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(Ebook) Protecting Participants and Facilitating Social and
Behavioral Sciences Research by Surveys, and Social Science
Research Panel on Institutional Review Boards, National
Research Council ISBN 9780309088527, 9780309511360,
0309088526, 0309511364 Pdf Download
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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.
The project that is the subject of this report was supported by contract no.
SBR-9709489 between the National Academy of Sciences and the National Science
Foundation. Any opinions, findings, conclusions, or recommendations expressed in this
publication are those of the author(s) and do not necessarily reflect the views of the
organizations or agencies that provided support for the project.
Additional copies of this report are available from the National Academies Press, 500
Fifth Street, NW, Washington, D.C. 20001; (202) 334-3096; Internet, http://www.nap.edu
The National Academy of Engineering was established in 1964, under the char-
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
members, sharing with the National Academy of Sciences the responsibility for
advising 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 engi-
neers. Dr. Wm. A. Wulf is president of the National Academy of Engineering.
www.national-academies.org
PANEL ON INSTITUTIONAL REVIEW BOARDS, SURVEYS, AND
SOCIAL SCIENCE RESEARCH
v
COMMITTEE ON NATIONAL STATISTICS
2003
vi
BOARD ON BEHAVIORAL, COGNITIVE,
AND SENSORY SCIENCES
2003
vii
Acknowledgments
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.
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
xiii
Omitting Elements of Informed Consent 108
Conclusion 111
References 183
Appendices 191
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
xv
List of Figures
6-1 Boxplots for Hypothetical Proportion of Expedited Reviews Across IRBs 163
xvi
List of Boxes
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.
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