—the focus of regular discussion and reflection within aparticular setting and, indeed, an evolving element of the culture of the setting itself. Third,
efforts should be made to ensure that codes are not perceived as restrictions on academic
freedom but rather as expressions of the responsibility critical to the conduct of ethical, sociallyaware research. Finally, to succeed in any one setting, a code of conduct will need leaders andchampions to ensure its advance and its status as a living, evolving document.
To ensure that codes become an integral part of the culture of research in a given setting, theparticipants and Working Group coalesced around a central recommendation—that NSABB
undertake the development of a codes of conduct tool kit adaptable to different settings.
Suggestions for such a tool kit included sample components for a code of conduct, a summaryof best practices for formulating, finalizing, and disseminating codes of conduct, and a selectionof the often fascinating literature on codes of conduct in general and in dual use research inparticular. Subsequent to the Roundtable, and after review of the many suggestions andrecommendations made by participants, the NSABB staff has developed this toolkit, and it isincluded in Section IV.

24

Appendix A
a project of theDual use research of concern—research that
may be used for beneficent goals as well as
malevolent purposes—presents scientists in
multiple disciplines and fields with twochallenges. One is to become and remainaware of the dual use potential of their work.
The other challenge is to become and remain
responsible for the dual use research ofconcern that they themselves and theircolleagues conduct.
Professional societies, academic institutions,industries, private corporations, and individual
scientists can use a variety of strategies toraise awareness and to cultivate responsibility
in dual use research of concern. A code of
conduct for scientists engaged in dual use
research is one such strategy. Here, several
tools useful in contemplating and perhaps
implementing this strategy are offered. This
toolkit, a project of the National Science
Advisory Board on Biosecurity, distills thescholarly reflections and practical experienceof groups and individuals who have longwrestled with a paradox at the heart ofscience: that science can be used to benefit,
but also to harm human and other living
beings.
26

Suggestions for use
Before you get started

Essential background on dual use research and codesof conduct

Tools for getting startedAssessing the need for a code of conduct
Assessing feasibility and support
Recruiting leaders and champions
Defining the process

Tools for formulating a code

Determining the content: the key responsibilities
Determining the content: some examples
Navigating the extremes of generality and specificity
Drafting, vetting and finalizing a code

Tools for disseminating a codeDeveloping a dissemination plan
Utilizing existing venues
Designing educational interventions

Tools for evaluating a codeConfronting the challenges of determining impact
Utilizing realistic measures for code evaluations

Selected resources27

ADAPTABILITY & AUDIENCE The tools in thiscode of conduct tool kit have been designed andproduced for adaptability to the needs of different
audiences: with thought and care, they can be
deployed in any one of several settings, including
professional societies, academic institutions, andindustry—wherever dual use research is conducted
and the researchers themselves are committed to the
responsible conduct of research.

FIRST, EXPLORE THE ENTIRE TOOLKIT The tool kit is designed for anyone
interestedinformulating
anddisseminating a code of conduct or in
exploring such a possibility in a given
setting. To make the best use of this tool
kit, readers are encouraged to readthrough the entire kit before picking up
any one of the tools described in thefollowing.

THE ULTIMATE GOAL

This tool kit offers a set ofmeans to an end or ultimate goal: a community of
researchers who are aware of—and take responsibility
for—dual use research. There are other means to thisend, including educational interventions targeted at
graduate students, faculty, staff scientists, members ofprofessional societies, and others. Choosing the rightmeans is a matter of knowing your specific context andfiguring out which of the available means is best foryour context.
28

ESSENTIAL BACKGROUND Before embarking on
the multiple steps of a code of conduct process, it isuseful either to become aware of or to review key
points about dual use research and codes of conduct.

A PERENNIAL PROBLEM WORTHY OF
HEIGHTENED CONCERN Information from life
sciences research is clearly vital to improving publichealth, agriculture, and the environment andmaintaining and strengthening our national security andeconomy. Yet the very information and tools developed
to better the health, welfare, and safety of humankind
also can be misused for harmful purposes.
The development of new technologies and thegeneration of information with the potential forbenevolent and malevolent purposes are “dual use
research.” This dual use quality is inherent in asignificant portion of life sciences research. In fact, it canbe argued that virtually all life sciences research has
dual use potential.

CALLS TO ACTION

Over the past several years,
especially following the terrorist attacks of September
11, 2001 and the subsequent anthrax attacks utilizing
the U.S. Postal Service over the course of several weeks
beginning on September 18, 2001, there have been
increasing calls to consider the possibility that new
information from life sciences research could be
subverted for malevolent purposes and to institute newbiosecurity measures to minimize this risk.
29

CALLS TO ACTION (continued)

Concerns
about the dual use potential of biotechnology
research were central to the establishment of the
National Science Advisory Board for Biosecurity(NSABB) in 2005. A federal advisory commission,
NSABB was created to advise the US government on
the formulation and implementation of appropriate
policies for the oversight of dual use research. In June
2007, NSABB published its Proposed Framework for
the Oversight of Dual Use Life Sciences: Strategies for
Minimizing the Potential Misuse of ResearchInformation.
At the center of the NSABB reportis the conviction that scientists
themselves are the most critical
tool for oversight: through theirown efforts to be aware of andresponsive to the dual use
potential of their own research,
they are a cornerstone of any
effective system of oversight.
Thus, initiatives by scientists themselves and byscientific societies and associations—initiatives
designed to raise awareness and cultivate
responsibility—are crucial to the effective oversight ofdual use research. As voluntary, “grass roots” efforts,
codes of conduct exemplify the sort of approach that
the NSABB envisions as pivotal to the effective
oversight of dual use research.
30

CODES IN GENERAL: Asking moral questions—questions like what should or should not be done—isan activity that defines humankind. Ever since we, asa species, began to answer such questions, we havesought to gather the resulting insights and convictions
in ways that lend themselves to remembrance andcommunication to others, be they contemporaries or
successive generations. We have, that is, codified ouranswers to moral questions and disseminated them byword of mouth and via oral traditions, in written
codes, and in oaths that are publicly sworn.
Such codifications of precepts governing moral
behavior have often been the outcome of efforts (1)to form and solidify the identity of a group and (2) toaddress and prevent immoral behavior. The
Nuremburg Code of 1947 is a good example of thelatter: it was crafted with the explicit aim ofpreventing the unethical use of human beings inbiomedical research horrifically exemplified in theinfamous Nazi experiments. The Oath of Hippocrates
and the 1847 Code of Ethics by the American Medical
Association are statements of moral precepts thathave been—and continue to be—considered central
to the moral and professional identity of physicians.

CODES OF CONDUCT IN DUAL USE RESEARCH A
code of conduct for scientists engaged in dual use
research serves both aims. Such a code makes explicit
a key aspect of the social responsibilities ofscientists—and it
31

CODES OF CONDUCT IN DUAL USE RESEARCH(cont) does so in a way that is voluntary and, in itself,reflects an ethic of responsibility. At the same time, sucha code usually seeks to identify behaviors critical toprevention of misuse.
For individuals and groups interested in codes of conduct
for dual use research, this toolkit brings together various
tools for use in each of several successive phases of codedevelopment. Before these phases and the relevant tools
are introduced, it might be helpful to specify further thetypes of research that constitute what the NSABB has
defined as “dual use research of concern.” In its June2007 report, NSABB proposed a criterion for identifying
dual use research of concern:
Research that, based on current
understanding, can be reasonably
anticipated to provide knowledge,
products, or technologies that
could be directly misapplied byothers to pose a threat to publichealth and safety, agricultural
crops and other plans, animals, theenvironment, or materiel.
In addition, NSABB identified seven categories of researchmight satisfy this criterion and thus be identified as dual
use research of concern. This research could encompass
knowledge, products, or technologies that would:
1) Enhance the harmful consequences of a biologicalagent or toxin.
2) Disrupt immunity or the effectiveness of immunization
without clinical and/or agricultural justification.
323) Confer to a biological agent or toxin, resistance toclinically and/or agriculturally useful prophylactic ortherapeutic interventions against that agent or toxin or
facilitate their ability to evade detection methodologies.
4) Increase the stability, transmissibility, or the ability todisseminate a biological agent or toxin.
5) Alter the host range or tropism of a biological agent or
toxin.
6) Enhance the susceptibility of a host population.
7) Generate a novel pathogenic agent or toxin, or
reconstitute an eradicated or extinct biological agent.

33

ASSESSING THE NEED FOR A CODE OF CONDUCT:A code of conduct is one of several potential means to
the end or goal of a culture of responsibility in dual use
research. Formal educational interventions and mindful
mentoring are other means to the same end. If the aim
is to create or enhance such a culture within the settingof an institution (e.g., in a research center, an academic
department or division, or a specific laboratory), or tofoster a sense of heightened awareness andresponsibility among members of a professional society,
it is important to consider the anticipated benefits andthe associated costs of each of these various means.

Potential advantages of formulating a code: Undertaken as a voluntary, grass roots initiative, theprocess of formulating a code of conduct can bevery effective in raising awareness about dual use
dilemmas.
 The process of debating and reaching agreement on
the content of a code—the specific responsibilities
or values that will be spelled out in its provisions—can be very empowering and can inculcate a senseof “ownership,” commitment, and achievement
among engaged individuals.

Potential costs of formulating a code:
 Time is money.
Formulating, finalizing,
communicating, and sustaining a code of conduct—as a living document—are all essential but timeconsuming activities.
 Depending upon the nature and extent of dual use
research underway in your institution, the effort
that might be devoted to a code of conduct may bebetter expended on other related initiatives.

34

ASSESSING THE NEED FOR A CODE OF CONDUCT,
continued: There are other important questions to ask
and answer in assessing the need for a code of conduct,
especially in the institutional setting. For example:
 What is the extent of dual use research in yourinstitution? How many faculty are engaged in dual
use research? In what departments, divisions, orcenters/institutes?
 Are there are other programs or initiatives underway
in your institution to promote awareness andresponsibility in dual use research? Is the topic ofdual use research addressed in your institution’s
programs for the responsible conduct of research?
How effective have these programs or initiatives
been?

ASSESSING FEASIBILITY AND SUPPORT: If there is aclear need for a code of conduct, then the next step is toassess the feasibility of effectively meeting the need andgarnering support for the requisite effort:
 Are there individuals who can be enlisted as
champions, leaders, or supporters of an effort toformulate and disseminate a code of conduct?
 Is there administrative support for such an effort?
 Is there any financial support for such an effort?
 In a given institution, laboratory, or professionalsociety, are there existing organizational venues andprocesses that might be utilized in formulating acode, publicizing and finalizing drafts, anddisseminating an approved code?
35RECRUITINGLEADERSAND

CHAMPIONS

The
inspiration to formulate a code of conduct for dual use
research—or to incorporate dual use provisions in anexisting code of conduct—may strike an individual orindividuals at any “level” of an organization (e.g., rank-andfile members of a professional society) or institution (e.g.,
graduate students or post-doctoral fellows, younger ormore senior faculty). Such an inspiration and the resolve to
move forward can yield a grass-roots initiative with thepromise of success, especially as a voluntary effort by groupof individual scientists to define and commit themselves toa collective understanding of the responsibilities inherent intheir work as scientists, an understanding that they haveforged among themselves through debate and discussion.

Early on , however, it is important to
identify and recruit leaders andchampions—individuals who canlend the effort credibility andstrategic support. Such individuals
need not occupy formal positions of leadership within an
organization or institution, but they should be people
whose reputations and influence can help to catalyze andsustain the effort through all of its phases. Almost every
group has more than one individual, at multiple “levels,”
whose opinions are valued and sought out: such “thought
leaders” may be found among graduate students, younger
faculty, as well as more

36

DEFINING THE PROCESS A code of conduct process
has three phases:
1. formulating the code (or provisions regarding dual use
research for an existent code);
2. disseminating the code; and3. ensuring the ongoing vitality of the code

The activities specific to each phase will depend upon thespecific circumstances, but at the outset of the effort, it isimportant to envision what those activities might be. And it
is important, as well, to define the specifics of each activity
in terms of:Who will be responsible for the activity and who,
beyond those responsible, will be engaged in theactivity
When the activity will occur or over what time period
What the anticipated outcome of the activity will be

It is likely that revisions in the process will be made in thecourse of each phase, but it is, nonetheless, useful toproject forward and envision the process as a whole.
All phases of the process, however, should be distinguishedby three traits:
 Transparency: Catalysts, leaders, and champions of
the process should conduct their activities in a waythat is public, accessible, and inclusive
 Communication: They should strive to ensure that
all relevant stakeholders—those who will be expected
to live by the code—are kept informed of the process
as it moves forward
 Engagement: They should also ensure that all
relevant stakeholders are engaged and have theopportunity to contribute their thoughts, opinions,suggestions, and recommendations to catalysts,
leaders, and champions.
37What should a code of conduct
say? And how? How general or
how specific should its provisions
be? How long or short? These
are among the questions encounteredat the stage of formulating a code of
conduct. To help you through thisstage, several tools are presented
here: Some considerations in the developmentof codes of conduct for dual use research.
Developed by the National Science Advisory
Board for Biosecurity, these considerations
provide the basic “raw material” for a code of
conduct and identify who is responsible for whatin dual use research, from the initial stages ofconceiving and designing the project or study tothe publication of its results.

 Some examples of adopted codes ofconduct. Several professional societies havedeveloped and adopted codes of conduct withspecific reference to dual use research.

 Some thoughts on the question of how
general or how specific the provisions of acode should be, along with somesuggestions for how to go about the keytask of formulating a code of conduct.
38

Considerations in Developing a Code ofConsiderationsin Developing a
Conduct for Dual Use research in the Life
ofis Conduct
Dual Use
Code
Sciences
Appendix 3 tofor
the NSABB’s
esearchin theLifeOversight
Sciences is
RJune
007 report,
Proposed
Use Life
SciencesJune
ppendix for3 Dualto theNSABB’s
AFramework
Research:
Strategies
for Minimizingthereport,Proposed
Oversight
2007
Potential Misuse of Research Information.
Framework for Dual Use Life
Sciences Research: Strategies for
Minimizing the Potential Misuse
of Research Information.

The “considerations” enunciate a basic ethicalprinciple:

Individuals involved in any stageof life sciences research have an
ethical obligation to avoid or
minimize the risks and harm that
could result from malevolent useof research outcomes.
The principle is relevant and applicable to allstages of the research process:
Designing, Proposing,
Reviewing

Conducting,Managing

Collaborating,Communicating

Educating and MentorIng
39

Considerations in Developing a
Code of Conduct for Dual Use
Research in the Life Sciences,(continued)

The basic ethical principle is “fleshed out” in 5
core responsibilities of scientists engaged in dual
use research. These core responsibilities are to

1.

Assess their research for dual use
potential

2.

Stay informed regarding relevant
literature, guidance, and requirements

3.

Train others to identify andappropriately manage and communicate
dual use research of concern

4.

Serve as role models of responsible
behavior

5.

Be alert to potential misuse of research
40

SOME EXAMPLES OF ADOPTED CODES OFCONDUCT Other organizations in the life (and other)sciences have adopted codes of conduct with specificprovisions for dual use research. Their work is provided
here, in part or whole, as examples of how such provisions
might be specifically formulated.

American Society for Microbiology (ASM) Code of
Ethics. The following provisions are from the current

version, which was reviewed and approved by theorganization’s Council in 2005.
Preface: The American Society for Microbiology isdedicated to the utilization of microbiological sciences forthe promotion of human welfare and for the accumulationof knowledge. These goals demand honesty andtruthfulness in all activities sponsored or supported by theSociety.
Guiding Principles(1) ASM members aim to uphold and advance the integrity
and dignity of the profession and practice of microbiology.

(2) ASM members aspire to use their knowledge and skills
for the advancement of human welfare.
(6) ASM members are obligated to discourage any use of
microbiology contrary to welfare of humankind, including
the use of microbes as biological weapons. Bioterrorism
violates the fundamental principles upon which the Society
was founded and is abhorrent to the ASM and its
members. ASM members will call to the attention of the
public or the appropriate authorities misuses of
microbiology or of information derived from microbiology.
41

American Medical Association (AMA) Code of
Medical Ethics: The AMA’s Code of Ethics dates back to1847 and has, since then, evolved in tandem with theprofession of medicine and the delivery of health care. The
Code enunciates eight principles of medical ethics (eachbeginning with the phrase “A physician shall…), but also
includes a series of opinions rendered by the Association’s
Council on Ethical and Judicial Affairs and providing ethicalguidance on a wide range of issues, including dual use
research.

Opinion 2.078 - Guideline to Prevent Malevolent Useof Biomedical ResearchPhysicians who engage in biomedical researchare bound by the ethical obligations of the medical
profession and also are required to meet responsibilities ofthe scientific community. Beyond their commitment to theadvancement of scientific knowledge and the betterment ofpublic health, physician-researchers must strive to maintainpublic trust in the profession through their commitment topublic welfare and safety, as demonstrated throughindividual responsibility, commitment to peer review, andtransparency in the design, execution, and reporting ofresearch.
Biomedical research may generate knowledge
with potential for both beneficial and harmful application.
Before participating in research, physician-researchers
should assess foreseeable ramifications of their research inan effort to balance the promise of benefit from biomedical
innovation against potential harms from corrupt applicationof the findings.
42

American Medical Association (AMA) Code of
Medical Ethics: Opinion 2.078 - Guideline toPrevent Malevolent Use of Biomedical Research(continued)-

In exceptional cases, assessment of the balanceof future harms and benefits of research may preclude
participation in the research; for instance, when the goalsof research are antithetical to the foundations of the
medical profession, as with the development of biologicalor chemical weapons. Properly designed biomedical
research to develop defenses against such weapons isethical.
The potential harms associated with someresearch may warrant regulatory oversight. Physicianresearchers have a responsibility not only to adhere to
standards for research, but also to lend their expertise to
the development of safeguards and oversightmechanisms, both nationally and internationally.
Oversight mechanisms should balance the needto advance science with the risk of malevolent application.
After research has been conducted, consideration should
be given to the risk of unrestricted dissemination of theresults. Only under rare circumstances should findings bewithheld, and then only to the extent required toreasonably protect against dangerous misuse.
These ethical principles should be part of theeducation and training of all physicians involved inbiomedical research. (II, III, V, VII)

43

The InterAcademic Panel (IAP) Statement on
Biosecurity. The IAP describes itself as a global networkof science academies, which are national organizations
whose members are leaders in their respective disciplines
and that often advise governments on issues that may beilluminated through scientific research. In November 2005,
it issued this statement enunciated the obligations andresponsibilities of scientists engaged in dual use research.

1. Awareness. Scientists have an obligation to do noharm. They should always take into consideration thereasonably foreseeable consequences of their own
activities. They should therefore:• always bear in mind the potential consequences –possibly harmful – of their research and recognize that
individual good conscience does not justify ignoring thepossible misuse of their scientific endeavour;• refuse to undertake research that has only harmful
consequences for humankind.

2. Safety and Security. Scientists working with agents
such as pathogenic organisms or dangerous toxins have a
responsibility to use good, safe and secure laboratory
procedures, whether codified by law or common practice.

44

The InterAcademic Panel (IAP) Statement on
Biosecurity, continued
3. Education and Information. Scientists should beaware of, disseminate information about and teachnational and international laws and regulations, as well as
policies and principles aimed at preventing the misuse of
biological research.

4. Accountability. Scientists who become aware ofactivities that violate the Biological and Toxin Weapons
Convention or international customary law should raise
their concerns with appropriate people, authorities andagencies.

5. Oversight. Scientists with responsibility for oversightof research or for evaluation of projects or publications
should promote adherence to these principles by thoseunder their control, supervision or evaluation and act asrole models in this regard.

45

FORMULATING A CODE OF CONDUCT: SOMERULES OF THUMB There is no “magic” formula thatcan be followed in formulating a code—some method that is
guaranteed to have good results. Some rules of thumb,however, are useful in thinking through the process of
formulating and finalizing a code of conduct:

Rule of Thumb #1
It is useful to assign the drafting of a code to one or two
individuals. The drafts, however, should be reviewed andrevised by a group of individuals who represent various“constituencies” within an institution or professional society.
Although the group should be populated with individuals
sympathetic to the process and the anticipated outcome (adraft code of conduct), it should also include some skeptics.

Rule of Thumb #2
In determining the specific content of a code of conduct, acareful review of the NSABB considerations and of thepreceding examples would be helpful.
The NSABB
considerations offer examples of relatively general precepts(in the key obligations), as well as detailed descriptions ofroles and responsibilities at various phases of the research
process. Determining how general or specific the provisionsof a code should be will depend, in large measure, on theparticular aims that individuals or organizations hope toachieve: to offer general guidelines or to provide precise
prescriptions of expected behaviors.

Rule of Thumb #3
Once a draft is complete, the drafting committee shouldseek reactions and suggestions for revision through abroad-based consultative process.
46

FORMULATING A CODE OF CONDUCT: SOMERULES OF THUMB (continued)
Rule of Thumb #4
Before initiating the code development process, it isimportant to determine how a draft code will be finalized
and approved. In most institutions and professionalsocieties, there are established procedures: an academic
institution may require approval by a faculty senate or aprofessional society may require a referendum by its
membership. In finalizing a code of conduct for dual use
research, however, in addition to following these establishedprocedures, it is important to emphasize a key goal: that thecode will be sustained as a living document. Thus, it iscritical to underscore the need for periodic re-examinationsof the code and its provisions, especially in light ofdevelopments in dual use research, both in general andwithin a given institution, organization, or professionalsociety.

47

DEVELOPING A DISSEMINATION PLAN

The
importance of envisioning the whole process, from start tofinish, has already been emphasized. If that advice isfollowed, then ideas for how a formulated and approved
code of conduct could and perhaps should be disseminatedin a given a context will already have been developed,
before this phase of the process commences. Such a plan
will specify the methods and venues for disseminating a
finalized code:

Methods:

Dissemination is communication andcommunication occurs either through the written or the
spoken word. Both types of communications can andshould be deployed in disseminating a code of conduct.

 Written communications include email, letters,
newsletters, announcements and press releases, syllabi,etc.
 Spoken communications include speeches andaddresses, informal talks, lectures, formal dialogues, andunstructured conversation and discussion

Venues: In disseminating a code of conduct, existingvenues, as well as venues specifically designed for thispurpose, can and should be used. Most organizations andinstitutions have vehicles for internal and external
communications that might be tapped—newsletters,
magazines, journals, broadcast email announcements, etc.
They also have routine gatherings—annual meetings for
professional societies, international and national scientificconferences and assemblies, faculty and staff meetings inacademic institutions—that should be exploited for the
purpose of disseminating a code of conduct.
48

UTILIZING EXISTING VENUES In fact, a case can bemade for the proposition that existing venues are critical tothis phase of the process. Using existing venues—new
faculty or graduate student orientation, faculty meetings,
lab meetings, professional society meetings, etc.—helps tointegrate a code of conduct within the daily life and,ultimately, culture of an institution.

DESIGNING EDUCATIONAL INTERVENTIONS
Educational interventions—continuing educational courses
for faculty, courses and seminars for graduate andundergraduate students, symposia—are ideal vehicles fordisseminating a code of conduct. In designing suchinterventions, it is important to keep in mind somesuggestions, based on well-tested principles of adultlearning:

Case-based learning engages learners immediately
and vividly: The concrete examples of dual use research
provided in the BEFORE YOU START section of this tool kit
present dilemmas that challenge the moral imagination andproblem solving skills of learners at all levels.

Interactive discussion is often more effective thanmore didactic modes of teaching and learning:
Learners are more apt to become immersed in the content
of an educational intervention if they have the opportunity
to question, discuss, and debate. Retention of material isalso aided by this method.

49

ENSURING THE VITALITY OF A CODE OF
CONDUCT FOR DUAL USE RESEARCH Any written
statement of moral precepts is at risk of being forgotten or
trivialized or of becoming irrelevant—unless steps are taken
to avoid these fates and to ensure that a code remains aliving document. A “living” code of conduct is one whose
import and relevance is actively promoted anddemonstrated by its champions, as well as renewed in lightof developments in science, regulation, and the law. Here,too, a few suggestions are in order: In most academic institutions, scientists at all levels are
required to undergo periodic education in the responsible
conduct of research (RCR). RCR programs are ideal for the
integration of materials about an approved (or evencontemplated) code of conduct for dual use research—alongwith specific examples, especially if drawn from theimmediate context.
 Developments in the relevant laws and regulations (e.g.,
the NIH’s Guidelines for Research Using Recombinant DNA
Molecules) should be tracked and, if
necessary, provide the impetus torevisions in the code. Such revisions
should be widely publicized within
the institution or professionalsociety to ensure awareness.
 Developments in the life (andother) sciences should also be
tracked and used to challenge, test,
and illustrate the various provisionsof a code of conduct.

50

A FORMIDABLE CHALLENGE:

The end, theoverarching goal, of a code of conduct for dual use research
is a culture of responsibility within a particular discipline or
institution or organization devoted to scientific research. A
code of conduct is only one of several possible means tothis end. Determining how effective a means it is or has
been in the concrete circumstances of a particular setting is
an exceptionally difficult challenge.

In part, this is due to the complexity of morally significant
behavior. The “causes’ of such behavior—our fidelity to,ignorance or rejection of certain norms—are very difficult
to isolate and weigh. An individual’s “upbringing,”; herhabitual predispositions to embrace or eschew what isgood, right or just; the influences of others; the immediate
circumstances: these are just a few of the factors that
impinge on and shape our moral behaviors and decisions.
Because the goal of a code is a culture of responsibility, it
makes sense to integrate specific measures of a code within
broader attempts to assess the “state” of such a culture
within a given a setting. For example, it might prove useful
to ask individuals within a given setting—e.g., graduate
students and faculty—whether they are aware of the dual
use dilemma and, if they are, how their awareness wasdeveloped and formed: through educational interventions;engagement in specific projects with dual use potential;
and/or involvement with, knowledge of or commitment toa code of conduct. Such an evaluation is an outcomes
evaluation.

51

Such an evaluation is distinct from a process evaluation,
focused on the process of formulating and disseminating acode of conduct. A process evaluation seeks “feedback” onthe methods and venues utilized in the various phases ofcode development. Such an evaluation focuses on how
well the process was conceived and executed.

TOOLS FOR EVALUATION Both types of evaluation—
outcomes and process—make use of various tools:

 Focus groups: With focus groups, the aim is to gather
a representative sample of individuals from a group and tosolicit evaluative information of a qualitative nature fromthem through well designed questions. Usually, focus
groups are professionally facilitated.

 Surveys (paper-based and on-line): Surveys utilize
simple binary questions (yes/no, true/false) or questions
whose answers are rendered in the form of a Likert scale.

 Evaluations embedded within educational
interventions, e.g., examinations, etc.: Evaluations
that are used to assess individuals’ understanding or
knowledge may incorporate specific questions or exercisesthat are designed to gauge awareness of a code of
conduct—of its rationale, background, and specificprovisions.

52

ON-LINE EDUCATIONAL RESOURCES

Tools foreducating individuals and groups about dual use research canbe used in lieu of or in conjunction with the development of acode of conduct for dual use research. There are several online educational tools available, including:Case Studies in Dual Use Biological Research, an 8-module
resource that has been developed by the Federation ofAmerican Scientists and that is accessible at
http://www.fas.org/biosecurity/education/dualuse/index.html.
Biosecurity, a brief but useful introduction to the background,relevant regulations and guidelines, and resources on dual use
research accessible at the website, Resources for Research
Ethics Education: http://research-ethics.net/topics/biosecurity.
Applied Dual-Use Biosecurity Education is an on-line distancelearning module that has been developed by the University ofBradford School of Social and International Studies. Only
enrolled students can access the module, which provides
students with 30 Masters level credits once completed. For
more information, click on
http://brad.ac.uk/peace/courses/postgraduatecourses/applieddual-usebiosecurityeducation/.
Dual Use Research: Promoting Understanding, Cultivating
Responsibility is an educational tool developed under the
auspices of the National Science Advisory Board for
Biosecurity. The tool can be accessed at
http://oba.od.nih.gov/biosecurity.biosecurity.html.
53

SCHOLARLY RESOURCES The scholarly (and popular)
literature on dual use research is growing. Some of the key
resources include:
AAMC. Developing a Code of Ethics in Research: for Scientific Societies.
1997: 42 pps.
Anderson, MS. Normative orientations of university faculty and doctoral
students. Science and Engineering Ethics, 2000; 6, 443–461. Discussion
463–465.
Atlas RM. Responsible conduct by life scientists in an age of terrorism.
Sci Eng Ethics. 2009 Sep;15(3):293-301. Epub 2009 May 7. PubMed
PMID: 19421897.
Bullock M, Panicker S. Ethics for all: differences across scientific society
codes. Sci Eng Ethics. 2003 Apr;9(2):159-70. PubMed PMID: 12774648.

Campbell A, Glass KC. The legal status of clinical and ethics policies,
codes, and guidelines in medical practice and research. McGill Law J.
2001 Feb;46(2):473-89. PubMed PMID: 16523580.
Cournand A. The code of the scientist and its relationship to ethics.
Science.1977 Nov 18;198(4318):699-705. PubMed PMID: 910153.
Davis M. What can we learn by looking for the first code of professional
ethics? Theor Med Bioeth. 2003;24(5):433-54. Review. PubMed PMID:
14760870.
Ehni H-J. Dual use and the ethical responsibility of scientists. Arch.
Immunol. Ther. Exp. 2008, 56:147-152.
Frankel MS. Scientific Societies as Sentinels of Responsible
Research Conduct. Proceedings of the Society for Experimental Biology
and Medicine, 2000 224: 216–219.
Frankel MS, Bird SJ. The role of scientific societies in promoting research
integrity. Sci Eng Ethics. 2003 Apr;9(2):139-40. PubMed PMID:
12848197.
54

SCHOLARLY RESOURCES, continued
Graham D. Revisiting Hippocrates: does an oath really matter? JAMA.
2000 Dec 13;284(22):2841-2. PubMed PMID: 11147972.
Grinnell F. Ambiguity, trust and the responsible conduct of research. Sci
Eng Ethics. 1999 Apr;5(2):205-14.
Iverson M, Frankel MS, Siang S. Scientific societies and research
integrity: what are they doing and how well are they doing it? Sci Eng
Ethics. 2003 Apr;9(2):141-58. PubMed PMID: 12774647.
Jones NL. A code of ethics for the life sciences. Sci Eng Ethics. 2007
Mar;13(1):25-43. PubMed PMID: 17703607.
Kant L, Mourya DT. Managing dual use technology: it takes two to tango.
Sci Eng Ethics. 2010 Mar;16(1):77-83. Epub 2008 Apr 26. PubMed PMID:
18438721.
Kenny NP. The CMA Code of Ethics: more room for reflection. CMAJ.
1996 Oct 15; 155(8):1063-5. PubMed PMID: 8873634
Keuleyan E. Liberty to decide on dual use biomedical research: an
acknowledged necessity. Sci Eng Ethics. 2010 Mar;16(1):43-58. PubMed
PMID: 18427955.
Koepsell D. On genies and bottles: scientists' moral responsibility anddangerous technology R&D. Sci Eng Ethics. 2010 Mar;16(1):119-33.
PubMed Central PMCID: PMC2832882.
Komesaroff PA, Kerridge IH. The Australian Medical Council draft code ofprofessional conduct: good practice or creeping authoritarianism? MedJ Aust. 2009 Feb 16;190(4):204-5. PubMed PMID: 19220187
Malloy DC, Sevigny P, Hadjistavropoulos T, Jeyaraj M, McCarthy EF,
Murakami M, Paholpak S, Lee Y, Park I. Perceptions of the effectivenessof ethical guidelines: an international study of physicians. Med HealthCare Philos. 2009 Nov;12(4):373-83. PubMed PMID: 19544088.
55

SCHOLARLY RESOURCES, continued
Marchant GE, Pope LL. The problems with forbidding science.
Sci Eng Ethics. 2009 Sep;15(3):375-94. Epub 2009 Apr 7.
PubMed PMID: 19350416.
Mario JR. A review of Anglo-American forensic professional
codes of ethics with considerations for code design. Forensic
Sci Int. 2002 Feb 18;125(2-3):103-12. Review. PubMed PMID:
11909650.
McKinney JA, Emerson TL, Neubeert MJ. The effects of ethicalcodes on ethical perceptions of actions towards stakeholders. J
Bus Ethics 18 June 2010.
National Research Council. A survey of attitudes and actions on
dual use research in the life science: A collaborative effort of
the National Research Council and the American Association
for the Advancement of Science. Washington DC 2004: The
National Academies Press.
Patterson P. Toward an effective code of conduct. OR Manager.
2009 Jan;25(1):17-8. PubMed PMID: 19226879.
Patterson P. What makes a behavior code effective? OR
Manager. 2009 Jan;25(1):19-20. PubMed PMID: 19226880.
Parker MH. Normative lessons: codes of conduct, selfregulation and the law. Med J Aust. 2010 Jun 7;192(11):65860. PubMed PMID: 20528720.

Pustovit SV, Williams ED. Philosophical aspects of dual use
technologies. Sci Eng Ethics. 2010 Mar;16(1):17-31. Epub 2008
Oct 21. PubMed PMID: 18937057.
56

SCHOLARLY RESOURCES, continued
Rappert B. Codes of conduct and biological weapons: an inprocess assessment. Biosecur Bioterror. 2007 Jun;5(2):145-54.
PubMed PMID: 17608600.
Rappert B. Responsibility in the life sciences: assessing the roleof professional codes. Biosecur Bioterror. 2004;2(3):164-74.
PubMed PMID: 15588054.
Rappert B. Coding ethical behaviour: the challenges of
biological weapons. Sci Eng Ethics. 2003 Oct;9(4):453-70.
PubMed PMID: 14652899.
Schuurbiers D, Osseweijer P, Kinderlerer J. Implementing theNetherlands code of conduct for scientific practice-a casestudy. Sci Eng Ethics. 2009 Jun;15(2):213-31. Epub 2009 Jan 21.
PubMed PMID: 19156537.
Selgelid MJ. Dual-use research codes of conduct: lessons fromthe life sciences. Nanoethics 2009; 3:175-183.
Sohl P, Bassford HA. Codes of medical ethics: traditionalfoundations and contemporary practice. Soc Sci Med. 1986;
22(11):1175-9. PubMed PMID: 3529416.
Somerville M, Atlas RM. Ethics: A weapon to counterbioterrorism. Science. 2005 (307):1881-1882.
Spier RE. "Dual use" and "intentionality": seeking to preventthe manifestation of deliberately harmful objectives: A
summary and some reflections on 'The Advancement of
Science and the Dilemma of Dual Use: Why We Can't Afford to
Fail'. Sci Eng Ethics. 2010 Mar;16(1):1-6. PubMed PMID:
19798590.
57

SCHOLARLY RESOURCES, continued
Sutton V. Smarter regulations: commentary on "Responsible
conduct by life scientists in an age of terrorism". Sci Eng Ethics.
2009 Sep;15(3):303-9. PubMed PMID: 19590982.
Taylor PL. Scientific self-regulation-so good, how can it fail?
Commentary on "The problems with forbidding science". Sci
Eng Ethics. 2009 Sep;15(3):395-406. Epub 2009 Apr 10.
PubMed PMID: 19360483.
Veatch RM. The sources of professional ethics: why professions
fail. Lancet 2009 Mar 21;373(9668):1000-1. PubMed PMID:
19330942.
Verpeet E, Dierckx de Casterle B, Van der Arend A, Gastmans
CA. Nurses' views on ethical codes: a focus group study. J Adv
Nurs. 2005 Jul;51(2):188-95. PubMed PMID: 15963191.

58

Dual Use Research of Concern
promoting understanding ▪ cultivating responsibility

Appendix B
An Educational Tool Developed Under the Auspices of the National Science Advisory Board for Biosecurity

Dual Use Research of Concern
promoting understanding * cultivating responsibility

About this educational tool:This is an introduction to dual use research of concern. It is offered as atool for achieving several interrelated purposes, including promoting
discussion, increasing awareness, and cultivating responsibility for dual
use research of concern. It is just one of several available tools foreducating individuals and groups about the challenges presented by life
sciences (and related) research that may have both beneficial andmalicious applications.

Dual Use Research of Concern: Promoting Understanding + Cultivating
Responsibility has been designed for adaptation to the needs of different
learners. In part or in whole, it can be used for self-directed learning by
individuals or for learning and discussion by groups.

60

Preface61

In 1918, World War I ended,
but a pandemic of influenza, whichbegan in 1917 and ended in 1920, wasat its height.

Its impact, in terms of morbidity and mortality,
was and remains unprecedented.
At least 50 million people, 3 percent of
the world’s population, died.
Approximately 500 million were infected.

These grim statistics account for the controversy
spawned by the reconstruction of the previously
extinct 1918 flu virus, reported in a paper
published by a group of investigators in Sciencein October 2005*.
* T.M. Tumpey et al , Characterization of the Reconstructed 1918 Spanish Influenza Pandemic
Virus, Science 310, 77-80 (2005).

62

In “Characterization of the Reconstructed
1918 Spanish Influenza Pandemic Virus,”
Terrence M. Tumpey and his colleagues
reported on their success in using“reverse genetics” to produce an
influenza virus nearly identical to the1918 pandemic virus.

Their aim was to study the extraordinary
virulence of the virus. The results of suchresearch could aid vaccine development
efforts to protect the public against
future pandemics or in the event of afuture outbreak of a similarly pathogenic
flu.
But, the research could be misused andput to malevolent purposes—for
example, to reconstruct the virus andpose a threat to public health.
The research on the 1918 influenza virus
vividly illustrates the dilemmas that canarise with the conduct and publication ofdual use research.
63

DUAL USE RESEARCH OF CONCERN
Promoting Understanding ▪ Cultivating Responsibility

contents
Part 1 - an era of heightened concern: the historical backgroundPart 2 - defining dual use research of concern
Part 3 - researcher responsibilities
Part 4 - a framework for risk assessment and management
Part 5 - communicating research with dual use potential
Part 6 - cases with questions for discussion and reflection64

An era of heightened concern
part 165

An era of heightened concern
The 1990s

September 11, 2001

A decade of mounting
concerns about
terrorism—including
bioterrorism.

1990s

September 18, 2001
Letters containing sporesof Bacillus anthracis, thecausative agent of anthrax,
were mailed to two U.S.
Senators and several news
media offices. Five people
died; 17 others were
infected.

2000

2001
66

An era of heightened concern
2001

2002

2002

In the Journal of Virology,
Australian researchersreport that in reengineering a mousepox
virus, they unexpectedly
produced a much morevirulent virus—raisingfears about the potential
for bioterrorism.

In Science, investigators
report that they havereconstructed thepoliovirus from chemicallysynthesizedoligonucleotides that werelinked together and thentransfected into cells.

In PNAS, researchersreport on theirinvestigations into theimmune response to avirulence gene fromvaccinia, including
information on how toincrease viral virulence.

2001

2002
67

An era of heightened concern
2004

2004

2005

The National ResearchCouncil publishes the Fink
Report recommendingthat scientists be educatedabout their responsibilities
with regard to dual use
research.

The National Science
Advisory Board for
Biosecurity is establishedto provide advice,guidance, and leadership
regarding biosecurity
oversight of dual use
research. Holds firstmeeting in 2005.

In Science, researchers
from the Centers for
Disease Control and theircolleagues report that they
have successfullyreconstructed theinfluenza virus that caused
the 1918 flu pandemic.

2004

2005
68

Defining dual use research of concern

part 269

If dual use research is distinguishedfrom other types of life sciences
research by its potential forbenevolent and malevolent
application, then few of the productsof life sciences research—informationor technologies—lack that potential.
The challenge: formulating adefinition that enables identificationof research warranting concern,
vigilance, and perhaps oversight.

70

Dual use research of concern
A definition proposed by the National Science Advisory Board on Biosecurity

According to National Science Advisory Board for Biosecurity(NSABB), dual use research of concern is “*R+esearch that,based on current understanding, can be reasonably
anticipated to provide knowledge, products, or technologies
that could be directly misapplied to pose a threat to publichealth and safety, agricultural crops and other plants,
animals, the environment, or materiel.”** Established in 2005, the NSABB is a Federal advisory committee chartered to provide advice,guidance, and leadership regarding biosecurity oversight of dual use research to all Federal
departments and agencies with an interest in life sciences research. The NSABB advises on andrecommends specific strategies for the efficient and effective oversight of federally conducted or
supported dual use biological research, taking into consideration national security concerns and theneeds of the research community. The definition of dual use research is from the NSABB’s 2007 report,
Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing
the Potential Misuse of Research Information.
71

The NSABB has identified 7 categories of research that might qualify as
dual use research of concern and should therefore receive closer
scrutiny during its design, conduct, and perhaps publication. These
include research that might
1.

Enhance the harmful consequences of abiological agent or toxin.
Example: Information on how to make aseasonal strain of the influenza virus as deadly as
the 1918 pandemic strain.

2.

Disrupt immunity or the effectiveness of an
immunization without clinical and/or agricultural
justification.
Example: information on the insertion of an
immunosuppressive cytokine into a viral genome
to render the antiviral immune response lesseffective.

72

The NSABB has identified 7 categories of research that might
qualify as dual use research of concern and should therefore
receive closer scrutiny. These include research that might
1.

Enhance the harmful consequences of abiological agent or toxin.
Example: Information on how to make aseasonal strain of the influenza virus as deadly as
the 1918 pandemic strain.

2.

Disrupt immunity or the effectiveness of an
immunization without clinical and/or agricultural
justification.
Example: information on the insertion of an
immunosuppressive cytokine into a viral genome
to render the antiviral immune response lesseffective.

73

7 categories of research that might qualify as dual use
research of concern—research that might
3.

Staphylococcus aureus

Confer to a biological agent or toxin,
resistance to clinically and/or
agriculturally useful prophylactic ortherapeutic interventions against thatagent or toxin or facilitate their ability toevade detection methodologies.

Example: Information on how to confer
doxycycline resistance to Vibrio vulnificus
or antibiotic resistance to agriculturally
relevant microbes, such as rendering
Erwinia amylovora resistant to
streptomycin.

74

7 categories of research that might qualify as dual use
research of concern—research that might4.

Increase the stability, transmissibility, or the ability
to disseminate a biological agent or toxin.
Examples: information on changing genetic factors
to increase transmissibility and altering the route oftransmission or vector to increase the ease andeffectiveness by which an agent may betransmitted.

5.
Variola virus

Alter the host range or tropism of a biological agent
or toxin.
Example: Knowledge of how to convert nonzoonotic
agents into zoonotic agents, altering the tropism ofviruses, and expanding the varieties of the sameplant that an altered pathogenic agent could infect. 75

7 categories of research that might qualify as dual use
research of concern—research that might
6.

Enhance the susceptibility of a host population.
Example: Information on how to create a stable recombinant
Lactobacillus casei that could effectively block the host’s ability tosynthesize an important immune signal, such as tumor necrosis factor
alpha, which may directly facilitate the evasion of normal hostdefenses.

7.

Generate a novel pathogenic agent or toxin or reconstitute an eradicatedor extinct biological agent .
Examples: Information on how to construct a de novo microbial
pathogen using unique gene sequences or combinations of sequencesthat do not exist in nature; or on how to reconstitute a pathogen that nolonger exists in nature, such as the 1918 pandemic influenza virus.
76

Researcher responsibilities

part 377

The responsible conduct of dual use research
The critical role of researchers
Although the responsible conduct of dual use research requires theactive, thoughtful engagement of funding organizations,institutions, and others, the researchers themselves can and must
play a central role …

… After all, they know their research best and are in the best
position to anticipate the types of knowledge, products or
technologies that might be generated, the potential for misuse, andthe degree of immediacy of that threat.

78

Researcher responsibilities span the successive
phases of the research process
Institutional
approval

Project
concept
and design

Development ofpublication or
othercommunication ofresearch results

Fundingstage

Ongoing
research

Publication ofmanuscript orother product79Researcher responsibilities
Being cognizant of theconcept of dual use
Seepart 2 research of concern, andaware of the risks of
misuseAssessing, on an ongoingbasis, their research fordual use potential,
beginning with research
design and including
publication of the results

Being knowledgeable
about and complying
with all local and federal
policies for oversight

Ensuring that laboratory
staff, students, and otherresearch personnel aretrained in dual use issues
and risk mitigation

Keeping their
institutions informed ofthe dual use potential of
their researchCommunicating dual use Seepart 5
research responsiblySeepart 480

A framework for risk assessmentand management

part 481

Is this dual use research of concern?
A framework for assessing and managing risks

QUESTION 1:
Could thisresearch yield
information that
could beintentionally
misused tothreaten publichealth and safetyor other aspectsof national
security?

QUESTION 2:
What is thenature of thethreat that could
be posed from
intentional
misapplication of
the information
and what are thepotential
consequences?

QUESTION 3:
Based on theaboveconsiderations,
how likely(reasonably
anticipated) is itthat theinformation could
be used to pose athreat to publichealth and safetyor other aspects ofnational security?

QUESTION 4:
Could thisresearch yield
information that
could potentiallybenefit the life
sciences and/or
public health andsafety and otheraspects ofnational
security?

QUESTION 5:
Do the potential
risks outweighthe potential
benefits?

The framework’s 5 key questions82

Is this dual use research of concern?
A framework for assessing and managing risks
1. Could this research yield information that could be intentionally misused tothreaten public health and safety or other aspects of national security?

• What is the nature of the information? Is it novel?
• Is the information applicable to other, perhaps common organisms,
biologics, etc.?
• Could the information be directly misused to pose a threat? Does theinformation need to be combined with other information to pose athreat? If so, is that other information already available?

83Is this dual use research of concern?
A framework for assessing and managing risks
2. What is the nature of the threat that could be posed from the intentional
misapplication of the information and what are the potential consequences?

•

•
•
•

•
•

What is the potential nature (e.g., economic, agricultural, public health) andwhat is the potential impact of the threat?
What is the scope of the potential threat (e.g., how many/which people, plants,
animals might be adversely affected)?
Are there currently countermeasures for this threat?
What type of technical expertise and/or physical resources would be needed toapply the information for malevolent purposes?
In what timeframe might the information be misused? Is there concern about
immediate or near-future potential use, or is the concern about misuse in the
distant future?
Would it require a low or high degree of technical skill and sophistication to use
the dual use information for harmful purposes?
84

Is this dual use research of concern?
A framework for assessing and managing risks
3. Based on the preceding considerations, how likely—reasonably
anticipated—is it that the information cold be used to pose a threat to publichealth and safety or other aspects of national security?

If there is NO
discernable
potential threat

If there IS adiscernable
potential threat

Then, discontinue the analysis andproceed with the research but continue
to be vigilant regarding dual use issues
that may arise during the conduct of theresearchThen, proceed with the analysis

85

Is this dual use research of concern?
A framework for assessing and managing risks
4. Could this research yield information that could potentially benefit the life
sciences and/or public health and safety and other aspects of national
security?

• If so, what is the nature of that information?
• What is the nature of the potential benefit?
• How much of a benefit might there be?

86Is this dual use research of concern?
A framework for assessing and managing risks
5. Do the potential risks outweigh the potential benefits?

• If not, determine applicable risk management strategies.
• If so, consider whether the research should be modified,conducted at a later time when the benefits outweigh therisks, or delayed (perhaps, in rare cases, even discontinued).
• The risk/benefit assessment should be conductedperiodically.

87

Communicating dual use research of concern

part 588

Decisions about the
responsible communicationof research with dual use
potential should address thefollowing in sequence:
1) Content
2) Timing3) Extent of distribution89Dual use research of concern potential:
Communication decisions
Option 1

Communicate as is.

Option 2

Communicate with addition of appropriate
contextual information, e.g., significanceof the research findings, the usefulness of
the information or technology to thescientific community, the dual use
potential of the information, etc.

Option 3

Communicate a modified version of the
product, e.g., by de-coupling the materialof concern from some or all of thepotentially useful scientific information.

1st

Content

90

Dual use research of concern potential :Communication decisions

Option 1

Communicate immediately.

Option 2

Defer communication until a clearly
defined and agreed-upon endpoint isreached, e.g., a condition is met such that
communication no longer poses the same
degree of risk.

2ndTiming91

Dual use research of concern potential :Communication decisions
Option 1

Do not limit distribution.

Option 2

Limit access to selected individuals on a“need to know” basis. (Thus, with thisoption, it would be necessary to identify
categories of individuals who should haveaccess and under what circumstances.)

Option 3

Do not publish the product or otherwise
make it accessible to the public.

3rd

Extent ofDistribution

92

Cases with questions
for discussion and reflection
part 693

There are several strategies for raising awareness about, andinculcating responsibility for dual use research of concern.

For example, some professionalsocieties have developed codes of conduct for dual
use research of concern.

To facilitate the consideration, formulation, and dissemination ofsuch a code, the NSABB has developed a Codes of Conduct Toolkit,
available at: [web address]

94

Educational
interventions
targeted atstudents
and investigatorsin the life sciences
are crucial
to raising awarenessand inculcating responsibility.

95

Case-based interventions
use real or realistic
scenarios
to challenge groups andindividuals to wrestle withthe dual use dilemma andreason through the questionofWhat should you do?
in every phase of the dual
use research process.

96The cases:
Objectives for learning and discussion
 Demonstrate an understanding of the dual use dilemma,
including “real life” and hypothetical examples of dual use
research Demonstrate an ability to identify aspects and products ofresearch with the potential for misuse Demonstrate an understanding—and ability to formulate—workable strategies for minimizing the risk of misuse Delineate responsibilities and define appropriate conduct
when designing, conducting, and communicating dual use
research97

1. Before the Study: Using Adenovirus
Sonia is a doctorate student who is developing a new projectin which she plans to test a gene transfer technique to treatcolon cancer tumors. The technique uses a modified
adenovirus as a vector. It modifies the adenovirus in such a
way that it specifically targets colon carcinoma cells and canbe used to deliver tumor suppressor genes with the aim of
overcoming the mutated genes that are implicated as thecause of the tumors. Modified adenoviruses have been usedas vectors for gene transfer before but with only partial
success. Sonia’s technique is an improvement on existing
methods and promises to avert or resolve the problems thathave hampered success in the past. Moreover, the method
is easy to use and relatively cheap. Although she has not
published on the new method as yet, her colleagues have alltested it and are very impressed; indeed, they haveencouraged her to patent the method.
98

1. Before the Study: Using Adenovirus
continued

Sonia’s enthusiasm for her work, however, has been dimmed
a bit by an off-handed comment by her colleague, Dan, who
observed that the technique could be used to deliver toxins
and other harmful agents to cause harm to animals,
agriculture and perhaps even to humans. Now, Sonia is not
sure what to do.
Q: Should Sonia disregard Dan’s comment—after all, she isworking on a possible treatment for cancer?
Q: Should Sonia inform others about the potential for misuseof her newly developed method? If so, whom should she
inform? Her colleagues? The editors and readers of thejournal or journals in which she might publish her work?
Q: Is there some other course of action that Sonia should
consider?
Q: Are there conditions under which research like Sonia’s
should be prevented from being carried out?

99

2. During a Study:
Studying Streptococcus Pneumoniae
Ann, a post-doctoral fellow is working with Peter, a seniorresearcher, on a study of antimicrobial resistance in grampositive pathogenic bacteria. Ann is studying recently
isolated strains of Streptococcus pneumoniae that havedeveloped antibiotic resistance and cause significantly
increased pneumonia morbidity and mortality. She has
identified a gene that she believes is responsible for the
resistance, one that encodes part of a membrane-boundprotein pump that removes materials from bacterial cells.
And with that gene, she has created a variant with increased
capacity that provides heightened resistance.

1002. During a Study:
Studying Streptococcus Pneumoniae
continued

Q: This research has the clear potential to yield public healthbenefits, but it could also be used for malevolent purposes.
What, if anything, should Ann and Peter do to minimize therisks of misuse of the research?
Q: Should Ann and Peter be held responsible if the findings oftheir research are malignantly misused?

101

3. The Editor’s Point of View:
Studying the Interaction between a Virus andthe Human Immune System
Sue and David submit to a major virology journal a manuscript
describing how the insertion of an immunosuppressive cytokine
into Pithecine virus viral genome renders the antiviral immune
response less effective. The manuscript has been read by manyof their colleagues, all of whom agreed that the findings
reported are significant and could lead to better understandingof the interactions between this virus and normal immune
function.
Several days later, David receives a call from the journal editor,
who tells him that the draft paper will undergo special review
due to the ‘dual use nature’ of the research.
102

3. The Editor’s Point of View:
Studying the Interaction between a Virus andthe Human Immune System
continued

When David informs Sue of his conversation withthe editor, she is understandably very worried thatthe manuscript may not be accepted for publication
as a result of this special review. While the paper isunder review, she and David reflect on the new dual
use research of concern review policies being
adopted by journals to which they regularly submit.

103

3. The Editor’s Point of View:
Studying the Interaction between a Virus andthe Human Immune System
continued

Q: What considerations should guide editorial
decisions about the publication of manuscripts
describing dual use research?
Q: Who should be involved in reviewing the paper?
Q: If a manuscript is to be published, what
measures should editors take to minimize thepotential for misuse?
Q: If the paper is rejected due to its dual use
potential, what, if anything, should be done toensure that the paper is not published elsewhere?
1044. Conference Talk/Poster Session:
Working with Clostridium Botulinum –Some Surprising Results
The bacterium Clostridium botulinum produces a toxin thatcauses about 150 cases of food poisoning a year in the
United States. Bioterrorists could exploit several of its
properties—it is accessible, easy to prepare in large
quantities, and would be deadly if added to the food orwater supply. To counteract the effects of such an attack, a
research team screened a library of compounds with thepotential to inhibit the activity of botulinum toxin to
determine if they could be used therapeutically after anattack.

105

4. Conference Talk/Poster Session:
Working with Clostridium Botulinum –Some Surprising Results
continued

During the studies, the group found a small moleculescaffold that strongly enhances the catalytic activity throughan apparent increase in binding affinity—in fact, thecompound enhanced the activity of the toxin up to fourteenfold. This finding could yield both benefits and harms. In
minute doses, botulium toxin is used to treat cerebral palsy,
spasmodic dysphonia, and other conditions and this finding
could make this use even more effective therapeutically. But
the discovery could be put to misuse as well in ways that areboth easy and frightening to imagine.

1064. Conference Talk/Poster Session:
Working with Clostridium Botulinum –Some Surprising Results
continued

Q: Should these researchers share the results of theirresearch at a scientific conference? What considerations
should inform a decision on whether to share the findings?
Q: Are there ways to share findings while minimizing therisks of misuse?

107

5. Dual Use of Concern in Another Lab – Cellmatrix Interaction and Tumor Growth andMetastasis
Dr. Gray is interested in cell-matrix interaction and its role intumor growth and metastasis. She finds that membraneprotein X is over-expressed in tumor cells and thinks that it
may regulate cell adhesion and invasion. She hypothesizes
that the N-terminal domain would make a good dominantnegative inhibitor and discovers that expressing this domain
inhibits adhesion and kills tumor cells. To produce pure
protein to use as a drug to treat cancer, Dr. Gray and hercolleague Dr. White develop a bacterial expression-secretion
system and are able to isolate the recombinant N-terminal
domain from bacterial culture medium. They are excited tofind that it kills tumor cells at remarkably low concentrations(0.1 μg/ml), and they name the recombinant fragment "Nstatin." They show that it does not kill normal cells until theyuse 20-fold higher doses.
108

5. Dual Use in Another Lab – Cell-matrix
Interaction and Tumor Growth and Metastasis
continued

Their findings show that exceptionally low doses are needed
for an effective cancer drug, but they also have results thatsuggest that if taken orally, even low doses kill mice. Theirwork illustrates that apart from being a potential drug forcancer, N-statin could be very cheap rat/mouse poison,because the bacterial expression-secretion system provides
an easy source of the material.
Dr. Gray and Dr. White share with you their new methods
and findings which you find impressive--especially thepotency of the biological drug candidate—but you worry
that the method and the findings with respect to toxicity
pose real risks with respect to dual use concerns andbiosafety.

109

5. Dual Use in Another Lab – Cell-matrix
Interaction and Tumor Growth and Metastasis
continued

Q: What should you do in this case? Should you alert the
researchers? the IBC? Someone else?
Q: Should the method and the findings be shared with others
working in this area? And if so, should they be notified of thepotential dual use of this research?

110Appendix C - NSABB Codes of Conduct Workgroup Charge
NSABB Codes of Conduct Workgroup (CCWG)
Workgroup Charge
I. Proposed Workgroup Charge
According to its charter, one key function of the NSABB is to “[A]dvise on the development,utilization and promotion of codes of conduct to interdisciplinary life scientists, and relevant
professional groups.” In its Proposed Framework for the Oversight of Dual Use Life Sciences
Research: Strategies for Minimizing the Potential Misuse of Research Information (June 2007),
the NSABB articulated “considerations in developing a code of conduct for dual use researchin the life sciences” (appendix 3 of the Framework), which includes a set of core
responsibilities regarding dual use research of concern and a comprehensive delineation of
responsibilities in the research process. The NSABB Codes of Conduct Workgroup (CCWG) is
now charged with several tasks to promote the dissemination, awareness, and adoption ofcodes of conduct by academic institutions as well as by professional societies and individuals
engaged in dual use research.
The Workgroup’s pursuit of its charge is premised on certain assumptions regarding thedevelopment of codes of conduct. First, the development and implementation of codes ofconduct should be voluntary activities on the part of professional societies, institutions, andgroups of researchers (e.g., a laboratory team). Second, especially with regard to thechallenges of dual use research, codes are optimally used for the purposes of educating andraising awareness among scientists throughout the organization.
The tasks of the Working Group are to:(1) Advise on ways to promote the adoption of Codes by Academic Institutions andScientific Societies;(2) Provide guidance on how to maintain Codes as “living” documents that continue
to reflect changes in the field of dual use research.
To achieve these tasks the WG will:
1. Identify the relevant people within academic institutions who have theauthority and reach to disseminate Codes (for example, VP for
Research, Department Head, etc);
2. Identify the relevant people within scientific associations who have theauthority and reach to disseminate Codes;
3. Advise on ways to engage these individuals on the issue of Codes;
4. Identify barriers to awareness and adoption of conduct codes;
5. Advise on ways to overcome these barriers;111

6. Identify strategies for realizing the potential of codes in shaping
behaviors and practices.
II. Proposed Objectives
1) Assessment of “the state of the issue,” that is, the extent to which professional societies
and institutions have adopted—or are considering the adoption of—codes of conduct;
the response of members of societies and of leadership, faculty, and staff of institutions
that have done so, and other relevant parameters.
2) Identification of barriers to disseminating, raising awareness about, and adopting codesof conduct.
3) Strategies for effectively disseminating, raising awareness about, and encouraging the
adoption of codes of conduct.
III. Proposed Approaches
a. Review of Previous NSABB Work Addressing Codes of Conduct: Strategic Plan for Outreach and Education on Dual Use Research Issues (December
10, 2008)
 Proposed Framework for the Oversight of Dual Use Life Sciences Research:
Strategies for Minimizing the Potential Misuse of Research Information (June 2007)o “Principles for the Responsible Communication of Research with Dual
Use Potential”
o “Points to Consider in Assessing the Risks and Benefits ofCommunicating Research Information with Dual Use Potential”
o “Considerations in Developing a Code of Conduct for Dual Use Researchin the Life Sciences”
Note: the Codes of Conduct Workgroup will build upon, as opposed toreconsidering, previous NSABB recommendations on this document.
 Reports from the 1st, 2nd, and 3rd International Roundtable on Dual Use Life
Sciences Research Goal 1: Ensure that WG members are well informed about the past work of the
NSABB on the issues surrounding codes of conduct.
 Goal 2: Summarize the previous work of the NSABB will be summarized for final
report.
b. For objective 1), utilizing direct contacts and literature as well as website reviews,
assess the current status of codes of conduct adoption by relevant professionalsocieties and institutions (see appendix for a list of the targeted societies)
 Goal 1: Inform WG members of the results of this survey and the key findings
from the survey (especially with respect to any discernible impact of NSABB’s
work thus far).
 Goal 2: Summarize survey data and key findings for final report.

112

c. For objective 2), on the basis of the survey described in b., select societies andinstitutions that have adopted and sought to implement codes of conducts, as well asgroups that have not, and conduct a more targeted effort aimed at identifying barriers
encountered or perceived (i.e., encountered by groups that have adopted codes andperceived or encountered by those that have not). Also, if and where possible,
identify strategies that have been effective.
 Goal 1: Identify key barriers to code dissemination, adoption, and awareness.
 Goal 2: Keep working group informed about the results of the survey and theeffort to identify barriers.
d. For objective 3), convene the working group for the purposes of (1) reviewing theinformation and data gathered through b and c, (2) analyzing the identified barriers todissemination, adoption, and awareness, and (3) strategizing about ways ofcircumventing, surmounting, or mitigating these barriers.
 Over-arching Goal 1: Encourage adoption of codes of conduct by individuals,
professional societies, and institutions.
 Subsidiary Goal 2: Develop a set of “points to consider” for making codes ofconduct “living documents” in multiple contexts (e.g., in professional andscientific societies as well as in institutions and by individuals).
 Subsidiary Goal 3: Develop a plan for communicating the “points to consider”.
 Subsidiary Goal 4: Develop a plan for assessing the impact of the “points toconsider”.
Please note: If feasible, the working group should consider holding a public forum(or consultation) as another approach to achieving objective 3). Discussions areunderway with other NSABB working groups to determine if such aforum/consultation might be held in conjunction with a similar activity by anotherworking group.
IV. Products/Deliverables
a. Summary of information/data and key findings from survey of professional societies
and institutions.
b. Summary of key barriers to the dissemination, adoption, and awareness of codes ofconduct and of effective strategies for these purposes.
c. Final report incorporating (a) and (b), along with “points to consider” for realizing thepotential of codes of conduct as guides to behavior and practice.
V. Proposed Structure/Organization
 Working Group co-chairs: Kenneth Berns & Andrew Sorensen WG Membership: Christine Grant, Paul Keim, Stuart Levy, John Lumpkin, Mark Nance,
James Roth
 NSABB staff: Paul Lewis, Allan Shipp, Dan Davis, Ori Lev and Symma Finn.

113

VI. Outcome/Impact Assessment
Measure impact of “points to consider” at specified intervals after
introduction/communication.

114

Appendix D – NSABB Roster
NSABB Roster

Acting ChairPaul S. Keim, Ph.D.*
Division Director, Pathogen Genomics
Translational Genomics Research Institute;
Cowden Endowed Chair in Microbiology
Northern Arizona University
Flagstaff, AZ
Voting Members
Kenneth I. Berns, M.D., Ph.D.*
Director of Genetics Institute
University of Florida
Genetics Institute
Gainesville, FL
Arturo Casadevall, M.D., Ph.D.
Professor and Chairman
Dept. of Microbiology and Immunology
Albert Einstein School of Medicine
Bronx, NY
Murray L. Cohen, Ph.D., M.P.H., C.I.H.
President and Chairman
Frontline Healthcare Workers®
Safety Foundation, Ltd.
Atlanta, GA
Susan A. Ehrlich, J.D., LL.M. (biotechnology & genomics)
Judge (ret.), Arizona Court of Appeals
Adjunct Professor, Department of Microbiology & Immunology,
University of Texas Medical Branch – Galveston,
Galveston National Laboratory
Lynn W. Enquist, Ph.D.
Professor and Chair
Dept. of Molecular Biology
Princeton University;115

Editor in Chief, Journal of Virology
Princeton, NJ
J. Patrick Fitch, Ph.D.
Laboratory Director
National Biodefense Analysis andCountermeasures Center
President, Battelle National Biodefense
Institute, LLC
Frederick, MD
David R. Franz, D.V.M., Ph.D.
Vice President and Chief Biological Scientist
Midwest Research Institute;
Director, National Agricultural Biosecurity Center
Kansas State University
Frederick, MD
Claire M. Fraser-Liggett, Ph.D.
Director, Institute of Genome Sciences
University of Maryland School of Medicine
Baltimore, MD
General John A. Gordon
General, USAF (Retired)
Alexandria, VA
Christine M. Grant, J.D.*
CEO/Founder
InfecDetect Rapid Diagnostic Tests, LLC
Princeton, NJ
Michael J. Imperiale, Ph.D.
Professor
Dept. of Microbiology and Immunology
University of Michigan Medical School
Ann Arbor, MI
Joseph Kanabrocki, Ph.D., C.B.S.P.
Assistant Dean for Biosafety
Associate Professor of Microbiology
Biological Sciences Division
University of Chicago
Chicago, IL

116

Stanley M. Lemon, M.D.
Professor
Division of Infectious Diseases
University of North Carolina School of Medicine
Chapel Hill, NC
Stuart B. Levy, M.D.*
Director
Center for Adaptation Genetics and Drug Resistance;
Professor of Medicine and Molecular Biology and Microbiology
Tufts University School of Medicine
Boston, MA
John R. Lumpkin, M.D., M.P.H.*
Senior Vice President and Director of the HealthCare Group
Robert Wood Johnson Foundation
Princeton, NJ
Jeffery F. Miller, Ph.D.
Professor and Chair
Department of Microbiology, Immunology
and Molecular Genetics
David Geffen School of Medicine
University of California – Los Angeles
Los Angeles, CA
Randall Murch, Ph.D.
Associate Director
Research Program Development
Virginia Tech – Northern University
Alexandria, VA
Mark E. Nance, J.D.*
General Counsel
Medical Diagnostics
GE Healthcare
Princeton, NJ
Michael T. Osterholm, Ph.D., M.P.H.
Director, Center for Infectious Disease Research and Policy;
Associate Director, Dept. of Homeland Security
National Center for Food Protection and Disease;
Professor, School of Public Health
University of Minnesota
Minneapolis, MN
117

David A. Relman, M.D.
Professor of Microbiology & Immunology
and of Medicine
Stanford University School of Medicine
Stanford, CA
James A. Roth, D.V.M., Ph.D., D.A.C.V.M.*
Director, Center for Food Security and Public Health
Executive Director, Institute for International Cooperation in Animal Biologics
College of Veterinary Medicine
Iowa State University
Ames, IA
Andrew Sorensen, PhD*§
Senior Vice President for Development Special Assistant to the President for
Advancement President, The Ohio State University Foundation The Ohio State
University Columbus, OH
Anne K. Vidaver, Ph.D.
Professor Emeritus
Department of Plant Pathology
University of Nebraska-Lincoln
Lincoln, NE
Non-voting Ex Officio Members
Jason Boehm, Ph.D.
Office of the Director
National Institute of Standards and Technology
Department of Commerce
Parag R. Chitnis, Ph.D.
Deputy Director
Division of Molecular and Cellular Biosciences
National Science Foundation
Brenda A. Cuccherini, Ph.D., M.P.H.
Special Assistant to the Chief R&D Officer
Office of Research and Development
Veterans Health Administration
Department of Veterans Affairs
Anthony S. Fauci, M.D.
Director
National Institute of Allergy and Infectious Disease118

National Institutes of Health
Department of Health and Human Services
Franca R. Jones, Ph.D.
LCDR, MS, USN
Senior Policy Analyst
Office of Science and Technology Policy
Executive Office of the President
Anne E. Kinsinger
Associate Director for Biology
U.S. Geological Survey
Department of the Interior
Tom Hopkins, Ph.D.
Assistant to the Secretary of Defense for Nuclear and Chemical and Biological Programs(Acting)
Department of DefensePeter R. Jutro, Ph.D.
Deputy Director
National Homeland Security Research Center
Environmental Protection Agency
Lisa Kaplowitz, M.D., MSHA
Director, Office of Policy and Planning
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
David R. Liskowsky, Ph.D.*
Director, Medical Policy & Ethics
Office of the Chief Health and Medical Officer
National Aeronautics & Space Administration
CDR Carmen Maher
Acting Deputy Director
Office of Counterterrorism and Emerging Threats (OCET)
Office of the Chief Scientist
Office of the Commissioner
Food and Drug Administration
Department of Health and Human Services
Susan Coller-Monarez, Ph.D.
Deputy Chief Medical and Science Officer
Science and Technology Directorate
Department of Homeland Security
119

Janet K. A. Nicholson, Ph.D.
Associate Director for Laboratory Science
National Center for Infectious Diseases
Centers for Disease Control and Prevention
Department of Health and Human Services
Christopher Park
Director, Biological Policy Staff
Bureau of International Security and Nonproliferation
U.S. Department of State
Caird E. Rexroad, Jr., Ph.D.*
Associate Administrator
Agricultural Research Service
U.S. Department of Agriculture
Amanda Dion-Schultz, Ph.D.
Office of the Chief Scientist
David G. Thomassen, Ph.D.
Chief Scientist
Office of Biological & Environmental Research
Office of Science
Department of Energy
Edward You
Supervisory Special Agent
FBI Weapons of Mass Destruction Directorate
Countermeasures Unit
Bioterrorism Program
Federal Bureau of Investigation
Department of JusticeFederal Representatives
Jessica Petrillo*
Scientific Advisor
Biological Policy Staff
Bureau of International Security and Nonprolifiration
U.S. Department of State
120

Laura Kwinn, Ph.D. *Office of Medicine, Science and Public Health, Office of the Assistant Secretary for
Preparedness and Response, U.S.
Department of Health and Human
Services
Theresa Lawrence, Ph.D. *Office of Medicine, Science and Public Health,
Office of the Assistant Secretary for
Preparedness and Response, U.S.
Department of Health and Human
Services
Codes of Conduct Working Group Staff
Dan Davis, Ph.D.
Senior Bioethics Policy Advisor
Office of Biotechnology Activities
Office of Science Policy, Office of the Director
National Institutes of Health
Ori Lev, Ph.D.
Health Science Policy Analyst (contractor)
Office of Biotechnology Activities
Office of Science Policy, Office of the Director
National Institutes of HealthPaul Lewis, Ph.D.
Executive Director, NSABB
Office of Biotechnology Activities
Office of Science Policy, Office of the Director
National Institutes of HealthAllan Shipp, M.H.A
Director of Outreach
Office of Biotechnology Activities
Office of Science Policy, Office of the Director
National Institutes of Health* Codes of Conduct Working Group Member§ Deceased

121

122

Appendix E – Roundtable: Promoting Awareness and Responsibility in Dual Use Research:
A Critical Assessment of the Role of Codes of Conduct

NSABB Codes of Conduct
Working GroupNATIONALSCIENCEADVISORY
BOARD FOR
BIOSECURITY

A ROUNDTABLE ON
Promoting Awareness and Responsibility in Dual Use Research:
A Critical Assessment of the Role of Codes of Conduct
National Institutes of Health
Building 31, 6th Floor, Room 10
Bethesda, MD
October 20, 2010
Agenda7:45 amLight Refreshments

8:00 am

Session I
Codes of Conduct and the Responsible Conduct of Dual Use Research: an
Overview of the work of the NSABB
Co-Chairs:
Kenneth I. Berns, M.D., Ph..D
Director of Genetics Institute
University of Florida
Andrew A. Sorensen, Ph.D.
Senior Vice President for Development
Special Assistant to the President for Advancement
President of The Ohio State University Foundation
The Ohio State UniversityPresentation on working group activities to date:o The “considerations” regarding the core responsibilities ofresearchers in the life sciences (Appendix 3 of the Oversight
Framework of June 2007)
o Outreach and survey efforts before and after the development of
the “considerations”

1238:30 am

Session II
Scholarly Work on Codes – An Overview
Moderator:
Paul S. Keim, Ph.D., Division Director, Pathogen Genomics, The Translational
Genomics Research Institute, Northern Arizona University
Speaker: Brian Rappert, Ph.D., University of ExeterPresentation informed by an academic literature review on how Codes ofConduct have been developed, promoted, and implemented acrossdifferent fields – Business, Academia, Government and professionalsocieties- how they were developed and used in the life sciences, as wellas in the area of dual use research.
The purpose of this session is to identify effective strategies fordeveloping, implementing, and ensuring the vitality of codes of conduct,
especially in the sciences and particularly with reference to dual use
research.

9:30 amBreak

9:40 am

Session III
Lessons Learned: Codes of Conduct and Professional Societies
Moderator:
Stuart B. Levy, M.D., Director, Center for Adaptation Genetics & Drug
Resistance, Tufts University School of Medicine
Speakers:
 Ronald Atlas, Ph.D., American Society of Microbiology (ASM) Jan Leach , Ph.D., American Phytopathological Society (APS) Mark S. Frankel, Ph.D., Director, Program on Scientific Freedom,
Responsibility & Law, American Assn. for the Advancement of Science(AAAS)
A session devoted to the discussion of such questions as:

1. What were the motivating aims in the development and implementationof codes of conduct?
124

2. Who led the effort?
3. What processes and what individuals or groups were involved indeveloping codes of conduct?
4. Once formulated, how were codes of conduct adopted and promulgated?
5. How are codes used?
6. Have the codes been modified, and if so, why?
7. Have adopted codes of conduct proven effective in achieving the
motivating aims?
8. What lessons were learned with regard to the development,
implementation, and dissemination of codes of conduct?
9. NSABB’s goal is to promote the development and adoption of codes ofconduct by more professional societies. What factors were conducive tothe development and adoption of codes of conduct in the professionalsocieties that now have them in place?
10:50

Break

11:00

Session IV
Lessons to Be Learned: Strategies and Challenges in Adopting Codes ofConduct in the Academic Setting
Moderator:
Mark E. Nance, J.D., General Counsel, GE Healthcare
Speakers:
 Carol Whitacre, PhD, Vice President for Research, The Ohio State
University
 Scott Steele, PhD, Director, Office of Research Alliances, University ofRochester Francis Macrina, PhD, Vice President for Research, Virginia
Commonwealth University
 Kenneth L. Dretchen, PhD, Chairman and Professor, Department ofPharmacology, and Senior Associate Vice President for Regulatory
Affairs, Georgetown University Medical Center Naomi Schrag , JD, Associate Vice President for Research Compliance,
Office of the Executive Vice President for Research, Columbia
University

A session devoted to the overarching question of how codes might bepromoted and sustained in the academic setting. Insights from industry
will be discussed. Specific questions include:
1. What might be barriers to the adoption of codes?
2. How can these barriers be overcome?
125

3. How should codes be developed in academic settings (top-down,bottom-up, particular offices etc.)?
4. How should codes be disseminated through the institutions?
5. How can the codes “vitality” be sustained?
6. What might be effective ways of promoting the adoption of codes in
the wider community?
7. How can the adoption of codes be promoted as a moral versus legal
approach?
12:20

Lunch

12:45

Session V
Promoting the Responsible Conduct of Dual Use Research: A Conversation
with RCR Leaders
Moderator:
Christine M. Grant, J.D., CEO/Founder, InfecDetect Rapid Diagnostic Tests, LLC
Speakers:
 Michael W. Kalichman, Ph.D., Director, Research Ethics Program,
University of California – San Diego John Galland, Ph.D., Director, Division of Education and Integrity, Officeof Research Integrity, Department of Health and Human Services
 John E. Dahlberg, Ph.D., Director, Division of Investigative Oversight,
Office of Research IntegrityA session devoted to exploring potential linkages between codes ofconduct, promoting awareness of dual use research, and education in the
responsible conduct of research. Questions for discussion include:
1. How can RCR education integrate the issue of dual use in general andthe adoption of codes in particular?
2. Are there good models or best practices for doing so?
3. What might be the challenges to overcome?

1:45 pm

Review of the Roundtable Discussions and Next Steps (CCWG Members Only)

2:30 pm

Adjournment126Appendix F - Roundtable Participants’ Biographical SketchesRonald Atlas, PhD, is co-chair of the Public and Scientific Affairs Board Biodefense
Committee of the American Society for Microbiology and Professor of Biology at
the University of Louisville. He received his BS degree from the State University
at Stony Brook, his MS and PhD degrees from Rutgers the State University, and aDSc (honoris causa) from the University of Guelph. He has served as President of
the American Society for Microbiology, as a member of the NIH Recombinant
Advisory committee, as chair of NASA’s Planetary Protection Committee, as chairof the Wellcome Trust Pathogens, Immunology and Population Health Strategy
Committee, as a member of the US Department of Homeland Security’s Scienceand Technology Advisory Committee, and as chair of the Board of Directors of the
One Health Commission. He is the author of nearly 300 manuscripts and 20 books.
He is a fellow in the American Academy of Microbiology.

John E. Dahlberg, PhD, has been the Director of the Division of Investigative
Oversight of the Office of Research Integrity, US Department of Health andHuman Services, since April 2006. He received a BA from Brandeis University in
1963 and a PhD in microbiology from Purdue University in 1968. After postdoctoral fellowships at the Public Health Research Institute of the City of New
York and at Rutgers University, he spent sixteen years at the National Cancer
Institute in Bethesda carrying out research on retroviruses with an initialemphasis on ultrastructure and virus classification. Subsequently he focusedincreasingly on immunoassay development and molecular biology and, using all ofthese technologies, began research on lentiviruses in 1980. In 1988, Dr. Dahlberg
joined a small biotechnology company as director of research and development,
where he developed procedures for growing macrophage cells in serum-free
medium and using them to test drugs for their ability to inhibit HIV replication. Dr.
Dahlberg joined the Office of Scientific Integrity in 1992, just prior to its being
reorganized into ORI. While at ORI, he has developed a variety of computer-aided
techniques to assist in analysis of data and detection of evidence of data
falsification.



Dr. Kenneth Dretchen currently serves as a professor and chair of the Departmentof Pharmacology at Georgetown University Medical Center. He is actively
involved in teaching the principles of pharmacology to medical and graduate
students. Dr. Dretchen previously served as the Dean of Research for 5 years andthe Senior Associate Vice-President for Regulatory Affairs for the medical center.
In these two positions he was responsible for promoting and facilitating faculty
research efforts as well as serving as the Institutional Official for the university. In
this regard, he was responsible for all of the regulatory activities of the university

127

including the IRB, Animal Care and Use Committee, biohazards and radiation
safety.
Dr. Dretchen maintains an active research program. In conjunction with General
Dynamics he has been involved in the development of a stand-alone detection
system for biological and chemical threat agents. Furthermore, he was part of
the team including Meridian Medical Technologies and the DoD that developed
the antidote kit for chemical weapons of mass destruction. The kit is carried bymembers of the military and stored in the Strategic National Stockpile.
Dr. Dretchen is a member of the National Biodefense Science Board. This is athirteen-member federal advisor committee that reports to the Secretary of
DHHS. The responsibility of the board includes advising the Secretary on:
emerging infectious diseases, pandemic influenza and chemical, biological andradiological threat agents.
Mark S. Frankel, PhD, is director of the Scientific Freedom, Responsibility and Law
Program at the American Association for the Advancement of science (AAAS),
where he develops and manages AAAS’s activities related to professional ethics,
science and society, and science and law. At AAAS he has directed or co-directed
projects on research integrity and scientific misconduct, codes of ethics inscientific and engineering societies, the ethical and policy implications of humanstem cell research, the implications of advances in neuroscience research for thelegal system, the use of science in the courtroom, and personalized medicine,among others. Dr. Frankel is a former member of the Board of Directors of the
National Patient Safety Foundation and currently serves on the Boards of theFood and Drug Law Institute and the Center for Law, Science & Innovation at
Arizona State University. He is also a member of the Science and Ethics Advisory
Group at Roche Genetics in Basel, Switzerland. He serves on the editorial boardsof Science and Engineering Ethics, Ethics & Behavior, and the Journal of Empirical
Research on Human Research Ethics. He is editor of AAAS’s quarterly publication,
Professional Ethics Report, and a Fellow of AAAS.

John C. Galland, PhD, is the Director of the Division of Education and Integrity in
the Office of Research Integrity, US Department of Health and Human Services.
Before joining ORI on March 27, 2009, Dr Galland was Director of the UC DavisLaboratory Management Institute. While at the Institute, Dr. Galland developed acurriculum and unique pedagogy for educating scientists in the practical businessof running a research program. This pedagogy was described in the journals
Nature, Science, Cell, The Scientist, The Chronicle of Higher Education, the National
Postdoctoral Association’s The PostdocKET, and Laboratory Manager. The
curriculum was delivered through an annual program for postdoctoral scholars at
UC Davis and a summer Certificate Program offered to people worldwide. Bothprograms consisted of 140 contact hours of instruction. Additional educational
128

programs were conducted for industry, government, national laboratories, otheracademic institutions, and scientific associations.
Dr. Galland also taught a graduate course for the UC Davis School of Veterinary
Medicine entitled “Philosophy and Ethics for the Biological Scientist”. In 2004, Dr.
Galland became one of 20 partners in the Howard Hughes Medical
Institute/Burroughs Wellcome Scientific Management Program for Postdoctoral
Fellows and Faculty and acknowledges their influence on the program at UC
Davis.
Dr. Galland received both his MS and PhD degrees from UC Davis. Before
returning to UC Davis, he was Professor of Veterinary Medicine at Kansas State
University where he taught public health and zoonotic diseases and conducted
research on food-borne pathogens.
Michael Kalichman, PhD, is the founding director of the Research Ethics Programat the University of California, San Diego, in La Jolla, California. Since 1988, he hastaught multiple seminars and courses to help UCSD Training Grant Program
Directors comply with NIH requirements for training in the responsible conduct of
research. He has been a consultant or speaker on the topic of research ethics forboth national and international workshops and advisory groups, including panels
and conferences for the American Association for the Advancement of Science,
National Academy of Sciences, National Institutes of Health, and the Office of
Research Integrity. With Francis Macrina of Virginia Commonwealth University,
he has taught numerous courses for instructors of research ethics courses. He is
project director for a Web-based resource for instructors of courses in the
responsible conduct of research (http://research-ethics.net) and directs NIHfunded projects to assess the effectiveness of teaching research ethics and thestandards of conduct in research. Kalichman is also the founding and pastpresident for the Responsible Conduct of Research Education Consortium(RCREC), which is now part of the Association for Practical and Professional
Ethics. He is a co-founder and co-director of the Center for Ethics in Science andTechnology (http://ethicscenter.net) for the San Diego region and founding
director of the San Diego Research Ethics Consortium (http://sdrec.ucsd.edu).



Jan Leach, PhD, is a University Distinguished Professor at Colorado State
University and an Adjunct Scientist at the International Rice Research Institute(Philippines). She is an authority on the molecular biology of plant–pathogen
interactions. Her research focuses on understanding the molecular basis ofdurable disease resistance, particularly in rice-pathogen interactions. Other
projects currently underway in her laboratory are related to bioenergy (genetics
of biomass production), improving health benefits of crop plants, and thedevelopment of novel tools for detection and monitoring of microbes associatedwith plants. She is a Fellow and a past President of the American
129

Phytopathological Society. She is also a Fellow of the American Association for
the Advancement of Science (AAAS), served as Chair of the AAAS Section O(Agriculture, Food, and Renewable Resources) in 2007, and is currently a memberof the Section O steering committee. Leach is a Fellow of the American Academyof Microbiology. Prior to her appointment at CSU, Dr. Leach was named a
University Distinguished Professor at Kansas State University in 1998. She served
as president of the International Society of Molecular Plant–Microbe Interactions.
Leach has served or chaired advisory committees for a number of national andinternational projects, programs and institutions, including the U.S. Rice Genome
Sequencing Project, the Research Core for Interdisciplinary Science (RCIS) at
Okayama University (Japan), Rural Development Agency (Korea), and a National
Research Council (NRC) study.
Francis L. Macrina, PhD, is the Edward Myers Professor of Dentistry and Vice
President for Research at Virginia Commonwealth University (VCU). Dr. Macrina's
longstanding scientific interests have been in the molecular pathogenesis ofinfectious diseases, and his research at VCU was continuously supported by the
National Institutes of Health (NIH) for 33 years. This NIH funding included
Research Career Development and MERIT Awards from the National Institute of
Dental and Craniofacial Research. He has authored over 115 scientificpublications. His current scholarly interests also include behavioral andeducational research in scientific ethics. Dr. Macrina has served two terms on NIH
study sections and was both a member and the chair of the NIDCR Board of
Scientific Counselors. He also served a four year term on the NIH National
Advisory Dental and Craniofacial Research Council. He has served on the editorial
boards of the Journal of Bacteriology and Infection and Immunity. He was bothco-editor-in-chief and editor-in-chief of Plasmid, serving in these roles for a total of
13 years. He is frequently invited to speak on scientific integrity teaching, and has
been involved in teaching workshops sponsored by PRIM&R, the American
Society for Microbiology (ASM), Sigma XI, and the National Academy of Sciences.
He has served as a member of the ASM Ethics Committee and the Ethics
Committee of the American Association for Dental Research. He was a founding
member and officer of the Responsible Conduct of Research Educational
Consortium, now a unit of the Association of Practical and Professional Ethics. He
has been a consultant to the USHHS Office of Research Integrity, the National
Institutes of Health, the National Science Foundation and the National Science
Advisory Board for Biosecurity on matters related to scientific integrity andresponsible conduct of research. He completed two years of service as a memberof the NAS/AAAS Committee on Assessing Fundamental Attitudes of Life
Scientists as a Basis for Biosecurity Education. The third edition of his widely used
text, Scientific Integrity, Text and Cases in Responsible Conduct of Research was
published by ASM Press in March, 2005. He is presently writing the 4th edition ofthis book which is expected to be published in the fall of 2011.

130



Brian Rappert, PhD, is the Head of Department and an Associate Professor of
Science, Technology and Public Affairs in Sociology & Philosophy at the Universityof Exeter. His long term interest has been the examination of how choices canand are made about the adoption and regulation of technologies, particularly in
conditions of uncertainty and disagreement. Over the last 5 years he has
undertaken extensive educational engagement efforts with individuals andgroups in the life sciences regarding the potential destructive use of theirresearch. In 2010 he published Education and Ethics in the Life Sciences (freely
available at http://epress.anu.edu.au/education_ethics/pdf_instructions.html). His
other books include Controlling the Weapons of War and Biotechnology, Security
and the Search for Limits, Biosecurity (co-ed), and Experimental Secrets.

Naomi J. Schrag, JD, is the Associate Vice President for Research Compliance in
the Office of the Executive Vice President for Research. She oversees work onsuch issues as research misconduct, conflict-of-interest and international researchcompliance, and collaborates closely with other offices across the University todevelop integrated approaches to compliance and training. Before joining
Columbia in January 2006, Ms. Schrag practiced law for nine years, focusing on
regulatory compliance and litigation involving biomedical research, with clients
including pharmaceutical companies and not-for-profit organizations. Ms. Schragalso clerked in the Court of Appeals for the Second Circuit. Ms. Schrag graduatedfrom New York University School of Law in 1995. Before entering law school, she
worked on an oral history of the Holocaust for the Museum of Jewish Heritage.



Scott Steele, PhD, joined the University of Rochester in December of 2008 andcurrently serves as the Director of a new Office of Research Alliances. In this role
he is identifying and fostering strategic research partnerships and educational
alliances between the University’s research community and industry, government
agencies and laboratories, and other academic institutions. He is actively involved
with the University of Rochester Clinical and Translational Science Institute,serving as the Director of the Public-Private Partnership Key Function. Dr. Steele
also serves on research and technology related committees at the University ofRochester, including the Technology Transfer Policy Committee and the
University Research Group, both chaired by the Provost. Prior to joining the
University of Rochester, Dr. Steele served in the White House Office of Scienceand Technology Policy (OSTP), initially as a representative of the National Scienceand Technology Council and was later designated as the Executive Director of the
President’s Council of Advisors on Science and Technology (PCAST). PCAST
provides advice and recommendations to the President on a range of science andtechnology issues and Dr. Steele coordinated PCAST studies exploring issues innanotechnology, energy technologies, personalized medicine, and approaches toenhance university-private sector research partnerships. Previously, Dr. Steele
served as a senior policy specialist at the Federal Bureau of Investigation (FBI).
Within the FBI’s Weapons of Mass Destruction program, he focused on131developing a number of science and national security policies and plans, including
forming partnerships between the scientific, public health, law enforcement andbroader national security communities.


Caroline C. Whitacre, PhD, serves as the Vice President for Research at The Ohio
State University in Columbus, Ohio. She is a Professor of Molecular Virology,
Immunology and Medical Genetics and holds joint appointments in the
Departments of Pathology, Internal Medicine and Veterinary Biosciences. She
served as Associate Vice President for Health Sciences Research and Vice Dean for
Research in the College of Medicine from 2001-2008. Dr. Whitacre received her BA
and PhD degrees at Ohio State University and did postdoctoral training at
Northwestern University Medical School in Chicago. She returned to Ohio Statein 1981 where she has been on the faculty since that time. She served for 12 years
as the Chair of the Department of Molecular Virology, Immunology and Medical
Genetics in the College of Medicine.
Dr. Whitacre’s research is in the area of the immunology of multiple sclerosis(MS). Her laboratory examines the treatment of MS and its animal model using
oral tolerance. This research has led to clinical trials in MS, rheumatoid arthritis,
uveoretinitis, and diabetes. She has also worked in the area of hormonal
regulation of autoimmunity, and more recently focused on sex differences andthe effects of pregnancy on autoimmune disease. Dr. Whitacre has served as chairof an NIH study section, as well as Chair of the Task Force on Gender, MS andAutoimmunity for the National Multiple Sclerosis Society. She also chaired thePresidential Commission on University Governance at Ohio State. In recognitionof her University activities, she was awarded the OSU Faculty Award forDistinguished University Service in 2001 and the Distinguished Scholar Award in2008. In 2004, she was named a Fellow of the American Association for the
Advancement of Science.

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Appendix G – Bibliography of Literature Review

Code of Conduct for
Dual Use Research in the Life Sciences
Literature Review
Selected Articles 1977-2010
AAMC. Developing a Code of Ethics in Research: for Scientific Societies. 1997: 42 pps.
Anderson, MS. Normative orientations of university faculty and doctoral students. Science andEngineering Ethics, 2000; 6, 443–461. Discussion 463–465.
Atlas RM. Responsible conduct by life scientists in an age of terrorism. Sci Eng Ethics. 2009
Sep;15(3):293-301. Epub 2009 May 7. PubMed PMID: 19421897.
Bullock M, Panicker S. Ethics for all: differences across scientific society codes. Sci Eng Ethics. 2003
Apr;9(2):159-70. PubMed PMID: 12774648.
Campbell A, Glass KC. The legal status of clinical and ethics policies, codes, and guidelines in medical
practice and research. McGill Law J. 2001 Feb;46(2):473-89. PubMed PMID: 16523580.
Cournand A. The code of the scientist and its relationship to ethics. Science.1977 Nov 18;198(4318):699705. PubMed PMID: 910153.
Davis M. What can we learn by looking for the first code of professional ethics? Theor Med Bioeth.
2003;24(5):433-54. Review. PubMed PMID: 14760870.
Ehni H-J. Dual use and the ethical responsibility of scientists. Arch. Immunol. Ther. Exp. 2008, 56:147152.
Frankel MS. Scientific Societies as Sentinels of Responsible Research Conduct. Proceedings of the Society
for Experimental Biology and Medicine, 2000 224: 216–219.
Frankel MS, Bird SJ. The role of scientific societies in promoting research integrity. Sci Eng Ethics. 2003
Apr;9(2):139-40. PubMed PMID: 12848197.
Graham D. Revisiting Hippocrates: does an oath really matter? JAMA. 2000 Dec 13;284(22):2841-2.
PubMed PMID: 11147972.
Grinnell F. Ambiguity, trust and the responsible conduct of research. Sci Eng Ethics. 1999 Apr;5(2):20514.
Iverson M, Frankel MS, Siang S. Scientific societies and research integrity: what are they doing and how
well are they doing it? Sci Eng Ethics. 2003 Apr;9(2):141-58. PubMed PMID: 12774647.

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Jones NL. A code of ethics for the life sciences. Sci Eng Ethics. 2007 Mar;13(1):25-43. PubMed PMID:
17703607.
Kant L, Mourya DT. Managing dual use technology: it takes two to tango. Sci Eng Ethics. 2010
Mar;16(1):77-83. Epub 2008 Apr 26. PubMed PMID: 18438721.
Kenny NP. The CMA Code of Ethics: more room for reflection. CMAJ. 1996 Oct 15; 155(8):1063-5.
PubMed PMID: 8873634
Keuleyan E. Liberty to decide on dual use biomedical research: an acknowledged necessity. Sci Eng
Ethics. 2010 Mar;16(1):43-58. PubMed PMID: 18427955.
Koepsell D. On genies and bottles: scientists' moral responsibility and dangerous technology R&D. Sci
Eng Ethics. 2010 Mar;16(1):119-33. PubMed Central PMCID: PMC2832882.
Komesaroff PA, Kerridge IH. The Australian Medical Council draft code of professional conduct: goodpractice or creeping authoritarianism? Med J Aust. 2009 Feb 16;190(4):204-5. PubMed PMID: 19220187
Malloy DC, Sevigny P, Hadjistavropoulos T, Jeyaraj M, McCarthy EF, Murakami M, Paholpak S, Lee Y, Park
I. Perceptions of the effectiveness of ethical guidelines: an international study of physicians. Med HealthCare Philos. 2009 Nov;12(4):373-83. PubMed PMID: 19544088.
Marchant GE, Pope LL. The problems with forbidding science. Sci Eng Ethics. 2009 Sep;15(3):375-94.
Epub 2009 Apr 7. PubMed PMID: 19350416.
Mario JR. A review of Anglo-American forensic professional codes of ethics with considerations for code
design. Forensic Sci Int. 2002 Feb 18;125(2-3):103-12. Review. PubMed PMID: 11909650.
McKinney JA, Emerson TL, Neubeert MJ. The effects of ethical codes on ethical perceptions of actions
towards stakeholders. J Bus Ethics 18 June 2010.
National Research Council. A survey of attitudes and actions on dual use research in the life science: A
collaborative effort of the National Research Council and the American Association for the Advancementof Science. Washington DC 2004: The National Academies Press.
Patterson P. Toward an effective code of conduct. OR Manager. 2009 Jan;25(1):17-8. PubMed PMID:
19226879.
Patterson P. What makes a behavior code effective? OR Manager. 2009 Jan;25(1):19-20. PubMed PMID:
19226880.
Parker MH. Normative lessons: codes of conduct, self-regulation and the law. Med J Aust. 2010 Jun
7;192(11):658-60. PubMed PMID: 20528720.
Pustovit SV, Williams ED. Philosophical aspects of dual use technologies. Sci Eng Ethics. 2010
Mar;16(1):17-31. Epub 2008 Oct 21. PubMed PMID: 18937057.

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Rappert B. Codes of conduct and biological weapons: an in-process assessment. Biosecur Bioterror.
2007 Jun;5(2):145-54. PubMed PMID: 17608600.
Rappert B. Responsibility in the life sciences: assessing the role of professional codes. Biosecur Bioterror.
2004;2(3):164-74. PubMed PMID: 15588054.
Rappert B. Coding ethical behaviour: the challenges of biological weapons. Sci Eng Ethics. 2003
Oct;9(4):453-70. PubMed PMID: 14652899.
Schuurbiers D, Osseweijer P, Kinderlerer J. Implementing the Netherlands code of conduct for scientificpractice-a case study. Sci Eng Ethics. 2009 Jun;15(2):213-31. Epub 2009 Jan 21. PubMed PMID:
19156537.
Selgelid MJ. Dual-use research codes of conduct: lessons from the life sciences. Nanoethics 2009; 3:175183.
Sohl P, Bassford HA. Codes of medical ethics: traditional foundations and contemporary practice. Soc Sci
Med. 1986; 22(11):1175-9. PubMed PMID: 3529416.
Somerville M, Atlas RM. Ethics: A weapon to counter bioterrorism. Science. 2005 (307):1881-1882.
Spier RE. "Dual use" and "intentionality": seeking to prevent the manifestation of deliberately harmful
objectives: A summary and some reflections on 'The Advancement of Science and the Dilemma of Dual
Use: Why We Can't Afford to Fail'. Sci Eng Ethics. 2010 Mar;16(1):1-6. PubMed PMID: 19798590.
Sutton V. Smarter regulations: commentary on "Responsible conduct by life scientists in an age ofterrorism". Sci Eng Ethics. 2009 Sep;15(3):303-9. PubMed PMID: 19590982.
Taylor PL. Scientific self-regulation-so good, how can it fail? Commentary on "The problems withforbidding science". Sci Eng Ethics. 2009 Sep;15(3):395-406. Epub 2009 Apr 10. PubMed PMID:
19360483.
Veatch RM. The sources of professional ethics: why professions fail. Lancet 2009 Mar
21;373(9668):1000-1. PubMed PMID: 19330942.
Verpeet E, Dierckx de Casterle B, Van der Arend A, Gastmans CA. Nurses' views on ethical codes: a focus
group study. J Adv Nurs. 2005 Jul;51(2):188-95. PubMed PMID: 15963191.

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136

Appendix H: Survey of Scientific Societies 2010`

General CodeMention of Dual Use

American Association for the
Advancement of Science (AAAS)no

Center for Science, Technology & Security Policy has adatabase linking to different educational projects,
educational materials, etc. Tne Center also did research on
the topic and organized workshops and conferences. It put
out a report "Professional and Graduate-Level Programs on
Dual Use Research and Biosecurity for Scientists Working
in the Biological Sciences" which recommends integrating
this issue into science education. It has a statement on theneed to allow unrestricted dissemination of knowledge.

American Institute of Biological
Sciencesyesno

The American PhytopathologicalSociety (APS)yes

yes, Statement from the APS Council

American Society for Biochemistry
and Molecular Biology

yes

no

The American Society for
Microbiology

yes

yes, ASM Council Statement

Federation of American Scientists

no

In its mission statement. It has an elaborate program onbiosecurity that includes online modules on dual use
research that can be used to highlight the issue.

FASEB

no

They have created a sub committee and put out an elaborate
statement on dual use research and the need to integrate it
into science curricula.

National Academy of SciencesnoProject in the Board of Life Sciences on biosecurity,
collaborates with AAAS on programs and workshops. Links
to FAS and others.

The Society for Integrative andComparative Biology (SICB)

yes

no

Society for Neuroscience

yes

no

Society of Toxicology

yesThey have a very general statement : "Give due
consideration to the ethical, legal, social and policy
implications of their research and communications."

The American Biological Safety
Association (ABSA)

yes

They have a page on biosafety and an "ABSA Biosecurity
Task Force White Paper: Understanding Biosecurity".

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`

General CodeMention of Dual Use

Biotechnology Industry Organization yes - ethics statement

No mention of dual use but of social issues.

The American College of Laboratory
Adequate Veterinary Care
Animal Medicine (ACLAM)noCouncil for Agricultural Science andpaper on ethics
Technology (CAST)

no

Public Responsibility in Medicine andmission statement
Research (PRIM&R)

General statement about social responsibility without any
mention of dual use.

American Academy of Forensic
Scienceyes

American Mathematical Society*yesInternational Union of
Microbiological Societies

yesInternational Council of Science(ICSU)

no - but has statements on
research integrity and otherissues.

yes, an excerpt: "Freedom to publish must sometimes yield
to security concerns, but mathematicians should resist
excessive secrecy demands whether by government or
private institutions."
yes, a specific code for dual use: "IUMS Code of Ethics
against Misuse of Scientific Knowledge, Research andResources".
no mention of dual use

The International Union ofyes
Biochemistry and Molecular Biology

Part of their general code of ethics, it does not mention dual
use but does invoke biosecurity issues: "7. They will not
engage knowingly in research that is intended for the
production of agents of biological warfare or bioterrorism,
nor promote such agents."

Royal Society of New Zealandyes

One part of the code focuses on genetics and has somerelation to issues of dual use: "The power to geneticallymodify living organisms lies alongside the power to harness
the energy of the atom in placing a special responsibility on
those who have the knowledge and skills to do so. It isessential that all scientists and technologists keep firmly inmind the general requirements of this Code of Ethics andthat they do nothing that could potentially be detrimental tothe community or harmful to the environment."

American Medical Association

yes

Section in their code of ethics: "Opinion 2.078 - Guideline toPrevent Malevolent Use of Biomedical Research".

International Union of Pure andApplied Chemistry

yes

They have a group that is working on a code that includes
reference to dual use. The last update on the work of thegroup is from 2008.

The International Association of
Synthetic Biology

no

yes

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`

General CodeMention of Dual Use

Institute of Medicne

noReport on dual use research from 2005 - from the Board on
Global Health.

The American Society of Gene & Cell
yes
Therapy (ASGCT)noRoyal Society

no, but they published a paper calling for dual use oversightnoAmerican Academy of Microbiology nono

The American Association of
ImmunologistsnoAmerican Society for Virologynono

The American Society ofParasitologists

nono

The Association of Applied Biologists nono

The Biophysical SocietynonoSociety for Developmental BiologynoSociety for General MicrobiologynonoSociety for Industrial Microbiologynono

The American Society for
Rickettsiologynono

The Alliance for the Prudent Use of
Antibiotics (APUA)nono

Association for Biology Laboratory
Educationnono

European Society for Emerging
Infections

no

no

139

`

General CodeMention of Dual Use

Federation of European
Microbiological Societies

nonoInternational Society for Interferon
and Cytokine ResearchnonoInternational Society for Molecular
Plant-microbe Interactionsnono

The International Society for
Antiviral Research (ISAR)nono

Association of American Universities nono

Association of American Medical
Collegesnono

Association of Public and Land-grantno
Universities

no

The American Physiological Society

part of FASEB

American Society For Cell Biology(ASCB)

no

no

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Appendix I
Considerations in Developing a Code of Conduct for Dual Use Researchin the Life Sciences1
INTRODUCTION
Important benefits to society have been achieved in no small measure by scientists who havestrived to conduct their work conscientiously and with integrity. This commitment forms thebasis of a culture of responsibility in which scientists consider the risks and implications of
their research and take appropriate measures to ensure that they carry out their work safely,
ethically, and in a manner that warrants continued public trust and support. To achieve thisaim, scientists should consider the relevant standards and guideposts for ethical andresponsible research conduct as well as the potential impact their research may have onsociety. The importance of thoughtful consideration of ethics and research is amplified whenscientists engaged in well-intended research are confronted with its potential for misuse.
In recent years, increased attention has been directed to the possibility that the knowledge,
products, or technologies derived from some life sciences research may be misapplied to posea threat to public health, agriculture, plants, animals, the environment, or materiel. Researchwith this potential is known as “dual use research of concern.” All those involved in life
sciences research have a responsibility to avoid or minimize the foreseeable risks and harmthat could result from malevolent use of research outcomes.

The National Science Advisory Board for Biosecurity (NSABB) has given extensive consideration
to the characteristics that define dual use research of concern. Following its charge, the NSABB
is proposing a series of recommendations and tools to help the scientific community identify
and manage the risks associated with this type of research. The NSABB has observed that
there is a need not only to raise life scientists’ awareness of the dual use potential of theirresearch but also to provide and promote principles of research conduct that will sustain aculture of responsibility within the scientific community.
One useful tool for raising awareness of the potential for dual use research and promoting
responsible research behavior is a code of conduct. Typically developed by societies,
associations, and institutions, a code of conduct articulates shared values and standards ofconduct. Codes also can be used to educate people regarding their ethical responsibilities. The
value of a code is reinforced when it is discussed in training sessions, at meetings, and during
the course of routine activities.
USING THIS DOCUMENT

1

Excerpted from: NSABB, Proposed Framework for the Oversight of Dual Use Life Sciences Research, pp.43-50 (Bethesda, MD: National
Institutes of Health, June 2007), oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf.

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The following document lays a foundation for a code of conduct that explicitly addresses dual
use research of concern by:• Describing the general utility and potential applications of such a code
• Articulating a core set of responsibilities related to dual use research that can serve asa foundation for a code
• Delineating additional responsibilities related to specific phases of the research
process and research-related activities
The core set of responsibilities and the additional specific responsibilities outlined below
provide a template that users of this document can adopt verbatim, modify, or use as the basis
for developing more specific guidance on ethical behavior. This document is intended to be
used in tandem with other elements of the framework of policy and guidance pertinent to thisissue that are now under development.
AUDIENCES FOR THIS DOCUMENT
Every individual associated with the life sciences should be aware of the potential dual use ofscientific knowledge, products, or technology and be knowledgeable of the ethical obligations
that ensue in regard to research that can be considered “dual use of concern.” Specifically, theconsiderations in this document are intended to apply to the following audiences:

Life sciences societies and associations. Life sciences societies and associations are importantsources of guidance for scientists on the ethical standards that apply to their disciplines. These
organizations are encouraged to enhance their bylaws or codes of conduct to address theconsiderations within this document. They may choose to adopt any portion of this document
into an existing code or to modify its contents in order to adapt them to a specific disciplineand context. Alternatively, organizations may choose to adopt or create a stand-alone
document to give it particular salience. In either case, organizations generally adopt or modify
their codes through a governance process involving broad discussion with the membership;
therefore, the process of considering the ethical standards applicable to dual use research ofconcern is a valuable exercise in its own right. Whatever the manner in which a societychooses to develop and adopt a code on dual use research of concern, the code should be
widely disseminated to members (for example, by publishing it in society newsletters andjournals). It should be revisited frequently at annual membership meetings and other events inorder to refresh and reinforce its impact and to address evolving issues.
Research institutions. Whether public or private, academic or industrial, research institutions
are responsible for the integrity of their research programs. Institutions that oversee a body ofresearch typically have rules, guidelines, and standard operating procedures to guide staff on
how to conduct research in an ethical and legal manner, as well how to conform to institutionspecific policies and requirements. Institutions should consider the adoption anddissemination of specific guidance on dual use research in faculty handbooks, procedures
manuals, institutional Web sites, training and education of students and staff, and otherappropriate venues. Many such institutions also offer formalized employee orientation
programs and courses of instruction in the responsible conduct of research. It would be142

appropriate and helpful to incorporate the topic of dual use research, along with related
guidance on ethical and legal responsibilities, in such courses and programs.
Industry. Life scientists who are engaged in research for commercial purposes share the same
responsibilities for safeguarding the public welfare as their colleagues in the academic or
public sectors. Each commercial organization will have its own mechanisms for raisingawareness of dual use research of concern and for developing policies to address related
issues.
Research leadership. Scientists who have risen to leadership positions (for example, society
presidents, medical school deans, and department chairs in universities) serve as role models
for other scientists. In particular, those who are responsible for oversight of research programs
should consider how their institutions are addressing the responsibilities outlined in thisdocument. For example, it is important to ensure that issues related to dual use research ofconcern are well understood by life scientists, that dual use research of concern is reported inaccordance with institutional policies, and that life scientists are aware of and compliant withother applicable requirements. All those who have gained the respect of other scientists
through their work can play a critical role in assuring that the issues associated with dual use
research of concern are thoughtfully addressed.
Individual life scientists. Scientists bear the primary responsibility for the integrity of theirown research. By their actions and explicit guidance, they can foster a sense of ethicalresponsibility in the research team and an awareness of applicable laws and guidelines. This
document may aid in increasing their awareness of their responsibilities in the area of dual use
research of concern and help them mentor students, trainees, and technical staff. Mentors areencouraged to involve these individuals in laboratory discussions of dual use research ofconcern, the ethical responsibilities that are outlined in this document, and the relevance of
these responsibilities to their work.
Technicians, trainees, and others involved in the research process. Technical staff,
postdoctoral fellows, students, and others who contribute to research activities bear their own
measure of responsibility for the integrity of these projects. These individuals are also
encouraged to review this document carefully, consider how it may apply to current work, andengage their instructors and mentors in addressing any questions they may have regarding its
relevance.
Funding agencies/institutions. Institutions and agencies that fund research establish theframework for decisions about the research considered eligible for funding and provide
oversight to ensure responsible stewardship of funds. In order to avoid endangering publichealth, agriculture, plants, animals, the environment, or materiel, they are responsible for
ensuring that projects that could be considered dual use research of concern are identified
prior to funding. When a project meets the criteria for this type of research, the funders
should ensure that a process is in place to manage risks through a thoughtful and informed
consideration of options that could mitigate or manage them.
143Journal editors, reviewers, and publishers. Those who play decisionmaking roles in theprocess of communicating scientific information have an ethical responsibility to consider
whether the information being considered for publication could be used to endanger publichealth, agriculture, plants, animals, the environment, or materiel. Depending on their analysisof the risks and benefits of communications regarding information or technology that meetcriteria for dual use research of concern, they may choose to proceed in a way that mitigatesor manages the risks associated with communication, for example, by adding contextual
information not found in the original article or delaying communication until a time at which
the risks would be reduced.
CORE RESPONSIBILITIES OF LIFE SCIENTISTS IN REGARD TO DUAL USE RESEARCH OF
CONCERN
The text box below identifies the fundamental responsibilities of all life scientists with regard
to dual use research of concern. These obligations flow from the underlying principle ofconcern for the public good and should lie at the heart of any code of conduct that addresses
this topic.

LIFE SCIENTISTS: CORE RESPONSIBILITIES REGARDING DUAL USE RESEARCH OF CONCERN
Life sciences research is a critically important endeavor that has benefited society byadvancing our understanding of living systems. Critical to the future of scientific progress
and freedom is the preservation of public trust and support, which scientists haveearned through their attention to responsible research practice. Despite a scientist’s
conscientious approach to research conduct, the knowledge, products, or technologies
derived from some life sciences research may be misused by others to pose a threat to
public health, agriculture, plants, animals, the environment, or materiel. Research withthis potential is known as “dual use research of concern.”
Individuals involved in any stage of life sciences research have anethical obligation
to avoid or minimize the risks and harm that could result from malevolent use of
research outcomes.
Toward that end, scientists should: Assess their own research efforts for dual use potential and report as appropriate
 Seek to stay informed of literature, guidance, and requirements related to dual
use research Train others to identify dual use research of concern, manage it appropriately,
and communicate it responsibly
 Serve as role models of responsible behavior, especially when involved inresearch that meets the criteria for dual use research of concern
 Be alert to potential misuse of research

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RESPONSIBILITIES IN THE RESEARCH PROCESS

Research is a complex, iterative process, and the potential for dual use may be recognized atmany junctures and through different activities. Consequently, while it is valuable to be mindfulof the core responsibilities articulated above, those involved in life sciences research may also
benefit from a more specific review of their responsibilities in regard to dual use research ofconcern.
Proposing Research
When designing and proposing research, the ethical responsibilities of life scientists include:
1. Considering whether the knowledge, products, or technology resulting from the research
could be deliberately misused to endanger public health, agriculture, plants, animals, theenvironment, or materiel
2. Striving to design research that promotes beneficial scientific advances, while avoiding or
minimizing elements of study design that raise concerns about dual use
3. Weighing carefully the benefits of study elements presenting dual use concerns that cannot
be completely eliminated against the harm that could occur through their deliberate misuse
4. Considering ways to modify the research design to manage and mitigate potential misuse
when it is clear that the benefits of the research with dual use potential outweigh thepotential harmManaging Research
The ethical responsibilities of persons who manage research programs, whether within the public
or private sector, include the following:
1. Promoting awareness of dual use research of concern and the ethical responsibilities it entails
2. Developing and maintaining systems, policies, and training to ensure that dual use research ofconcern is identified and managed appropriately
3. Implementing federal, state, and other appropriate guidelines specific to dual use research ofconcern
Reviewing Research
The ethical responsibilities of those responsible for establishing and managing the review
process (e.g., funding agencies) include the following:
1. Ensuring that when research proposals are reviewed, appropriate systems are in place toidentify the possibility of dual use of concern and to address related issues. Examples ofcommon means of reviewing research proposals include Institutional Animal Care and Use
Committees (IACUCs), Institutional Biosafety Committees (IBCs), Institutional Review Boards(IRBs), and peer review groups.
2. Ensuring that both researchers and reviewers are knowledgeable of, and adhere to, all ethical,
institutional, and legal requirements that apply to the review of possible dual use research ofconcern.
3. Reconsidering institutional review systems periodically to ensure that they reflect current
criteria defining dual use research of concern and are consistent with applicable federal andstate guidelines.
145

The ethical responsibilities of individuals serving on peer review groups or otherwise engaged inresearch review include the following:
1. Becoming well educated about dual use research of concern and related ethical, legal, andinstitutional requirements, as well as applicable federal and state guidelines
2. Being mindful during the review process of whether the research could meet the criteria fordual use of concern
3. Using methods in keeping with the reviewer’s charge and context to make appropriate people
aware that the research being reviewed meets the criteria for dual use research of concern
Conducting Research
The ethical responsibilities of life scientists engaged in research include the following:2
1. Observing safe practices and ethical behaviors in the laboratory, clinic, field, and classroom
and ensuring that subordinate personnel do so as well
2. Using appropriate security measures and continually reassessing their adequacy as concerns
about potential misuse evolve
3. Observing applicable guidelines for the responsible conduct of dual use research of concern
4. Being attentive to the dual use potential of the knowledge, products, or technology resulting
from research activities as they emerge
5. Alerting responsible institutional officials when dual use research of concern is identified andwhen decisions must be made to manage associated risks
Collaborating on Research
Research endeavors frequently involve the participation and cooperation of multiple laboratories
and disciplines, which can be subject to different management, codes of conduct, cultural values,
or operating procedures. Besides the ethical responsibilities associated with conducting research,scientists involved in such collaborations have the additional obligations of:
1. Engaging in open dialog regarding whether knowledge, products, or technology resulting fromthe research could be considered dual use research of concern; when such research ispursued, ensuring that all parties are aware of their ethical responsibilities
2. Agreeing on specifically assigned responsibilities to ensure ethical oversight of all aspects ofresearch with dual research potential, including its outcomes.
3. Considering and respecting expressions of concern regarding the possible dual use ofknowledge, products, or technology resulting from the research and ensuring that theseconcerns are raised with those charged with responsibility for research oversight
4. Considering appropriate measures to reduce or eliminate risks to public health, agriculture,
plants, animals, the environment, or materiel resulting from the research project
5. Maintaining a current awareness of national and international standards and policies
regarding dual use research of concern
Communicating the Results of Dual Use Research of Concern

2

Safe laboratory practices are embodied in such documents as CDC-NIH Biosafety in Microbiological and Biomedical Laboratories(www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm), NIH Guidelines for Research Involving Recombinant DNA Molecules(www4.od.nih.gov/oba/rac/guidelines/guidelines.html), and Biological Safety: Principles and Practices (ASM Press, www.asm.org/),
and applicable occupational and safety regulations and standards.

146

Regardless of the stage of the research process and the form of the communication, those
involved in communications regarding knowledge, products, or technology that can beconsidered dual use research of concern have the following ethical responsibilities:
1. Being aware of ethical and legal considerations relevant to communications regardingknowledge, products, or technology that can be considered dual use research of concern.
2. Analyzing potential risks to public health, agriculture, plants, animals, the environment, ormateriel that could result from research-related communications, balancing them against thepotential benefits.
3. Considering options for communication that may reduce or eliminate risks whencommunicating information with dual use potential is clearly warranted by its benefits.
Examples of mitigating strategies may include a delay in releasing the information, theaddition of appropriate contextual information, or communicating the information to a more
limited audience.
Scientific Education and Mentorship
Practicing scientists who serve as role models to developing scientists (e.g., their trainees,
students, and staff) have the following ethical responsibilities:
1. Raising developing scientists’ awareness of what constitutes dual use research of concern andwhy it matters
2. Informing developing scientists of their ethical, legal, and institutional responsibilities whenengaged in dual use research of concern, as well as applicable federal and state guidelines– Encouraging open and respectful discussion of issues related to dual use research ofconcern, including whether or not a particular project could be considered dual use
research of concern

147