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The document discusses the integrity in scientific research as assessed by the National Research Council. It highlights the importance of fostering an ethical research environment and provides recommendations for promoting integrity through education and institutional approaches. The report is backed by various experts and supported by the Office of Research Integrity, U.S. Department of Health and Human Services.

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Integrity in Scientific Research National Research Council Available Instanly

The document discusses the integrity in scientific research as assessed by the National Research Council. It highlights the importance of fostering an ethical research environment and provides recommendations for promoting integrity through education and institutional approaches. The report is backed by various experts and supported by the Office of Research Integrity, U.S. Department of Health and Human Services.

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Committee on Assessing Integrity in Research Environments

Board on Health Sciences Policy


and
Division of Earth and Life Studies

THE NATIONAL ACADEMIES PRESS


Washington, D.C.
www.nap.edu
THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, N.W. • Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board
of the National Research Council, whose members are drawn from the councils of the
National Academy of Sciences, the National Academy of Engineering, and the Institute of
Medicine. The members of the committee responsible for the report were chosen for their
special competences and with regard for appropriate balance.

Support for this project was provided by the Office of Research Integrity, U.S. Department
of Health and Human Services. The views presented in this report are those of the Institute
of Medicine and National Research Council Committee on Assessing Integrity in Research
Environments and are not necessarily those of the funding agencies.

International Standard Book Number: 0-309-08523-3; 0-309-08479-2 (pbk.)

Library of Congress Control Number: 20021102-17

Additional copies of this report are available for sale from the National Academies Press,
500 Fifth Street, N.W., Box 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in
the Washington metropolitan area); Internet, http:// www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at:
www.iom.edu.

Copyright 2002 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.


The National Academy of Sciences is a private, nonprofit, self-perpetuating soci-
ety of distinguished scholars engaged in scientific and engineering research, dedi-
cated to the furtherance of science and technology and to their use for the general
welfare. Upon the authority of the charter granted to it by the Congress in 1863,
the Academy has a mandate that requires it to advise the federal government on
scientific and technical matters. Dr. Bruce M. Alberts is president of the National
Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter
of the National Academy of Sciences, as a parallel organization of outstanding
engineers. It is autonomous in its administration and in the selection of its mem-
bers, sharing with the National Academy of Sciences the responsibility for advis-
ing the federal government. The National Academy of Engineering also sponsors
engineering programs aimed at meeting national needs, encourages education
and research, and recognizes the superior achievements of engineers. Dr. Wm. A.
Wulf is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of


Sciences to secure the services of eminent members of appropriate professions in
the examination of policy matters pertaining to the health of the public. The
Institute acts under the responsibility given to the National Academy of Sciences
by its congressional charter to be an adviser to the federal government and, upon
its own initiative, to identify issues of medical care, research, and education. Dr.
Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sci-
ences in 1916 to associate the broad community of science and technology with
the Academy’s purposes of furthering knowledge and advising the federal gov-
ernment. Functioning in accordance with general policies determined by the
Academy, the Council has become the principal operating agency of both the
National Academy of Sciences and the National Academy of Engineering in pro-
viding services to the government, the public, and the scientific and engineering
communities. The Council is administered jointly by both Academies and the
Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and
vice chair, respectively, of the National Research Council.

www.national-academies.org
COMMITTEE ON ASSESSING INTEGRITY
IN RESEARCH ENVIRONMENTS
ARTHUR H. RUBENSTEIN (Chair), Executive Vice President,
University of Pennsylvania for the Health System, and Dean, School
of Medicine, University of Pennsylvania School of Medicine,
Philadelphia
MURIEL J. BEBEAU, Professor, School of Dentistry, University of
Minnesota, Minneapolis
STUART BONDURANT, Professor of Medicine and Dean Emeritus,
University of North Carolina at Chapel Hill
DAVID R. COX, Professor of Genetics and Pediatrics, Stanford
University School of Medicine, Stanford
ROBERT C. DYNES, Chancellor and Professor of Physics, University of
California, San Diego
MARK S. FRANKEL, Program Director, American Association for the
Advancement of Science, Washington, D.C.
PENNY J. GILMER, Professor of Chemistry and Biochemistry,
Department of Chemistry and Biochemistry, Florida State
University, Tallahassee
FREDERICK GRINNELL, Professor of Cell Biology and Director,
Program in Ethics in Science and Medicine, University of Texas
Southwestern Medical Center, Dallas
JOYCE M. IUTCOVICH, President, Keystone University Research
Corporation, Erie, Pennsylvania
STANLEY G. KORENMAN, Associate Dean for Ethics and the Medical
Scientist Training Program and Professor of Medicine, University of
California at Los Angeles School of Medicine, Los Angeles
JOSEPH B. MARTIN, Dean, Harvard Medical School, Boston
ROBERT R. RICH, Executive Associate Dean and Professor of
Medicine and Microbiology/Immunology, Emory University School
of Medicine, Atlanta
LOUIS M. SHERWOOD, Senior Vice President for Medical and
Scientific Affairs, Merck & Co., Inc., West Point, Pennsylvania
MICHAEL J. ZIGMOND, Professor of Neurology and Psychiatry,
University of Pittsburgh, Pittsburgh

Health Sciences Policy Board Liaison


ADA SUE HINSHAW, Dean, School of Nursing, University of
Michigan, Ann Arbor

v
Project Staff
THERESA M. WIZEMANN, Study Director, Board on Health Sciences
Policy
MEHREEN N. BUTT, Senior Project Assistant, Board on Health
Sciences Policy
FREDERICK J. MANNING, Senior Program Officer, Board on Health
Sciences Policy
ROSEMARY CHALK, Senior Program Officer, Board on Health Care
Services

Auxiliary Staff
ANDREW POPE, Director, Board on Health Sciences Policy
DALIA GILBERT, Research Assistant, Board on Health Sciences Policy
ALDEN CHANG, Administrative Assistant, Board on Health Sciences
Policy
CARLOS GABRIEL, Financial Associate
ROBIN SCHOEN, Program Officer, Board on Life Sciences, Division on
Earth and Life Sciences

Consulting Writer
KATHI E. HANNA

Copy Editors
TOM BURROUGHS
MICHAEL K. HAYES

vi
Reviewers

This report has been reviewed in draft form by individuals chosen for
their diverse perspectives and technical expertise, in accordance with pro-
cedures approved by the National Research Council’s (NRC’s) Report
Review Committee. The purpose of this independent review is to provide
candid and critical comments that will assist the institution in making its
published report as sound as possible and to ensure that the report meets
institutional standards for objectivity, evidence, and responsiveness to
the study charge. The review comments and draft manuscript remain
confidential to protect the integrity of the deliberative process. We wish
to thank the following individuals for their review of this report:

JOHN F. AHEARNE, Sigma Xi Center, The Scientific Research Society


PAUL J. FRIEDMAN, University of California, San Diego
C. KRISTINA GUNSALUS, University of Illinois at Urbana-
Champaign,
RUSSEL E. KAUFFMAN, The Wistar Institute
DAVID KORN, Association of American Medical Colleges
JEFFREY D. KOVAC, University of Tennessee
MARCEL C. LAFOLLETTE, George Washington University
MARY FAITH MARSHALL, Kansas University Medical Center
RICK ANTONIO MARTINEZ, Johnson and Johnson
JUDITH P. SWAZEY, The Acadia Institute

vii
viii REVIEWERS

Although the reviewers listed above have provided many constructive


comments and suggestions, they were not asked to endorse the conclu-
sions or recommendations, not did they see the final draft of the report
before its release. The review of this report was overseen by BERNARD
LO, University of California, San Francisco, appointed by the Institute of
Medicine, and HAROLD C. SOX, Annals of Internal Medicine, appointed
by the NRC’s Report Review Committee, who were responsible for mak-
ing certain that an independent examination of this report was carried out
in accordance with institutional procedures and that all review comments
were carefully considered. Responsibility for the final content of this re-
port rests entirely with the authoring committee and the institution.
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Acknowledgments

The committee is indebted to the researchers and administrators who


presented informative talks to the committee and participated in lively
discussions at the open meetings, including Melissa Anderson, Stephanie
Bird, Ruth Fischbach, Peter Fiske, Barbara Mishkin, Howard Schachman,
Joan Schwartz, Harold Varmus, Bart Victor, and Peter Yeager (see Appen-
dix A for affiliations and discussion topics). The committee is grateful to
Barbara Brittingham, Steven Crow, Beth Fischer, Alasdair MacIntyre, Jean
Morse, George Peterson, James Rogers, David Smith, David Stevens, and
Naomi Zigmond, who graciously made themselves available by phone
and e-mail for consultation and technical advice, and to Kenneth Pimple
and David Guston, who were commissioned to prepare technical litera-
ture reviews and historical reviews (see Appendix A). Thanks to Diane
Waryold and the Center for Academic Integrity for kindly providing their
Academic Integrity Assessment Guide. The committee also thanks the
Institute of Medicine and National Research Council staff who presented
overviews of previous Academy work on integrity in research, including
Rosemary Chalk, Robin Schoen, and Debbie Stine.
Many thanks to Bruce Alberts, president of the National Academy of
Sciences and chair of the National Research Council, Kenneth Shine, then
president of the Institute of Medicine, Clyde Behney, deputy director of
the Institute of Medicine, and Andrew Pope, director of the Institute of
Medicine Board on Health Sciences Policy, for advice and guidance in
addressing the task. Thanks also to Kathi Hanna, Michael Hayes, and
Tom Burroughs for assistance with editing the text of the report.

ix
x ACKNOWLEDGMENTS

The committee also wishes to thank Nicholas Steneck, University of


Michigan, for his contributions during the early stages of the study, and
Jennifer Rietfors, an intern at the American Association for the Advance-
ment of Science, for assistance with information on accrediting bodies.
This report was made possible by the generous support of the Office
of Research Integrity, U.S. Department of Health and Human Services.
Thanks to Chris Pascal and Larry Rhoades for providing background
information, advice, and encouragement throughout the course of the
study.
Contents

EXECUTIVE SUMMARY 1

1 INTRODUCTION 16

2 INTEGRITY IN RESEARCH 33

3 THE RESEARCH ENVIRONMENT AND ITS IMPACT ON


INTEGRITY IN RESEARCH 49

4 INSTITUTIONAL APPROACHES TO FOSTERING


INTEGRITY IN RESEARCH 72

5 PROMOTING INTEGRITY IN RESEARCH THROUGH


EDUCATION 84

6 EVALUATION BY SELF-ASSESSMENT 112

7 CONCLUDING REMARKS AND RECOMMENDATIONS 124

xi
xii CONTENTS

APPENDIXES

A DATA SOURCES AND LITERATURE REVIEW FINDINGS 135

B OUTCOME MEASURES FOR ASSESSING INTEGRITY IN


THE RESEARCH ENVIRONMENT 143

C DEVELOPMENTS IN MISCONDUCT AND INTEGRITY


POLICIES SINCE PUBLICATION OF
THE 1992 COSEPUP REPORT 167

D ADDITIONAL RESOURCES REGARDING


PROFESSIONAL SKILLS 178

E COMMITTEE AND STAFF BIOGRAPHIES 184

INDEX 195
Tables, Figures, and Boxes

TABLES
1-1 Grants Funded by ORI in the First Round of Research on
Integrity in Research, 23
1-2 NSF Awards Directly Related to Integrity in Research,
1989 to Present, 24
1-3 NSF Awards Indirectly Related to Integrity in Research,
1989 to Present, 24
1-4 Addressing the Charge, 29
A-1 Search Terms, 136
A-2 Number of Relevant Articles, by Journal, 137
A-3 Number of Relevant Articles, by Category, 138

FIGURES
1 Open systems model of the research organization, 7
2 Environmental influences on research integrity that are
external to research organizations, 8
3-1 Open systems model of the research organization, 51
3-2 Environmental influences on research integrity that are
external to research organizations, 64

xiii
xiv TABLES, FIGURES, AND BOXES

BOXES
1 Integrity in Research, 5
2 Recommendations, 12
1-1 Glossary of Terms Used in This Report, 30
2-1 Definition of Institutional Conflict of Interest, 44
5-1 The Four-Component Model of Morality, 88
A-1 Invited Presentations, 140
C-1 Time Line of Some Significant Events in Research Integrity,
1991 to Present, 174
Executive Summary

The pursuit and diffusion of knowledge enjoy a place of distinction in


American culture, and the public expects to reap considerable benefit
from the creative and innovative contributions of scientists. Most Ameri-
cans have a positive attitude toward science and technology and are will-
ing to demonstrate their support through public investments in science
and research institutions. Public funding is based on the principle that the
public good is advanced by science conducted in the interest of humanity.
Such support is qualified, however. The public will support science only
if it can trust the scientists and the institutions that conduct research.
Major social institutions, including research institutions, are expected to
be accountable to the public. Fostering an environment that promotes
integrity in the conduct of research is an important part of that account-
ability. As a consequence, it is more important than ever that individual
scientists and their institutions periodically assess the values and profes-
sional practices that guide their research as well as their efforts to perform
their work with integrity.
Considerable effort has been devoted to the task of defining research
misconduct and elaborating methods for investigating allegations of mis-
conduct. Much less attention has been devoted, however, to the task of
fostering a research environment that promotes integrity. This report fo-
cuses on the research environment and attempts to define and describe
those elements that enable and encourage unique individuals, regardless
of their role in the research organization or their backgrounds on entry, to
act with integrity. Although integrity and misconduct are related, the

1
2 INTEGRITY IN SCIENTIFIC RESEARCH

focus of this report is on integrity. The Institute of Medicine (IOM) Com-


mittee on Assessing Integrity in Research Environments, which prepared
this report, does not discuss or draw conclusions about current or pro-
posed regulations or definitions relating to misconduct. The committee’s
goal was to define the desired outcomes and set forth a set of initiatives
that it believes will enhance integrity in the research environment. The
committee considered approaches that can be used to promote integrity
and methods that can be used to assess the effectiveness of those efforts.
The majority of these approaches and methods can and should be initi-
ated as soon as feasible and administered by research institutions them-
selves so that government regulation will not be required.

CHARGE TO THE COMMITTEE


In January 2001, IOM, in collaboration with the National Research
Council’s Division on Earth and Life Studies, formed the Committee on
Assessing Integrity in Research Environments, in response to a request
from the Office of Research Integrity (ORI) of the U.S. Department of
Health and Human Service (DHHS). In general, the committee was
charged with addressing the need of DHHS to track the state of integrity
in the research environment. More specifically, the committee was asked
to do the following:

1. define the concept “research integrity”;


2. describe and define the concept “research environment”;
3. identify elements of the research environment that promote re-
search integrity;
4. indicate how the elements may be measured;
5. suggest appropriate methodology for collecting the data;
6. cite appropriate outcome measures;
7. make recommendations regarding the adoption and implementa-
tion by research institutions, government agencies, scientific societies, and
others (as appropriate) of those elements of the research environment
identified to promote integrity in research; and
8. convene a public meeting to discuss the IOM report, its recommen-
dations, and potential strategies for their implementation.

To respond to the charge, the committee explored various data


sources in its effort to provide ORI with a means for tracking the state of
integrity in the research environment. In addition to reviewing the pro-
fessional literature, the committee also reviewed numerous reports, regu-
lations, and guidelines of the federal government and articles and editori-
EXECUTIVE SUMMARY 3

als in the popular press. The committee invited experts to make public
presentations, commissioned background papers, and sought additional
technical assistance from knowledgeable individuals.

OVERARCHING CONCLUSIONS
Several overarching conclusions emerged as the committee addressed
DHHS’s need to develop means for assessing and tracking the state of
integrity in the research environment:

• Attention to issues of integrity in scientific research is very impor-


tant to the public, scientists, the institutions in which they work, and the
scientific enterprise itself.
• No established measures for assessing integrity in the research
environment exist.
• Promulgation of and adherence to policies and procedures are nec-
essary, but they are not sufficient means to ensure the responsible con-
duct of research.
• There is a lack of evidence to definitively support any one way to
approach the problem of promoting and evaluating research integrity.
• Education in the responsible conduct of research is critical, but if
not done appropriately and in a creative way, then education is likely to
be of only modest help and may be ineffective.
• Institutional self-assessment is one promising approach to assess-
ing and continually improving integrity in research.

The committee found that existing data are insufficient to enable it to


draw definitive conclusions as to which elements of the research environ-
ment promote integrity. The elements discussed in the report appear to be
associated with integrity in research, but the specific contribution of each
element remains poorly defined. Empirical studies evaluating the ethical
climate before and after implementation of specific policies or practices
are lacking.
Because of the limited empirical data on factors influencing respon-
sible conduct in the scientific environment, the committee drew on more
general theory (e.g., theories of organizational behavior, ethical decision
making, and adult learning) to formulate the suggestions presented in the
report. The findings and conclusions are based on the committee’s collec-
tive knowledge and experience after its review of the literature in the
science and business arenas as well as its discussions with experts who
presented talks at the committee’s open meetings.
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118 LANGUR

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314 two loving

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