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Suggested citation: National Research Council (2003). Protecting Participants and


Facilitating Social and Behavioral Sciences Research. Panel on Institutional Review
Boards, Surveys, and Social Science Research. Constance F. Citro, Daniel R. Ilgen, and
Cora B. Marrett, eds. Committee on National Statistics and Board on Behavioral,
Cognitive, and Sensory Sciences. Washington, DC: The National Academies Press.
The National Academy of Sciences is a private, nonprofit, self-perpetuating so-
ciety of distinguished scholars engaged in scientific and engineering research,
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ter of the National Academy of Sciences, as a parallel organization of outstand-
ing engineers. It is autonomous in its administration and in the selection of its
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The National Research Council was organized by the National Academy of


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chair and vice chair, respectively, of the National Research Council.

www.national-academies.org
PANEL ON INSTITUTIONAL REVIEW BOARDS, SURVEYS, AND
SOCIAL SCIENCE RESEARCH

C ORA B. M ARRET T (Chair), Academic Affairs, University of Wisconsin


System Administration
D ANIEL R. I LGEN (Vice Chair), Department of Psychology and
Management, Michigan State University
T ORA KAY B IKSON, Department of Behavioral Sciences, The RAND
Corporation, Santa Monica, California
R OBERT M. G ROVES, Survey Research Center, University of
Michigan, and Joint Program in Survey Methodology
R OBERT M. H AUSER, Center for Demography of Health and Aging,
University of Wisconsin-Madison
V. J OSEPH H OTZ, Department of Economics, University of California
at Los Angeles
PATRICIA M ARSHALL, Department of Biomedical Ethics, Case
Western Reserve University
A NNA C. M ASTROIANNI, School of Law and Institute for Public
Health Genetics, University of Washington
J OHN J. M C A RDLE, Department of Psychology, University of Virginia
E LEANOR S INGER, Institute for Social Research, University of
Michigan
W ILLIAM A. Y OST (Liaison), Board on Behavioral, Cognitive, and
Sensory Sciences; Graduate School, Loyola University, Chicago

C ONSTANCE F. C ITRO, Study Director


J AMIE C ASEY, Research Assistant
TANYA M. L EE, Project Assistant

v
COMMITTEE ON NATIONAL STATISTICS
2003

J OHN E. R OLPH (Chair), Marshall School of Business, University of


Southern California
J OSEPH G. A LTONJI, Department of Economics, Yale University
R OBERT M. B ELL, AT&T Labs—Research, Florham Park, New Jersey
L AWRENCE D. B ROWN, Department of Statistics, The Wharton
School, University of Pennsylvania
R OBERT M. G ROVES, Survey Research Center, University of
Michigan, and Joint Program in Survey Methodology
J OEL L. H OROWITZ, Department of Economics, Northwestern
University
W ILLIAM KALSBEEK, Survey Research Unit, Department of
Biostatistics, University of North Carolina
A RLEEN L EIBOWITZ, School of Public Policy and Social Research,
University of California at Los Angeles
T HOMAS A. L OUIS, Bloomberg School of Public Health, Johns
Hopkins University
V IJAYAN N AIR, Department of Statistics and Department of Industrial
and Operations Engineering, University of Michigan
D ARYL P REGIBON, AT&T Labs—Research, Florham Park, New Jersey
K ENNETH P REWIT T, School of Public Affairs, Columbia University
N ORA C ATE S CHAEFFER, Department of Sociology, University of
Wisconsin-Madison
M AT THEW D. S HAPIRO, Department of Economics, University of
Michigan

A NDREW A. W HITE, Director

vi
BOARD ON BEHAVIORAL, COGNITIVE,
AND SENSORY SCIENCES
2003

A NNE P ETERSEN (Chair), W.K. Kellogg Foundation, Battle Creek,


Michigan
L INDA M ARIE B URTON, Center for Human Development and Family
Research, Pennsylvania State University
S TEPHEN J. C ECI, Department of Human Development, Cornell
University
E UGENE K. E MORY, Department of Psychology, Emory University
R OCHEL G ELMAN, Department of Psychology and Cognitive Science,
Rutgers University
A NTHONY W. J ACKSON, The Galef Institute, Los Angeles, California
P ETER L ENNIE, Dean for Science, New York University
M ARCIA C. L INN, Graduate School of Education, University of
California at Berkeley
E LISSA L. N EWPORT, Department of Brain and Cognitive Sciences,
University of Rochester
C HARLES R. P LOT T, Division of Humanities and Social Sciences,
California Institute of Technology
M ICHAEL L. R UT TER, Social, Genetic, and Developmental Psychiatry
Research Centre, University of London
A RNOLD S AMEROFF, Center for Human Growth and Development,
University of Michigan
J AMES W. S TIGLER, Department of Psychology, University of
California at Los Angeles
W ILLIAM A. Y OST, Graduate School, Loyola University, Chicago

C HRISTINE R. H ARTEL, Director

vii
Acknowledgments

The Panel on Institutional Review Boards, Surveys, and Social Sci-


ence Research thanks the many people who contributed their time and
expertise to the preparation of this report.
We are grateful to everyone who attended the panel’s first meet-
ing and provided perspectives on issues of human research participant
protection in the social, behavioral, and economic sciences (SBES).
We acknowledge the wealth of information that we obtained from web-
sites of private and public organizations and from previous surveys
of the review process for research with human participants (see the
appendices). We also acknowledge the very useful paper by George
Duncan, of Carnegie Mellon University, on confidentiality and data ac-
cess issues for institutional review boards (IRBs), which is reproduced
as Appendix E. We thank the staff of the National Research Council
for their helpful advice and input, including Andrew White, director
of the Committee on National Statistics; Christine Hartel, director of
the Board on Behavioral, Cognitive, and Sensory Sciences; and Laura
Lyman Rodriguez and Jessica Aungst, staff to the Institute of Medicine
Committee on Assessing the System for Protecting Human Research
Participants. That committee produced the very useful report, Respon-
sible Research, which provides an invaluable perspective on the work
of IRBs, primarily in the biomedical fields. Eugenia Grohman, director
of the reports office of the Division of Behavioral and Social Sciences
and Education, made important contributions to our report through
her fine technical editing.
Our panel was assisted by a very able staff. We are grateful to Vir-
ginia A. deWolf, now at the U.S. Bureau of Transportation Statistics,
who served as the panel’s first study director. She did a masterful job of
organizing the panel’s meetings, reaching out to other groups that are
active in human research participant protection issues, and assembling
a wealth of background materials to inform the panel’s deliberations.
Jamie Casey conducted the panel’s review of websites of 47 major re-
search institutions to determine their guidance and policies for review
of research protocols involving human participants, tracked down of-
ten obscure materials for the panel’s use, and assisted the panel at
its meetings. Tanya Lee made excellent arrangements for panel meet-

ix
ings. Daniel Cork contributed his outstanding typographic skills to the
preparation of the report for printing.
The panel is especially grateful to Constance Citro, who served as
the panel’s study director beginning in May 2002. She insisted that our
work reflect the highest standards of evidence and worked unfailingly
to uncover sources for that evidence. We draw attention in particular
to the synthesis she developed on the evolution of federal guidelines for
the protection of human participants in research, which is recounted
in Chapter 3. From disparate sources, she developed a coherent and
original account of that process. More broadly, with extraordinary dili-
gence, she managed the completion of the panel’s work.
I want to extend special thanks to Daniel Ilgen, who served as vice
chair of the panel. He assumed the role despite a lengthy list of other
commitments. He listened to our deliberations and crafted arguments
noteworthy for their clarity. He worked tirelessly with Connie to ensure
that our efforts warranted the imprimatur of the National Research
Council.
All of the panel members made important contributions of their
time and expertise, not only bringing to bear examples and perspec-
tives from their own specialties, but also engaging in intensive dialogue
to reach consensus on key issues for participant protection in SBES re-
search. It was an honor to serve with them.
The panel also benefited from our two liaison members. William
Yost, Loyola University, Chicago, liaison from the Board on Behav-
ioral, Cognitive, and Sensory Sciences to our panel, attended all our
meetings and provided a very useful perspective to the panel’s deliber-
ations. Roderick J.A. Little, University of Michigan, attended our early
meetings as liaison from both the IOM committee and the Committee
on National Statistics.
This report has been reviewed in draft form by individuals chosen
for their diverse perspectives and technical expertise, in accordance
with procedures approved by the National Research Council’s Report
Review Committee. The purpose of this independent review is to pro-
vide 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 delibera-
tive process.
We wish to thank the following individuals for their review of this
report: Evan G. DeRenzo, Center for Ethics, Washington Hospital Cen-
ter, Washington, DC; Lowell W. Gerson, Office of Addiction Medicine,
Northeastern Ohio Universities College of Medicine, Rootstown, OH;

x
Jeff Kahn, Center for Bioethics, University of Minnesota; Richard A.
Kulka, Research Triangle Institute, Research Triangle Park, NC; Rod-
erick J.A. Little, Department of Biostatistics, University of Michigan;
Richard E. Nisbett, Culture and Cognition Program and Department
of Psychology, University of Michigan; Lee N. Robins, Department of
Psychiatry, Washington University School of Medicine, St. Louis, MO;
and Joan E. Sieber, Department of Psychology, California State Univer-
sity, Hayward.
Although the reviewers listed above have provided many construc-
tive comments and suggestions, they were not asked to endorse the
conclusions or recommendations nor did they see the final draft of the
report before its release. The review of this report was overseen by
Henry W. Riecken, Behavioral Sciences, University of Pennsylvania,
and Mary Jane Osborn, Department of Microbiology, University of Con-
necticut Health Center. Appointed by the National Research Council,
they were responsible for making certain that an independent exami-
nation 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 report rests entirely with the
authoring committee and the institution.

Cora B. Marrett, Chair


Panel on Institutional Review Boards,
Surveys, and Social Science Research

xi
Contents

Executive Summary 1
Panel Charge and Scope 1
Enhancing Informed Consent 2
Enhancing Confidentiality Protection 4
Effective Review of Minimal-Risk Research 5
Needed Information 7
System-Level Issues 7

1 Introduction 9
The Issues 10
Panel Charge and Scope 11
Activities 14
Organization of Report 15

2 Basic Concepts 23
Principles and Practices for Ethical Research 23
Harms, Risks, and Benefits 26
Minimal Risk 31
Role of IRBs 35
SBES Research 43
Conclusion 53

3 Regulatory History 59
From 1945 to 1966 60
From 1966 to 1974 61
From 1974 to 1981 64
From 1981 to 1991 73
Developments Since 1991 74
Conclusion 79

4 Enhancing Informed Consent 81


IRB Focus on Informed Consent 86
Research to Improve Consent Procedures 93
Informed Consent for Special Populations 94
Third-Party Consent 98
Waiving Written Consent 101

xiii
Omitting Elements of Informed Consent 108
Conclusion 111

5 Enhancing Confidentiality Protection 113


History of Confidentiality Protection in the Participant
Protection System 115
Confidentiality Protection in the Federal Statistical System 119
Protecting Confidentiality Today 123
The Role of Researchers, IRBs, OHRP, and Funding Agencies
in Protecting Confidentiality 133
A Confidentiality Protection System for Public-Use Microdata 138
Concluding Note: Minimal Disclosure Risk is Not Zero Risk 140

6 Enhancing the Effectiveness of Review: Minimal-Risk


Research 143
Guidance on the Review Process 144
Guidance for Initial Review 146
Continuing Review 157
Documenting Risks and Harms 159
Ongoing Data System 160
In-Depth Studies 163

7 System Issues 165


Guidance and Support for IRBs 166
Qualifications and Performance Standards 168
Communication Among IRBs and Researchers 171
Organization of and Among IRBs 175
Developing National Policy for Human Research Participant
Protection 178
Continuing System Evolution 180

References 183

Appendices 191

A Tracing Changes in Regulatory Language 193

B Selected Organizations and Resources for Human Research


Participant Protection 217

C Agenda for Panel’s First Meeting 221

D Selected Studies of IRB Operations: Summary Descriptions 225

xiv
E Confidentiality and Data Access Issues for Institutional
Review Boards George T. Duncan 235
Introduction 235
Critical Issues 236
Tension Between Disclosure Risk and Data Utility 242
Conclusions 247
References and Bibliography 247

Biographical Sketches of Panel Members and Staff 253

xv
List of Figures

2-1 Types of Possible Harm Anticipated by Investigators for Protocols, by Type


of Research 29
2-2 Average Reviews by IRBs in Each Decile of Workload Volume, 1995 37
2-3 SBES and Biomedical Protocols by Type of Method Used 46

6-1 Boxplots for Hypothetical Proportion of Expedited Reviews Across IRBs 163

xvi
List of Boxes

1-1 Key Features of the Common Rule 17


1-2 Categories of Research for Which Minimal-Risk Protocols Can Receive
Expedited Review 20

2-1 Laboratory Experiment Examples 48


2-2 Field Experiment Examples 49
2-3 Natural Behavior Observation Examples 51
2-4 Unstructured or Semistructured Interview Examples 54
2-5 Structured Interview (Sample Survey) Examples 56
2-6 Secondary Analysis Examples 57

3-1 Examples of Ethically Troubling SBES Research from the 1970s 66


3-2 SBES Concerns in the 1970s 68

4-1 Basic Elements of Informed Consent 82


4-2 Additional Elements of Informed Consent and Provisions for Waiver or
Alteration 84
4-3 Documentation of Consent and Waiver Conditions 85

5-1 Health and Retirement Survey Design and Content 126

A-1 Applicability of IRB Regulations 194


A-2 Definition of Research 195
A-3 Definition of Human Subject 196
A-4 Research Eligible for Exemption 197
A-5 Expedited Review (SBES-Related Categories) 200
A-6 Criteria for IRB Review 203
A-7 Basic Elements of Informed Consent 206
A-8 Additional Elements of Informed Consent 209
A-9 Conditions for Waiver of Informed Consent 211
A-10 Documentation of Informed Consent and Waiver Conditions 213
A-11 Definition of Minimal Risk 216

xvii
Executive Summary

T
HE U.S. SYSTEM for protecting people who volunteer to partic-
ipate in research is widely perceived to need improvement. A
major concern is that the linchpins of the protection system—
institutional review boards (IRBs)—are overloaded and underfunded
and so may not be able to adequately protect participants from harm
in high-risk research, such as clinical trials of experimental drugs.
Three other concerns—often voiced about research in the social,
behavioral, and economic sciences (SBES), but generally applicable to
human participant protection—are important. The first is that the re-
view process too often focuses on documenting consent to participate
in research so as to satisfy the letter of federal requirements, when
IRBs and researchers instead need to focus on developing the most
effective processes for helping individuals reach an informed, volun-
tary decision about participation. The second concern is that IRBs, re-
searchers, and the entire human participant protection system may pay
too little attention to the challenge of countering increasing threats to
the confidentiality of research data because of technological and other
changes, such as the ability to readily access and link large databases
through the Internet. The third concern is that the review process may
delay research or impair the integrity of research designs, without nec-
essarily improving participant protection, because the type of review
is not commensurate with risk—for example, full board review for
minimal-risk research that uses such methods as surveys, structured
interviews, participant observation, laboratory experiments, and anal-
yses of existing data.

PANEL CHARGE AND SCOPE

The Panel on Institutional Review Boards, Surveys, and Social Sci-


ence Research was established by the Committee on National Statistics
and the Board on Behavioral, Cognitive, and Sensory Sciences, both
standing committees of the National Academies’ National Research
Council. The panel was charged to examine the structure, function,
and performance of the IRB system as it relates to SBES research and
to recommend research and practice to improve the system.

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