ORI

Introduction to the

Responsible Conduct

of Research

Nicholas H. Steneck

illustrations by David Zinn
ORI

Introduction to the

Responsible Conduct

of Research

Nicholas H. Steneck

illustrations by David Zinn
iii

Advances in scientific knowledge have provided the foundation for 

improvements in public health and have led to enhanced health and 

quality of life for all Americans. Many of these advances can be 

traced to the work of the U.S. Department of Health and Human 

Services (HHS), which supports the world’s largest medical

research effort.

Research conducted with support from HHS also helps to 

assure the safety of foods and health care products, is vital in the 

fight against drug and alcohol abuse, and in many other ways

fosters the Department’s mission to improve health and to help 

those in need of assistance.

As the custodian of the largest share of our Nation’s resources 

devoted to biomedical and behavioral research, HHS takes seriously 

the challenge of ensuring these resources are used responsibly. 

Special programs already exist to oversee the protection of human 

and animal subjects in research, to review conflicts of interest, and 

to assure laboratory safety and responsible grants management.

With this publication, we hope to encourage researchers and 

research institutions to make a special effort to understand, discuss, 

and teach others about the responsible conduct of research. 

 

 Tommy G. Thompson

 Secretary

 U.S. Department of Health and Human Services

Message from the Secretary of

Health and Human Services
v

Foreword

The Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and 

Human Services and the American public. This responsibility extends to around 

$30 billion in Federal research support, devoted primarily to the biomedical and 

behavioral sciences through intramural and extramural programs, and to the 

thousands of researchers, research staff, and research administrators who work 

on PHS-funded research.

As part of its efforts to promote integrity in PHS-funded research, ORI is

authorized to undertake activities and to support programs that enhance education in 

the responsible conduct of research (RCR). The ORI Introduction to the Responsible 

Conduct of Research is being issued to further this important mission. 

The importance of formal RCR education was first explicitly recognized in the 

1989 Institute of Medicine Report, The Responsible Conduct of Research in the 

Health Sciences, and has since been endorsed by other groups and members of the 

research community. Thanks to this support, researchers who want to learn about 

or help others understand responsible conduct in research have many resources 

available, from formal courses to web-based instruction programs, a growing array 

of challenging books, and the experience of established researchers conveyed 

through mentoring.

The ORI Introduction to RCR seeks to supplement existing resources by making

a comprehensive overview of basic rules of the road for responsible research

available to all PHS-funded researchers. It has been prepared with the needs of 

small and mid-size research institutions and beginning researchers in mind, since 

we have often been asked to provide resources for this community, but it may find 

use in other settings.

In issuing this publication, it needs to be stressed that ORI is not establishing or 

even recommending how RCR ought to be taught. We understand that responsible 

conduct in research can be and is learned in different ways, that the standards 

for responsible conduct can vary from field to field, and that in many situations 

two or more responses to a question about responsible research may be considered 

acceptable research practice. We hope the ORI Introduction to RCR will therefore 

be seen as the beginning and not the end of learning about this important aspect 

of professional life. 

 Chris B. Pascal, J.D.

Director

Office of Research Integrity
vi vii

Contents

Message from the Secretary of Health and Human 

 Services..................................................................................... iii

Foreword ........................................................................................v

Preface...........................................................................................xi

PART I. SHARED VALUES........................................................................ 1

1. Rules of the Road .......................................................... 5

1a. Professional self-regulation...............................................6

1b. Government regulation .....................................................9

1c. Institutional policies........................................................12

1d. Personal responsibility....................................................14

2. Research Misconduct ................................................... 19

2a. Federal research misconduct definition 

 and policies...................................................................20

2b. Institutional research misconduct policies.....................23

2c. Putting research misconduct into perspective...............26

PART II. PLANNING RESEARCH............................................................... 31

3. The Protection of Human Subjects................................. 35

3a. Federal regulations .........................................................36

3b. Definitions........................................................................39

3c. IRB membership and deliberations................................41

3d. Training............................................................................43

3e. Continuing responsibility................................................44

3f. Ethical issues...................................................................45

Disclaimer

The ORI Introduction to the Responsible Conduct of Research is not an official policy statement or guideline and should not 

be viewed as such. While every effort has been made to present an accurate description of Federal rules and the practices 

accepted by the research community for the responsible conduct of research, any statement in this ORI Introduction to RCR 

that is inconsistent with Federal law or regulation or official policy or guidance is superseded thereby. This document is also not 

intended to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its 

agencies, officers, or employees or any PHS-funded research institution or its officers, employees, or research staff.

Copyright and Acknowledgment Notice

ORI requests that any re-use or re-publication of any of the materials contained within the ORI Introduction to the Responsible 

Conduct of Research acknowledge the source. Copyright for the illustrations appearing herein is held by the artist, David Zinn. 

Limited personal and educational use of these illustrations is permitted with appropriate attribution to the artist. Inquiries 

regarding other uses of the illustrations should be addressed to the artist at dszinn@umich.edu. Other questions about re-use 

and re-publication should be addressed to askori@osophs.dhhs.gov.
viii ix

8. Collaborative Research ............................................... 117

8a. Roles and Relationships ................................................118

8b. Management...................................................................119

8c. Different research settings............................................123

PART IV. REPORTING AND REVIEWING RESEARCH ................................... 129

9. Authorship and Publication ......................................... 133

9a. Authorship......................................................................134

9b. Elements of a responsible publication..........................137

9c. Practices that should be avoided ..................................139

10. Peer review ............................................................... 147

10a. Meeting deadlines..........................................................148

10b. Assessing quality...........................................................150

10c. Judging importance.......................................................152

10d. Preserving confidentiality.............................................154

PART V. SAFE DRIVING AND RESPONSIBLE RESEARCH ............................ 159

4. The Welfare of Laboratory Animals ................................ 51

4a. Rules, policies, and guidelines ........................................52

4b. Definitions........................................................................55

4c. Institutional organization...............................................56

4d. Federal and voluntary oversight ....................................57

4e. Principles for the responsible use of 

 animals in research......................................................59

4f. Broader responsibilities ..................................................61

5. Conflicts of Interest...................................................... 67

5a. Financial conflicts............................................................68

5b. Conflicts of commitment.................................................... 73

5c. Personal and intellectual conflicts..................................76

5d. Reporting and managing significant conflicts ...............78

PART III. CONDUCTING RESEARCH ........................................................... 83

6. Data Management Practices.......................................... 87

6a. Data ownership................................................................88

6b. Data collection .................................................................90

6c. Data protection ................................................................93

6d. Sharing.............................................................................95

6e. Future considerations .....................................................97

7. Mentor and Trainee Responsibilities............................. 103

7a. Basic responsibilities ....................................................104

7b. Research environment...................................................107

7c. Supervision and review.................................................109

7d. Transition to independent researcher ..........................111
xi

Preface

Spurred by a growing belief in the importance of science and technology, public support for research increased dramatically over the course of the 

20th century. A century ago, research did not play a major role in the average 

person’s life. Today, few aspects of life are not touched in one way or another 

by the information and technologies generated through research.

With growing public support for research has come an understandable

concern about the way it is conducted. Public funds support roughly one-third 

of all research and development (R&D) in the U.S. and half of all basic research. 

Many researchers, therefore, spend a significant portion of their time working 

for the public. As public servants and also professionals, researchers have clear 

obligations to conduct their research in a responsible manner.

In general terms, responsible conduct in research is simply good citizenship 

applied to professional life. Researchers who report their work honestly, 

accurately, efficiently, and objectively are on the right road when it comes to 

responsible conduct. Anyone who is dishonest, knowingly reports inaccurate 

results, wastes funds, or allows personal bias to influence scientific findings is not. 

However, the specifics of good citizenship in research can be a challenge 

to understand and put into practice. Research is not an organized profession 

in the same way as law or medicine. Researchers learn best practices in a 

number of ways and in different settings. The norms for responsible conduct 

can vary from field to field. Add to this the growing body of local, state, and 

Federal regulations and you have a situation that can test the professional 

savvy of any researcher.

In general terms, responsible conduct 

in research is simply good citizenship 

applied to professional life.
xii xiii

the chapters, important points are summarized in bulleted lists ( P ) or noted 

in the margins (see left). Each chapter ends with a set of closing questions 

for further discussion ( 1 , 2 ...) and resources for reference and additional 

reading. The Web addresses given for the resources and elsewhere in this 

work were current at the time of printing. 

While written with all researchers in mind, special consideration has been 

given to the needs of students, postdocs, and researchers who do not have 

easy access to responsible conduct of research materials or to colleagues who 

can explain the intricacies of responsible conduct in research to them. Two 

or three hours with this book should provide anyone in this position with a 

better understanding of the reasons for and the scope of the most important 

responsibilities researchers have. 

Many colleagues have generously provided comments on parts or all of 

this work as it took shape over several drafts, including Ruth Bulger, Tony 

Demsey, Peggy Fischer, Carolyn Fassi, Nelson Garnett, Shirley Hicks, Erich 

Jensen, Mike Kalichman and his students, Nell Kriesberg, John Krueger, 

Tony Mazzaschi, Judy Nowack, Chris Pascal, Ken Pimple, Larry Rhoades, 

Fran Sanden, Mary Scheetz, Joan Schwartz, David Shore, Peggy Sundermeyer, 

and Carol Wigglesworth. Co-creator, artist David Zinn, patiently produced 

multiple versions of his drawings as we worked together to turn serious 

dilemmas into lighter but thought-provoking illustrations. ORI Director, 

Chris Pascal, and Associate Director, Larry Rhoades, deserve credit for 

initiating and carrying through on this project. If through promoting integrity 

and responsible conduct in research this work helps preserve the place of 

research in society today, it will have been a project well worth undertaking.

Nicholas H. Steneck

Ann Arbor, MI

i

The ORI Introduction to the Responsible Conduct of Research has been 

written primarily for researchers and research staff engaged in research 

supported by the Public Health Service but is applicable to scholarly research 

in general. As an “introduction,” it seeks to provide a practical overview of 

the rules, regulations, and professional practices that define the responsible 

conduct of research. The coverage is not exhaustive and leaves room for 

continued reading and discussion in the laboratory and classroom, at 

professional meetings, and in any other setting where researchers gather to 

discuss their work.

The content is organized around two ways of thinking about research. 

The main sections follow the normal flow of research, from a consideration 

of shared values to planning, conducting, reporting, and reviewing. The 

chapters within the main sections cover nine core instructional areas that 

have been widely recognized as central to the responsible conduct of research. 

An opening chapter on rules of the road and a brief epilogue on responsible 

research round out the coverage. 

Although designed to follow the normal flow of research, the chapters in 

this volume are all more-or-less self-contained and can be read in any order. 

Each opens with a short case in which students and researchers are faced 

with making decisions about the responsible conduct of research. Throughout 

Researchers learn best practices in a 

number of ways and in different settings. 

The norms for responsible conduct can 

vary from field to field.
Part I. Shared Values
2

ORI Introduction to the Responsible Conduct of Research

3

P HONESTY — conveying information 

truthfully and honoring 

commitments,

P ACCURACY — reporting findings precisely 

and taking care to avoid 

errors,

P EFFICIENCY — using resources wisely and 

avoiding waste, and

P OBJECTIVITY — letting the facts speak for 

themselves and avoiding 

improper bias.

Part I: Shared Values

THERE IS NO ONE BEST WAY TO UNDERTAKE 

research, no universal method that applies 

to all scientific investigations. Accepted 

practices for the responsible conduct of 

research can and do vary from 

discipline to discipline and even 

from laboratory to laboratory. There 

are, however, some important shared values 

for the responsible conduct of research that 

bind all researchers together, such as:

At the very least, responsible research is research that is 

built on a commitment to these and other important values 

that define what is meant by integrity in research. 

The opening chapters of the ORI Introduction to RCR

provide a framework for thinking about basic values in the 

context of the day-to-day practice of research. 

Chapter 1, Rules of the Road, presents a brief overview 

of the different ways research responsibilities are defined, 

ranging from formal regulations to informal codes and

common practices. 

Chapter 2, Research Misconduct, describes research 

practices that must be avoided and the obligation researchers 

have to report misconduct. 

Part I: Shared Values
5

Chapter 1. Rules of the Road

Setting off on the road to the responsible conduct of research

How should you conduct your research? What practices should you follow? The public and their professional 

colleagues expect researchers to follow many rules and 

commonly accepted practices as they go about their work 

advancing knowledge and putting knowledge to work. 

Responsible conduct in research is conduct that meets this 

expectation.

Society’s expectations for the responsible conduct of 

research are complex and not always well defined. Becoming 

a responsible researcher is not like becoming a responsible 

driver. Responsible driving is clearly defined through laws 

and written down in drivers’ manuals. Before individuals 

are allowed to drive, they are tested on both their knowledge of 

the rules of the road and their skills. Then, licensed drivers 

are constantly reminded of their responsibilities by signs, 

traffic signals, and road markings. They also know that 

their behavior as drivers is monitored and that there are 

specific penalties for improper behavior.

Guidance for the responsible conduct of research is not 

this well organized. Some responsible practices are defined 

through law and institutional policies that must be followed. 

Others are set out in non-binding codes and guidelines that 

should be followed. Still other responsible practices are 

commonly accepted by most researchers but not written 

down. Instead, they are transmitted informally through 

mentoring, based on the understandings and values of each 

mentor. This situation is further complicated by the fact 

that researchers are not routinely tested on their knowledge 

of responsible practices or licensed. Moreover, their behavior 

as researchers is inconsistently monitored and the penalties 

for irresponsible behavior vary considerably. 

Researchers do, of course, care deeply about responsible 

behavior in research and pay a great deal of attention to best 

research practices. The fact remains, however, that it can take 

Chapter 1: Rules of the Road
6

ORI Introduction to the Responsible Conduct of Research

7

Case Study

K

atherine, a postdoc in Dr. Susan B.’s laboratory, has just had a manuscript accepted for publication 

in a prestigious research journal, conditional on a few important changes. Most importantly, the 

editor has requested that she significantly shorten the methods section to save space. If she makes 

the requested changes, other researchers may not be able to replicate her work.

Asked about the situation, Dr. B. recommends that Katherine go ahead with the changes. After all, if 

other researchers want more information they can always get in touch. She remains concerned that 

an inadequate explanation of her methods could lead other researchers to waste time and valuable 

research dollars attempting to replicate her work.

Should Katherine make the requested changes?

Should she be concerned about providing inadequate information to colleagues?

Is reducing detail in methods sections a reasonable way to go about saving valuable space in journals?

How can Katherine get definitive answers to these and other questions

about the responsible conduct of research?

As professionals, researchers have not been particularly 

concerned about rules for self-regulation. Since the goal of 

research is to advance knowledge through critical inquiry and 

scientific experimentation, it has commonly been assumed 

that the normal checking that goes on in testing new ideas

is sufficient to keep researchers honest. Based on this

assumption, research arguably does not need specific rules 

for self-regulation because it is, by definition, an activity 

that routinely monitors itself.

The lack of a perceived need for specific rules poses 

problems for researchers who want guidance on responsible 

research practices. Intellectually and professionally

researchers organize their lives around fields of study. 

They are biologists, chemists, and physicists, increasingly 

working in specialized areas, such as biophysics,

biochemistry, molecular biology, and so on. However, the

societies that represent fields of study for the most part 

have not developed comprehensive guidelines for responsible 

research practices. Many do have codes of ethics, but most 

codes of ethics are simply general statements about ideals 

and do not contain the specific guidance researchers need to 

work responsibly in complex research settings. 

Fortunately, there are a few important exceptions to this 

last generalization. Comprehensive descriptions of responsible 

research practices can be found in (see the resources listed at 

the end of this chapter for references):

National Academy of Sciences, On Being a Scientist (1995)

The scientific research enterprise, like other human activities, is built on a foundation of trust.

Scientists trust that the results reported by others are valid. Society trusts that the results of 

research reflect an honest attempt by scientists to describe the world accurately and without bias. 

The level of trust that has characterized science and its relationship with society has contributed to a

period of unparalleled scientific productivity. But this trust will endure only if the scientific community 

devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct.

http://www.nap.edu/readingroom/books/obas/preface.html

some effort to find out what these practices are and how to 

act when the complex rules for responsible practice seem to 

conflict with one another.

This chapter describes the four basic sources of rules of 

the road for the responsible conduct of research: 

P professional codes,

P government regulations,

P institutional policies, and

P personal convictions.

If you are primarily interested in learning more about your 

responsibilities rather than understanding their origin, skip 

ahead to the substantive chapters that follow, returning to 

this chapter later, when it might have more relevance.

1a. Professional self-regulation

Prior to World War II, society provided little public support 

for research and did not expect much from researchers in 

return. Researchers were more or less left alone to run

their own affairs, except when they assumed other roles,

as teachers, physicians, or engineers. 

ORI Introduction to the Responsible Conduct of Research Chapter 1: Rules of the Road
8

ORI Introduction to the Responsible Conduct of Research

9

1b. Government regulation

As public support for research grew after World War II, the 

public, through its elected officials, became more interested 

in the way research is practiced. Over time, concerns began 

to surface about some of these practices, focusing initially 

on the use of animals and humans in research and later on 

research misconduct. When it appeared that the research 

community was not doing enough to address these concerns, 

government turned to regulation.

Government regulations usually begin in Congress. When 

a potential problem is identified, Congress calls hearings to 

learn more about the problem and then passes legislation 

to fix it. The regulations covering the use of humans and 

animals in research as well as research misconduct stem 

from three acts passed by Congress:

P the 1966 Animal Welfare Act (PL 89-544),

P the 1974 National Research Act (PL 93-348), and

P the 1985 Health Research Extension Act (PL 99-158).

These and other research-related acts give the Federal

Government the authority to regulate the research it funds.

Along with the authority to address problems, Congress 

usually provides guidance on general objectives, but it 

seldom drafts detailed regulations. This job falls to the 

Federal agencies in the Executive Branch of government, 

which are responsible for carrying out the law. Federal 

agencies translate Congressional directives into regulations 

(also called rules), policies, and guidelines. 

In 1989, the Department of Health and Human Services 

(HHS) established the Office of Scientific Integrity (OSI) 

and the Office of Scientific Integrity Review (OSIR), in 

response to the 1985 Health Research Extension Act. The 

Office of Research Integrity (ORI) was established in 1992 

and assumed the responsibilities previously assigned to 

P reports and policy statements issued by the National

Academy of Sciences, the American Association for the

Advancement of Science, the Association of American

Medical Colleges, and Sigma Xi;

P guidance on responsible publication practices published in 

journals; and

P a few comprehensive professional codes.

When applicable, the guidance provided by professional

societies is a good place to begin learning about responsible 

research practices.

i

American Chemical Society

The Chemist’s Code of Conduct (1994)

Chemists Acknowledge Responsibilities To: 

The Public. Chemists have a professional responsibly to serve the public interest and 

welfare and to further knowledge of science....

The Science of Chemistry. Chemists should seek to advance chemical science, understand the 

limitations of their knowledge, and respect the truth....

The Profession. Chemists should remain current with developments in their field, share 

ideas and information, keep accurate and complete laboratory records, 

maintain integrity in all conduct and publications, and give due credit to the 

contributions of others. Conflicts of interest and scientific misconduct, such as 

fabrication, falsification, and plagiarism, are incompatible with this Code. 

The Employer. Chemists should promote and protect the legitimate interests of their 

employers, perform work honestly and competently, fulfill obligations, 

and safeguard proprietary information.

Employees. Chemists, as employers, should treat subordinates with respect for their

professionalism and concern for their well-being....

Students. Chemists should regard the tutelage of students as a trust conferred 

by society for the promotion of the student’s learning and professional 

development....

Associates. Chemists should treat associates with respect, regardless of the level of 

their formal education, encourage them, learn with them, share ideas 

honestly, and give credit for their contributions.

http://www.iit.edu/departments/csep/PublicWWW/codes/coe/acs-chma.htm

i

Chapter 1: Rules of the Road
10

ORI Introduction to the Responsible Conduct of Research

11

misconduct (see Chapter 2), ORI issued as guidelines a 

Model Policy and Procedures for Responding to Allegations 

of Scientific Misconduct (http://ori.hhs.gov/html/policies/

model.asp). In this case, the model policy is intended to 

provide guidance and does not impose binding requirements 

on institutions. 

The plethora of Federal regulations, policies, and

guidelines that affect research can be confusing. They do not 

always speak with one voice. The same aspect of a research 

project can be subject to regulations by more than one 

Federal agency, as for example the use of human or animal 

subjects. Common Federal regulations, such as the Federal 

Policy on Research Misconduct (discussed in Chapter 2) and 

the “Common Rule” for human subjects research (discussed 

in Chapter 3), are not truly common regulations until they 

have been adopted by all agencies. In addition, distinctions 

between regulations, policies, requirements, guidelines, and 

recommended practices can be difficult to understand. 

OSI and OSIR. In addition to responding to misconduct, 

ORI undertook a number of steps to promote integrity and 

responsible research practices. The ORI Introduction to 

RCR is a result of that effort.

Regulations. When Federal agencies translate

Congressional directives into regulations, they must follow 

provisions set out in the Federal Administrative Procedure 

Act (5 USC 551-702). As its name implies, this act

establishes procedures for developing new regulations, 

including steps for getting public input. Before establishing 

a new regulation, an agency must issue a draft regulation, 

obtain and consider public comment, and then issue the 

final regulation. Each step must be published in the Federal 

Register–the “official daily publication for rules, proposed 

rules, and notices of Federal agencies and organizations, as 

well as executive orders and other presidential documents” 

(http://www.gpoaccess.gov/fr/index.html). Objections

raised during the public comment period must be addressed 

before the final regulation is adopted. After it is adopted, 

the final regulation is incorporated into the Code of Federal 

Regulations and becomes official government regulatory 

policy that must be followed.

Agency policies and guidelines. Executive Branch 

agencies have the authority to issue some policies as part

of their normal operation. The National Institutes of

Health (NIH), for example, has the authority to establish 

policies for grant awards. From time to time, it changes 

these policies to assure that its research funds are spent 

wisely and responsibly. It is in this capacity that NIH issued 

a special RCR “Training Grant Requirement” in 1989 and 

the more recent “Required Education in the Protection of 

Human Research Participants” (discussed in Chapter 3). 

Federal agencies also issue Guidelines, which recommend but do not require a particular course of action. To 

help research institutions handle allegations of research 

Required Education in the Protection of Human Research Participants

June 5, 2000 (Revised August 25, 2000)

National Institutes of Health

Policy: Beginning on October 1, 2000, the NIH will require education on the protection of 

human research participants for all investigators submitting NIH applications for 

grants or proposals for contracts or receiving new or non-competing awards for 

research involving human subjects.

Background: To bolster the Federal commitment to the protection of human research participants, 

several new initiatives to strengthen government oversight of medical research were 

announced by HHS Secretary Shalala on May 30, 2000. This announcement also 

reminds institutions of their responsibility to oversee their clinical investigators and 

institutional review boards (IRBs). One of the new initiatives addresses education and 

training. This NIH announcement is developed in response to the Secretary’s directive.

http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

i

Chapter 1: Rules of the Road
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ORI Introduction to the Responsible Conduct of Research

13

deliberate violation of research regulations, abuses of 

confidentiality, and even the failure to report misconduct 

(discussed in Chapter 2). Most also require institutional 

review for more human subjects research than is required 

by Federal regulation.

Large research institutions usually have Web sites that 

contain some or all of the following information:

P copies of institutional research policies,

P links to state and Federal policies,

P required forms and instructions for completing them,

P responsible conduct of research training programs, and

P lists of key personnel.

There is, of course, little or no coordination across different 

research institutions, so the information on an institution’s 

Web site pertains only to that institution. But if you are 

looking for a comprehensive set of rules of the road for 

responsible research, check your home institution’s

research administration Web site or one from a

comparable institution.

Researchers are well advised to seek help when it comes 

to understanding Federal and state research regulations. 

The Federal agencies that regulate research have

comprehensive Web pages that list and explain their policies 

and regulations and readily answer questions. For local 

advice, your institutional research administrators may be 

the best place to begin.

1c. Institutional policies

Research institutions (universities, hospitals, private 

research companies, and so on) are required by law to

have policies that cover various aspects of their research 

programs if they accept Federal funds. They must have

committees to review human and animal research

(discussed in Chapters 3 and 4). They must have procedures 

for investigating and reporting research misconduct 

(Chapter 2) and conflicts of interest (Chapter 5). They must 

approve and manage all research budgets, ensure that 

laboratory safety rules are followed, and follow established 

practices for the responsible use of hazardous substances in 

research. They must also provide training for researchers 

who use animal or human subjects in their research and for 

individuals supported on NIH training grants.

To help manage their responsibilities, most research 

institutions have research offices/officers and institutional 

research policies. Both provide excellent sources of guidance

for responsible conduct in research, since both are the 

products of the institution’s efforts to clarify its own

responsibilities. In addition, institutional policies are often 

more comprehensive than Federal and state policies since 

they must encompass the full panoply of institutional 

responsibilities. So, for example, many research institutions

have more comprehensive definitions of research misconduct

than the Federal Government to cover other practices that 

can undermine the integrity of research, such as the 

Stanford University - Research Policy Handbook

Document 2.1

Title: Principles Concerning Research

Originally issued: Dec 8, 1971

Current version: Dec 8, 1971

Classification: Stanford University Policy

Summary: Presents broad principles to guide the research enterprise and

assure the integrity of scholarly inquiry at Stanford University.

http://www.stanford.edu/dept/DoR/rph/2-1.html

i

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Chapter 1: Rules of the Road
14

ORI Introduction to the Responsible Conduct of Research

15

1d. Personal responsibility

As important as rules of the road are for the responsible 

conduct of research, they have two important limitations. 

First, rules generally set minimum standards for behavior 

rather than strive for the ideal. The rules say that you can 

drive at 65 miles per hour over a stretch of road, but there 

may be times or circumstances when 55 would be better. 

If you use human subjects in research, you must follow 

specific rules, but there may be situations in which you 

should strive for a higher standard of conduct. Responsible 

research requires more than simply following rules.

Second, rules will not resolve some of the personal

conflicts and moral dilemmas that arise in research. Journals 

have rules against listing undeserving authors on papers 

(individuals who have not made significant contributions

to the research described in the paper). These same rules

do not tell you what to do if the undeserving author can 

have a significant influence on your career. Rules also 

cannot replace the critical reasoning skills needed to assess 

ethically controversial human or animal experiments or 

conflicts of interest. Researchers will face ethical dilemmas 

in research. They should be able to recognize these dilemmas 

and know how to resolve them (discussed in Chapter 11).

The rules of the road for research therefore need to be 

supplemented with good judgment and a strong sense of 

personal integrity. When meeting deadlines, you can cut 

corners by filling in a few missing data points without 

actually running the experiments or adding a few references 

to your notes that you have not read. You can resist sharing 

data with colleagues or leave some information on method 

out of a publication to slow down the competition. You can 

ignore your responsibilities to students or a mentor in order 

to get your own work done. You can do all of these things 

and more, but should you?

i

Chapter 1: Rules of the Road

In the final analysis, whatever decision you make

when you confront a difficult decision about responsibility

in research, you are the one who has to live with the 

consequences of that decision. If you are uncertain whether 

a particular course of action is responsible, subject it to one 

simple test. Imagine what you are preparing to do will be 

reported the next day on the front page of your local newspaper. If you are comfortable having colleagues, friends, and 

family know what you did, chances are you acted responsibly, 

provided, of course, you also understand your responsibilities 

as a researcher, as described in the rules of the road covered 

in the rest of the ORI Introduction to RCR.

Questions for discussion

 1 Is research a profession?

 2 How do researchers learn about the responsible conduct 

of research?

 3 How should researchers learn about the responsible conduct 

of research?

 4 What factors influence researchers’ attitudes toward the 

responsible conduct of research?

 5 How is integrity in research monitored? Is self-regulation 

of integrity in research effective?
16

ORI Introduction to the Responsible Conduct of Research

17

Additional Reading

Barnbaum, DR, Byron, M. Research Ethics: Text and Readings, Upper 

Saddle River, NJ: Prentice Hall, 2001. 

Beach, D. The Responsible Conduct of Research, New York: VCH 

Publishers, 1996. 

Bulger, RE, Heitman, E, Reiser, SJ. The Ethical Dimensions of the 

Biological and Health Sciences, 2nd ed. Cambridge, UK; New 

York: Cambridge University Press, 2002. 

Elliott, D, Stern, JE. Research Ethics: A Reader, Hanover, NH: 

Published by University Press of New England for the Institute 

for the Study of Applied and Professional Ethics at Dartmouth 

College, 1997. 

Frankel, M, Bird, S. eds. “The Role of Scientific Societies in 

Promoting Research Integrity,” Science and Engineering Ethics 9, 

2 (2003). 

Grinnell, F. The Scientific Attitude, 2nd ed. New York: The Guilford 

Press, 1992. 

Korenman, SG, Shipp, AC. Teaching the Responsible Conduct of 

Research through a Case Study Approach: A Handbook for 

Instructors, Washington, DC: Association of American Medical 

Colleges, 1994. 

Macrina, FL. Scientific Integrity: An Introductory Text with Cases, 

2nd ed. Washington, DC: ASM Press, 2000. 

Penslar, RL. Research Ethics: Cases and Materials, Bloomington: 

Indiana University Press, 1995.

Resnik, DB. The Ethics of Science : An Introduction, Philosophical 

Issues in Science, London; New York: Routledge, 1998.

Shamoo, AE, Resnik, DB. Responsible Conduct of Research, New 

York: Oxford University Press, 2003.

Sigma Xi. The Responsible Researcher: Paths and Pitfalls, 1999. 

Stern, JE, Elliott, D. The Ethics of Scientific Research: A Guidebook 

for Course Development, Hanover, NH: University Press of New 

England, 1997.

Whitbeck, C. Ethics in Engineering Practice and Research, Cambridge; 

New York: Cambridge University Press, 1998.

Resources

Policies, Reports, and Policy Statements

Sigma Xi. Honor in Science, New Haven, CN: Sigma Xi, 1984. 

(available at: http://www.sigmaxi.org/publications/)

National Academy of Sciences. Committee on the Conduct of Science. 

On Being a Scientist: Responsible Conduct in Research, 2nd ed. 

Washington, DC: National Academy Press, 1995. (available at: 

http://www.nap.edu/readingroom/books/obas/)

Association of American Medical Colleges. Developing a Code of 

Ethics in Research: A Guide for Scientific Societies, Washington, 

DC: AAMC, 1997. (available at: http://www.aamc.org/publications/

ersn.htm)

National Institutes of Health. Guidelines for the Conduct of Research 

in the Intramural Research Programs at NIH, 1997. (available at: 

http://www.nih.gov/campus/irnews/guidelines.htm)

Institute of Medicine. The Responsible Conduct of Research in the 

Health Sciences, Washington, DC: National Academies of Science, 

1989. (available at: http://www.nap.edu/books/0309062373/html/)

General Information Web Sites

American Association for the Advancement of Science. Integrity 

in Scientific Research, 2000. http://www.aaas.org/spp/video/. 

(Information on five videos on integrity in research.)

Bird, S, Spier, R, eds. Science and Engineering Ethics, 1995 ff. http:

//www.opragen.co.uk/. (Includes articles on the responsible 

conduct of research.)

National Institutes of Health. Research Conduct and Ethics 

Instruction Materials, nd. http://www1.od.nih.gov/oir/sourcebook/

ResEthicsCases/cases-toc.htm

North Carolina State University. Research Ethics Initiative, 2003. 

http://www.fis.ncsu.edu/Grad/ethics/

Office of Research Integrity. Home Page, 2003. http://ori.hhs.gov/

Online Ethics Center for Engineering and Science. Home Page, 2003. 

http://onlineethics.org/

RCR Education Consortium. Home Page, 2002-2004. http://rcrec.org/

Shamoo, AE, ed. Accountability in Research: Policies and Quality 

Assurance, 1994 ff. http://www.tandf.co.uk/journals/titles/

08989621.html. (Includes articles on research integrity and 

related issues.)

Chapter 1: Rules of the Road
19

Chapter 2. Research Misconduct

Public concern about misconduct in research first surfaced in the early 1980’s following reports of cases of 

egregious misbehavior. One researcher republished under 

his own name dozens of articles previously published by 

others. Other researchers in one way or another falsified 

or fabricated research results. To make matters worse, it 

seemed as if research institutions sometimes ignored or 

deliberately covered up problems rather than investigate 

them. Eventually Congress stepped in and required Federal 

agencies and research institutions to develop research 

misconduct policies.

Research misconduct policies provide guidance on

responsible conduct in three areas. They:

P establish definitions for misconduct in research,

P outline procedures for reporting and investigating

misconduct, and

P provide protection for whistleblowers (persons who report 

misconduct) and persons accused of misconduct.

Together, the definitions of and procedures for handling 

allegations of misconduct in research form an initial foundation 

for effective self-regulation in research.

Although Federal policies technically apply only to 

federally funded research, many research institutions apply 

Federal research misconduct policies to all research. Many 

research institutions have also broadened the basic Federal 

definitions to include other inappropriate practices. In 

combination, Federal and institutional research misconduct 

policies define research practices that researchers must 

avoid. Failure to do so can result in the termination of 

employment or ineligibility to receive Federal funding.

Chapter 2: Research Misconduct

When research misconduct becomes public
20

ORI Introduction to the Responsible Conduct of Research

21

Case Study

Dr. José M. is beginning his fifth year as an independent researcher. His work is going well. He has published a number of important articles and secured a large grant for future work. Based on this 

progress, he expects his pending promotion review to proceed without problems.

Late one afternoon a graduate student hands José two papers written by a senior colleague in his 

department. She has circled graphs in each of the papers that are clearly the same but reported as 

representing two different experiments. After checking the graphs carefully and reviewing the

supporting data, José agrees that something is wrong. The senior colleague, who will almost

certainly be a member of his promotion review, has either made a careless mistake or falsified 

information in a publication. What should he do?

Ask the senior colleague about graphs?

Bring the publications to the attention of his department chair?

Report the problem anonymously to a research administrator?

Encourage the graduate student to report the problem?

Nothing, at least until after the promotion review is completed?

To be considered research misconduct, actions must:

P represent a “significant departure from accepted practices”;

P have been “committed intentionally, or knowingly, or

recklessly”; and 

P be “proven by a preponderance of evidence.”

These further stipulations limit the Federal Government’s 

role in research misconduct (fabrication, falsification, or 

plagiarism) to well-documented, serious departures from 

accepted research practices.

When using the common Federal definition to discuss

research misconduct, it is important to understand that it 

establishes a minimum standard for measuring acceptable 

behavior, not a standard for judging all research behavior. 

In particular, it does not imply that all other behaviors are 

acceptable. It also does not encompass criminal behavior, 

personal disputes, violations of grant management policies or 

other unacceptable behaviors not unique to research, such as 

discrimination or harrassment. The government’s main 

concern in establishing this definition is to assure that 

publicly funded research is accurate and appropriately 

represented by clearly stating that three practices, commonly 

referred to as “FFP,” are wrong.

2a. Federal research misconduct definition and policies

After a decade of sometimes spirited debate, in December 

2000 the Office of Science and Technology Policy (OSTP) 

in the Executive Office of the President adopted a Federal 

Policy on Research Misconduct. The OSTP Policy is in 

most respects similar to earlier ones adopted by the Public 

Health Service (PHS) and the National Science Foundation 

(NSF), but it did recommend some significant changes to 

the definition of research misconduct. When it is finally 

implemented by all government research agencies (the 

target date of December 2001 was not met), all federally 

funded researchers will be subject to a uniform definition of 

research misconduct.

Definition. The OSTP Policy defines “research misconduct” 

as “fabrication, falsification, or plagiarism in proposing, 

performing, or reviewing research, or in reporting research 

results” (see accompanying box for details). It also sets the 

legal threshold for proving charges of misconduct. 

Federal Policy on Research Misconduct

I. Research Misconduct Defined. Research misconduct is defined as fabrication, falsification, or 

plagiarism in proposing, performing, or reviewing research, or in reporting research results.

• Fabrication is making up data or results and recording or reporting them.

• Falsification is manipulating research materials, equipment, or processes, or changing 

or omitting data or results such that the research is not accurately represented in the 

research record.

• Plagiarism is the appropriation of another person’s ideas, processes, results, or words 

without giving appropriate credit.

• Research misconduct does not include differences of opinion.

http://www.ostp.gov/html/001207_3.html

i

Chapter 2: Research Misconduct
22

ORI Introduction to the Responsible Conduct of Research

23

instances, research institutions also take their own actions, 

such as terminating a researcher’s employment or requiring

supervision of future research activities. By like token, 

making allegations of misconduct—blowing the whistle—

can sometimes place a whistleblower’s career at risk. 

Although by law institutions must not retaliate against 

whistleblowers who report in good faith, they sometimes do.

The new common Federal policy provides guidelines 

for protecting both parties—the whistleblower and the 

respondent—in research misconduct investigations. As a 

general rule, research misconduct allegations must not be 

made public until they have been fully investigated and 

confirmed. There are, however, exceptions to this rule. If the 

misconduct could pose a threat to public health or safety, 

such as misconduct in a clinical trial, it must immediately 

be brought to the attention of the person heading the trial, 

the person with oversight authority, or both. ORI and the 

Federal sponsor must also be notified immediately. In such 

cases, the names of the persons charged should remain 

confidential, but steps must be taken to safeguard the 

subjects in the trial.

Similarly, research institutions and researchers must not 

in any way penalize or take action against individuals who 

report research misconduct in good faith. Even if accusations 

are not sustained, as long as they are brought in good faith, 

informants must be protected and given support since they 

play a vital role in professional self-regulation.

2b. Institutional research misconduct policies

Institutional research misconduct policies generally follow 

the pattern recommended by the Federal Government, but 

almost always include some additional elements that for 

one reason or another are assumed to have local importance. 

This is particularly true for the definition of research 

misconduct. Institutional definitions must include some 

Reporting and investigation. Federal misconduct 

policy assumes that researchers and research institutions 

bear the primary responsibility for reporting and investigating 

allegations of misconduct. This assumption is consistent 

with the position, strongly supported by most researchers, 

that research is a profession and should regulate its own 

conduct (see Chapter 1).

Successful professional self-regulation depends on

conscientious community participation. For individual 

researchers, this means they must assume responsibility

for their own actions, take misconduct seriously, and

report apparent misconduct by other researchers.

Every institution that receives PHS funding must have 

procedures in place for receiving and investigating reports 

of research misconduct. These procedures must include:

P the designation of individuals who are authorized to receive 

and investigate allegations of misconduct,

P provisions for an initial inquiry to determine whether the 

allegations have any merit,

P provisions for a formal investigation to reach conclusions 

about the truth of the allegations,

P the designation of an individual who is authorized to weigh 

(adjudicate) the conclusions reached in the investigation 

and impose administrative actions to redress the 

misconduct (sanctions) or take steps to vindicate the 

person charged, and

P provisions for reporting findings to ORI.

Researchers should be familiar with these procedures and 

their institution’s definition of research misconduct

(discussed below).

Basic protections. Researchers who commit misconduct 

place their careers at risk. The Federal Government can 

debar researchers who commit misconduct from receiving 

Federal funds for a specified period of time. In most 

i

Chapter 2: Research Misconduct
24

ORI Introduction to the Responsible Conduct of Research

25

ideas with colleagues with the understanding that they

will not be used or made public without permission (see 

Chapter 8). Federal regulations, such as the Health

Insurance Portability and Accountability Act of 1996 (see 

Chapter 3), impose confidentiality requirements on human 

subjects research. The abuse of confidentiality may not 

undermine the validity of research data, but it can 

undermine the integrity of the research process. Therefore, 

some institutions include such abuses under their definition 

of research misconduct.

Authorship and publication violations. As will be 

discussed in Chapter 9, there are well-established 

guidelines for getting credit for work done (authorship) 

and making research results known (publication). Some 

violations of these guidelines do not rise to the level of 

FFP, as defined in Federal policy. For example, the Federal 

Government usually does not get involved in disputes over 

authorship or investigate charges of trivial publication 

(dividing the results of a single experiment into multiple 

publications so that there are more to list on a résumé). 

However, given the importance of the integrity of the 

research record, some research institutions include authorship 

and publication violations in their misconduct policies.

Failure to report misconduct. Failure to report many 

crimes can be considered a crime and result in penalties. 

This is particularly true if failure to report a crime puts 

other individuals or society at risk. Research misconduct 

can put individuals at risk, if, for example, the misconduct 

affects information that is used for making medical or 

public decisions. Failure to report research misconduct also 

undermines professional self-regulation. Therefore, some 

research institutions include failure to report misconduct in 

their research misconduct policies.

Obstruction of investigations and retaliation.

To emphasize the importance of research misconduct 

investigations, some institutions also include obstruction 

version of FFP, but then sometimes add other practices 

that also constitute misconduct in the particular local setting. 

Thus, depending on where a researcher works, any of the 

following practices could be reported as misconduct in 

research.

Violation of Federal rules. As will be discussed in later 

chapters, research is subject to many rules or regulations 

other than research misconduct policies. Although the 

violation of a research rule or regulation is not considered 

misconduct under the common Federal definition of

research misconduct, many research institutions

explicitly state that the violation of any research

regulation is research misconduct.

Abuse of confidentiality. Confidentiality plays a 

number of important roles in research. Most peer review is 

done confidentially (see Chapter 10). Researchers also share 

University Research Misconduct Policies

Rice University. Research misconduct may include the fabrication/ falsification of data, 

plagiarism, or other practices that seriously deviate from those that are commonly accepted 

within the scientific community for proposing, conducting, reviewing, or reporting research. It 

also encompasses the failure to comply with federal requirements for protecting researchers, 

human and animal subjects, and the public. In general, gross negligence of research standards 

and any action taken with the intent to defraud are considered forms of research misconduct. 

It does not, however, include honest error or honest differences in interpreting or judging data.

http://www.ruf.rice.edu/~presiden/Policies/Research/324-99.html

University of New Mexico. A researcher commits research misconduct under UNM’s 

policy if he or she fabricates or falsifies data or research results or plagiarizes another person’s 

ideas or work. Research misconduct also occurs if a researcher wantonly disregards truth 

or objectivity or fails to comply or attempt to comply with legal requirements governing the 

research; however, other University policies and procedures will be followed in resolving such 

cases. It is important to understand that research misconduct is not a mistake in reasoning, 

disagreeing with recognized authorities, misinterpreting results, an error in planning or carrying 

out an experiment, or an oversight in attribution.

http://www.unm.edu/~ripls/faqremis.htm

Chapter 2: Research Misconduct
26

ORI Introduction to the Responsible Conduct of Research

27

of investigations and retaliation against whistleblowers 

under research misconduct.

Other practices. Early in the evolution of Federal 

research misconduct policies, the National Science Foundation

(NSF) and the Public Health Service (PHS) included a broad 

provision in their definitions to catch other practices that 

“seriously deviate” from commonly accepted practices. NSF 

in particular felt that FFP left out behaviors that could 

undermine the integrity of the research it funded. While the 

“serious deviations” clause no longer exists in the common 

Federal definition, except as a standard for judging FFP, it 

can still be found in some institutional policies. Researchers 

therefore need to be aware of the fact that in some settings, 

actions that seriously deviate from commonly accepted 

practices can be considered research misconduct.

2c. Putting research misconduct into perspective

Research misconduct has understandably received considerable 

public attention. Researchers who act dishonestly waste public 

funds, harm the research record, distort the research process, 

undermine public trust, and can even adversely impact public 

health and safety. Research misconduct policies, whether 

Federal, state, institutional, or professional, identify seriously 

inappropriate behaviors and establish procedures for dealing 

with them.

Judged on the basis of the number of confirmed cases, 

misconduct apparently is not common in research. Over the 

last decade, PHS and NSF combined have averaged no more 

than 20 to 30 misconduct findings a year. This puts the 

annual rate of misconduct in research at or below 1 case for 

every 10,000 researchers. However, before making too much 

of this assessment, two important cautions need to be kept 

in mind.

First, the number of confirmed cases is probably less 

than the number of actual cases. Underreporting is to be 

i

expected, as it is in criminal and other types of inappropriate 

behavior. Moreover, several studies have suggested that 

researchers do not report suspected misconduct, even 

though they should (see Korenman, Additional Reading). 

Since every case of misconduct can potentially undermine 

public support for research, researchers should take their 

responsibility to look out for and report research 

misconduct seriously.

Second, the responsibility to avoid misconduct in research 

is a minimum standard for the responsible conduct of 

research, so the fact that most researchers do not engage 

in research misconduct does not necessarily imply that the 

level of integrity in research overall is high. Responsible 

research requires careful attention to many other 

expectations for appropriate practice, as discussed in the 

remainder of the ORI Introduction to RCR.

Questions for discussion

 1 Should other practices besides fabrication, falsification, and 

plagiarism be considered misconduct in research?

 2 Is it fair to use “significant departure from accepted practices” 

to make judgments about a researcher’s behavior?

 3 Should researchers report misconduct if they are concerned 

that doing so could adversely impact their career?

 4 What evidence is needed to demonstrate that a researcher 

committed misconduct “intentionally, or knowingly, or 

recklessly”?

 5 What are appropriate penalties for different types of 

misconduct?

Chapter 2: Research Misconduct
28

ORI Introduction to the Responsible Conduct of Research

29

Resources

Policies, Reports, and Policy Statements

Wells, FO, Lock, S, Farthing, MJG. Fraud and Misconduct in 

Biomedical Research, London: BMJ Books, 2001.

Department of Health and Human Services. Commission on Research 

Integrity. Integrity and Misconduct in Research, Washington, DC: 

Health and Human Services, 1995.

National Academy of Science. Committee on Science Engineering and 

Public Policy. Panel on Scientific Responsibility and the Conduct 

of Research. Responsible Science: Ensuring the Integrity of the 

Research Process, Washington, DC: National Academy Press, 

1992.

National Science Foundation. Research Misconduct, 45 CFR 689 

(1987). (available at: http://www.access.gpo.gov/nara/cfr/waisidx

_02/45cfr689_02.html)

Office of the President. Office of Science and Technology Policy. 

“Federal Policy on Research Misconduct,” Federal Register 65 (6 

December 2000): 76260-64.

Office of Research Integrity, ORI Model Policy and Procedures for 

Responding to Allegations of Scientific Misconduct, 1995, revised 

1997. (available at: http://ori.hhs.gov/html/policies/model.asp)

Public Health Service. Responsibility of PHS Awardee and

Applicant Institutions for Dealing With and Reporting Possible 

Misconduct in Science, 42 CFR Part 50, Subpart A (1989). 

(available at: http://ori.hhs.gov/html/misconduct/regulation_

subpart_a.asp)

United States. Congress. House. Committee on Science and 

Technology. Subcommittee on Investigations and Oversight. 

Fraud in Biomedical Research, Washington, DC: GPO, 1981.

General Information Web Sites

National Science Foundation, Office of Inspector General. Home Page, 

2003. http://www.oig.nsf.gov/

Office of Research Integrity. Handling Misconduct, 2003. http:

//ori.hhs.gov/html/misconduct/introduction.asp

Additional Reading

Braxton, JM, Bayer, AE. “Perceptions of Research Misconduct and 

an Analysis of their Correlates.” In Perspectives on Scholarly 

Misconduct in the Sciences, edited by John M. Braxton, Columbus, 

OH: Ohio State University Press, 1999, 236-258. 

Korenman, SG, Berk, R, Wenger, NS, Lew, V. “Evaluation of the 

Research Norms of Scientists and Administrators Responsible for 

Academic Research Integrity,” Journal of the American Medical 

Association 279, 1 (1998): 41-47.

Parrish, DM. “Scientific Misconduct and Correcting the Scientific 

Literature,” Academic Medicine 74, 3 (1999): 221-230.

Pascal, CB. “Scientific Misconduct and Research Integrity for the 

Bench Scientist,” Proceedings of the Society for Experimental 

Biology and Medicine 224, 4 (2000): 220-230.

Price, AR. “Anonymity and Pseudonymity in Whistleblowing to the 

U.S. Office of Research Integrity,” Academic Medicine 73, 5 (1998): 

467-472.

Rhoades, LR. “The American Experience: Lessons Learned,” Science 

and Engineering Ethics 6,1 (2000): 95-107.

School of Education. University of Indiana. Understanding 

Plagiarism, 2002. (available at: http://education.indiana.edu/

~frick/plagiarism)

United States. President’s Commission for the Study of Ethical 

Problems in Medicine and Biomedical and Behavioral Research. 

Whistleblowing in Biomedical Research: Policies and Procedures 

for Responding to Reports of Misconduct: Proceedings of a 

Workshop, September 21-22, 1981, Washington, DC: GPO, 1981.

Chapter 2: Research Misconduct
Part II. Planning Research
32

ORI Introduction to the Responsible Conduct of Research

33

Part II: Planning 

Research

RESEARCH BEGINS WITH IDEAS, QUESTIONS 

and hypotheses. What causes this 

particular phenomenon? What would 

happen if...? How can I find out...? 

Researchers think first 

about problems and ways 

to solve them and about the resources 

they will need to perform experiments.

Planning for any project should include the consideration 

of responsibilities. In some cases, work cannot begin 

until it has been approved. In other cases, confronting 

potential problems before they arise can help ensure that 

they do not turn into real problems later.

The chapters in this section cover three areas where 

appropriate planning and approval are essential:

Chapter 3, The Protection of Human Subjects, describes 

the regulations covering the use of humans in research.

Chapter 4, The Welfare of Laboratory Animals, describes 

similar regulations for animals used in research.

Chapter 5, Conflicts of Interest, discusses what researchers should do when their interests are or appear to be in 

conflict.

Planning is essential in other areas as well. Responsible 

research administration, the safe use of hazardous materials, 

and the fair treatment of students and employees should 

be addressed early in any project. However, with the use 

of humans and animals and, increasingly, the potential 

influence of conflicting interests, there is no choice. These 

responsibilities must be fully addressed before the first 

subject is contacted, the first animal purchased, or any 

agreement signed.

Part II: Planning Research
35

Chapter 3. The Protection of Human Subjects

The use of human subjects in research benefits society in many ways, from contributing to the development of 

new drugs and medical procedures to understanding how 

we think and act. It also can and has imposed unacceptable 

risks on research subjects. To help ensure that the risks do 

not outweigh the benefits, human subjects research is 

carefully regulated by society.

Case Study

T

wo weeks into the new semester, the professor in Mary’s course on family health gives the class 

a special assignment that was not on the course syllabus. Over the next week, everyone in the 

class is to talk with three classmates who are not in the course about the way their families deal with 

medical emergencies and chronic illness. Next week they should come to class prepared to report on 

their interviews. The Professor warns them, however, that in talking about their conversations they 

should not mention any names to protect the privacy of their classmates.

The assignment makes Mary uneasy. In her basic psychology course last semester she learned about 

some of the rules pertaining to the use of human subjects in research. However, when she raises 

her concerns with her professor, he assures her that her informal conversations with classmates are 

not research and therefore not subject to regulation. Moreover, since she will not be mentioning any 

names, there are no privacy issues to worry about.

Should Mary be content with these assurances and conduct the interviews?

If she still has concerns, where should she turn for advice?

Did the professor act properly in giving this assignment to the class?

Investigators who conduct research involving humans 

that is subject to regulation must comply with all relevant 

Federal regulations as well as any applicable state and local 

laws, regulations, and policies related to the protection of human subjects. They are also expected to follow other relevant 

codes that have been formulated by professional groups. To 

meet these responsibilities requires, among other things:

P knowing what research is subject to regulation,

P understanding and following the rules for project approval,

Chapter 3: The Protection of Human Subjects

Designing a responsible informed consent form
36

ORI Introduction to the Responsible Conduct of Research

37

P getting appropriate training, and

P accepting continuing responsibility for compliance through 

all stages of a project.

If you expect to use or study living humans in your research, 

no matter how harmless that use may seem, and receive 

Federal funding, familiarize yourself with your responsibilities

and check with someone in a position of authority before 

making any contacts or undertaking any work.

3a. Federal regulations

Society protects the welfare of individuals in many ways, 

but it did not specifically address the issue of the welfare 

of research subjects until after World War II. Following the 

War, widespread concerns about atrocities committed during 

the War in the name of research led to the formulation of a 

code for human subjects research known as the Nuremberg 

Code (1947). Although not binding on researchers, the 

Nuremberg Code and the later Declaration of Helsinki 

(1964; latest revision and clarification, 2002) provided the 

first explicit international guidelines for the ethical

treatment of human subjects in research.

The Nuremberg Code and Declaration of Helsinki did not 

put an end to unethical human subjects research. During 

the Cold War, U.S. researchers tested the effects of radiation 

on hospital patients, children, and soldiers without obtaining 

informed consent or permission to do so. Through the 1950’s 

and 1960’s, well after antibiotics effective for the treatment 

of syphilis were discovered, scores of African-American 

males in a long-term syphilis study (conducted by the U.S. 

Public Health Service in Tuskegee, Alabama) were not 

offered treatment with the new drugs so that researchers 

could continue to track the course of the disease. These and 

other questionable practices raised serious public concern 

and led eventually to government regulation.

i

To prevent these and similar abuses from continuing,

in 1974 Congress required the Department of Health, 

Education and Welfare (HEW, currently Health and Human 

Services—HHS) to clarify its rules for the use of human 

subjects in research. With this mandate in hand, HEW 

codified its procedures under Title 45 of the Code of Federal 

Regulations, Part 46 (45 CFR 46). (At roughly the same 

time, the FDA codified its rules for human subjects research 

under 21 CFR 50 and 56.)

Congress also called in 1974 for the creation of a National 

Commission for the Protection of Human Subjects of 

Excerpts, Nuremberg Code (1947)

1. The voluntary consent of the human subject is absolutely essential. 

2. The experiment should be such as to yield fruitful results for the good of society. 

3. The experiment should be so designed and based on the results of animal experimentation 

and a knowledge of the natural history of the disease. 

4. The experiment should be so conducted as to avoid all unnecessary physical and mental 

suffering and injury.

5. No experiment should be conducted where there is an a priori reason to believe that death or 

disabling injury will occur.

6. The degree of risk to be taken should never exceed that determined by the humanitarian 

importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the 

experimental subject against even remote possibilities of injury, disability, or death. 

8. The experiment should be conducted only by scientifically qualified persons. 

9. During the course of the experiment the human subject should be at liberty to bring the 

experiment to an end.

10. During the course of the experiment the scientist in charge must be prepared to terminate 

the experiment at any stage, if he has probable cause to believe, in the exercise of the

good faith, superior skill and careful judgment required of him that a continuation of the 

experiment is likely to result in injury, disability, or death to the experimental subject. 

http://ohsr.od.nih.gov/nuremberg.php3

Chapter 3: The Protection of Human Subjects
38

ORI Introduction to the Responsible Conduct of Research

39

Biomedical and Behavioral Research. During the 4 years 

it met, the Commission issued a number of reports on the 

protection of research subjects and recommended principles 

for judging the ethics of human subjects research

(discussed below).

In 1991 most Federal departments and agencies that 

conduct or support human subjects research adopted a

common set of regulations for the protection of human

subjects referred to as the “Common Rule” (45 CFR 46,

Subpart A). Additional requirements on three sensitive 

research areas are also included in 45 CFR 46:

P Subpart B – Additional Protections for Pregnant Women, 

Human Fetuses and Neonates Involved in Research.

P Subpart C – Additional Protections Pertaining to 

Biomedical and Behavioral Research Involving Prisoners

as Subjects.

P Subpart D – Additional Protections for Children Involved as 

Subjects in Research.

Together, 45 CFR 46, Subparts A-D, provide a

comprehensive articulation of society’s expectations for 

the responsible use of human subjects in research.

Authority for enforcing the HHS regulations for the 

protection of human subjects who participate in research 

conducted or supported by HHS now rests with the Office

for Human Research Protections (OHRP) in the Office of 

Public Health and Science (OPHS). If you have specific 

questions about the Federal requirements for the protection 

of human subjects, contact your local institutional officials, 

OHRP (for research conducted or supported by HHS), or 

appropriate officials at the department or agency conducting 

or supporting the research.

3b. Definitions

Researchers are responsible for obtaining appropriate

approval before conducting research involving human 

subjects. The need for approval rests on three seemingly 

obvious but not always easy-to-interpret considerations: 

1) whether the work qualifies as research, 2) whether it 

involves human subjects, and 3) whether it is exempt. All 

three considerations are discussed in the Common Rule and 

guide decisionmaking about the use of human subjects in 

research. The authority to make decisions about the need 

for approval rests with the Institutional Review Board (IRB, 

discussed below) or other appropriate institutional officials.

Research. The Common Rule defines research as 

“systematic investigation, including research development, 

testing and evaluation, designed to develop or contribute to 

generalizable knowledge” (§ 46.102(d), see box, next page, 

for full definition). This means that a project or study is 

research if it:

P is conducted with the intention of drawing conclusions 

that have some general applicability and

P uses a commonly accepted scientific method.

The random collection of information about individuals 

that has no general applicability is not research. Scientific 

investigation that leads to generalizable knowledge is.

Human subjects. Human subjects are “living individual(s) 

about whom an investigator conducting research obtains: (1) 

data through intervention or interaction with the individual; 

or (2) identifiable private information” (§ 46.102(f), see box, 

next page, for full definition). Humans are considered subjects 

and covered by Federal regulations if the researcher:

P interacts or intervenes directly with them, or

P collects identifiable private information.

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ORI Introduction to the Responsible Conduct of Research

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If one of these two conditions applies and if the project or 

study qualifies as research, then institutional approval is 

needed before any work is undertaken.

Exempt research. Some studies that involve humans may 

be exempt from the requirements in the Federal regulations. 

Studies that fall into the following categories could qualify 

for exemptions, including:

P research conducted in established or commonly 

accepted educational settings;

P research involving the use of educational tests;

P research involving the collection or study of existing data,

documents, records, pathological specimens, or diagnostic

specimens, if unidentifiable or publicly available;

P research and demonstration projects which are conducted 

by or subject to the approval of department or agency 

heads; or

P taste and food quality evaluation and consumer 

acceptance studies.

It is critically important to note, however, that decisions 

about whether studies are exempt from the requirements of 

the Common Rule must be made by an IRB or an appropriate 

institutional official and not by the investigator.

3c. IRB membership and deliberations

Federally funded research that uses human subjects must 

be reviewed and approved by an independent committee 

called an Institutional Review Board or IRB. The IRB 

provides an opportunity and place for individuals with 

different backgrounds to discuss and make judgments about 

the acceptability of projects, based on criteria set out in the 

Common Rule.

Under the Common Rule, IRBs must have at least five 

members and include at least one scientist, one nonscientist, and “one member who is not otherwise affiliated 

with the institution and who is not part of the immediate 

family of a person who is affiliated with the institution”

(§ 46.107(d)). IRBs have authority to approve, require 

modification of (in order to secure approval), and disapprove 

all research activities covered by the Common Rule. They 

also are responsible for conducting continuing review of 

research at least once per year and for ensuring that 

45 CFR 46. 102

Protection of Human Subjects – Definitions

(d) Research means a systematic investigation, including research development, testing and 

evaluation, designed to develop or contribute to generalizable knowledge. Activities which 

meet this definition constitute research for purposes of this policy, whether or not they are 

conducted or supported under a program which is considered research for other purposes. For 

example, some demonstration and service programs may include research activities.

- - - - - - - - - - - - - - -

(f) Human subject means a living individual about whom an investigator (whether 

professional or student) conducting research obtains

(1) data through intervention or interaction with the individual, or

(2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, 

venipuncture) and manipulations of the subject or the subject’s environment that are 

performed for research purposes. Interaction includes communication or interpersonal contact 

between investigator and subject. Private information includes information about behavior 

that occurs in a context in which an individual can reasonably expect that no observation or 

recording is taking place, and information which has been provided for specific purposes by an 

individual and which the individual can reasonably expect will not be made public (for example, 

a medical record). Private information must be individually identifiable (i.e., the identity of the 

subject is or may readily be ascertained by the investigator or associated with the information) 

in order for obtaining the information to constitute research involving human subjects. 

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

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ORI Introduction to the Responsible Conduct of Research

43

proposed changes in approved research are not initiated 

without IRB review and approval, except when necessary 

to eliminate apparent immediate hazards to the subject.

IRBs weigh many factors before approving proposals. 

Their main concern is to determine whether (§ 46.111(a)):

P risks to subjects are minimized;

P risks to subjects are reasonable in relation to anticipated

benefits, if any, to subjects, and the importance of the

knowledge that may reasonably be expected to result;

P selection of subjects is equitable;

P informed consent will be sought from each prospective

subject or the subject’s legally authorized representative;

P informed consent will be appropriately documented;

P when appropriate, the research plan makes adequate

provision for monitoring the data collected to ensure the

safety of subjects; and

P when appropriate, there are adequate provisions to protect

the privacy of subjects and to maintain the confidentiality 

of data.

Researchers should consider each of these issues before 

completing their research plan and submitting it to an IRB 

for approval.

Making decisions about whether human subjects will 

be treated fairly and appropriately or given adequate 

information requires judgments about right and wrong 

(moral judgments). In the 1979 Belmont Report, the 

National Commission recommended three principles for 

making these judgments:

P respect for persons and their right to make decisions 

for and about themselves without undue influence or 

coercion from someone else (the researcher in most cases);

P beneficence or the obligation to maximize benefits and 

reduce risks to the subject; and

The Belmont Report (1979)

Ethical Principles and Guidelines for the Protection of Human 

Subjects of Research 

SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed 

into law, thereby creating the National Commission for the Protection of Human Subjects of 

Biomedical and Behavioral Research. One of the charges to the Commission was to identify 

the basic ethical principles that should underlie the conduct of biomedical and behavioral 

research involving human subjects and to develop guidelines which should be followed to 

assure that such research is conducted in accordance with those principles. 

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

P justice or the obligation to distribute benefits and risks 

equally without prejudice to particular individuals or 

groups, such as the mentally disadvantaged or members of 

a particular race or gender.

While this list does not exhaust the principles that can be 

used for judging the ethics of human subjects research, it 

has nonetheless been accepted as a common standard for 

most IRB deliberations. Knowing this, researchers should 

spend time considering whether their work does provide 

adequate respect for persons, appropriately balances risks 

and benefits, and is just.

3d. Training

To help assure that researchers understand their 

responsibilities to research subjects, the National Institutes 

of Health (NIH) currently requires

...education on the protection of human research 

participants for all investigators submitting NIH 

applications for grants or proposals for contracts or 

receiving new or non-competing awards for research 

involving human subjects. (http://grants2.nih.gov/grants/

guide/notice-files/NOT-OD-00-039.html)

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Many institutions, including NIH, provide this training 

through special Web-based programs that summarize 

essential information and in some cases require some 

evidence of mastery. A description of the education program 

and who was trained must be included in applications for 

grants and contracts before they will be considered.

3e. Continuing responsibility

Once a project has been approved by an IRB, researchers 

must adhere to the approved protocol and follow any

additional IRB instructions. This, unfortunately, is where 

a few researchers and institutions have occasionally run 

into problems and temporarily had their “assurance” (FWA 

- Federalwide Assurance) suspended. The continuing 

responsibilities that researchers have include:

P enrolling only those subjects that meet IRB approved

inclusion and exclusion criteria,

P properly obtaining and documenting informed consent,

P obtaining prior approval for any deviation from the

approved protocol,

P keeping accurate records, and

P promptly reporting to the IRB any unanticipated problems

involving risks to subjects or others.

While research institutions are increasingly monitoring

the progress of human subjects research, the primary 

responsibility for conducting experiments as approved still 

lies with the individual researchers and staff who conduct 

the experiments.

3f. Ethical issues

Despite the many rules governing research with humans, 

tough choices continually arise that have no easy answers.

Informed consent. It is widely agreed that research 

subjects should be fully informed about experiments in 

which they may participate and give their consent before 

they enroll. However, some subjects, such as children, 

some adults with impaired decisionmaking capacity, and 

some critically ill patients, cannot give informed consent, 

either because they are not old enough to understand the 

information being conveyed or because they have lost their 

ability to understand.

These and other problems could be eliminated by 

forbidding researchers to do studies that raise difficult 

questions about respect for persons, beneficence, and justice, 

but this would make it difficult or even impossible to get 

some crucial information needed to make informed decisions 

about medicine and public health. Since children do not 

respond to medicines in the same way as adults, it is 

important to include children in some clinical trials. 

However, it is not easy to decide when they should be 

included and how consent can/should be obtained.

Federalwide Assurance (FWA)

The Federal Policy (Common Rule) for the protection of human subjects at Section 103(a) 

requires that each institution “engaged” in Federally supported human subject research file 

an “Assurance” of protection for human subjects. The Assurance formalizes the institution’s 

commitment to protect human subjects. The requirement to file an Assurance includes both 

“awardee” and collaborating “performance site” institutions.

Under the Federal Policy (Common Rule) at Section 102(f) awardees and their collaborating 

institutions become “engaged” in human subject research whenever their employees or agents 

(i) intervene or interact with living individuals for research purposes; or (ii) obtain, release, or 

access individually identifiable private information for research purposes.

In addition, awardee institutions are automatically considered to be “engaged” in human subject 

research whenever they receive a direct HHS award to support such research, even where all 

activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, 

the awardee institution bears ultimate responsibility for protecting human subjects under the 

award. The awardee is also responsible for ensuring that all collaborating institutions engaged in 

the research hold an OHRP approved Assurance prior to their initiation of the research.

http://ohrp.osophs.dhhs.gov/humansubjects/assurance/fwas.htm

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Right to withdraw. It is widely agreed that research 

subjects should have the right to withdraw from experiments 

at any time, but in some cases they cannot. In the final stages 

of development, mechanical hearts are tested on patients 

whose own heart is about to fail. But if it has not failed,

and once the mechanical heart replaces the weakened

heart, there is no turning back. The patient can technically 

withdraw from the experiment and undergo no further 

testing, but he or she cannot withdraw from the conditions 

imposed by the experiment, no matter how distressing living 

with the mechanical heart might be. Knowing this, under 

what conditions should these experiments be allowed?

Risk without benefit. In one recent experiment, 

researchers wanted to test whether a common surgical 

procedure used to relieve arthritis pain had any benefits. 

To gather information about benefits they designed a 

clinical trial in which subjects in the control group 

received sham surgery. An operation was performed, but 

the common surgical procedure was not performed.

The researchers in this case complied with all regulations, 

which included thorough IRB review. None of the patients 

experienced any adverse effects, and the study concluded that 

the common surgical procedure did not provide significant 

benefits. However, since surgery always involves some risk, 

the subjects in the control group were placed at risk without 

any expectation that they would benefit. Should this be 

allowed, and if so, under what circumstances?

These and other questions must ultimately be answered 

by IRBs during the review process. Researchers who serve 

on IRBs need additional training to help them deal with the 

growing complexities of biomedical, social, and behavioral 

research. Researchers who use human subjects in research 

should seriously consider having some formal training in 

bioethics so that they can participate in the critical reasoning 

process needed to respond to the complex moral issues 

raised by the use of human subjects in research.

i

Questions for discussion

 1 Why should some research on humans be exempted

from regulation?

 2 What other criteria could be used to identify necessary

members for IRBs?

 3 What should subjects know about proposed research and

their protection before they enroll as subjects?

 4 What other principles could be used for evaluating the ethics 

of human subjects research besides respect for persons, 

beneficence, and justice?

 5 Should subjects be allowed to enroll in experiments that 

either promise no direct benefit to them or cannot provide 

them with the opportunity to withdraw completely?

Chapter 3: The Protection of Human Subjects
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Resources

Policies, Reports, and Policy Statements

Directives for Human Experimentation: Nuremberg Code. 1949. 

(available at: http://ohsr.od.nih.gov/nuremberg.php3)

World Medical Association. Declaration of Helsinki: Ethical 

Principles for Medical Research Involving Human Subjects, 

Helsinki, Finland: World Medical Association, 1964, 2002. 

(available at: http://www.wma.net/e/policy/b3.htm)

The National Commission for the Protection of Human Subjects of 

Biomedical and Behavioral Research. The Belmont Report: Ethical 

Principles and Guidelines for the Protection of Human Subjects 

of Research, Washington, DC: DHHS, 1979. (available at: http:

//ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm)

United States. Congress, 99th Congress. Health Research Extension 

Act of 1985, PL 99-158, 1985. (available at: http://grants2.nih.gov/

grants/olaw/references/hrea1985.htm)

National Institutes of Health. Guidelines for the Conduct of Research 

Involving Human Subjects at the National Institutes of Health, 

1995. (available at: http://ohsr.od.nih.gov/guidelines.php3)

———. Required Education in the Protection of Human Research 

Participants, National Institutes of Health, 2000. (available at: 

http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-00-

039.html)

Federal Policy for the Protection of Human Subjects, 45 CFR 46, 

Subpart A (2001). (available at: http://ohrp.osophs.dhhs.gov/

humansubjects/guidance/45cfr46.htm)

General Information Web Sites

Food and Drug Administration. Information Sheet: Guidance for 

Institutional Review Boards and Clinical Investigators, 1998. http:

//www.fda.gov/oc/ohrt/irbs/default.htm

National Institutes of Health. Standards for Clinical Research 

within the NIH Intramural Research Program, 2000. http:

//www.cc.nih.gov/ccc/clinicalresearch/index.html

National Institutes of Health. Bioethics Resources on the Web, 2003. 

http://www.nih.gov/sigs/bioethics/

———. IRB Review Standards, OHSR Infosheets, Forms, Etc., nd. 

http://ohsr.od.nih.gov/info/

National Institutes of Health, Office of Human Subjects Research. 

Home Page, nd. http://206.102.88.10/ohsrsite/

Office for Human Research Protections, HHS. Home Page, 2003.

http://ohrp.osophs.gov/

Additional Reading

Eckstein, S, King’s College (University of London). Centre of Medical 

Law and Ethics. Manual for Research Ethics Committees, 6th ed. 

Cambridge, UK; New York: Cambridge University Press, 2003.

Federman, DD, Hanna, KE, Rodriguez, LL. Institute of Medicine 

(U.S.). Committee on Assessing the System for Protecting Human 

Research Participants. Responsible Research: A Systems Approach 

to Protecting Research Participants, Washington, D.C.: National 

Academies Press, 2002.

Gallin, JI. Principles and Practice of Clinical Research, San Diego, 

CA: Academic Press, 2002.

Jensen, E. Not Just Another GCP Handbook: A Practical Guide to 

FDA/DHHS Requirements, New York, NY: PJB Publications Ltd., 

2003. (available at: http://www.pjbpubs.com/cms.asp?pageid=287

&reportid=626)

Loue, S. Textbook of Research Ethics: Theory and Practice, New York, 

N.Y.: Kluwer Academic/Plenum Pub. Corp., 2000.

Penslar, RL, National Institutes of Health (U.S.). Office for Protection 

from Research Risks. Protecting Human Research Subjects: 

Institutional Review Board Guidebook, 2nd ed. Bethesda, MD; 

Washington, DC: GPO, 1993.

Shamoo, AE, Khin-Maung-Gyi, FA. Ethics of the Use of Human 

Subjects in Research: Practical Guide, London; New York: Garland 

Science, 2002.

Chapter 3: The Protection of Human Subjects
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4. The Welfare of Laboratory Animals

Animal research is as carefully regulated as human research, but for different reasons. With humans, 

regulation stems from the need to assure that the benefits 

all humans gain from human research do not impose 

unacceptable burdens on some research participants. 

Animals may benefit from the information gained through 

animal experimentation and some research with animals 

is conducted specifically for the purpose of improving 

animal health (veterinary medicine and animal husbandry 

research). But most animal research is conducted primarily 

for the benefit of humans, not animals. Moreover, 

unlike humans, animals cannot consent to participate 

in experiments or comment on their treatment, creating 

special needs that should be taken into consideration in 

their care and use.

The special needs of animals have evolved over time

into policies for the appropriate care and use of all animals 

Case Study

After many years using fish and frogs to study brain function, Dr. Ruth Q. encountered some problems that can be explored only using new animal models. For the near future, she plans to 

turn to mice or rats, but eventually may have to do some research using cats or dogs. To help prepare 

the way for this new research, she decides to put a note about her plans in the progress report for 

her current research grant, which runs out next year.

The day after she gave a draft of the progress report to her long-time research assistant, he came 

to her with a troubled look on his face. Although he never told her, the main reason he applied for 

the job in her laboratory many years ago was the fact that she did not use warm-blooded animals in 

her research. If she changed her animal models as planned, he would have to quit his job and had no 

prospects for getting another position that paid as well and was as rewarding.

Does Dr. Q. have any obligation to consider her research assistant's views before she redirects his research?

Why are objections raised to the use of some animals in research and how can those objections be answered?

Why are there more objections to using some animals in research compared to others?

Chapter 4: The Welfare of Laboratory Animals

How do researchers decide which animals are used in research?
52

ORI Introduction to the Responsible Conduct of Research

53

involved in research, research training, and biological testing 

activities. Researchers can meet their responsibilities by:

P knowing what activities are subject to regulation,

P understanding and following the rules for project approval,

P obtaining appropriate training, and

P accepting continuing responsibility for compliance through 

all stages of a project.

If you expect to use or study living animals in your research, 

regardless of the level of invasiveness, familiarize yourself 

with your responsibilities and check with someone in a 

position of authority before making any plans or

undertaking any work.

4a. Rules, policies, and guidelines

The current rules, policies, and professional guidelines 

for the responsible use of animals in research are the 

product of roughly 50 years of ongoing discussion between 

government, the public, animal care professionals, and 

i

Animal Welfare Act as Amended (7 USC, 2131-2156)

Section 1.

(a) This Act may be cited as the “Animal Welfare Act.”

(b) The Congress finds that animals and activities which are regulated under this Act are 

either in interstate or foreign commerce or substantially affect such commerce or the 

free flow thereof, and that regulation of animals and activities as provided in this Act is 

necessary to prevent and eliminate burdens upon such commerce and to effectively regulate 

such commerce, in order—

(1) to insure that animals intended for use in research facilities or for exhibition 

purposes or for use as pets are provided humane care and treatment;

(2) to assure the humane treatment of animals during transportation in commerce; 

and

(3) to protect the owners of animals from the theft of their animals by preventing the 

sale or use of animals which have been stolen.

http://www.nal.usda.gov/awic/legislat/awa.htm

PHS Policy on Humane Care and Use of Laboratory Animals

(Amended, August 2002)

II. Applicability

This Policy is applicable to all PHS-conducted or supported activities involving animals, 

whether the activities are performed at a PHS agency, an awardee institution, or any other 

institution and conducted in the United States, the Commonwealth of Puerto Rico, or any 

territory or possession of the United States. 

http://grants2.nih.gov/grants/olaw/references/phspol.htm

researchers. The conclusions reached through these

discussions are laid out in two key sources of information

for researchers who use animals in their work: Federal 

regulations and professional guidelines.

Federal regulations. Over the last 50 years, Congress 

has addressed the responsible use of animals in research on 

a number of occasions and drafted two important statutes:

P the 1966 Animal Welfare Act (revised 1970, 1976, 1985, 

and 1990) and

P the 1985 Health Research Extension Act, Sec. 495.

The former broadly assigns authority for the responsible 

transportation, care, and use of animals to the United 

States Department of Agriculture (USDA), as implemented 

by Title 9 of the Code of Federal Regulations. It covers 

animals used “in research facilities or for exhibition 

purposes or for use as pets.” The latter law delegates 

authority for the responsible use of animals in “biomedical 

and behavioral research” to the Secretary of Health and 

Human Services (HHS), acting through the Director of 

the National Institutes of Health (NIH) and the Office of 

Laboratory Animal Welfare (OLAW), NIH.

Researchers who use animals in research, including 

observational research, or teaching, can come under the 

jurisdiction of the USDA animal welfare regulations and/or 

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the PHS Policy on Humane Care and Use of Laboratory 

Animals (hereafter, PHS Policy), which carries out the 

provisions of the 1985 Health Research Extension Act. 

They therefore should be familiar with both.

Guidelines. In the late 1950’s, a group of animal-care 

professionals formed the “Animal Care Panel” (ACP) 

specifically for the purpose of establishing a professional 

standard for laboratory animal care and facilities. Their 

work led to the publication of a comprehensive and 

influential Guide for Laboratory Animal Facilities and Care 

(1963, revised 1965, 1968, 1972, 1978, 1985, and 1996). The 

current edition, now called the Guide for the Care and Use of 

Laboratory Animals, or Guide, as it is commonly referenced, 

was prepared by a committee appointed by the National 

Research Council of the National Academy of Sciences and 

provides guidance on:

P Institutional Policies and Responsibilities;

P Animal Environment, Housing, and Management;

P Veterinary Medical Care; and

P Physical Plant.

The Guide is widely accepted by both government and 

research institutions as the most authoritative source of

information on most animal care and use questions. The 

PHS Policy requires that PHS-funded institutions use 

the Guide as a basis for developing and implementing an 

institutional program for animal care and use.

4b. Definitions

The term “animal” is defined differently in the statutes, 

codes, policies, and guidelines that govern animal research. 

Federally funded research is guided by two key definitions:

P The PHS Policy, which applies to all PHS-funded activities 

involving animals, defines “animals” as “any live, vertebrate

animals used or intended for use in research, research 

training, experimentation, or biological testing or for 

related purposes.”

P The Federal Code that implements the Animal Welfare 

Act (Title 9) covers warm-blooded animals but excludes 

“[b]irds, rats of the genus Rattus and mice of the genus 

Mus bred for use in research, and horses not used for 

research purposes and other farm animals....”

Many institutions apply uniform and consistent standards 

to all activities involving animals regardless of the source 

of funding or legal requirements as a way of ensuring broad 

compliance with all regulations covering the care and use of 

animals in research.

Researchers are not authorized to make decisions about 

covered or excluded research themselves. Therefore, anyone 

who plans to use animals in research, teaching, testing and 

other covered activities is well advised to assume a broad 

definition and to consult with their institutional committee 

(see below) before ordering animals or beginning work.

Guide for the Care and Use of Laboratory Animals (1996)

The Guide for the Care and Use of Laboratory Animals (the Guide) was first published in 

1963 under the title Guide for Laboratory Animal Facilities and Care and was revised in 1965, 

1968, 1972, 1978, and 1985. More than 400,000 copies have been distributed since it was 

first published, and it is widely accepted as a primary reference on animal care and use. The 

changes and new material in this seventh edition are in keeping with the belief that the Guide 

is subject to modification with changing conditions and new information. 

The purpose of the Guide, as expressed in the charge to the Committee to Revise the Guide 

for the Care and Use of Laboratory Animals, is to assist institutions in caring for and using 

animals in ways judged to be scientifically, technically, and humanely appropriate. The 

Guide is also intended to assist investigators in fulfilling their obligation to plan and conduct 

animal experiments in accord with the highest scientific, humane, and ethical principles. 

The recommendations are based on published data, scientific principles, expert opinion, and 

experience with methods and practices that have proved to be consistent with high-quality, 

humane animal care and use.

http://www.nap.edu/readingroom/books/labrats/preface.html

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4c. Institutional organization

The task of assuring that researchers adhere to the

regulations and guidelines for the responsible care and

use of animals is generally recognized to be an institutional 

responsibility. Institutions vest authority for animal care 

and use in an “institutional official” (IO), who in turn 

appoints the Congressionally mandated Institutional 

Animal Care and Use Committee (IACUC), administers 

institutional care and use units at institutions that are large 

enough to have such, and handles other general matters 

relating to the care and use of animals at that institution.

IACUCs. Following the provisions of the 1985 Health 

Research Extension Act, PHS Policy, USDA regulations, the 

Guide, and the Association for Assessment and Accreditation 

of Laboratory Animal Care (AAALAC) require research 

institutions to establish an IACUC. IACUCs oversee and 

evaluate all aspects of the institution’s animal program, 

procedures, and facilities. Its members must include a 

doctor of veterinary medicine, one researcher who uses 

animals in research, and one person who is not affiliated 

with the institution. Many IACUCs also have a researcher 

who does not use animals or a member who has some 

grounding in ethics.

IACUC Members are appointed by their institution, 

but they have considerable independent authority. Their 

responsibilities include: P reviewing and approving all animal use research proposals, P reviewing the institution’s animal care program, P inspecting (at least twice a year) the institution’s animal 

facilities,

P receiving and reviewing concerns raised about the care 

and use of animals, and

P submitting reports to the Institutional Official.

IACUCs also have independent authority to suspend 

projects if they determine that they are not being conducted 

in accordance with applicable requirements. This authority 

comes directly from Congress through the Health Research 

Extension Act and can be exercised independent of any 

other institutional administrative authority.

Animal care and use units. Research institutions with 

large animal research programs generally have centralized 

animal care and use units that provide veterinary support, 

training in procedures, and advice on analgesics, anesthesia, 

euthanasia, and occupational health and safety. While the staff 

employed in these units cannot approve research protocols for 

the institution or make decisions specifically assigned to 

the institutional IACUC, as animal care professionals they 

are an excellent local source of information about the 

responsible care and use of animals in research.

4d. Federal and voluntary oversight

OLAW, USDA, and a voluntary accreditation program 

(Association for Assessment and Accreditation of Laboratory 

Animal Care—AAALAC) are charged with or assume the 

task of assuring that research institutions live up to their 

responsibilities for the care and use of animals in research.

OLAW. OLAW relies on an “assurance” mechanism to 

monitor institutional compliance with the PHS Policy. An 

“Assurance” is a signed agreement submitted by a research 

institution confirming that it will: P comply with applicable rules and policies for animal care 

and use,

P provide a description of the institution’s program for animal 

care and use,

P maintain an appropriate IACUC, and P appoint a responsible IO for compliance.

The Assurance is considered the cornerstone of a trust 

relationship between the institution and the PHS and grants

considerable authority to institutions for self-regulation.

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Association for Assessment and Accreditation of Laboratory Animal 

Care [AAALAC] International

AAALAC is a private nonprofit organization that promotes the humane treatment of animals 

in science through a voluntary accreditation program....

More than 650 companies, universities, hospitals, government agencies and other research 

institutions have earned AAALAC accreditation, demonstrating their commitment to responsible 

animal care and use. These institutions volunteer to participate in AAALAC's program, in 

addition to complying with the local, state and Federal laws that regulate animal research.

http://www.aaalac.orgabout.htm

An OLAW-approved Assurance and compliance with PHS 

policy are considered terms and conditions of receiving PHS 

funds. Compliance is monitored by OLAW through annual 

mandatory institutional reporting to OLAW and in the 

event of noncompliance, serious deviations from the Guide, 

or IACUC suspensions. OLAW conducts limited site visits 

and reviews, and if necessary conducts investigations of 

reported noncompliance. Institutions that fail to submit an 

Assurance or to live up to the terms of their Assurance can 

have their approval to use animals in research, teaching, 

and testing suspended.

USDA. The animal welfare regulations also have 

mandatory reporting requirements, but USDA is an 

inspection-based system carried out by USDA Veterinary 

Medical Officers. Rather than allowing institutions to 

“assure” their own compliance, USDA visits sites, either 

announced or unannounced, to check whether institutions 

are in compliance. If violations are found, the institution is 

then subject to administrative fines and penalties.

Accreditation programs. Animal use programs can 

be, and most large ones are, accredited by the Association 

for Assessment and Accreditation of Laboratory Animal 

Care (AAALAC) International. AAALAC is “a private 

nonprofit organization that promotes the humane treatment 

of animals in science through a voluntary accreditation 

program.” It is governed by a Board of Trustees representing 

scientific, professional, and educational organizations. Its 

Council on Accreditation is composed of animal care and 

use professionals and researchers who conduct the program 

evaluations that determine which institutions are awarded 

accreditation.

AAALAC relies on widely accepted guidelines, such as

the Guide, and other peer-reviewed resources when 

evaluating an institution’s animal research program. 

During the accreditation process, AAALAC accreditors 

evaluate all aspects of an institution’s animal research 

program. If an institution meets AAALAC’s standards, it 

receives an accreditation for a specified period of time and 

can use this accreditation to demonstrate its commitment 

to high standards for the care and use of animals.

4e. Principles for the responsible use of animals in research

There is a range of views about the morality of animal 

experimentation. Antivivisectionists hold that humans have 

no right to place their own welfare above the welfare of 

animals and therefore all animal experimentation is 

immoral. Many animal welfare organizations find that 

some scientifically necessary experimentation is acceptable, 

but that it should be kept to a minimum and conducted on 

animals low on the phylogenetic scale, in ways that minimize 

pain and suffering. Many scientists feel that extensive 

animal experimentation is necessary and moral, provided 

it is based on sound scientific practices and utilizes quality 

animal care, along with minimization of pain and distress.

To help researchers and IACUCs make decisions about 

the responsible and appropriate use of animals in research, 

the Federal government has adopted nine Principles for the 

Utilization and Care of Vertebrate Animals used in Testing, 

Research, and Training (see box, next page). These principles 

specify requirements for planning and conducting research 

and are useful to investigators and IACUCs. When questions 

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arise, PHS policy and USDA regulations provide further 

criteria for researchers and IACUCs to consider in 

assessing protocols.

Further practical advice on ways to assure appropriate 

respect for animals can be found in the “three Rs of 

alternatives” devised by Russell and Burch in 1959:

P Replacement—using non-animal models such as 

microorganisms or cell culture techniques, computer 

simulations, or species lower on the phylogenetic scale.

P Reduction—using methods aimed at reducing the numbers 

of animals such as minimization of variability, appropriate 

selection of animal model, minimization of animal loss, 

and careful experimental design.

P Refinement—the elimination or reduction of unnecessary 

pain and distress.

Although PHS Policy is not explicit in addressing refinements,

the requirements to use appropriate animal models and 

numbers of animals and to avoid or minimize pain and 

distress are, for all practical purposes, synonymous with 

requirements to consider alternative methods that reduce, 

refine, or replace the use of animals. USDA animal welfare 

regulations require a written narrative of the methods used 

and sources consulted to determine the availability 

of alternatives.

Knowing the concerns society has about the use of animals 

in research, researchers should be prepared to explain why 

they are using a particular species in their research; why pain 

or discomfort cannot be avoided; why it may be necessary to 

sacrifice the animals; and why non-animal options cannot be 

used to gather the same information or to achieve the same 

ends, based on the principles set out in the U.S. Government 

Principles and other sources of guidance.

4f. Broader responsibilities

Even with all of the care and review that currently is used 

to assure the responsible use of animals in research, animal 

research is still controversial and raises concerns that 

cannot easily be set aside.

Pain and suffering. Some experimental information 

cannot be gained without subjecting animals to pain and 

suffering. Researchers who study the effects of severe 

trauma, such as child abuse, can learn a great deal about 

physiological change by subjecting animals to different levels 

of pain and suffering. This can be done by administering 

mild electric shocks, forcing animals such as rats to swim 

until they reach exhaustion, or subjecting them to other 

traumatic treatments. How much pain and suffering is 

acceptable in experiments is not easily determined.

Concern for different species. There is widespread 

agreement that some animals, such as primates and 

US Government Principles for the Utilization and Care of Vertebrate 

Animals Used in Testing, Research, and Training 

[Researchers should:]

1. follow the rules and regulations for the transportation, care, and use of animals;

2. design and perform research with consideration of relevance to human or animal health, 

the advancement of knowledge, or the good of society;

3. use appropriate species, quality, and the minimum number of animals to obtain valid 

results, and consider non-animal models;

4. avoid or minimize pain, discomfort, and distress when consistent with sound scientific 

practices;

5. use appropriate sedation, analgesia, or anesthesia; 

6. painlessly kill animals that will suffer severe or chronic pain or distress that cannot be 

relieved;

7. feed and house animals appropriately and provide veterinary care as indicated;

8. assure that everyone who is responsible for the care and treatment of animals during 

the research is appropriately qualified and trained; and

9. defer any exceptions to these principles to the appropriate IACUC.

http://grants1.nih.gov/grants/olaw/references/phspol.htm

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household pets, deserve more protection than other animals, 

such as worms and clams. There is less agreement about the 

relative protection that is needed for species within general 

groups of animals, such as cats, dogs, pigs, rabbits, mice, 

and rats. What moral considerations set one species apart 

from another when making decisions about the use to which 

it can be put in experiments?

Unnecessary experiments. Members of the public 

disagree about the use to which animals can reasonably be 

put in research, testing, and teaching. Animals are used to 

test the safety of experimental drugs, but should they also 

be used to test the toxicity of chemicals or cosmetics (as 

once was common, but has largely been abandoned)? Should 

they be used to train surgeons to do elective surgery? Do 

researchers sometimes use more animals in an experiment 

than is absolutely necessary or use animals when other 

means of testing would provide the same information?

Discussions about the responsible use of animals in research 

are not likely to dissipate in the near future. If animals 

are essential to your research and cannot be replaced; if 

you cannot reduce the number without compromising the 

experiment; and if you cannot further refine your methods 

to reduce pain and suffering, then presumably you have 

done all you can to meet your responsibility. However, do 

not forget that society does not have to permit the use of 

animals in research. It can seek to protect animals through 

complex and expensive regulations if it loses confidence in 

the research community’s ability to regulate itself.

i

Questions for discussion

 1 Should all animals used in research be treated the same 

or are there reasons to treat some animals differently than 

others?

 2 Are there some animals that should not be used in 

research? 

 3 What circumstances justify pain and suffering of 

experimental animals?

 4 How should research animals be procured? How should 

they be housed and treated during experiments?

 5 How should members of IACUCs be selected? What 

constituencies should be represented on IACUCs?

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Resources

Policies, Reports, and Policy Statements

United States. Congress. Animal Welfare Act, PL 89-544, 1966. 

(available at: http://www.nal.usda.gov/awic/legislat/awa.htm)

National Academy of Sciences. Institute of Laboratory Animal 

Resources Commission of Life Sciences. Guide for the Care and 

Use of Laboratory Animals, Washington, DC: National Academy 

Press, 1996. (available at: http://www.nap.edu/readingroom/books/

labrats/)

Public Health Service. Public Health Service Policy on Humane 

Care and Use of Laboratory Animals, Washington, DC: GPO, 

2002. (available at: http://grants2.nih.gov/grants/olaw/references/

phspol.htm)

U.S. Department of Agriculture. Animal Care Policy 

Manual, Washington, DC: GPO, 2002. (available at: http:

//www.aphis.usda.gov/ac/polmanpdf.html)

National Institutes of Health. U.S. Government Principles for the 

Utilization and Care of Vertebrate Animals Used in Testing, 

Research, and Training, Bethesda, MD: National Institutes of 

Health, nd. (available at: http://grants1.nih.gov/grants/olaw/

references/phspol.htm)

General Information Web Sites

Association for the Assessment and Accreditation of Laboratory 

Animal Care. Home Page, nd. http://www.aaalac.org/

National Institutes of Health. Office of Laboratory Animals Welfare. 

Home Page, 2003. http://grants2.nih.gov/grants/olaw/olaw.htm

U.S. Department of Agriculture. Animal Care Program. Home Page, 

nd. http://www.aphis.usda.gov/ac/

Additional Reading

Baird, RM, Rosenbaum, SE. Animal Experimentation: The Moral 

Issues, Buffalo, NY: Prometheus Books, 1991.

Gluck, JP, DiPasquale, T, Orlans, FB. Applied Ethics in Animal 

Research: Philosophy, Regulation, and Laboratory Applications, 

West Lafayette, IN: Purdue University Press, 2002.

Hart, LA. Responsible Conduct with Animals in Research, New York: 

Oxford University Press, 1998.

Monamy, V. Animal Experimentation: A Guide to the Issues, 

Cambridge, United Kingdom; New York: Cambridge University 

Press, 2000.

Paul, EF, Paul, J. Why Animal Experimentation Matters: The Use 

of Animals in Medical Research, New Studies in Social Policy, 

New Brunswick, NJ: Social Philosophy and Policy Foundation: 

Transaction, 2001.

Rudacille, D. The Scalpel and the Butterfly: The War Between Animal 

Research and Animal Protection, New York: Farrar, Straus and 

Giroux, 2000.

Russell, WMS, Burch, RL. The Principles of Humane Animal 

Experimental Technique, London: Methuen, 1959.

Smith, CP, Animal Welfare Information Center (U.S.). Animal 

Welfare and Ethics: Resources for Youth and College Agricultural 

Educators, Revised and enlarged ed. AWIC resource series; no. 

6, Beltsville, MD: U.S. Department of Agriculture Agricultural 

Research Service National Agricultural Library Animal Welfare 

Information Center, 2000.

Chapter 4: The Welfare of Laboratory Animals
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5. Conflicts of Interest

Researchers work hard, often spending long hours and sometimes weekends in the laboratory, library, or at 

professional meetings. Their motivation for working hard 

stems from many sources. Research:

P advances knowledge,

P leads to discoveries that will benefit individuals and society,

P furthers professional advancement, and/or

P results in personal gain and satisfaction.

Each of these incentives or interests is commonly recognized 

as responsible and justifiable.

Researchers are allowed to and even encouraged to profit 

from their work (see the discussion of the Bayh-Dole Act, 

below). Professional advancement as a researcher depends 

on productivity. Society expects researchers to use the 

Case Study

E

arly in his undergraduate education, Dr. Sam M. decided to dedicate his studies to finding a cure 

for a psychological disorder that seemed to run in his family. As a biology major, he pursued 

independent research projects and worked long hours as a lab assistant. He then enrolled in a PhD 

program in psychopharmacology and is now completing a 3-year postdoc in the neurosciences.

During his postdoc he worked on a promising compound he first discovered during his graduate years. 

His work has gone well and he feels the time is right to explore clinical applications. After more than a 

decade of living on student and postdoc wages, he is also ready for a better paying job.

As Sam weighs the options of an academic versus an industry job, he begins to wonder about who 

owns or will own the useful applications of his work, if and when there are any. Will it be owned by:

his graduate institution, where he first worked on the promising compound?

his postdoc institution, where he refined his ideas?

his future academic or industry employer?

himself, based on his hard work and innovative ideas?

society, which funded parts of his education and most of his research?

Who has a legitimate interest in Sam’s work and when do his own personal financial

interests create a conflict of interest?

Chapter 5: Conflicts of Interest

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ORI Introduction to the Responsible Conduct of Research

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funds it supplies to advance knowledge and to make useful 

discoveries. Personal gain and satisfaction provide strong 

incentives for doing a good job and acting responsibly.

Researchers’ interests can and often do conflict with one 

another. The advancement of knowledge is usually best 

served by sharing ideas with colleagues, putting many 

minds to work on the same problem. But personal gain is 

sometimes best served by keeping ideas to oneself until they 

are fully developed and then protected through patents, 

copyrights, or publications. Legitimate research interests 

can create competing responsibilities and lead to what is 

commonly called conflicts of interest.

It is important to understand that conflicts of interest 

are not inherently wrong. The complex and demanding 

nature of research today inevitably gives rise to competing 

obligations and interests. Researchers are expected to serve 

on committees, to train young researchers, to teach, and 

to review grants and manuscripts at the same time they 

pursue their own research. Conflicts of interest cannot and 

need not be avoided. However, in three crucial areas:

P financial gain,

P work commitments, and

P intellectual and personal matters,

special steps are needed to assure that conflicts do not 

interfere with the responsible practice of research.

5a. Financial conflicts

Personal interests and the prospect of financial gain should

not, but unfortunately can, improperly influence a researcher’s 

fundamental obligation to truth and honesty. Although 

researchers should not, they can find ways to delay 

unfairly a competitor’s work in order to secure a patent or 

some other financial advantage for themselves. Financial 

interests can provide a strong incentive to overemphasize 

or underemphasize research findings or even to engage 

in research misconduct (Chapter 2). Financial conflicts 

of interest are situations that create perceived or actual 

tensions between personal financial gain and adherence to 

the fundamental values of honesty, accuracy, efficiency, and 

objectivity (Section I).

Financial interests are not inherently wrong. Researchers 

are permitted to benefit financially from their work. A 1980 

Congressional law known as the Bayh-Dole Act encourages 

researchers and research institutions to use copyrights, 

patents, and licenses to put research ideas to use for the 

good of the public. Prior to this time, there were no uniform 

policies regulating the ownership of ideas developed with 

public funding. Bayh-Dole essentially gives that ownership to 

research institutions as an incentive to put ideas to work for 

the overall good of society. It not only approves of but,

in fact, strongly encourages researchers and research 

institutions to have financial interests as a way of ensuring 

that the public’s investment in research is used to stimulate 

economic growth.

While financial interests should not and in most instances 

do not compromise intellectual honesty, they certainly can, 

especially if the financial interests are significant. 

Bayh-Dole Act (Public Law: 96-517)

Policy and Objective

35 USC Part II, Chapter 18, Section 200

It is the policy and objective of the Congress to use the patent system to promote the utilization 

of inventions arising from federally supported research and development efforts; to promote 

collaboration between commercial concerns and nonprofit organizations, including universities; 

to ensure that inventions made by nonprofit organizations and small business firms are used in a 

manner to promote free competition and enterprise without unduly encumbering future research 

and discovery; to promote the commercialization and public availability of inventions made in the 

United States by United States industry and labor; to ensure that the Government obtains sufficient 

rights in federally supported inventions to meet the needs of the Government and protect the 

public against nonuse or unreasonable use of inventions; and to minimize the costs of administering 

policies in this area.

http://www.uscode.house.gov/DOWNLOAD/35C18.DOC

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Universities are currently starting hundreds of new 

businesses based on researchers’ ideas. Some of these 

businesses will generate significant profits (hundreds of 

thousands to millions of dollars each year). If the difference 

between commercial success and failure rests on one key 

publication, the pressure to put the best face on that 

publication can be considerable.

Financial conflicts also arise from the ever-present 

pressure researchers have to secure funds to support their 

research. A private sponsor might withdraw support from a 

project if it does not produce the “right” results. Success in 

the stiff competition for research grants can rest on having 

the “right” preliminary results. Research is expensive, 

funding often in short supply. The pressure simply to 

survive, much less profit personally, can and does create 

financial conflicts of interest.

Federal policies. Concerns about the actual or potential 

adverse effect of financial interests on research prompted 

the Public Health Service (PHS) and the National Science 

Foundation (NSF) to adopt conflict of interest policies in the 

mid-1990’s. These policies require research institutions to 

establish administrative procedures for:

P reporting significant conflicts before any research is 

undertaken;

P managing, reducing, or eliminating significant financial 

conflicts of interest; and

P providing subsequent information on how the conflicts were 

handled.

Significant financial conflict is defined as:

P additional earnings in excess of $10,000 a year, or

P equity interests in excess of 5 percent in an entity that 

stands to benefit from the research.

The financial interests of all immediate family members are 

included in these figures.

State and local policies. Although the Federal 

requirements apply only to PHS- and NSF-funded research, 

many research institutions have adopted global policies 

that apply to all researchers. Many also use different values 

for defining significant, to as low as any financial interest. 

Researchers therefore should check their local conflict-ofinterest policy to find out when and what they are required 

to report. They also need to keep in mind that many states 

have their own conflict-of-interest policies, which apply to 

all state-paid employees.

Department of Health and Human Services

Conflict of Interest Definitions

45 CFR 94.3

Significant Financial Interest means anything of monetary value, including but not limited 

to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests 

(e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., 

patents, copyrights and royalties from such rights). The term does not include:

(1) Salary, royalties, or other remuneration from the applicant institution;

(2) Any ownership interests in the institution, if the institution is an applicant under the 

SBIR program;

(3) Income from seminars, lectures, or teaching engagements sponsored by public or 

nonprofit entities;

(4) Income from service on advisory committees or review panels for public or nonprofit entities;

(5) An equity interest that when aggregated for the Investigator and the Investigator’s 

spouse and dependent children, meets both of the following tests: Does not exceed 

$10,000 in value as determined through reference to public prices or other reasonable 

measures of fair market value, and does not represent more than a five percent ownership interest in any single entity; or

(6) Salary, royalties or other payments that when aggregated for the investigator and the 

investigator’s spouse and dependent children over the next twelve months, are not 

reasonably expected to exceed $10,000. 

http://www.access.gpo.gov/nara/cfr/waisidx_02/45cfr94_02.html

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Professional societies and journal policies.

A number of professional societies have issued reports 

or made recommendations on appropriate ways to handle 

conflicts of interest. Similarly, more and more journals now 

require researchers to disclose real or potential financial 

conflicts. Sometimes disclosure must be made to the journal 

editor, who decides what, if any, action is needed. Sometimes 

disclosures must be included in the publication itself. Before 

submitting an article to a journal for publication, researchers 

should carefully check and make sure they have followed 

that publication’s conflict of interest policies.

5b. Conflicts of commitment

Conflicts of commitment arise from situations that place 

competing demands on researchers’ time and loyalties. At 

any time, a researcher might be:

P working on one or more funded projects;

P preparing to submit a request for a new project;

P teaching and advising students;

P attending professional meetings and giving lectures;

P serving as a peer reviewer;

P sitting on advisory boards; or

P working as a paid consultant, officer, or employee in a 

private company.

Each of these activities requires time and makes demands 

on a researcher’s institutional commitments. Care needs 

to be taken to assure that these commitments do not 

inappropriately interfere with one another.

Allocation of time. Researchers must be careful to 

follow rules for the allocation of time. Federally funded 

researchers must follow the rules for cost accounting 

published by the Office of Management and Budget 

in a document known as Circular A-21. Most research 

New England Journal of Medicine

Conflict of Interest Policy

June 13, 2002

[B]eginning with this issue of the Journal, we have modified the statement in Information for 

Authors to read as follows: 

Because the essence of reviews and editorials is selection and interpretation of 

the literature, the Journal expects that authors of such articles will not have any 

significant financial interest in a company (or its competitor) that makes a product 

discussed in the article.

The addition of the word “significant” acknowledges that not all financial associations are 

the same. Some, such as the receipt of honorariums for occasional educational lectures 

sponsored by biomedical companies, may be appropriately viewed as minor and unlikely 

to influence an author’s judgment. Others, such as ownership of substantial equity in a 

company, are of greater concern. It is our intent to focus on the financial relationships that, 

in our judgment, could produce bias, or the perception of bias, in an article.

http://content.nejm.org/cgi/content/full/346/24/1901#R6

AAMC Task Force Recommendations

Financial Conflicts of Interest in Clinical Research

(December 2001)

B. In the event of compelling circumstances, an individual holding significant financial 

interests in human subjects research may be permitted to conduct the research. Whether 

the circumstances are deemed compelling will depend in each case upon the nature of the 

science, the nature of the interest, how closely the interest is related to the research, and 

the degree to which the interest may be affected by the research....

C. Institutional policies should require full prior reporting of each covered individual’s 

significant financial interests that would reasonably appear to be affected by the 

individual’s research, updated reporting of any relevant change in financial circumstances, 

and review of any significant financial interests in a research project by the institution’s 

COI committee prior to final IRB approval of the research. COI committee findings and 

determinations should inform the IRB’s review of any research protocol or proposal, 

although the IRB may require additional safeguards or demand reduction or elimination of 

the financial interest....

http://www.aamc.org/members/coitf/firstreport.pdf

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institutions also have rules for how researchers spend their 

time, particularly time serving as paid consultants, giving paid 

lectures, or working as an employee in a private company. 

At a minimum, these rules require that researchers:

P honor time commitments they have made, such as devoting 

a specified percentage of time to a grant or contract;

P refrain from charging two sources of funding for the same 

time; and

P seek advice if they are unsure whether a particular 

commitment of time is allowed under an institution’s or the 

Federal Government’s policies.

Although researchers will frequently work on several 

projects at the same time, in the final analysis primary 

work obligations must be met. In addition, the time devoted 

to one project ordinarily cannot be billed to another.

Relationships with students. Academic researchers 

involved in start-up ventures often have opportunities to 

hire students. This puts them in a situation where they can 

hire their own students. As mentors, they have a primary 

obligation to help students develop into independent 

researchers. As heads of start-up companies, their primary 

obligation is to see promising ideas commercialized. While 

the two responsibilities can complement one another, they 

can also be in conflict. Should an individual who is both the 

researcher’s student and employee be advised to develop 

a promising idea that could lead to an independent career 

or to work on a more routine problem that will benefit the 

start-up company? Situations such as these create conflicts 

and should be avoided or appropriately managed.

Use of resources. Equipment and supplies purchased 

with public funds can easily be used to advance private 

research interests. While this might seem like a harmless 

practice, particularly if the equipment is not in constant 

use, unless a researcher has permission to use the 

equipment to support private research, this practice is not 

appropriate. The equipment can be used for other university 

work since this is allowed by the government. But it cannot 

be used for a personal project without permission. It also 

cannot be used for research that is explicitly prohibited by 

the Federal government, such as stem cell research using 

lines not authorized by the President’s policy.

Disclosure of affiliations. It is widely agreed that 

outside affiliations that create conflicts of interest should 

be listed on academic publications, but should researchers 

list their academic affiliations on other publications? As 

president or CEO of a new company, is it appropriate for 

a researcher to also note in the end-of-the-year financial 

report that she or he is also a full professor at a prestigious 

university? Should researchers who serve on private boards 

list their academic affiliation? Researchers must be careful 

to separate their academic or institutional work from their 

Stanford University

Conflict of Commitment Policy

1. Outside consulting privileges are not normally available to Academic Staff. They may 

consult only with permission, as noted below. Under no circumstances may any Academic 

Staff member’s outside consulting work exceed the limits imposed by the faculty consulting 

policy, i.e., 13 days per calendar quarter (that is, one day in seven) on a full-time 

equivalent basis.... Academic Staff may not use University resources, including facilities, 

personnel, equipment, or confidential information, except in a purely incidental way, as 

part of any outside consulting activities nor for any other purposes that are unrelated to 

the mission of the University.

2. Academic Staff must maintain a significant presence on campus (main or overseas) 

throughout each quarter in which they are employed by Stanford, consistent with the 

scope of their appointment.

3. Academic Staff must not allow other professional activities to detract from their primary 

allegiance to Stanford. For example, Academic Staff employed on a full-time basis must 

not have significant outside managerial responsibilities nor act as a principal investigator 

on sponsored projects that could be conducted at Stanford University but instead are 

submitted and managed through another institution.

http://www.stanford.edu/dept/DoR/rph/4-4.html

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private work. In particular, they should not inappropriately 

use their institutional research affiliation to advance their 

private interests by implying, for example, that private work 

has the support of their research institution if it does not.

Representing outside entities. The results researchers 

commercialize in private ventures, such as drugs used 

in a university hospital, a software program used in an 

accounting office, or a consultation service for employees, 

might be used by their primary employer. In these cases, 

the researcher could be the resident expert on the goods and 

services in question. Each employer in this case presumably 

wants the best deal on the goods and services, whereas the 

researcher is also interested in personal profits, creating a 

conflict of commitment.

Since the situations described above are often not 

subject to specific policies or guidance, judgments about 

responsible conduct often rest with the researcher. In making 

judgments about the best way to deal with institutional 

conflicts, it is helpful to take into consideration:

P how others will view your commitments and

P the judgment of someone who has no stake in the outcome.

In addition, it is always a good idea, even if it is not

required, to seek advice from an institutional official.

5c. Personal and intellectual conflicts

Researchers are also expected to avoid bias in proposing, 

conducting, reporting, and reviewing research. They 

therefore should be careful to avoid making judgments or 

presenting conclusions based solely on personal opinion or 

affiliations rather than on scientific evidence.

Personal conflicts are usually the easiest to identify 

and resolve. Researchers generally should not serve as 

reviewers for grants and publications submitted by close 

colleagues and students. Their presumed interest in seeing 

Federal Advisory Committee Act

Public Disclosure Requirements Applicable to the 

National Academy of Sciences

January 5, 1997

The Academy shall determine and provide public notice of the names and brief biographies of 

individuals that the Academy appoints or intends to appoint to serve on the committee. The 

Academy shall determine and provide a reasonable opportunity for the public to comment on 

such appointments before they are made or, if the Academy determines such prior comment 

is not practicable, in the period immediately following the appointments. The Academy shall 

make its best efforts to ensure that (A) no individual appointed to serve on the committee has 

a conflict of interest that is relevant to the functions to be performed, unless such conflict is 

promptly and publicly disclosed and the Academy determines that the conflict is unavoidable, (B) 

the committee membership is fairly balanced as determined by the Academy to be appropriate 

for the functions to be performed, and (C) the final report of the Academy will be the result 

of the Academy’s independent judgment. The Academy shall require that individuals that the 

Academy appoints or intends to appoint to serve on the committee inform the Academy of the 

individual’s conflicts of interest that are relevant to the functions to be performed.

http://www4.nas.edu/NAS/nashome.nsf/Multi+Database+Search/9F5DB50425874D65852566EA0078DB98?OpenDocument

their colleagues and students succeed could conflict with 

their obligation to makes judgments based solely on the 

evidence at hand. Most granting agencies require reviewers

to disclose conflicts of interest, including personal conflicts, 

as a condition of service.

Intellectual conflicts are more difficult to identify, but are 

nonetheless important. If a researcher holds strong personal 

views on the importance of a particular area of research 

or set of research findings, those views should be disclosed 

so that others can take them into consideration when 

judging the researcher’s statements. The same is true of 

strong moral convictions that could influence a researcher’s 

scientific opinions. This is particularly true when researchers 

serve as expert witnesses or advisors. It is for precisely this 

reason that the National Academy of Sciences, which has 

provided essential science advice to the Federal Government 

since the Civil War, carefully considers all conflicts of 

interest when it sets up advisory panels (see box, below).

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Questions for discussion

 1 Is $10,000 or a 5 percent equity stake an appropriate level 

for raising concerns about possible conflicts of interest or 

should other values be used?

 2 Should researchers be allowed/encouraged to profit personally 

from their research apart from their normal compensation?

 3 What are appropriate mechanisms for managing financial 

conflicts of interest?

 4 What are appropriate mechanisms for protecting students 

from a mentor’s conflict of commitment?

 5 What are appropriate mechanisms for managing intellectual 

and personal conflicts of interest?

5d. Reporting and managing significant conflicts

If a researcher has a significant conflict of interest, as 

defined by Federal, state, institutional, journal, or other 

policies, it must be reported and managed or eliminated. 

“Managing” a conflict means finding a way to assure that 

the interests do not adversely influence the research. Some 

options for managing conflicts of interest include:

P requiring full disclosure of all interests so that others are 

aware of potential conflicts and can act accordingly;

P monitoring the research or checking research results for 

accuracy and objectivity; or

P removing the person with the conflict from crucial steps in 

the research process, such as the interpretation of data or 

participating in a particular review decision.

These and other options are either worked out by a conflict 

of interest review committee or an administrator charged 

with overseeing conflicts of interest.

If the conflicts cannot be managed and could have an 

adverse impact on the research, then they must be 

eliminated, by divesting equity, reducing the income 

received from the research, assigning supervisory 

responsibilities to someone else, stepping out of the room 

when a particular proposal is discussed, or some other action.

Finally, it is important to note that research administrators, funding agencies, journal editors, and conflict of 

interest committees, not the researcher, should make final 

decisions about the management of conflicts of interest. This 

protects the researcher from charges of acting in her or his 

own interest and helps assure that the most responsible 

decisions are made.

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Resources

Policies, Reports, and Policy Statements

Association of American Medical Colleges. Guidelines for Dealing 

with Faculty Conflicts of Commitment and Conflicts of Interest in 

Research, Washington, DC: AAMC, 1990. (available at: 

http://www.aamc.org/research/dbr/coi.htm)

National Institutes of Health. “Objectivity in Research,” Federal 

Register 60, 132 (1995): 35809-35819. (available at: 

http://grants2.nih.gov/grants/guide/notice-files/not95-179.html)

National Science Foundation. “Investigator Financial Disclosure 

Policy,” Federal Register 60, 132 (1995): 35820. (available at: 

http://www.nsf.gov/pubs/stis1996/iin118/iin118.txt)

US Congress. 105th Congress. First Session. Federal Advisory 

Committee Act Amendments of 1997, PL 105-153 (1997). (available 

at: http://thomas.loc.gov/)

Office of Management and Budget. Circular A-21, Washington, 

DC: OMB, 2000. (available at: http://www.whitehouse.gov/omb/

circulars/a021/a021.html)

Association of American Universities. Report on Individual and 

Institutional Financial Conflict of Interest, Washington, DC: AAU, 

2001. (available at: http://www.aau.edu/research/conflict.html)

Food and Drug Administration. Guidance: Financial Disclosure by 

Clinical Investigators, Washington, DC: FDA, 2001. (available at: 

http://www.fda.gov/oc/guidance/financialdis.html)

Office for Human Research Protections. Public Health Service. Draft 

Interim Guidance: Financial Relationships in Clinical Research: 

Issues for Institutions, Clinical Investigators, and IRBs to 

Consider when Dealing with Issues of Financial Interests and 

Human Subject Protection, Washington, DC: OHRP, 2001. 

(available at: http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/

finguid.htm)

Association of American Medical Colleges. Task Force on 

Financial Conflicts of Interest in Clinical Research Protecting 

Subjects, Preserving Trust, Promoting Progress II: Principles 

and Recommendations for Oversight of an Institution’s Financial 

Interests in Human Subjects Research, Washington, DC: AAMC, 

2002. (available at: http://www.aamc.org/members/coitf/)

Council on Government Relations. Recognizing and Managing 

Personal Conflicts of Interest, Washington, DC: COGR, 2002. 

(available at: http://www.cogr.edu/files/publications_research.htm)

Drazen, JM, Curfman, GD. “Financial Associations of Authors,” 

The New England Journal of Medicine 346, 24 (2002): 1901-1902. 

(available at: http://content.nejm.org/cgi/content/full/346/24/

1901#R6)

Institute of Medicine. National Academies of Science. Study Conduct: 

Bias and Conflict of Interest, Washington, DC: IOM, nd.

(available at: http://www.iom.edu/subpage.asp?id=5350)

General Information Web Sites

Association of American Universities. Conflict of Interest and 

Misconduct, nd. http://www.aau.edu/research/conflict.html

Association of University Technology Managers. Home Page, nd. 

http://www.autm.net/index_ie.html

National Institutes of Health. Office of Extramural Research. 

Conflict of Interest, nd. http://grants1.nih.gov/grants/policy/coi/

Additional Reading

Boyd, EA, Bero, LA. “Assessing Faculty Financial Relationships 

With Industry: A Case Study,” Journal of the American Medical 

Association 284 (2000): 2209-2214.

Campbell, TID. “Understanding the Potential for Misconduct in 

University-industry Relationships: An Empirical Study.” In 

Perspectives on Scholarly Misconduct in the Sciences, edited by 

John M. Braxton, 259-282. Columbus, OH: Ohio State University 

Press, 1999.

Cho, MK, Shohara, R, Schissel, A, Rennie, D. “Policies on Faculty 

Conflicts of Interest at US Universities,” Journal of the American 

Medical Association 284 (2000): 2203-2208.

Jefferson, T, Smith, R, Yee, Y, Drummond, M, Pratt, M, Gale, R. 

“Evaluating the BMJ Guidelines for Economic Submissions: 

Prospective Audit of Economic Submissions to BMJ and The 

Lancet,” Journal of the American Medical Association 280, 3 

(1998): 275-277.

National Institutes of Health. Financial Conflict of Interest and 

Research Objectivity: Issues for Investigators and Institutional 

Review Boards, Washington, DC: NIH, 2000. (available at: http:

//grants1.nih.gov/grants/guide/notice-files/NOT-OD-00-040.html)

Shamoo, AE. “Role of Conflict of Interest in Scientific Objectivity: 

A Case of a Nobel Prize Work,” Accountability in Research 2, 1 

(1992): 55-75.

United States. Congress. House. Committee on Government 

Operations. Human Resources and Intergovernmental Relations 

Subcommittee. Federal Response to Misconduct in Science, Are 

Conflicts of Interest Hazardous to our Health?: Hearing before a 

Subcommittee of the Committee on Government Operations, House 

of Representatives, One Hundredth Congress, second session, 

September 29, 1988, Washington: U.S. G.P.O., 1989.

Chapter 5: Conflicts of Interest
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Part III. Research
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Part III: Conducting 

Research

ONCE PLANNING IS COMPLETE, RESEARCHERS CAN

finally get on with the work they presumably 

enjoy most—conducting research. This is when 

hypotheses and new techniques are 

finally tested, when efforts get 

underway to solve problems and 

put new information to use. At this stage in 

any research project, three additional areas

of responsibility become important:

Chapter 6, Data Management Practices, discusses how 

researchers should collect, store, protect, and share data, 

mindful of the need to maintain its integrity, validity, and 

accuracy. Ownership issues must be considered. Some 

data must be shared with colleagues; other data must 

be protected from unapproved use. Some data must be 

preserved for specified periods of time; some destroyed to 

protect confidentiality.

Chapter 7, Mentor and Trainee Responsibilities, covers 

the role of the researcher as teacher. The continued growth 

of research in all fields is vitally dependent upon a constant 

supply of well-trained researchers. New researchers learn 

many of the techniques of their profession as they work 

side by side with established researchers. Established 

researchers therefore should take their responsibilities as 

mentors seriously.

Chapter 8, Collaborative Research, explores special 

responsibilities that arise when researchers work with 

colleagues, whether in their own discipline or in other 

disciplines, at other institutions, and in other countries. 

When collaborating with colleagues, how should intellectual 

property agreements be worked out? Which country or 

institution’s research policies should be followed? How should 

project funds and project responsibilities be managed?

Part III: Conducting Research
87

Case Study

Dr. Marion W. long ago learned that good data management practices are essential to responsible research. She therefore carefully supervises the work of her assistants and 

students, checking notebooks, backing up computer files, and from time to time verifing results 

for herself. 

As she is wrapping up work on one project before starting another, the technology transfer 

officer at her university calls. A graduate student who previously worked in her laboratory has 

moved to another university and filed a patent for work that may have been done in Dr. W.’s 

laboratory on her research funds? If this is the case, the graduate student may not be able to 

lay claim to the patent.

What records will Dr. W. need to prove that the work was done in her laboratory?

Who owns and controls the data collected in her laboratory? 

Do computer records pose any unique problems in this case?

6. Data Management Practices

Researchers spend much of their time collecting data. Data are used to confirm or reject hypotheses, to identify 

new areas of investigation, to guide the development 

of new investigative techniques, and more. We launch 

space probes to collect data that help us understand the 

origins of the universe and use gene databases as tools for 

understanding and curing disease. Science as we know and 

practice it today cannot exist without data.

Data management practices are becoming increasingly 

complex and should be addressed before any data are collected by taking into consideration four important issues:

P ownership,

P collection,

P storage, and

P sharing.

The integrity of data and, by implication, the usefulness of 

the research it supports, depends on careful attention to 

detail, from initial planning through final publication.

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6a. Data ownership

Research produces data. As a product, common sense might 

suggest that the person who conducts the research should 

own the product—the data. In fact, conditions imposed by 

funders, research institutions, and data sources may dictate 

otherwise.

Funders. Funders provide support for research for 

different reasons. Government is interested in improving 

the general health and welfare of society. Private companies 

are interested in profits, along with benefits to society. 

Philanthropic organizations are interested in advancing 

particular causes. These different interests translate into 

different ownership claims. Typically:

P Government gives research institutions the right to use data 

collected with public funds as an incentive to put research 

to use for the public good (see the discussion of the 

Bayh-Dole Act, Chapter 5).

P Private companies seek to retain the right to the 

commercial use of data.

P Philanthropic organizations retain or give away ownership 

rights depending on their interests.

Since the claims of funders can and do vary considerably, 

researchers must be aware of their obligations to them 

before they begin collecting data.

With government funding, it is important to distinguish 

between grants and contracts. Under grants, researchers must carry out the research as planned and submit 

reports, but control of the data remains with the institution 

that received the funds (see below). Contracts require the 

researcher to deliver a product or service, which is then 

usually owned and controlled by the government. If your 

research is supported with government funds, make sure 

you know whether you are working under a grant or a 

contract. The difference is significant and could determine 

who has the right to publish and use your results.

Research institutions. Support for research is

typically awarded to research institutions, not to individual 

researchers. As the recipients of research funds, research 

institutions have responsibilities for budgets, regulatory 

compliance, contractual obligations, and data management. 

To assure that they are able to meet these responsibilities, 

research institutions claim ownership rights over data 

collected with funds given to the institution. This means 

that researchers cannot automatically assume that they can 

take their data with them if they move to another institution. 

The research institution that received the funds may have 

rights and obligations to retain control over the data.

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University of Pittsburgh

Guidelines on Data Retention and Access

Data Ownership and Access to Data

Both the principal investigator and the University have responsibilities, and hence, rights 

concerning access to, use of, and maintenance of original research data. Research data belongs 

to the University of Pittsburgh, which can be held accountable for the integrity of the data 

even after the researchers have left the University. Although the primary data should remain in 

the laboratory where it originated (and hence at the University), consistent with the precepts 

of academic freedom and intellectual integrity, the investigator may be allowed to retain 

the research records and materials created by him/her. In the event that the investigator 

leaves the University, an Agreement on Disposition of Research Data may be negotiated by 

the investigator and the Department Chair or Dean to allow transfer of research records. 

However, consistent with the same precepts, it should be specified in the agreement that the 

University has the right of access to all research records and materials for a reasonable cause 

after reasonable prior notice regardless of the location of the responsible investigator....

Some circumstances may warrant an exception, requiring that the primary data be retained 

by the University....

Split of collaborative team: When a collaborative team is dissolved, University of Pittsburgh 

policy states that each member of the team should have continuing access to the data 

and materials with which he/she had been working, unless some other agreement was 

established at the outset. The unique materials prepared in the course of the research should 

be available/accessible under negotiated terms of a transfer agreement.

http://www.pitt.edu/~provost/retention.html

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Data sources. Increasingly research subjects and 

other entities that are the source of data are seeking some 

control over data derived from them. Countries with unique 

resources, such as tropical rain forests, individuals with 

rare medical conditions, and entities with unique databases, 

have at one time or another claimed ownership of research 

results based on their data. Research subjects and entities 

that have or can be the source of important data may no 

longer be willing to provide or be the source of data without 

some ownership stake in the end results.

Well before any data are collected, ownership issues and 

the responsibilities that come with them need to be carefully 

worked out. Before undertaking any work, make sure you 

can answer the following questions: P Who owns the data I am collecting? P What rights do I have to publish the data? P Does collecting these data impose any obligations on me?

If you do not have firm answers for each of these questions, 

preferably in writing when financial interests are involved, 

you are not ready to begin your research.

It is also important to note that in most cases ownership 

provisions must be approved by the institution that receives 

and is responsible for the administration of research funds. 

Researchers therefore should not enter into agreements 

that affect the control and use of data without getting 

institutional approval. The results could be disastrous and 

expensive if ownership is disputed later.

6b. Data collection

There is no one best way to collect data. Different types 

of research call for different collection techniques. There 

are, however, four important considerations that apply to 

all data collection and that will help ensure the overall 

integrity of both the process and the information collected.

Appropriate methods. Reliable data are vitally 

dependent on reliable methods. If you use a test that can 

detect an effect in one of every 100 samples to find an effect 

that may not occur more frequently than 1 in every 1,000 

cases, your results will not be reliable. Failure to find the 

effect could be due to either your experimental design or 

the lack of an effect, but you will not know which is true. 

The common saying, “garbage in, garbage out,” applies to 

research methods.

Although the need for appropriate methods might seem 

obvious, studies have suggested that researchers sometimes 

use inappropriate statistical tests to evaluate their results 

(see articles by DeMets and Gardner, Additional Reading). 

Methods can also be compromised by bias—choosing one 

method or set of experimental conditions so that a particular 

conclusion can be drawn—or sloppy technique. Whatever 

the origin, the use of inappropriate methods in research 

compromises the integrity of research data and should be 

avoided. Responsible research is research conducted using 

appropriate, reliable methods.

Attention to detail. Quality research requires attention 

to detail. Experiments must be set up properly and the results

accurately recorded, interpreted, and published. A failure to 

pay attention to detail can result in mistakes that will later 

have to be corrected and reported. Correcting the record takes 

time and resources that are better spent on the research itself.

Obviously, it is not possible to avoid all mistakes in 

research. However, take a look at the errata section of 

any scientific journal and ask yourself how the mistakes 

reported could have been avoided. Did the authors check to 

make sure that each figure was correctly labeled? Were the 

calculations double checked? Did someone check to make 

sure the authors were properly listed? Since others rely on 

their work, researchers have a responsibility to make sure 

their work is carefully undertaken and reported. Sloppy 

research wastes funds and should be avoided.

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Authorized. Many types of data collection need to be 

authorized before they can proceed. Typically permission is 

needed to use: P human and animal subjects in research; P hazardous materials and biological agents; P information contained in some libraries, databases, and 

archives;

P information posted on some Web sites; P published photographs and other published information; 

and

P other copyrighted or patented processes or materials.

Researchers have a responsibility to know when permission 

is needed to collect or use specific data in their research. If 

you are not sure whether permission is needed, check before 

proceeding with data collection.

Recording. The final step in data collection is the physical 

process of recording the data in some type of notebook (hard 

copy), computer file (electronic copy), or other permanent 

“record” of the work done. The physical formats for recording 

data vary considerably, from measurements or observations 

to photographs or interview tapes. However data are 

recorded, it is important to keep in mind that the purpose 

of any record is to document what was actually done and 

the results that were achieved.

In recording data, keep two simple rules in mind to 

avoid problems later, should someone ask about or 

question your work: P Hard-copy evidence should be entered into a numbered, 

bound notebook so that there is no question later about the 

date the experiment was run, the order in which the data 

were collected, or the results achieved. Do not use looseleaf notebooks or simply collect pages of evidence in a file. 

Do not change records in a bound notebook without noting 

the date and reasons for the change.

P Electronic evidence should be validated in some way to 

assure that it was actually recorded on a particular date 

and not changed at some later date. It is easy to change 

dates on computers and thereby alter the date a particular 

file seems to have been created. If you collect your data 

electronically, you must be able to demonstrate that they 

are valid and have not been changed.

As you record your data, it may be helpful to think about 

them as the legal tender of research—the currency researchers 

cash in when they apply for grants, publish, are considered 

for promotion, and enter into business ventures. To have and 

hold their value, research data must be properly recorded.

6c. Data protection

Once collected, data must be properly protected. They may 

be needed later: P to confirm research findings, P to establish priority, or P to be reanalyzed by other researchers.

Over time, data, as the currency of research, become an 

investment in research. If the data are not properly 

protected, the investment, whether public or private, could 

become worthless.

Data storage. The responsible handling of data begins 

with proper storage and protection from accidental damage, 

loss, or theft: P Lab notebooks should be stored in a safe place. P Computer files should be backed up and the backup data 

saved in a secure place that is physically removed from the 

original data.

P Samples should be appropriately saved so that they will not 

degrade over time.

P Care should be taken to reduce the risk of fire, flood, and 

other catastrophic events.

Properly store and protect your data. They are valuable.

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Confidentiality. Some data are collected with the 

understanding that only authorized individuals will use 

them for specific purposes. In such cases, care needs to be 

taken to assure that privacy agreements are honored. This 

is particularly true of data that contain personal information 

that can be linked to specific individuals. It is also true 

of confidential information about protected processes and 

materials. If a company shares confidential data about a 

process with a researcher prior to seeking a patent on that 

process, the researcher must take care to make sure the 

data are kept confidential.

Data that are subject to privacy restrictions must be 

stored in a safe place that is accessible only to authorized 

personnel. Using random codes to identify individual 

subjects, rather than names or social security numbers, 

can also further protect private information. Access to 

these codes can then be restricted to provide a double layer 

of protection. Whatever the method used to protect private 

or confidential information, the researcher who collects or 

uses the information has the primary responsibility for 

its protection.

Period of retention. Data should be retained for a 

reasonable period of time to allow other researchers to 

check results or to use the data for other purposes. There 

is, however, no common definition of a reasonable period 

of time. NIH generally requires that data be retained for 3 

years following the submission of the final financial report. 

Some government programs require retention for up to 7 

years. A few universities have adopted data-retention 

policies that set specific time periods in the same range, 

that is, between 3 and 7 years. Aside from these specific 

guidelines, however, there is no comprehensive rule for 

data retention or, when called for, data destruction.

It is difficult to predict when data collected sometime in 

the past could be useful. When a new disease emerges, such 

as AIDS, researchers use stored samples/data to pinpoint 

first occurrences and the likely course of development of the 

disease. Although the original data were not stored for this 

purpose, they nonetheless can be useful for tracking diseases 

years later. Stored data are also useful for understanding 

social questions. The Department of Energy committee that 

made recommendations on appropriate compensation for 

improper human radiation experiments conducted during 

the Cold War pulled together data collected as far back as 

the 1950’s. Researchers also cannot predict when someone 

will challenge their work and ask to see the original data.

Given the different reasons data could be useful over long 

periods of time, researchers should give some thought to 

retaining data longer than some minimum period required 

by specific regulations. How long is reasonable will vary 

from field to field and institution to institution. Nevertheless, 

it is important to have a clear retention policy that balances 

the best interests of society with those of the research 

institution and the individual researcher. Before throwing 

out notebooks, cleaning out files, or erasing your computer 

memory, give careful consideration to who might benefit 

from or ask to see your data in the future.

6d. Sharing

It is widely agreed that research data should be shared, but 

deciding when and with whom raises questions that are 

sometimes difficult to answer.

Researchers are not expected to and in most instances 

should not release preliminary data, that is, data that have 

not been carefully checked and validated. The one exception 

to this rule would be preliminary data that could potentially 

benefit the public. A researcher who has strong preliminary 

indications of a major threat to public health, such as 

unexpected side effects from a drug or an unrecognized 

environmental health problem, may have good reason to 

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share this information with the public and other researchers 

before it is fully validated. Data that have no immediate 

public benefit, such as the discovery of a basic scientific 

process that could eventually lead to public benefits, in most 

instances is best held until the researcher is confident that 

the results will stand.

Researchers can withhold confirmed or validated data 

until they have had time to establish their priority for 

their work through publication or, in rare cases, a public 

announcement. They do not have to release data on a 

day-to-day or experiment-to-experiment basis for other 

researchers to use, even though this might speed the 

advance of knowledge. Provided no agreements have been 

made to the contrary, keeping data confidential prior to 

publication is a commonly accepted practice that most 

researchers and funding agencies accept.

Once a researcher has published the results of an 

experiment, it is generally expected that all the information 

about that experiment, including the final data, should be 

freely available for other researchers to check and use. Some 

journals formally require that the data published in articles 

be available to other researchers upon request or stored in 

public databases. In the specific case of federally funded 

research that is used in setting policies that have the effect 

of law, research data must be made available in response 

to Freedom of Information Act (FOIA) requests (OMB, 

Circular A-110). There is, in other words, considerable 

support for sharing data with other researchers and the 

public unless there are compelling reasons for confidentiality.

6e. Future considerations

The continued evolution of data policies will likely be driven 

by a number of different issues, including the growing 

complexity of data and debates about proper control.

Complexity. Our capacity to generate data sometimes 

outstrips our capacity to store and share it. Data storage 

and sharing were major problems during the early years of 

the Human Genome project. They continue to pose problems 

for any research area that is able to generate massive 

amounts of information efficiently and inexpensively. DNA 

microarray chips can generate 10,000 bits of information 

with a single, easily conducted test. The logistics of storing 

and sharing this information presents a monumental 

challenge for everyone engaged in research. Even when 

researchers want to, it is not always clear how they should 

go about collecting, storing, and sharing data responsibly.

Control. In large projects, questions frequently arise about 

the control of data, particularly when financial interests 

are at stake. Should researchers participating in large, 

NIH Data Sharing Policy and Implementation Guidance

(Updated: March 5, 2003)

Goals of Sharing Data

Data sharing promotes many goals of the NIH research endeavor. It is particularly important 

for unique data that cannot be readily replicated. Data sharing allows scientists to expedite 

the translation of research results into knowledge, products, and procedures to improve 

human health.

There are many reasons to share data from NIH-supported studies. Sharing data reinforces 

open scientific inquiry, encourages diversity of analysis and opinion, promotes new research, 

makes possible the testing of new or alternative hypotheses and methods of analysis, 

supports studies on data collection methods and measurement, facilitates the education of 

new researchers, enables the exploration of topics not envisioned by the initial investigators, 

and permits the creation of new datasets when data from multiple sources are combined. 

In NIH’s view, all data should be considered for data sharing. Data should be made as 

widely and freely available as possible while safeguarding the privacy of 

participants, and protecting confidential and proprietary data. To facilitate data 

sharing, investigators submitting a research application requesting $500,000 or more of direct 

costs in any single year to NIH on or after October 1, 2003, are expected to include a plan for 

sharing final research data for research purposes, or state why data sharing is not possible.

http://grants1.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm

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Federal regulations (e.g., USA Patriot Act of 2001) that 

will assure reasonable control without unduly restricting 

the ability of researchers to share their work and ideas 

freely with one another (see the recent report, Biological 

Threats and Terrorism, Additional Reading). Researchers 

whose work could be affected by these concerns should keep 

abreast of ongoing policy development and regulation.

However these issues are resolved, researchers have 

been the most important component of responsible data 

management practices in the past and will likely remain so 

as long as the public feels the majority of researchers can 

be trusted. With this in mind, ask yourself how someone 

funding your research would feel if he or she had a chance 

to take a close look at your data management practices.

Questions for discussion

 1 Should research data belong to researchers rather than to 

research institutions?

 2 Should data recording practices be standardized to facilitate 

sharing and monitoring? What recording practices could be 

standardized? 

 3 What interpretation practices could be standardized? How 

does your laboratory verify the accuracy and validity of data 

before its disclosure or use in grant proposals and publications?

 4 Who should pay the cost of sharing data? Who should have 

access to the data?

 5 How long should researchers be able to withhold data to allow 

time to protect ownership claims? How long should research 

data be stored?

multi-site clinical trials have the right to publish their own 

findings, that is, retain some control over their own data, 

or should the collection, storage, and interpretation be 

centralized? This issue is currently unresolved and the 

subject of intense public debate.

National security. Recent events have heightened 

concerns about the possible use of data from publicly 

supported research by terrorists and nations that could 

pose a threat to national security. Efforts are underway to 

address these concerns through voluntary policies and new 

Research Committee, Society for Academic Emergency Medicine

Guidelines for Clinical Investigator Involvement in 

Industry-sponsored Clinical Trials

IV. Trial Data Management

1. The industry sponsor and the investigators should have a firm commitment to thorough 

monitoring of the trial at every step.

2. All data collected in the trial should be open to scrutiny by both the investigators and the 

industry sponsor.

3. Clinical investigators should have substantial input into the initial analytic plan and also 

any subsequent amendments that occur during the trial period.

4. When possible, statistical analysis of the data should be conducted by an entity 

independent of the researchers and the sponsor. For trials using interim analysis, use 

of an independent entity is particularly important. Decisions to prematurely stop a trial 

should be based upon predetermined criteria.

5. Consideration should be given to the use of an unbiased, blinded “clinical evaluation 

committee” for trials that involve assessment of potentially subjective endpoints.

6. The industry sponsors must share the results of all data analyses with the principal 

investigators. Selective withholding or incomplete reporting of data analyses to the 

principal investigators is unacceptable.

7. Trial results and data analysis should be shared with the principal investigators as soon as 

they become available. Delays by the industry sponsors for marketing or related purposes 

are unacceptable. 

www.saem.org/download/edward.pdf

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Resources

Policies, Reports, and Policy Statements

Council on Government Relations. Policy Considerations: Access to 

and Retention of Research Data, Washington, D.C.: 1995. 

(available at: http://www.cogr.edu/files/publications_research.htm)

University of Pittsburgh. Guidelines on Data Retention and Access, 

Pittsburgh, PA: University of Pittsburgh, 1997. (available at: http:

//www.pitt.edu/~provost/retention.html)

American Statistical Association. Ethical Guidelines for Statistical 

Practice, Alexandria, VA: American Statistical Association, 

1999. (available at: http://www.amstat.org/profession/

ethicalstatistics.html)

Harvard University Medical School. Office of Technology Licensing. 

Record-Keeping Procedures, 2000. (available at: http:

//www.hms.harvard.edu/otl/record.html)

United States. Congress. USA Patriot Act of 2001, PL 107-56, 

2001. (available at: http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:

publ056.107.pdf)

Food and Drug Administration. Good Laboratory Practices for 

Designing Toxicology Studies for Petition Submissions and 

Notifications, 21 CFR Part 58 (2002). (available at: http:

//www.cfsan.fda.gov/~dms/opa-pt58.html)

Society for Clinical Data Management. Good Clinical Data 

Management Practices, Version 2, Hillsborough, NJ: Society 

for Clinical Data Management, 2002. (available at: http:

//www.scdm.org/GCDMP/CDMPVersion2Jan29.PDF)

National Institutes of Health. NIH Data Sharing Policy and 

Implementation Guidance, 2003. (available at: http:

//grants1.nih.gov/grants/policy/data_sharing/data_sharing_

guidance.htm)

General Information Web Sites

National Institutes of Health. Office of Extramural Research. NIH 

Data Sharing Policy, Washington, DC: National Institutes of 

Health, nd., http //grants1.nih.gov/grants/policy/data_sharing/

Society for Clinical Data Management. Home Page, 2003. http:

//www.scdm.org/

Additional Reading

Campbell, EG, Clarridge, BR, Gokhale, M, Birenbaum, L, Hilgartner, 

S, Holtzman, NA, Blumenthal, D. “Data Withholding in Academic 

Genetics: Evidence from a National Survey,” Journal of the 

American Medical Association 287, 4 (2002): 473-480.

Council on Government Relations. Materials Transfer in Academia, 

Washington, DC: Council on Government Relations, 1997. 

(available at: http://www.cogr.edu/files/publications_

intellectual.htm)

DeMets, DL. “Statistics and Ethics in Medical Research,” Science and 

Engineering Ethics 5, 1 (1999): 97-111.

Gardner, MJ. “An Exploratory Study of Statistical Assessment of 

Papers Published in the British Medical Journal,” Journal of the 

American Medical Association 263, March 10 (1990): 1355-1357.

Kanare, HM. Writing the Laboratory Notebook, Washington, DC: 

American Chemical Society, 1985.

Knobler, SL, Mahmoud, AAF, Pray, LA, eds. Biological Threats 

and Terrorism: Assessing the Science and Response Capabilities: 

Workshop Summary. Washington, DC: National Academy Press, 

2002.

Stevens, AR. Ownership and Retention of Data, Washington, DC: 

National Association of College and University Attorneys, 1997. 

(available at: http://www.nacua.org/onlinepubs/ownership.html)

Chapter 6: Data Management Practices
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7. Mentor and Trainee Responsibilities

Case Study

At a recent meeting, several faculty in a large, research-oriented science department raised concerns about their mentoring program. While mindful of the many demands they all faced, 

they wondered whether changes were needed in the way the department assigned, trained, and 

oversaw mentors. The ensuing discussion raised some potentially good suggestions, which most 

agreed were best referred to a special committee for further discussion and recommendations. With 

a little arm twisting, Susan D., an advanced graduate student; Dr. Linda L., a postdoc; and Dr. Bill K., 

an established researcher, were recruited to serve.

At their first meeting, the three colleagues quickly agreed to tackle first the question of goals. If 

they knew what mentoring was expected to achieve, they could then assess the strengths and 

weaknesses of their current program and make suggestions for change. With this settled, they 

decided to spend some time talking with their peers and then get back together to compare notes. 

When they met the next time: 

What goals would you expect each member of the committee to recommend?

Why might different members of the committee recommend different goals? 

Assuming they came to the conclusion that some improvements were needed, what avenues are 

open to change the way mentors and trainees interact?

* The term “trainee” is used in this chapter to refer to anyone learning to be a researcher under an 

established researcher’s supervision. This includes principally graduate students and postdoctoral 

fellows (postdocs), but may also include undergraduate and high school students working on 

research projects or junior research faculty, research scientists, and research staff.

While conducting investigations, researchers often assume the added role of mentors to trainees.* The 

mentor-trainee relationship is complex and brings into play 

potential conflicts. How much time—training time for the 

mentor, research time for the trainee—should each devote to 

the other? Who gets credit for ideas that take shape during 

the course of a shared experiment? Who owns the results? 

When does a trainee become an independent researcher?

The essential elements of a productive mentor-trainee 

relationship are difficult to codify into rules or guidelines, 

Chapter 7: Mentor and Trainee Responsibilities

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ORI Introduction to the Responsible Conduct of Research

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leaving most of the decisions about responsible mentoring to 

the individuals involved. Common sense suggests that good 

mentoring should begin with:

P a clear understanding of mutual responsibilities,

P a commitment to maintain a productive and supportive 

research environment,

P proper supervision and review, and

P an understanding that the main purpose of the relationship 

is to prepare trainees to become successful researchers.

Understandings and agreements, however, will count for 

little if they are not backed up by firm commitments to 

make a relationship work.

Knowing the importance of personal commitments, 

researchers should carefully consider what responsibilities 

they have to trainees before they take on the essential task 

of training new researchers. Trainees, in turn, should be we 

aware of their responsibilities to mentors before accepting a 

position in a laboratory or program.

7a. Basic responsibilities

Mentor-trainee relationships begin when an experienced 

and an inexperienced researcher agree to work together. 

Each brings something to the table under such an 

arrangement. The experienced researcher has knowledge 

and skills that the inexperienced researcher needs to 

learn. She or he may also provide support for the trainee’s 

research and education. Inexperienced researchers, 

whether graduate student, postdoctoral student (postdoc), 

research staff, or junior researcher, provide labor and 

fresh ideas. Under a productive relationship, the two work 

together to advance knowledge and put ideas to work. 

When the relationship breaks down, it is often because one 

of the parties is not getting from the relationship what she 

or he expected.

National Academy of Sciences 

On Being a Mentor to Students in Science and Engineering

What is a Mentor? 

In the broad sense intended here, a mentor is someone who takes a special interest in 

helping another person develop into a successful professional. Some students, particularly 

those working in large laboratories and institutions, find it difficult to develop a close 

relationship with their faculty adviser or laboratory director. They might have to find their 

mentor elsewhere—perhaps a fellow student, another faculty member, a wise friend, or 

another person with experience who offers continuing guidance and support. 

In the realm of science and engineering, we might say that a good mentor seeks to help 

a student optimize an educational experience, to assist the student’s socialization into a 

disciplinary culture, and to help the student find suitable employment. These obligations can 

extend well beyond formal schooling and continue into or through the student’s career.

http://www.nap.edu/readingroom/books/mentor/

One way to avoid problems is to establish basic understandings about important issues early in the relationship. 

Trainees need to know:

P how much time they will be expected to spend on their 

mentor’s research;

P the criteria that will be used for judging performance and 

form the basis of letters of recommendation;

P how responsibilities are shared or divided in the research 

setting;

P standard operating procedures, such as the way data are 

recorded and interpreted; and, most importantly,

P how credit is assigned, that is, how authorship and 

ownership are established.

Clarifying these issues early in a mentor-trainee relationship 

can prevent problems from arising later.

The need for early understanding is not one sided. 

Mentors need to know that a trainee will:

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ORI Introduction to the Responsible Conduct of Research

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P do assigned work in a conscientious way,

P respect the authority of others working in the research 

setting,

P follow research regulations and research protocols, and

P live by agreements established for authorship and 

ownership.

Mentors invest time and resources in trainees. Trainees 

should respect this time and use resources responsibly, 

keeping their mentors informed about changing research 

interests or other circumstances that could affect their work.

Arriving at basic understandings early in a mentortrainee relationship is not easy, given the unequal power 

relationship between them. Mentors are in a position to lay 

out expectations, but it can be difficult for a trainee to raise 

questions early in a relationship about credit and authorship 

practices. To avoid putting trainees in the awkward position 

of having to raise these issues, mentors should be prepared 

to take the lead in raising issues that are of concern to the 

trainee as well as those that are of interest to the mentor. 

Developing written guidance on a laboratory’s authorship 

and publication practices should also be considered.

7b. Research environment

Different mentors establish different research environments. 

Some laboratories are highly competitive; others emphasize 

cooperation. Some mentors are intimately involved in all 

aspects of the projects they supervise; others delegate 

authority. Similarly, different researchers like to work in 

different environments. Some enjoy independence; others 

like to have close working relationships with colleagues. 

Some thrive in competitive environments; others prefer 

cooperative working relationships. Although there is no 

single formula for a “good” research environment, there are 

some fundamentals that mentors and trainees should keep 

in mind.

Equal treatment. Research ability is not tied to race, 

gender, ethnicity, or sexual orientation. These factors have 

no bearing on one’s success as a researcher. Therefore, 

research environments should not put someone at a 

disadvantage based on who they are. If competition is 

encouraged in a way that puts any distinguishable group 

at a significant disadvantage, it is not acceptable. All 

students should be subject to the same level of supervision 

and scrutiny. Aside from legal obligations to avoid 

discrimination in the workplace, researchers have a 

A Guide to Training and Mentoring in the 

Intramural Research Program at NIH

A mentor is a person who has achieved career success and counsels and guides another for 

the purpose of helping him or her achieve like success. Research supervisors should always 

be mentors; they have the responsibility to discuss with and advise a trainee on aspects 

of his or her work and professional development. The trainee may find additional mentors 

informally—or the training institution may designate them. They are very important in the 

overall experience of the trainee and may contribute to research productivity as well....

Training in the skills of mentorship itself is important, especially for those who plan careers 

in research or teaching. Postdoctoral trainees should learn to train and guide others, for 

example, by working with more junior individuals, supervising technical staff, or training 

students. The characteristics considered important by a fellow in selecting a supervisor 

and other mentors—interest in contributing to the career development of another scientist, 

research accomplishments, professional networking, accessibility, and past success cultivating 

the professional development of fellows—are characteristics that trainees may eventually 

strive to emulate in their own careers.

Although this Section has emphasized the responsibilities of supervisors and others in 

research institutions to provide mentoring to trainees to facilitate their professional 

development, trainees also have responsibilities. Collaborative research frequently requires 

productive interactions among fellows themselves as well as recognition of their roles as part 

of a team effort. In addition, fellows must have a commitment to the work of the laboratory 

and Institute and to the achievement of their goals. They cannot be passive participants in 

their training; they should appropriately make known their satisfactions, dissatisfactions, and 

needs clearly and often.

http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/mentor-guide.htm#Directory

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professional obligation to work to assure equal access to their 

profession, particularly if their work is publicly supported.

Professional practice. Researchers should maintain 

research environments that respect accepted practices 

for the responsible conduct of research. Trainees learn 

by example as well as formal training. They assume, not 

unreasonably, that the practices they observe are 

appropriate practices. Mentors therefore have an obligation 

to maintain research environments that set appropriate 

examples. They should not themselves make unreasonable 

authorship demands, fail to honor agreements made with 

trainees, inappropriately cut corners in research, or engage 

in other practices that run counter to accepted practices for 

the responsible conduct of research.

Training in the responsible conduct of research.

Beginning in 1989 and in line with recommendations made 

by the Institute of Medicine (IOM, 1989), the National 

Institutes of Health (NIH) required recipients of National 

Research Service Institutional Training Program awards 

(training grants) to offer instruction in the responsible 

conduct of research (RCR). The National Science Foundation 

(NSF) has a similar requirement for recipients of its 

Integrative Graduate Education and Research Traineeship 

(IGERT) Program awards. Later reports, notably by the 1995 

Commission on Research Integrity, called for broadening 

this requirement to all PHS-funded research, but such a 

requirement has not been implemented. Nonetheless, there 

is widespread agreement that RCR training should be 

integral to the research environment, with heavy emphasis 

given to the role the mentor plays in providing this training.

7c. Supervision and review

When mentors accept trainees, they assume responsibility 

for assuring that the persons under their supervision are 

appropriately and properly trained. This responsibility 

is particularly important in research since for the most 

part there are no other checks on the qualifications of new 

researchers. Researchers do not take licensing exams. They 

are judged primarily by the quality of their research, which 

should be best known to the person directly supervising 

their work, that is, to their mentor.

Proper supervision of a trainee takes time. In one way or 

another a mentor needs to:

P assure proper instruction in research methods,

P foster the intellectual development of the trainee,

University of Michigan

Mentoring within a Diverse Community

Need for Role Models 

Students from historically underrepresented or marginalized groups have a harder time 

finding faculty role models who might have had experiences similar to their own. As some 

students say, they want to find “someone who looks like me;” “someone who immediately 

understands my experiences and perspectives;” “someone whose very presence lets me know 

I, too, can make it in the academy.”

Feelings of Isolation

Students from historically underrepresented groups can feel particularly isolated or alienated 

from other students in their departments, especially if the composition of a program is highly 

homogenous.

Burden of Being a Spokesperson

Students from underrepresented groups often expend a lot of time and energy speaking up 

when issues such as race, class, gender, or sexual orientation arise or are being ignored. These 

students point out how most of their peers have an advantage in not carrying such a burden.

Seeking Balance

Students observe that professors need to devote large parts of their lives to their work in 

order to be successful in the academy. Students from all disciplines tell us that they feel 

faculty expect them to spend every waking minute on their work. This perception of faculty 

expectations, accurate or not, is of grave concern to students who have children or wish to, 

as well as for those who want to balance their lives with their other interests.

http://www.rackham.umich.edu/StudentInfo/Publications/FacultyMentoring/contents.html

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ORI Introduction to the Responsible Conduct of Research

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P impart an understanding of responsible research practices, 

and

P routinely check to make sure the trainee develops into a 

responsible researcher.

Mentors do not need to check all aspects of a trainee’s work 

directly. In large laboratories, postdocs often supervise 

graduate students and laboratory technicians might teach 

specific laboratory skills. Training in the responsible use 

of animals is often done through an animal care program. 

However, the ultimate responsibility for training rests with 

the mentor.

Proper supervision and review play an important role in 

quality control. Trainees can make mistakes. Some have 

deliberately falsified or fabricated data. Mentors should 

review work done under their supervision carefully enough 

to assure that it is well done and accurate. This can be 

accomplished by:

P reviewing laboratory notebooks and other compilations of 

data;

P reading manuscripts prepared by trainees carefully to 

assure that they are accurate, well-reasoned, and give 

proper credit to others;

P meeting with trainees on a regular basis to keep in touch 

with the work they are doing; and

P encouraging trainees to present and discuss data at 

laboratory meetings.

Some of this responsibility can be delegated to others, but 

as with all other matters regarding training, the mentor 

should assume ultimate responsibility.

7d. Transition to independent researcher

The ultimate goal of research training is to produce 

independent researchers who can establish their own 

research programs, take on trainees, and help researchdependent disciplines grow. This means that the mentor’s 

final responsibility to trainees is to help them get 

established as independent researchers.

History has repeatedly shown that experienced 

researchers often do not give over control to the next 

generation easily. They have a difficult time seeing ideas 

they planted grow in another person or having someone 

they trained head out in new directions. And yet in many 

fields, it is well documented that researchers are most 

productive early in their careers, when they are first 

making their way as independent researchers.

The problem of trainee versus independent researcher is 

most apparent in postdoctoral training. Postdocs, as they are 

commonly known, are usually well prepared to undertake 

independent work, and yet they are still working under 

someone else’s supervision. The fact that they are neither 

official students nor official faculty gives them few rights 

and protections. The fact that they are usually supported by 

Emory University School of Medicine

Policy for Postdoctoral Fellows

Mentor Obligations 

Postdoctoral research opportunities at Emory University School of Medicine are intended to foster 

the training of basic and clinical research scientists. Included within this goal is the concept that 

postdoctoral fellows, with the guidance of their mentors, will develop a scientific project that 

utilizes the creativity and independence of the fellow. In this spirit, the mentor will provide 

adequate facilities, funds, and the appropriate guidance to achieve the agreed-upon goals of the 

project. In addition, mentors should provide guidance in critical review of scientific information, 

grant writing, manuscript writing and preparation, presentation of scientific information, and 

in the art of performing research. Mentors should also advise and as possible, aid fellows in 

decisions regarding future employment potential and career paths. Mentor review of fellow 

performance and career development should be conducted at least once per year. A member(s) of 

the departmental senior faculty should be designated to serve as liaison with departmental postdoctoral fellows, faculty, and the Office of Postdoctoral Education and its advisory committees. 

http://www.emory.edu/WHSC/MED/POSTDOC/Web%20Forms/Adobe%20Forms/Policy%20for%20Postdoctoral%20Fellows,

EUSM%20,512000,shortform.pdf

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Questions for discussion

 1 Can elements of the mentor-trainee relationship be reduced 

to a written agreement that both parties would sign at the 

beginning of the relationship?

 2 What are the qualities of a good mentor? A good trainee?

 3 What are the qualities of a good research environment and 

how can they be fostered?

 4 What is the purpose of postdoctoral training and how long 

should it last?

 5 Can good mentoring be taught, monitored, and evaluated?

i

someone else’s funding leaves them open to exploitation. 

To protect against such exploitation, a new organization, 

the National Postdoctoral Association, has recently been 

established “to address national issues relevant to postdocs 

and focus public debate on how to improve the lives of 

postdocs at all levels.”

Researchers who supervise postdocs should carefully 

work out their relationship with this unique and important 

group of researchers in training. Some supervision is still 

necessary, but not as much as for graduate students. Postdocs may have their own funding and assume all the duties 

of a principal investigator, even if for administrative 

purposes their funding comes through their mentor. They 

may deserve first authorship on all of their papers, even 

though the mentor was involved in the research. Most 

importantly, they should be encouraged to develop the 

independence and record needed to get a regular research 

appointment, thereby paying back society’s investment in 

years of research training and the student’s investment in 

her or his own career.

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Resources

Policies, Reports, and Policy Statements

Institute of Medicine. The Responsible Conduct of Research in the 

Health Sciences, Washington, DC: National Academies of 

Science, 1989. (available at: http://search.nap.edu/books/

0309062373/html/)

National Institutes of Health. Alcohol, Drug, and Mental Health 

Administration. “Requirement for Programs on the Responsible 

Conduct of Research in National Research Service Award 

Institutional Training Programs,” NIH Guide for Grants and 

Contracts 18 (1989): 1.

Commission on Research Integrity. Integrity and Misconduct in 

Research: Report of the Commission on Research Integrity, 

Washington, DC: Health and Human Services, 1995.

Gottesman, MM. A Guide to Training and Mentoring in the 

Intramural Research Program at NIH, Bethesda, MD: National 

Institutes of Health, 1999. (available at: http://www1.od.nih.gov/

oir/sourcebook/ethic-conduct/mentor-guide.htm)

National Science Foundation. Integrative Graduate Education and 

Research Traineeship (IGERT) Program, Washington, DC: NSF, 

2002. (available at: http://www.nsf.gov/pubs/2002/nsf02145/

nsf02145.pdf)

General Information Web Sites

Association for Women in Science and Engineering. Home Page, 2003. 

http://www.awise.org/

MentorNet. The E-Mentoring Network for Women in Engineering and 

Science, 2003. http://www.mentornet.net/

National Postdoctoral Association. Home Page, 2003. http:

//www.nationalpostdoc.org/about/npa_overview/

Additional Reading

Association for Women in Science. Mentoring Means Future 

Scientists, Washington, DC: Association for Women in Science, 

1993.

Gadlin, H, Jessar, K. “Preempting Discord: Prenuptial Agreements 

for Scientists,” The NIH Catalyst, May-June (2002). (available at: 

http://ori.hhs.gov/html/programs/preempting_discord.asp)

National Academy of Sciences, National Academy of Engineering, 

Institute of Medicine. Adviser, Teacher, Role Model, Friend: 

On Being a Mentor to Students in Science and Engineering, 

Washington, DC: National Academy Press, 1997. (available at: 

http://www.nap.edu/readingroom/books/mentor/)

University of Michigan. Horace H. Rackham School of Graduate 

Studies. How to Mentor Graduate Students: A Guide for Faculty 

in a Diverse University, Ann Arbor, MI: University of Michigan, 

2002. (available at: http://www.rackham.umich.edu/StudentInfo/

Publications/FacultyMentoring/contents.html)

Chapter 7: Mentor and Trainee Responsibilities
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8. Collaborative Research

Researchers increasingly collaborate with colleagues who have the expertise and/or resources needed to carry 

out a particular project. Collaborations can be as simple as 

one researcher sharing reagents or techniques with another 

researcher. They can be as complex as multi-centered clinical 

trials that involve academic research centers, private 

hospitals, and for-profit companies studying thousands of 

patients in different states or even countries.

Any project that has more than one person working on it 

requires some collaboration, i.e., working together. In most 

projects, however, one person, commonly called the 

“principal investigator” or PI, is in charge. Others work 

under the PI’s direction. In this chapter, the focus will be 

on groups of researchers who are all more or less equal 

partners working on a common, “collaborative” project.

In collaborative projects, researchers continue to have the 

responsibilities discussed in other chapters in the ORI 

Case Study

S

haron, Ben, and Terra met during a late-night discussion at a professional meeting. They share 

a common interest in learning disorders but come from different scientific backgrounds. Sharon 

works at the cutting edge of brain imaging technology. Ben is an educational psychologist

interested in pre-school children in inner cities. Terra has been putting her knowledge as a 

physiologist to work exploring the effects of alternative medicines. 

As late night turns to early morning, the newly met trio begins to see benefits from working 

together and starts sketching out a grant proposal. The scientific ideas quickly fall into place, but 

some of the logistics raise questions that need answers. 

Who should submit the proposal, through which university?

Do all three need to get IRB approval to work on the project? 

What will happen if their work has practical applications?

How should they go about answering these questions? Are there other important questions that 

should be asked as well?

Chapter 8: Collaborative Research

Collaboration or competition?
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ORI Introduction to the Responsible Conduct of Research

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Introduction to RCR, but they assume some additional 

responsibilities stemming from collaborative relationships. 

These additional responsibilities arise from the added 

burdens of:

P the increasingly complex roles and relationships;

P common, but not necessarily identical, interests;

P management requirements; and

P cultural differences

inherent in any large project but especially in collaborative 

projects. Special attention to these added burdens can help 

keep collaborative projects running smoothly.

8a. Roles and relationships

Effective collaboration begins with a clear understanding 

of roles and relationships, which should begin the day the 

collaboration is established by discussing and reaching 

agreement on the details of the collaborative relations. 

Before any work is undertaken, there should be some 

common understanding of:

P the goals of the project and anticipated outcomes;

P the role each partner in the collaboration will play;

P how data will be collected, stored, and shared;

P how changes in the research design will be made;

P who will be responsible for drafting publications;

P the criteria that will be used to identify and rank 

contributing authors;

P who will be responsible for submitting reports and meeting 

other requirements;

P who will be responsible for or have the authority to speak 

publicly for the collaboration;

P how intellectual property rights and ownership issues will 

be resolved; and

P how the collaboration can be changed and when it will 

come to an end.

Clear understandings in advance are the best way to avoid 

complications and disagreements later in a collaboration.

Obviously, situations can arise during a collaboration 

that could not have been anticipated in advance. For this 

reason, it is important for effective communication to 

continue throughout any collaborative project. Collaborators 

should:

P share findings with colleagues in the collaboration and pay 

attention to what others are doing;

P report and discuss problems as well as findings;

P make other collaborators aware of any important changes, 

such as changes in key personnel; and

P share related news and developments so that everyone in 

the collaboration is equally knowledgeable about important 

information.

All of these points may seem obvious, but they can easily get 

lost in the day-to-day details of doing research. However, if 

you are working with collaborators, keep in touch. Without 

effective communication, collaborations can easily run into 

problems and dissolve.

8b. Management

In addition to effective communication, collaborative 

projects should have effective management plans that cover:

P financial issues,

P training and supervision,

P formal agreements, and

P compliance.

When a PI is in charge of all of the work done on a project, 

the lines of responsibility are clear. The PI is ultimately 

responsible for all aspects of the project, from financial 

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expenditures to staff training, data collection, reporting, 

and wrapping up the project. In collaborative research, the 

partners in the collaboration share responsibilities. Under 

these circumstances, an effective management plan is 

essential.

Financial management. The expenditure of Federal 

research funds is subject to financial management rules 

issued by the Office of Management and Budget in Circulars 

A-21 and A-110 (see boxes, below and next page). A-21 covers 

all aspects of financial management, from accounting 

procedures to reporting requirements. For example, one 

section carefully describes, in fairly technical terms,

allowable and unallowable expenses. Some travel costs are 

allowed; others are not. A-110 sets out rules for issuing 

government grants and contracts. It explains how equipment 

should be purchased and used, even after the project has 

come to an end.

Every federally funded research project must adhere to 

the rules set out in A-21 and A-110. Therefore, collaborative 

projects must be managed in ways that assure that all 

expenditures are in compliance, from those incurred by the 

primary investigators working at major research institutions 

to survey workers or clinicians working in the field.

Training and supervision. Wherever they work, 

research staff should be properly trained and supervised. 

In some instances the training is mandatory. Anyone who 

works with research animals or human subjects must have 

formal training. The same is true of staff who work with 

hazardous substances or biohazards. These requirements 

extend to everyone working on a collaborative project, 

whether they are at a different institution, in another 

state, or even another country. Management plans for 

collaborative projects therefore should include the training 

and supervision of all researchers and staff working on 

the project.

Formal agreements. Some aspects of collaborative 

projects must be worked out in advance in formal 

agreements. For example, when research is carried out in 

more than one place, it is sometimes necessary to transfer 

Office of Management and Budget

Circular A-21

48. Travel costs.

a. General. Travel costs are the expenses for transportation, lodging, subsistence, and 

related items incurred by employees who are in travel status on official business of the 

institution. Such costs may be charged on an actual basis, on a per diem or mileage basis 

in lieu of actual costs incurred, or on a combination of the two, provided the method 

used is applied to an entire trip and not to selected days of the trip, results in reasonable 

charges, and is in accordance with the institution’s travel policy and practices consistently 

applied to all institutional travel activities. 

b. Lodging and subsistence. Costs incurred by employees and officers for travel, including 

costs of lodging, other subsistence, and incidental expenses, shall be considered reasonable 

and allowable only to the extent such costs do not exceed charges normally allowed 

by the institution in its regular operations as a result of an institutional policy and the 

amounts claimed under sponsored agreements represent reasonable and allocable costs. 

c. Commercial air travel. Airfare costs in excess of the lowest available commercial 

discount airfare....

http://www.whitehouse.gov/omb/circulars/a021/a021.html

Office of Management and Budget

Circular A-110

34. Equipment.

(c) The recipient shall use the equipment in the project or program for which it was acquired 

as long as needed, whether or not the project or program continues to be supported 

by Federal funds and shall not encumber the property without approval of the Federal 

awarding agency. When no longer needed for the original project or program, the recipient 

shall use the equipment in connection with its other federally-sponsored activities, in the 

following order of priority: (i) Activities sponsored by the Federal awarding agency 

which funded the original project, then (ii) activities sponsored by other Federal 

awarding agencies. 

http://www.whitehouse.gov/omb/circulars/a110/a110.html

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materials from one institution to another. Since many 

materials are carefully controlled, to protect either safety or 

ownership, the terms of transfer should be carefully spelled 

out, including (see NIH-recommended provisions below):

P who owns the materials,

P the use to which they can be put, and

P proper acknowledgment of the source.

These agreements help protect the interests of the 

collaborators by assuring that ownership will be respected 

and that the materials will be properly used.

Compliance. Increasingly, research institutions must in 

one way or another certify that they are in compliance with 

specific research regulations. When research institutions 

are involved in collaborative projects, an institution’s 

responsibility for compliance can extend to other institutions. 

If the other institution is a U.S. university with a large 

research portfolio, that institution most likely already has a 

compliance plan in place. However, if the other institution 

does not do a great deal of research or is located in another 

country, it may not have thought about its compliance 

responsibilities. Management plans for collaborative projects 

must take into account the need for meeting compliance 

responsibilities throughout the project sites and not just at 

one institution.

8c. Different research settings

Most researchers devote their careers to one field of 

research and spend their time talking with colleagues with 

similar interests. However, science is increasingly best 

served when researchers work with colleagues in other 

fields. Physicians and engineers have teamed together 

to develop miniature wireless devices that can gather 

information while passing normally through the body. 

Computer scientists are working with organic chemists 

and biologists to develop faster computers and more flexible 

display devices. Collaborative projects encourage researchers 

to pursue interdisciplinary research.

For the most part, interdisciplinary research follows the 

same rules and practices as disciplinary research. There are 

times, however, when researchers in different fields bring 

different practices or expectations to a project. When this 

happens, researchers might think of adopting two commonsense rules:

P do not ignore any responsibilities, and

P when there are choices about appropriate action, select the 

most demanding option.

When in doubt, it makes sense to seek the highest rather 

than the lowest denominator.

Different expectations can enter a project in a number 

of ways, especially when judgments about responsible 

practice are involved. The government and some research 

National Institutes of Health

Recommended Provisions for a Materials Transfer Letter

1. The [supplied] MATERIAL is the property of the PROVIDER and is made available as a 

service to the research community. 

2. THIS MATERIAL IS NOT FOR USE IN HUMAN SUBJECTS. 

3. The MATERIAL will be used for teaching or not-for-profit research purposes only. 

4. The MATERIAL will not be further distributed to others without the PROVIDER’s written 

consent....

6. Any MATERIAL delivered pursuant to this Agreement is understood to be experimental in 

nature and may have hazardous properties....

7. The RECIPIENT agrees to use the MATERIAL in compliance with all applicable statutes 

and regulations. 

8. The MATERIAL is provided at no cost, or with an optional transmittal fee solely to 

reimburse the PROVIDER for its preparation and distribution costs. If a fee is requested, 

the amount will be indicated here: [insert fee]

http://ott.od.nih.gov/textonly/RTguide_final.html#princ

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institutions allow researchers to earn up to $10,000 through 

consulting or other outside employment before they have to 

declare a potential conflict of interest (discussed in Chapter 

5). Others institutions use lower thresholds, in some cases 

requiring researchers to report conflicts of interest if they 

have any outside financial interests. Different institutions 

also manage conflicts of interest in different ways, from 

supervision or reporting to outright prohibition. When there 

are differences in reporting policy, the prudent course of 

action is to go with the lowest financial threshold and accept 

the most stringent management plan, even though some 

researchers working on the collaborative project may not be 

required to do so.

Ownership issues also raise questions about which 

rules to follow. One party to a collaboration may have no 

interest in reporting a promising idea for development; 

another may feel under an obligation to do so, following 

either a university’s or Federal policy. There may also be 

different understandings among the different institutions 

that are part of a collaboration about what constitutes 

disclosable information and who owns the information 

once it is disclosed. Given the consequences of disputes 

that can erupt in these situations, it is essential that every 

collaborative project settle disclosure and ownership issues 

early in the project before disputes arise. Waiting longer 

opens the door for misunderstandings and disputed claims 

when one of the parties in the collaboration makes a 

valuable discovery.

Finally, there are significant differences in the way 

researchers in different fields and even different laboratories 

carry out the routine business of collecting data and 

publishing results. Some still collect data in bound laboratory 

notebooks; others use computers. In some fields, it is 

common practice to circulate early results in newsletters 

and/or abstracts; in other fields, journal publications are 

the preferred mode of communication. Different fields have 

i

different ways and standards for listing authors. These and 

other differences should be addressed openly and early in 

any collaboration to assure that misunderstandings do not 

arise later over data collection and publication.

Questions for discussion

 1 Why should collaborative research be encouraged?

 2 When should research collaborations be formalized?

 3 Are there any drawbacks to collaborative research? What 

problems can they raise?

 4 Which country’s rules should be used in collaborative projects 

that are carried out in different countries?

 5 What steps should be taken when a collaborative project 

comes to an end or a collaboration is dissolved?

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Resources

Policies, Reports, and Policy Statements

National Institutes of Health. “Principles And Guidelines for 

Recipients of NIH Research Grants and Contracts on Obtaining 

and Disseminating Biomedical Research Resources: Final Notice,” 

64 FR 72090 (1999). (available at: http://ott.od.nih.gov/textonly/

RTguide_final.html#princ)

Office of Management and Budget. OMB Circular A-110, Uniform 

Administrative Requirements for Grants and Other Agreements 

with Institutions of Higher Education, Hospitals and Other 

Non-Profit Organizations, Washington, DC: OMB, 1999. 

(available at: http://www.whitehouse.gov/omb/circulars/a110/

a110.html)

———. Circular A-21: Cost Principles for Educational Institutions, 

Washington, DC: OMB, 2000. (available at http://

www.whitehouse.gov/omb/circulars/a021/a021.html)

Additional Reading

Davis, TP, ed. Management of Biomedical Research Laboratories: 

Proceedings of a National Conference, Tucson, AZ: University of 

Arizona, 1999. (available at: http://ori.dhhs.gov/html/programs/

biomedtitle.htm)

Gadlin, H, Jessar, K. “Preempting Discord: Prenuptial Agreements 

for Scientists,” The NIH Catalyst, May-June (2002). (available at: 

http://ori.hhs.gov/html/programs/preempting_discord.asp)

Gottesman, MM. Funding of Intramural Research Program/ 

Extramural Research Program Collaborations, 1999. (available at: 

http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/fund-irp-erp3-00.htm)

Government-University-Industry Research Roundtable, NetLibrary 

Inc. Overcoming Barriers to Collaborative Research: Report of a 

Workshop, Washington, DC: National Academy Press, 1999.

Macrina, FL. Dynamic Issues in Scientific Integrity: Collaborative 

Research, Washington, DC: American Society for Microbiology, 

1995. (available at: http://www.asmusa.org/acasrc/pdfs/

research.pdf)

Schwartz, J. Silence is not Golden: Making Collaborations Work, 

Bethesda, MD: National Institutes of Health, nd. (available at: 

http://ori.hhs.gov/html/programs/science_is_not_golden.asp)

Vonortas, NS, Hamdi, M. United Nations Conference on Trade 

and Development. Partnerships and Networking in Science and 

Technology for Development, New York: United Nations, 2002.

Wagner, CS, United States. Office of Science and Technology Policy, 

Science and Technology Policy Institute (Rand Corporation). 

Linking Effectively: Learning Lessons from Successful 

Collaboration in Science and Technology, Santa Monica, CA: 

Rand, 2002.

Chapter 8: Collaborative Research
Part IV.

Reporting and 

Reviewing 

Research
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ORI Introduction to the Responsible Conduct of Research

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Part IV: Reporting 

and Reviewing 

Research

RESEARCH HAS NO VALUE IF IT IS NOT MADE 

public. Results are shared with colleagues 

so they can be tested, used to advance 

knowledge, and put to work. They 

are shared with the public and 

policymakers so that they can be 

used to make decisions about funding and 

practical application. 

While researchers might engage in research simply for their 

own satisfaction, if their work receives public support, they 

have a responsibility to share that work with others.

Chapter 9, Authorship and Publication, covers the 

responsibilities researchers have when they share 

results with others through informal communications, 

oral presentations, scholarly publications, and public 

statements. Whatever mechanism is used, research results 

should be shared honestly, efficiently, and without bias. 

Dishonesty and bias undermine the usefulness of research 

publications; inefficiency (publishing the same research 

several times) wastes public funds and the valuable time of 

reviewers and journal editors.

Chapter 10, Peer Review, describes the responsibilities 

researchers have when they review the work of other 

researchers. Non-peers—individuals who do not have equal 

training and knowledge—cannot evaluate the quality and 

importance of research. Peers can and therefore play a 

crucial role in many important decisions about the funding, 

publication, and use of research.

Part IV: Reporting and Reviewing Research
133

9. Authorship and Publication

Researchers share the results of their works with colleagues and the public in a variety of ways. Early 

results are usually shared during laboratory meetings, in 

seminars, and at professional meetings. Final results are 

usually communicated to others through scholarly articles 

and books. Public communication takes place through press 

releases, public announcements, newspaper articles, and 

public testimony. Some of these ways of communicating 

research results (i.e., of publication) are well structured and 

controlled; others are informal and have few controls.

Case Study

As his first major grant is coming to an end, several important elements of Dr. Sanjay K.’s research suddenly fall into place. The last series of experiments his graduate student ran clearly 

link the gene they are studying to a particular type of cancer. His postdoc’s work on the proteins 

associated with this gene could pave the way for possible cures. With these results in hand, he is 

finally ready to make a strong case for continued support and, happily, his pending promotion. All 

he has to do now is publish the results. 

A week later, Sanjay’s optimism starts to fade. As might have been expected, his department chair 

was delighted with his progress, but then suggested that the first paper announcing the results 

come out under her name to give it broader circulation. Meanwhile, his postdoc and graduate 

student have gotten into a heated debate about the order their names should appear on the paper; 

the university’s public affairs office has asked for a summary of the results for a press release; and 

the technology transfer office has called telling him to hold all publications until they can evaluate 

the commercial potential of his work.

What should Sanjay do?

Which of these problems should Sanjay tackle first?

Is there anything he could have done to assure that things went more smoothly

when he was ready to publish his results?

Whether structured or informal, controlled or free ranging, 

responsible publication in research should ideally meet some 

minimum standards. All forms of publication should present:

Chapter 9: Authorship and Publication

Responsible authorship?
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ORI Introduction to the Responsible Conduct of Research

135

P a full and fair description of the work undertaken,

P an accurate report of the results, and

P an honest and open assessment of the findings.

In assessing the completeness of any publications, 

researchers should ask whether they have described:

P what they did (methods),

P what they discovered (results), and

P what they make of their discovery (discussion).

It is, however, not as easy as one might anticipate to meet 

these expectations.

9a. Authorship

The names that appear at the beginning of a paper serve 

one important purpose. They let others know who conducted 

the research and should get credit for it. It is important to 

know who conducted the research in case there are questions 

about methods, data, and the interpretation of results. 

Likewise, the credit derived from publications is used to 

determine a researcher’s worth. Researchers are valued 

and promoted in accordance with the quality and quantity 

of their research publications. Consequently, the authors 

listed on papers should fairly and accurately represent the 

person or persons responsible for the work in question.

Contribution. Authorship is generally limited to 

individuals who make significant contributions to the work 

that is reported. This includes anyone who:

P was intimately involved in the conception and design of the 

research,

P assumed responsibility for data collection and interpretation,

P participated in drafting the publication, and

P approved the final version of the publication.

There is disagreement, however, over whether authorship 

should be limited to individuals who contribute to all phases 

of a publication or whether individuals who made more 

limited contributions deserve authorship credit.

The widely accepted Uniform Requirements for 

Manuscripts Submitted to Biomedical Journals, authored by 

the International Committee of Medical Journal Editors 

(ICMJE), sets a high standard for authorship. It recommends 

limiting authorship to persons who contribute to the 

conception and design of the work or to data collection and 

interpretation and, in addition, play an important role in 

drafting and approving the final publication. Anyone who 

plays a lesser role can be listed under acknowledgments but 

not at the beginning of the paper as an author.

As influential as they are, the ICMJE recommendations 

on authorship are not uniformly followed, even in journals 

that subscribe to the ICMJE Requirements. Practices for 

determining authors vary considerably by discipline and 

even from laboratory to laboratory. This places most of 

the responsibility for decisions about authorship on the 

researchers who participated in the work reported in each 

i

ICJME Statement on Authorship 

All persons designated as authors should qualify for authorship, and all those who qualify 

should be listed. Each author should have participated sufficiently in the work to take public 

responsibility for appropriate portions of the content. One or more authors should take 

responsibility for the integrity of the work as a whole, from inception to published article.

Authorship credit should be based only on 1) substantial contributions to conception and 

design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or 

revising it critically for important intellectual content; and 3) final approval of the version to 

be published. Conditions 1, 2, and 3 must all be met. Acquisition of funding, the collection of 

data, or general supervision of the research group, by themselves, do not justify authorship.

Authors should provide a description of what each contributed, and editors should publish 

that information. All others who contributed to the work who are not authors should be 

named in the Acknowledgments, and what they did should be described.

http://www.icmje.org/

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ORI Introduction to the Responsible Conduct of Research

137

publication. These decisions are best made early in any 

project, to avoid misunderstandings and later disputes 

about authorship.

Importance. Authors are usually listed in their order 

of importance, with the designation first or last author 

carrying special weight, although practices again vary by 

discipline. Academic institutions usually will not promote 

researchers to the rank of tenured faculty until they have 

been listed as first or last author on one or more papers.

As with the principle of contribution, however, there are 

no clear rules for determining who should be listed as first 

author or the order in which other authors should be listed. 

The ICMJE Requirements simply note that:

The order of authorship on the byline should be a joint

decision of the coauthors. Authors should be prepared

to explain the order in which authors are listed.

Some journals have specific rules for listing authors; 

others do not, again placing most of the responsibility for 

this decision on the authors themselves.

Corresponding or primary author. Many journals 

now require one author, called the corresponding or 

primary author, to assume responsibility for all aspects of a 

publication, including:

P the accuracy of the data,

P the names listed as authors (all deserve authorship and no 

one has been neglected),

P approval of the final draft by all authors, and

P handling all correspondence and responding to inquiries.

In accepting this responsibility, corresponding authors

should take special note of the fact that they are acting on 

behalf of their colleagues. Any mistakes they make or fail to 

catch will affect their colleagues’ as well as their own careers.

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Standards for Reporting Research Results

The CONSORT Statement

Abstract

To comprehend the results of a randomized controlled trial (RCT), readers must understand 

its design, conduct, analysis, and interpretation. That goal can be achieved only through 

complete transparency from authors. Despite several decades of educational efforts, the 

reporting of RCTs needs improvement. Investigators and editors developed the original 

CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve 

reporting by using a checklist and flow diagram. The revised CONSORT statement presented 

here incorporates new evidence and addresses some criticisms of the original statement. 

The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, 

Results, and Discussion. The revised checklist includes 22 items selected because empirical 

evidence indicates that not reporting the information is associated with biased estimates of 

treatment effect, or because the information is essential to judge the reliability or relevance 

of the findings. We intended the flow diagram to depict the passage of participants through 

an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, 

intervention allocation, follow-up, and analysis). The diagram explicitly shows the number of 

participants, for each intervention group, included in the primary data analysis. Inclusion of 

these numbers allows the reader to judge whether the authors have done an intention-totreat analysis.

http://www.consort-statement.org/

9b. Elements of a responsible publication

Each element of a publication serves an important 

purpose and must be carefully prepared to make sure it 

serves that purpose.

Abstracts. Abstracts summarize the content of publications in sufficient detail to allow other researchers to assess 

relevance to their own work. Abstracts, therefore, should 

neither understate nor overstate the importance of findings. 

Negative results that might be important to other researchers or the public should be mentioned. The data presented 

in the abstract should be the same as the data presented in 

the body of the publication—an obvious requirement, but 

one that studies of publication practices show some authors 

do not follow (see Pitkin, Additional Reading).

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To ensure completeness and accuracy, many journals 

now use structured abstracts. This assures that all of the 

key elements of the publication are mentioned and easily 

identified. With scientific publications now running in the 

millions per year in well over 100,000 journals, researchers 

cannot read all seemingly relevant publications in detail. 

They must rely on abstracts to point them to important 

developments and findings.

Methods. Researchers cannot check and build on the 

work of others without knowing how it was conducted. 

Methods therefore should be described in sufficient detail to 

allow other researchers to replicate them. When researchers 

use well-established methods, this section of a publication 

can be shortened, provided appropriate references are given 

to a full description of the methods along with any changes 

that have been made. New or unique methods should be 

described in more detail to allow other researchers to 

replicate the work.

Results. Research results should be reported in 

sufficient detail to allow other researchers to draw their 

own conclusions about the work. This does not mean that 

every piece of recorded data should be reported. Researchers 

can and must process their raw data before publication (to 

keep publications to a reasonable size if for no other reason). 

However, results should not be left out just because they 

do not agree with the conclusions the authors would like to 

reach. The results section should represent a complete 

summary of what was discovered, leaving interpretations 

for the closing discussion.

Discussion. Researchers can and should evaluate the 

significance of their findings under discussion—also called 

conclusion or summary. This portion of a publication helps 

those who are less familiar with the field understand the 

importance of the findings. It also provides a venue for 

identifying unresolved problems and future research needs.

Since the discussion is read by individuals who may not 

be able to evaluate its validity, it is particularly important 

that authors avoid bias and one-sided reporting in this 

section. Cautions and other interpretations should be 

mentioned along with the limitations of the study to provide 

a balanced view of the reported results. Review articles 

(articles that survey research findings in particular areas) 

should make an honest effort to cover all relevant work. 

It is not always easy to recognize one’s own biases, which 

is a good reason to ask colleagues to read and comment on 

manuscripts before they are submitted for publication.

Notes, bibliography, and acknowledgments. Notes, 

bibliography, and acknowledgments should be used to place 

publications in context and to give credit to others for their 

ideas, support, and work. They serve to:

P provide support for important statements of fact or 

assumptions,

P document the work of others used in the publication,

P point to additional reading and resources, and

P recognize the support of funding agencies or colleagues 

and staff who do not qualify as authors.

Since others rely on and trust this information, it, along 

with every other element of a responsible publication, 

should be fair and accurate.

9c. Practices that should be avoided

Competition in research for funding and recognition places 

considerable pressure on researchers to publish. Ideally, 

quality should matter more than quantity, but in reality 

quantity—the number of articles published—is often used 

as a measure of productivity and ability. However, no 

matter how important it may be to publish, some 

publication practices should be avoided.

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ORI Introduction to the Responsible Conduct of Research

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Honorary authorship. The practice of listing 

undeserving authors on publications, called “honorary” 

authorship, is widely condemned and in the extreme 

considered by some to constitute a form of research 

misconduct. However, common agreement notwithstanding, 

honorary authorship is a significant problem in research 

publication today (see articles by Drenth and Flanagin, 

Additional Reading). Researchers are listed on publications 

because they:

P are the chair of the department or program in which the 

research was conducted,

P provided funding for the research,

P are the leading researcher in the area,

P provided reagents, or

P served as a mentor to the primary author.

Persons in these positions can make significant contributions 

(see left) to a publication and may deserve recognition. 

However, they should not be listed if these are the only 

contributions they made.

Salami publication. Salami publication (sometimes 

called bologna or trivial publication) is the practice of 

dividing one significant piece of research into a number of 

small experiments (least publishable units or LPUs), simply 

to increase the number of publications. This practice may 

distort the value of the work by increasing the number of 

studies that appear to support it. It also wastes valuable 

time and resources. Before an article is published it is 

reviewed, edited, and in one form or another prepared for 

publication. After publication it is entered into indexes 

and databases, such as the National Library of Medicine’s 

PubMed®. Libraries and individuals purchase the journal 

in which it is published. If the same information could be 

summarized in one article as opposed to two, three, or more, 

everyone involved, from the publishers to libraries and the 

researchers who have to keep up to date on current 

information, benefits. Researchers therefore should avoid 

trivial or salami publication.

Duplicate publication. Duplicate publication is the 

practice of publishing the same information a second time 

without acknowledging the first publication. This practice 

not only wastes time and resources but can also distort the 

research record and endanger public health.

Researchers rely on meta-analyses (analyses of a group of 

similar experiments or studies of studies) to improve their 

understanding of difficult problems. One clinical trial or 

epidemiological study may not produce clear evidence, but 

the pooled results of many related studies can. However, if 

some of the studies in the pooled study (meta-analysis) have 

been published two or more times without proper notice, the 

results of the meta-analysis will be unfairly weighted in the 

The Council of Science Editors

A New Standard for Authorship (1998 proposal)

Paul J. Friedman, MD

Publication has become the essential achievement for academic advancement for both clinical and 

basic scientists, although the type and number of publications demanded may vary widely. Despite 

a recent increased emphasis on teaching as a meritorious activity, faculty and trainees realistically 

feel intense pressure to publish. One unfortunate result has been a proliferation of papers and 

journals and a variety of abuses of trainees, junior colleagues, and patients, and of integrity.

To help restore a sense of proportion and confidence in the validity of biomedical publication, 

this conference proposes a new step in the evolution of the concept of authorship. We 

propose to publish the contributions of the individuals associated with a manuscript. The 

information will be solicited on a modified copyright form, which will be filled out and signed 

by all the authors. We propose a check-off list, such as the following: 

Authorship contributions Data collection and/or processing 

Concept Analysis and/or interpretation 

Design Literature search 

Supervision Writing 

Resources Critical review 

Material Other 

http://www.cbe.org/services_FriedmanArticle.shtml

Chapter 9: Authorship and Publication
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ORI Introduction to the Responsible Conduct of Research

143

direction of the duplicate publication. Therefore, duplicate 

publication is not only deceptive but poses real dangers 

to public health and safety (see articles by Jefferson and 

Tramer, Additional Reading).

Premature public statements. Academic or scholarly 

publication practices are designed to assure that the 

information conveyed to broader audiences through these 

practices is accurate and fairly presented. While the system 

is not foolproof and erroneous or biased information is from 

time to time published, standard publication practices 

do serve an important quality control role in research. 

Accordingly, researchers should follow standard publication practices when making research results public and 

not issue premature public statements about their work 

before it has been reviewed. From time to time there may 

be overriding circumstances, such as early indications of 

a significant threat to public health or safety, but for the 

most part research results should be made public only after 

they have been carefully reviewed and properly prepared 

for publication.

Questions for discussion

 1 What are the accepted criteria for authorship in your field of 

research? If there are none, what should they be?

 2 Should researchers be allowed to omit some details from the 

methods section of their publications until they have had 

time to patent their methods?

 3 What should a researcher do if the journal that has accepted 

a publication will not let the researcher publish the method or 

results in as much detail as the researcher feels is necessary?

 4 What should a researcher do if an undeserving author in a 

position of some authority demands authorship status on a 

paper?

 5 What factors should be considered when making a decision 

to publish the results of a study in one article versus several 

articles?

Chapter 9: Authorship and Publication
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ORI Introduction to the Responsible Conduct of Research

145

Resources

Policies, Reports, and Policy Statements

Society for Neuroscience. Responsible Conduct Regarding Scientific 

Communication, SN, 1996. (available at: http://www.sfn.org/

content/AboutSfN1/Guidlines/guidelines.pdf)

Michigan State University. Michigan State University Guidelines on 

Authorship, East Lansing, MI: MSU, 1998. (available at: http:

//www.msu.edu/unit/vprgs/authorshipguidelines.htm)

International Committee of Medical Journal Editors. Uniform 

Requirements for Manuscripts Submitted to Biomedical Journals, 

2001. (available at: http://www.icmje.org/)

Council of Biology Editors. Scientific Style, CBE, 2002. (available at: 

http://writing.colostate.edu/references/sources/cbe/)

Additional Reading

Begg, C, Cho, MK, Eastwood, S, Horton, R, Moher, D, Oking, I, 

Pitkin, RM, Rennie, D, Schulz, KF, Simel, D, Stroup, D. “Improving 

the Quality of Reporting of Randomized Controlled Trials: The 

CONSORT Statement,” Journal of the American Medical 

Association 276 (1996): 637-639.

Bloemenkamp, DGM, Walvoort, HC, Hart, W, Overbeke, AJPM. 

“[Duplicate publication of articles in the Dutch Journal of 

Medicine in 1996],” Nederlands Tijdschrift voor Geneeskunde 143, 

43 (1999): 2150-2153.

Budd, JM, Sievert, M, Schultz, TR. “Phenomena of Retraction: 

Reasons for Retraction and Citations to the Publications,” Journal 

of the American Medical Association 280, 3 (1998): 296-297.

Budd, JM, Sievert, M, Schultz, TR, Scoville, C. “Effects of Article 

Retraction on Citation and Practice in Medicine,” Bulletin of the 

Medical Libraries Association 87, 4 (1999): 437-443.

Drenth, JP. “Multiple Authorship: The Contribution of Senior 

Authors,” Journal of the American Medical Association 280, 3 

(1998): 219-221.

Flanagin, A, Carey, LA, Fontanarosa, PB, Phillips, SG, Pace, BP, 

Lundberg, GD, Rennie, D. “Prevalence of Articles with Honorary 

Authors and Ghost Authors in Peer-reviewed Medical Journals,” 

Journal of the American Medical Association 280, 3 (1998): 222-

224.

Hoen, WP, Walvoort, HC, Overbeke, AJ. “What are the Factors 

Determining Authorship and the Order of the Authors’ Names? 

A Study Among Authors of the Nederlands Tijdschrift voor 

Geneeskunde (Dutch Journal of Medicine),” Journal of the 

American Medical Association 280, 3 (1998): 217-218.

Jadad, AR, Cook, DJ, Jones, A, Klassen, TP, Tugwell, P, Moher, M, 

Moher, D. “Methodology and Reports of Systematic Reviews and 

Meta-analyses: A Comparison of Cochrane Reviews with Articles 

Published in Paper-based Journals,” Journal of the American 

Medical Association 280, 3 (1998): 278-280.

Jefferson, T. “Redundant Publication in Biomedical Sciences: 

Scientific Misconduct or Necessity?” Science and Engineering 

Ethics 4, 2 (1998): 135-140.

Jones, AH, McLellan, F. Ethical Issues in Biomedical Publication, 

Baltimore: Johns Hopkins University Press, 2000.

Pitkin, RM, Branagan, MA. “Can the Accuracy of Abstracts be 

Improved by Providing Specific Instructions? A Randomized 

Controlled Trial,” Journal of the American Medical Association

280, 3 (1998): 267-269.

Pitkin, RM, Branagan, MA, Burmeister, LF. “Accuracy of Data in 

Abstracts of Published Research Articles,” Journal of the 

American Medical Association 281, 12 (1999): 1129-1130.

Scherer, RW, Crawley, B. “Reporting of Randomized Clinical Trial 

Descriptors and Use of Structured Abstracts,” Journal of the 

American Medical Association 280, 3 (1998): 269-272.

Speck, BW. Publication Peer Review: An Annotated Bibliography, 

Bibliographies and Indexes in Mass Media and Communications, 

no. 7, Westport, CT: Greenwood Press, 1993.

Tarnow, E. “The Authorship List in Science: Junior Physicists’ 

Perceptions of Who Appears and Why,” Science and Engineering 

Ethics 5, 1 (1999): 73-88.

Tramer, MR, Reynolds, DJ, Moore, RA, McQuay, HJ. “Impact of 

Covert Duplicate Publication on Meta-analysis: A Case Study,” 

British Medical Journal 315, 7109 (1997): 635-640.

Wilcox, LJ. “Authorship: The Coin of the Realm, The Source of 

Complaints,” Journal of the American Medical Association 280, 3 

(1998): 216-217.

Chapter 9: Authorship and Publication
147

10. Peer Review

Peer review—evaluation by colleagues with similar knowledge and experience—is an essential component 

of research and the self-regulation of professions. The 

average person does not have the knowledge and experience 

needed to assess the quality and importance of research. 

Peers do. Therefore many important decisions about 

research depend on advice from peers, including:

P which projects to fund (grant reviews),

P which research findings to publish (manuscript reviews),

P which scholars to hire and promote (personnel reviews), 

and

P which research is reliable (literature reviews and expert 

testimony).

The quality of the decisions made in each case depends 

heavily on the quality of peer review.

Case Study

Dr. Sung L. is struggling with the decision whether to agree to review the work of an advanced graduate student at another university for publication in the major journal in his field. He is 

familiar with the student's work and attended a session several months ago at which she presented 

a brief report on her work. It clearly overlaps with his research in a number of ways, which is one 

reason he has been asked to serve as a reviewer. 

Dr. L. knows he is qualified to do the review and is confident he can provide an objective, constructive 

judgment of the students's work. However, since his students are working on similar problems, 

he is concerned about the appearance of a conflict of interest. In addition, he is not sure he wants 

to learn more about the work in question until he publishes his own work, to avoid later charges 

that he unfairly used some of the student’s ideas. Finally, there is the matter of yet another lost 

weekend doing the review, when his department chair has already told him to cut down on unpaid 

professional service.

Should Dr. L. agree to do the review?

If he is uncertain about his responsibilities, where can he get advice?

Would the situation be different if he had been asked to review the student’s work for an

appointment or promotion decision?

Chapter 10: Peer Review

One of the benefits of serving as a peer reviewer?
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Peer review can make or break professional careers and 

directly influence public policy. The fate of entire research 

programs, health initiatives, or environmental and safety 

regulations can rest on peer assessment of proposed or 

completed research projects. For peer review to work, it 

must be:

P timely,

P thorough,

P constructive,

P free from personal bias, and

P respectful of the need for confidentiality.

Researchers who serve as peer reviewers should be mindful 

of the public as well as the professional consequences of 

their evaluations and exercise special care when making 

these evaluations.

10a. Meeting deadlines

The effort researchers put into peer review is for the 

most part not compensated. Researchers may receive 

reimbursement for travel and per diem when they attend 

special grant-review sessions and occasionally are paid a 

basic daily stipend, but this seldom covers the true cost of 

reviewing a manuscript or a stack of grant applications. As 

uncompensated effort, the time researchers devote to peer 

review can easily take second place to other obligations. 

Running a crucial experiment or submitting a grant 

application on time understandably is more important than 

reviewing someone else’s work.

However pressed you are for time, if you agree to do a 

review, you should find the time to meet your obligation in 

a timely manner. Research is competitive. Researchers are 

rewarded for discoveries. They should not lose their priority 

for a discovery due to the tardiness of a reviewer sending 

comments on a manuscript. Research is also useful. The 

announcement of discoveries that can benefit the public 

should not be delayed because someone who agreed to 

review a manuscript does not have the time to do the review.

Editors, program managers, and others who rely on peer 

review to make decisions generally provide a deadline for 

getting the review done when they first contact reviewers. 

Anyone who agrees to take on a peer review assignment 

under these conditions should meet the proposed deadline. 

If the time frame is not reasonable, either decline to do 

the review or ask for more time in advance. Do not delay 

someone else’s work just because you are short on time.

Editors of the Publications Division 

American Chemical Society

Ethical Obligations of Reviewers of Manuscripts

1. ...every scientist has an obligation to do a fair share of reviewing.

2. A chosen reviewer who feels inadequately qualified to judge the research reported in a 

manuscript should return it promptly to the editor.

3. A reviewer (or referee) of a manuscript should judge objectively the quality of the 

manuscript, of its experimental and theoretical work, of its interpretations and its 

exposition, with due regard to the maintenance of high scientific and literary standards. 

A reviewer should respect the intellectual independence of the authors.

4. A reviewer should be sensitive to the appearance of a conflict of interest....

- - - - - - - - - - - - - - -

6. A reviewer should treat a manuscript sent for review as a confidential document....

7. Reviewers should explain and support their judgments adequately....

8. A reviewer should be alert to failure of authors to cite relevant work by other 

scientists,...

9. A reviewer should act promptly, submitting a report in a timely manner.

10. Reviewers should not use or disclose unpublished information, arguments, or 

interpretations contained in a manuscript under consideration, except with the consent 

of the author....

http://pubs.acs.org:80/instruct/ethic2000.pdf

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Society for Neuroscience

Responsible Conduct Regarding Scientific 

Communication (1998)

2. Reviewers of Manuscripts

2.1. Thorough scientific review is in the interest of the scientific community.

2.2. A thorough review must include consideration of the ethical dimensions of a 

manuscript as well as its scientific merit.

2.3. All scientists are encouraged to participate if possible when asked to review a 

manuscript.

2.4. Anonymity of reviewers should be preserved unless otherwise stated in the guidelines 

for authors and for reviewers, or unless a reviewer requests disclosure.

2.5. Reviewers should be chosen for their high qualifications and objectivity regarding a 

particular manuscript.

2.6. Reviews should not contain harsh language or personal attacks.

2.7. Reviews should be prompt as well as thorough.

2.8. Reviewers must not use non-public information contained in a manuscript to advance 

their own research or financial interests.

2.9. Information contained in a manuscript under review is confidential and must not be 

shared with others.

http://web.sfn.org/content/AboutSfN1/Guidlines/guidelines.pdf

10b. Assessing quality

Journal editors, grant administrators, and others rely 

on peers to assess the quality of proposed and published 

research. Some parts of an application or manuscript can 

be checked fairly easily. Are the calculations correct? Is the 

method that has been used or proposed appropriate? Do the 

reported results support the conclusions? Other parts are 

more difficult to confirm. Have the data been accurately 

recorded and reported? Were the experiments run? Did the 

subjects give consent? Do the articles cited in the references 

and bibliography contain the information they are said to 

contain?

Peers who are asked to make judgments about the quality 

of a proposed or completed project must do their best to 

determine whether the work they have been asked to review 

is internally consistent and conforms to the practices of 

their field of research. This certainly includes:

P assessing whether the research methods are appropriate;

P checking calculations and/or confirming the logic of 

important arguments;

P making sure the conclusions are supported by the evidence 

presented; and

P confirming that the relevant literature has been consulted 

and cited.

At the very least, peer reviewers should be expected to 

assess whether the manuscript or proposal under review 

makes sense and conforms to accepted practices, based on 

the information presented.

Research that conforms to accepted practices can still 

have problems. Research quality can be compromised by:

P careless mistakes made in reporting data and/or listing 

citations;

P the deliberate fabrication and falsification of data;

P improper use of material by others (plagiarism);

P inaccurate reporting of conflicts of interest, contributors/

authors; and

P the failure to mention important prior work, either by others 

or by the researcher submitting a paper for publication.

However, how much peer reviewers can or should do to 

detect these and other deceptive or sloppy practices 

remains subject to debate.

There are limits to the amount of checking that is both 

reasonable and practical. Unless given permission to do so, 

reviewers should not discuss the work they are reviewing 

with the authors. In many cases, reviews are “blind” (no 

author identification), so reviewers could not check with 

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authors even if they wanted to. In addition, it is not 

reasonable to expect reviewers to check every reference 

and detail. The fact remains, however, that peer reviewers 

frequently miss problems that might have been detected 

had the reviewer checked a little more carefully.

If you agree to serve as a peer reviewer, remember that 

you have essentially been asked to provide your stamp of 

approval for someone else’s work. In such circumstances, 

it is wise to do your homework. Do not give your stamp of 

approval too easily.

10c. Judging importance

In addition to quality, peer reviewers are also asked to make 

judgments about the importance of proposed or published 

research. They are asked to answer questions such as:

P Assuming a researcher could carry out a proposed research 

project, is it important to do so?

P Are these research results important enough to publish?

P Has a researcher made important contributions to a field of 

study?

P Is this evidence important enough to be used in setting 

policy?

Along with quality, judgments about importance essentially 

determine which research is funded or published and which 

researchers are hired and relied upon for advice.

Peer reviewers do not always make judgments about 

importance with an open mind. Studies have shown that 

they can be swayed by:

P the stature of the researcher who conducted the research 

or the institution at which the research was conducted;

P country of origin;

P a preference for one research method over another, e.g., a 

clinical versus a laboratory approach; and

P the outcome of the studies under review.

For the most part, these factors should not have a bearing 

on judgments about importance and yet they do. Each has 

been shown to influence the judgments peer reviewers make 

about the publication of research results (see articles by 

Callaham, Cho, Dickersin, Godlee, Jadad, and Link, 

Additional Reading).

There is no simple solution to the problem of bias in peer 

review. Peers frequently are not of one mind about what is 

or is not important. One reviewer may feel that a field of 

research should move in one direction, a second in an 

entirely different direction. Often, it takes time and more 

research to find out whether a line of investigation or a 

particular set of findings is important. Nonetheless, 

researchers can take steps to lessen the impact of bias on 

their judgments and to help others judge for themselves 

whether a researcher has biases.

One way to lessen the impact of bias is to write 

transparent reviews. By “transparent” is meant laying out 

clearly for anyone reading the review how it was prepared, 

the literature that was used, and the reviewer’s own 

possible biases. If reviewers fully and carefully explain how 

their judgments about importance were made, others can 

assess whether they want to accept those judgments.

A second way that has been proposed to lessen the impact

of bias is to eliminate anonymous reviews. Some argue that 

this would lessen the candor and rigor of reviews; others 

that it would make reviewers more accountable. For the 

present, most reviews are anonymous, which places the 

burden for fairness on the reviewer. If you have strong 

feelings about a person or particular line of investigation, 

tell the person who asked you to do the review and consider 

whether you can, in fact, provide an impartial assessment.

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10d. Preserving confidentiality

Some information that is shared during peer review is 

shared confidentially, that is, with the understanding that 

it will not be shared with anyone else without permission. 

Confidentiality is generally required during:

P grant reviews,

P manuscript reviews, and

P personnel reviews.

During grant and manuscript reviews, confidentiality 

helps protect ideas before they are funded or published. In 

personnel reviews, confidentiality is important to protect 

personal privacy.

Peer reviewers have an obligation to preserve 

confidentiality during the review process if they have been 

asked to do so. While this obligation might seem obvious, it 

can be compromised in some seemingly harmless and other 

more harmful ways. For example, although researchers 

sometimes do, it is not acceptable to do any of the following 

without getting permission:

P ask students or anyone else to conduct a review you were 

asked to do;

P use an idea or information contained in a grant proposal 

or unpublished manuscript before it becomes publicly 

available;

P discuss grant proposals or manuscripts you are reviewing 

with colleagues in your department or at a professional 

meeting;

P retain a copy of the reviewed material (generally 

manuscripts and grant proposals should be shredded or 

returned after the review is complete); and

P discuss personnel and hiring decisions with colleagues who 

are not part of the review process.

There may be times when some added advice during a 

review may be helpful, but reviewers should not seek this 

advice without getting permission. It may also be tempting to 

use information in a grant application or manuscript to speed

up your own research, but until it has been made public, 

confidential information is not available for use, even to 

reviewers. If you are not comfortable protecting confidential 

information, then do not agree to be a peer reviewer.

Researchers who are in a position to pass judgment on the 

work of colleagues have significant power. They can hasten or

slow that work; credit or discredit it. They have the power to 

shape entire fields of research and to influence public policy. 

If you have that power, make sure you use it responsibly 

and with some compassion, knowing that what you say and 

do directly affects the careers of other researchers.

Questions for discussion

1 What should researchers or students do if a colleague or 

mentor asks them to take a look at a manuscript they have 

not been authorized to review?

2 What information contained in a manuscript or proposal 

should reviewers be expected to check?

3 Should peer review be anonymous?

4 How can researchers who sit on committees that advise on 

research directions separate their own interests from the best 

interests of the field they are helping shape?

5 What would happen if the public lost confidence in peer 

review and looked for other mechanisms to judge the quality 

and importance of research?

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Resources

Policies, Reports, and Policy Statements

National Institutes of Health. NIH Guide – Objectivity in Research, 

Bethesda, MD: NIH, 1995. (available at: http://grants2.nih.gov/

grants/guide/notice-files/not95-179.html)

University of Michigan Medical School. Guidelines for the Responsible 

Conduct of Research: Right and Responsibilities of Peer Review, 

Ann Arbor, MI: UM, 1999. (available at: http://www.responsibility.

research.umich.edu/UMMSpeer.html)

International Committee of Medical Journal Editors. Uniform 

Requirements for Manuscripts Submitted to Biomedical Journals, 

2001. (available at: http://www.icmje.org/)

General Information Web Sites

International Congress on Peer Review and Biomedical Publication. 

Home Page, 2003. http://www.ama-assn.org/public/peer/

peerhome.htm

Office of Extramural Research. National Institutes of Health. OER: 

Peer Review Policy and Issues, 2003. http://grants1.nih.gov/grants/

peer/peer.htm

Additional Reading

Armstrong, JS. “Peer Review for Journals: Evidence on Quality 

Control, Fairness, and Innovation,” Science and Engineering 

Ethics 3, 1 (1997): 63-84.

Black, N, van Rooyen, S, Godlee, F, Smith, R, Evans, S. “What 

Makes a Good Reviewer and a Good Review for a General Medical 

Journal?” Journal of the American Medical Association 280, 3 

(1998): 231-233.

Callaham, ML, Baxt, WG, Waeckerle, JF, Wears, RL. “Reliability 

of Editors’ Subjective Quality Ratings of Peer Reviews of 

Manuscripts,” Journal of the American Medical Association 280, 3 

(1998): 229-231.

Callaham, ML, Wears, RL, Weber, EJ, Barton, C, Young, G. “Positiveoutcome Bias and Other Limitations in the Outcome of Research 

Abstracts Submitted to a Scientific Meeting,” Journal of the 

American Medical Association 280, 3 (1998): 254-7.

Cho, MK, Justice, AC, Winker, MA, Berlin, JA, Waeckerle, JF, 

Callaham, ML, Rennie, D. “Masking Author Identity in Peer 

Review: What Factors Influence Masking Success?” Journal of the 

American Medical Association 280, 3 (1998): 243-245.

Dickersin, K. “How Important is Publication Bias? A Synthesis of 

Available Data,” AIDS Education and Prevention 9, 1 Suppl 

(1997): 15-21.

Dickersin, K, Fredman, L, Flegal, KM, Scott, JD, Crawley, B. “Is 

There a Sex Bias in Choosing Editors? Epidemiology Journals as 

an Example,” Journal of the American Medical Association 280, 3 

(1998): 260-264.

Evans, A, McNutt, R, Fletcher, S, Fletcher, R. “The Characteristics of 

Peer Reviewers Who Produce Good-quality Reviews,” Journal of 

General Internal Medicine 8, August 8 (1993): 422-428.

Fletcher, RH, Fletcher, SW. “Evidence for the Effectiveness of Peer 

Review,” Science and Engineering Ethics 3, 1 (1997): 35-50.

Godlee, F, Gale, CR, Martyn, CN. “Effect on the Quality of Peer 

Review of Blinding Reviewers and Asking Them to Sign Their 

Reports: A Randomized Controlled Trial,” Journal of the American 

Medical Association 280, 3 (1998): 237-240.

Jadad, AR, Cook, DJ, Jones, A, Klassen, TP, Tugwell, P, Moher, M, 

and Moher, D. “Methodology and Reports of Systematic Reviews 

and Meta-Analyses: A Comparison of Cochrane Reviews with 

Articles Published in Paper-Based Journals.” Journal of the 

American Medical Association 280, 3 (1998): 278-280.

Jefferson, T. Peer Review in the Health Sciences, London: British 

Medical Journal Books, 1999.

Justice, AC, Cho, MK, Winker, MA, Berlin, JA, Rennie, D. “Does 

Masking Author Identity Improve Peer Review Quality? A 

Randomized Controlled Trial,” Journal of the American Medical 

Association 280, 3 (1998): 240-242.

Link, AM. “US and Non-US Submissions: An Analysis of Reviewer 

Bias,” Journal of the American Medical Association 280, 3 (1998): 

246-247.

Pitkin, RM, Branagan, MA, Burmeister, LF. “Effectiveness of a 

Journal Intervention to Improve Abstract Quality,” Journal of the 

American Medical Association 283, 4 (2000): 481.

van Rooyen, S, Godlee, F, Evans, S, Black, N, Smith, R. “Effect of 

Open Peer Review on Quality of Reviews and on Reviewers’ 

Recommendations: A Randomised Trial,” British Medical Journal

318, 7175 (1999): 23-27.

van Rooyen, S, Godlee, F, Evans, S, Smith, R, Black, N. “Effect 

of Blinding and Unmasking on the Quality of Peer Review: A 

Randomized Trial,” Journal of the American Medical Association

280, 3 (1998): 234-237.

———. “Effect of Blinding and Unmasking on the Quality of Peer 

Review,” Journal of General Internal Medicine 14, 10 (1999): 

622-624.

Chapter 10: Peer Review
Part V.

Safe Driving and 

Responsible 

Research
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ORI Introduction to the Responsible Conduct of Research

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Part V: Safe Driving 

and Responsible 

Research

IT IS NOT EASY TO GO THROUGH LIFE DOING 

everything we must or should do all of 

the time. It should therefore come 

as no surprise that in many 

small and some significant 

ways, researchers do not always follow the 

rules of the road for responsible conduct in 

research. They roll through stop signs when 

they clean up their data more than they

should, accept honorary authorship, purchase something 

with grant funds that is not strictly allowed, or give 

colleagues more favorable reviews than they deserve. From 

time to time, they drive faster than the posted speeds to 

arrive at their destination—a grant, a publication, new 

knowledge—a little more quickly.

We ignore musts and shoulds in life for different reasons. 

For one, society sends mixed messages about obeying rules. 

Should you turn in someone for cheating or “mind your 

own business”? Rules also can conflict with one another. 

Should you report misconduct if doing so puts your career 

at risk? And finally, we are amazingly adept at “bending” or 

“stretching” the rules by thinking up good reasons why 

a questionable course of action is acceptable under a 

particular set of circumstances, that is, at justifying our 

actions, whatever they are.

The ease with which rules can be bent or ignored is 

particularly evident early in the career track the majority of 

researchers traditionally follows. Studies consistently 

suggest that well over half and probably closer to threequarters of college students cheat during their undergraduate

years. In two separate studies, 1 in 10 research trainees 

reported a willingness to break the rules to get grants 

funded or papers published. Roughly the same number of 

students applying for research fellowships and residencies 

in medicine significantly misrepresents their research 

publications on résumés, as confirmed in studies conducted 

Part V: Safe Driving and Responsibile Research
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ORI Introduction to the Responsible Conduct of Research

163

in six medical specialties. Presumably most individuals who 

cheat or inflate résumés know that it is wrong to do so, but 

they nonetheless find reason for engaging in these practices.

The same patterns of behavior can easily spill over into 

other aspects of research. The pressures that prompt students 

to bend or ignore the rules do not disappear after graduation. 

Getting into good schools is replaced by getting a good job and 

promotions. Competition for grades is replaced by competition 

to get funded and published. Too little time to study for tests 

is replaced by too little time to teach, mentor, provide service, 

and do research. The stakes may even increase later in careers, 

as family responsibilities are added into the mix and personal 

ambitions grow, making it even easier to put more pressure 

on the accelerator to get to your destination a little faster.

There are many quick-and-easy reasons that can be called 

up to justify bending or ignoring some of the rules of the 

road for responsible research:

P I already have enough information to know what the results 

will be, so there is no need to run the controls again, even 

though they did not give me the expected results the first 

time.

P No one funds truly exploratory research, so the only way to 

test new ideas is to use funds from an existing grant, even 

though these funds are for other work.

P If my bosses read my research papers rather than counting 

them, I wouldn’t have to publish the same research twice 

or chop it up into small, insignificant pieces.

P Given the competition in this field, you cut your own throat 

if you share your methods and information with colleagues 

too freely.

P They will cut off my funds if I report these results, so for 

the good of my laboratory and staff I should sit on them for 

a while longer.

P I know my research is not going to harm anyone, so why 

waste my time and the time of the IRB getting permission.

Rules are not always reasonable or rationally applied. Life 

and colleagues are not always fair. Good guys do sometimes 

seem to come in last.

However, the problem with quick-and-easy justifications 

and catchy phrases is they fail to take into consideration the 

larger consequences of our actions. What would happen if 

everyone decided, for one “good” reason or another, to run 

stop signs, drive on the wrong side of the road, or ignore 

the speed limit? Obviously, chaos would quickly ensue 

and driving would no longer be safe (or become even more 

hazardous than it is already). The same would be true 

of research if researchers routinely ignored responsible 

research practices and did what they thought was necessary 

simply to achieve some end, whether the discovery of truth, 

the development of something useful, or personal success.

As stated at the beginning of the ORI Introduction to 

RCR, there is no one best way to undertake research, no 

universal method that applies to all scientific investigations. 

Accepted practices for the responsible conduct of research 

can and do vary from discipline to discipline and even 

laboratory to laboratory. There are, however, some 

important shared values for the responsible conduct of 

research that bind all researchers together, including 

honesty, accuracy, efficiency, and objectivity. There are no 

excuses for compromising these values. Their central role in 

research is the responsibility of each and every researcher. 

Drive safely and be a responsible researcher.

Part V: Safe Driving and Responsibile Research
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ORI Introduction to the Responsible Conduct of Research

Resources

Additional Reading

Baker, DR, Jackson, VP. “Misrepresentation of Publications by 

Radiology Residency Applicants,” Academic Radiology 7, 9 (2000): 

727-729.

Bilge, A, Shugerman, RP, Robertson, WO. “Misrepresentation of 

Authorship by Applicants to Pediatrics Training Programs,” 

Academic Medicine 73, 5 (1998): 532-533.

Brown, S, Kalichman, MW. “Effects of Training in the Responsible 

Conduct of Research: A Survey of Graduate Students in 

Experimental Sciences,” Science and Engineering Ethics 4, 4 

(1998): 487-498.

Dale, JA, Schmitt, CM, Crosby, LA. “Misrepresentation of Research 

Criteria by Orthopaedic Residency Applicants,” Journal of Bone 

and Joint Surgery 81, 12 (1999): 1679-1681.

Eastwood, S, Derish, P, Leash, E, Ordway, S. “Ethical Issues in 

Biomedical Research: Perceptions and Practices of Postdoctoral 

Research Fellows Responding to a Survey,” Science and 

Engineering Ethics 2, 1 (1996): 89-114.

Goe, LC, Herrera, AM, Mower, WR. “Misrepresentation of Research 

Citations among Medical School Faculty Applicants,” Academic 

Medicine 73, 11 (1998): 1183-1186.

Grover, M, Dharamshi, F, Goveia, C. “Deception by Applicants to 

Family Practice Residencies,” Family Medicine 33, 6 (2001): 

441-446.

Gurudevan, SV, Mower, WR. “Misrepresentation of Research 

Publications among Emergency Medicine Residency Applicants,” 

Annals of Emergency Medicine 27, 3 (1996): 327-330.

Kalichman, MW, Friedman, PJ. “A Pilot Study of Biomedical 

Trainees’ Perceptions Concerning Research Ethics,” Academic 

Medicine 67, 11 (1992): 769-775.

McAlister, WP, Velyvis, JH, Uhl, RL. “Misrepresentation of Research 

Criteria by Orthopaedic Residency Applicants,” Journal of Bone 

and Joint Surgery 82-A, 10 (2000): 1512-1513.

Panicek, DM, Schwartz, LH, Dershaw, DD, Ercolani, MC, 

Castellino, RA. “Misrepresentation of Publications by Applicants 

for Radiology Fellowships: Is It a Problem?” American Journal of 

Roentgenology 170, 3 (1998): 577-581.

Patel, MV, Pradhan, BB, Meals, RA. “Misrepresentation of Research 

Publications among Orthopedic Surgery Fellowship Applicants: 

A Comparison with Documented Misrepresentations in Other 

Fields,” Spine 28, 7 (2003): 632-636; discussion 31.

Sekas, G, Hutson, WR. “Misrepresentation of Academic 

Accomplishments by Applicants for Gastroenterology 

Fellowships,” Annals of Internal Medicine 123, 1 (1995): 38-41.

Notes
Notes