Items in cart [0]
| [ Top of Page ] [ Home ] [ Contact Us ] [ Help ] [ The National Academies Home ] | ||
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page R1
PROTECTING PARTICIPANTS
AND FACILITATING SOCIAL AND
BEHAVIORAL SCIENCES RESEARCH
Panel on Institutional Review Boarcds, Surveys, anc] Social Science Research
Constance F. Citro, Daniel R. Ilgen, anc] Cora B. Marrett, Editors
Committee on National Statistics
anc]
Boa rc] on Behavioral, Cognitive, anc] Sensory Sciences
Division on Behavioral anc] Social Sciences anc] Eclucation
NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
OCR for page R2
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW 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.
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.
International Standard Book Number 0-309-08852-6 (book)
International Standard Book Number 0-309-51136-4 (PDF)
Library of Congress Control Number: 2003106396
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
Copyright 2003 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
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.
OCR for page R3
THE NATIONAL ACADEMIES
. . .
A`YISerS to the Notion on Science, Engineering, r~ndMeditine
The National Academy of Sciences is a private, nonprofit, self-perpetuating so-
ciety of distinguished scholars engaged in scientific and engineering research,
dedicated 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 gov-
ernment 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 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.
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 govern-
ment 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
Sciences in 1916 to associate the broad community of science and technology
with the Academy's purposes of furthering knowledge and advising the federal
government. 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 providing services to the government, the public, and the scientific and en-
gineering 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
OCR for page R4
OCR for page R5
PANEL ON INSTITUTIONAL REVIEW BOARDS, SURVEYS, AND
SOCIAL SCIENCE RESEARCH
CORA B. MARRETT (Cl~air), Academic Affairs, University of Wisconsin
System Administration
DANIEL R. ILGEN (Vice C1quirJ, Department of Psychology and
Management, Michigan State University
TORA KAY BIKSON, Department of Behavioral Sciences, The RAND
Corporation, Santa Monica, California
ROBERT M. GROVES, Survey Research Center, University of
Michigan, and Joint Program in Survey Methodology
ROBERT M. HAWSER, Center for Demography of Health and Aging,
University of Wisconsin-Madison
V. JOSEPH HOTZ, Department of Economics, University of California
at Los Angeles
PATRICIA MARSHALL, Department of Biomedical Ethics, Case
Western Reserve University
ANNA C. MASTROTANNT, School of Law and Institute for Public
Health Genetics, University of Washington
JOHN J. McARD~E, Department of Psychology, University of Virginia
ELEANOR SINGER, Institute for Social Research, University of
Michigan
WILLIAM A. YOST (LiaisonJ, Board on Behavioral, Cognitive, and
Sensory Sciences; Graduate School, Loyola University, Chicago
CONSTANCE F. C Intro, Study Director
JAMI E CAS KY, Research Assistant
TANYA M ~ LEE, Project Assistant
v
OCR for page R6
COMMITTEE ON NATIONAL STATISTICS
2003
JOHN E. ROLPH (Claire, Marshall School of Business, University of
Southern California
JOSEPH G. A~ToN~, Department of Economics, Yale University
ROBERT M. BELL, AT&T Labs Research, Florham Park, New Jersey
LAWRENCE D. BROWN, Department of Statistics, The Wharton
School, University of Pennsylvania
ROBERT M. GROVES, Survey Research Center, University of
Michigan, and Joint Program in Survey Methodology
Joey L. Horowitz, Department of Economics, Northwestern
University
WILLIAM KA~ssEEK, Survey Research Unit, Department of
Biostatistics, University of North Carolina
ARLEEN LE~sow~Tz, School of Public Policy and Social Research,
University of California at Los Angeles
THOMAS A. Louts, Bloomberg School of Public Health, Johns
Hopkins University
VIJAYAN NAIR, Department of Statistics and Department of Industrial
and Operations Engineering, University of Michigan
DARYL PREG~soN, AT&T Labs—Research, Florham Park, New Jersey
KENNETH PREWITT, School of Public Affairs, Columbia University
NORA CATE SCHAEFFER, Department of Sociology, University of
Wisconsin-Madison
MATTHEW D. SHAPIRO, Department of Economics, University of
Michigan
AND REW A. WH ITE, Director
V1
OCR for page R7
BOARD ON BEHAVIORAL, COGNITIVE,
AND SENSORY SCIENCES
2003
ANNE PETERSEN (Chair), W.K. Kellogg Foundation, Battle Creek,
Michigan
LINDA MARIE BURTON, Center for Human Development and Family
Research, Pennsylvania State University
STEPHEN J. CECI, Department of Human Development, Cornell
University
EUGENE K. EMORY, Department of Psychology, Emory University
RocHE~ GELMAN, Department of Psychology and Cognitive Science,
Rutgers University
ANTHONY W. JACKSON, The Galef Institute, Los Angeles, California
PETER LENNIE, Dean for Science, New York University
MARc~A C. LINN, Graduate School of Education, University of
California at Berkeley
E~ssA L. NEWPORT, Department of Brain and Cognitive Sciences,
University of Rochester
CHAR~Es R. PLOTT, Division of Humanities and Social Sciences,
California Institute of Technology
MICHAEL L. RUTTER, Social, Genetic, and Developmental Psychiatry
Research Centre, University of London
ARNo~D SAMEROFF, Center for Human Growth and Development,
University of Michigan
JAMES W. STIGLER, Department of Psychology, University of
California at Los Angeles
WILLIAM A. YOST, Graduate School, Loyola University, Chicago
CHRISTINE R. HARTEL, Director
. .
V11
OCR for page R8
OCR for page R9
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-
1X
OCR for page R10
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
OCR for page R11
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
X1
OCR for page R12
OCR for page R13
Contents
Executive Summary
Panel Charge and Scope
Enhancing Informed Consent
Enhancing Confidentiality Protection
Effective Review of Minimal-Risk Research
Needed Information
System-Level Issues
1 Introduction
The Issues
Panel Charge and Scope
Activities
Organization of Report
2 Basic Concepts
Principles and Practices for Ethical Research
Harms, Risks, and Benefits
Minimal Risk
Role of IRBs
SEES Research
Conclusion
3 Regulatory History
Prom 1945 to 1966
Prom 1966 to 1974
Prom 1974 to 1981
From 1981 to 1991
Developments Since 1991
Conclusion
4 Enhancing Informed Consent
IRB Focus on Informed Consent
Research to Improve Consent Procedures
Informed Consent for Special Populations
Third-Party Consent
Waiving Written Consent
. . .
x~
1
2
4
5
9
10
11
14
15
23
23
26
31
35
43
53
59
60
61
64
73
74
79
81
86
93
94
98
101
OCR for page R14
Omitting Elements of Informed Consent
Conclusion
Enhancing Confidentiality Protection
History of Confidentiality Protection in the Participant
Protection System
Confidentiality Protection in the Federal Statistical System
Protecting Confidentiality Today
The Role of Researchers, IRBs, CHIRP, and Funding Agencies
in Protecting Confidentiality
A Confidentiality Protection System for Public-Use Microdata
Concluding Note: Minimal Disclosure Risk is Not Zero Risk
6 Enhancing the Effectiveness of Review: Minimal-Risk
Research
Guidance on the Review Process
Guidance for Initial Review
Continuing Review
Documenting Risks and Harms
Ongoing Data System
In-Depth Studies
7 System Issues
Guidance and Support for IRBs
Qualifications and Performance Standards
Communication Among IRBs and Researchers
Organization of and Among IRBs
Developing National Policy for Human Research Participant
Protection
Continuing System Evolution
References
Appendices
A Tracing Changes in Regulatory Language
B Selected Organizations and Resources for Human Research
Participant Protection
C Agenda for Panel's First Meeting
D Selected Studies of IRB Operations: Summary Descriptions
x~v
108
111
113
115
119
123
133
138
140
143
144
146
157
159
160
163
165
166
168
171
175
178
180
183
191
193
217
221
225
OCR for page R15
E Confidentiality and Data Access Issues for Institutional
Review Boards George 1: Duncan
Introduction
Critical Issues
Tension Between Disclosure Risk and Data Utility
Conclusions
References and Bibliography
Biographical Sketches of Panel Members and Staff
xv
235
235
236
242
247
247
253
OCR for page R16
List of Figures
2-1 Types of Possible Harm Anticipated by Investigators for Protocols, by Type
of Research
2-2 Average Reviews by IRBs in Each Decile of Workload Volume, 1995
2-3 SEES and Biomedical Protocols by Type of Method Used
6-1 Boxplots for Hypothetical Proportion of Expedited Reviews Across IRBs
XVI
29
37
46
163
OCR for page R17
List of Boxes
1-1 Key Features of the Common Rule
1-2 Categories of Research for Which Minimal-Risk Protocols Can Receive
Expedited Review
2- 1 Laboratory Experiment Examples
2-2 Field Experiment Examples
2-3 Natural Behavior Observation Examples
2-4 Unstructured or Semistructured Interview Examples
2-5 Structured Interview (Sample Survey) Examples
2-6 Secondary Analysis Examples
3-1 Examples of Ethically Troubling SEES Research from the 1970s
3-2 SEES Concerns in the 1970s
4-1 Basic Elements of Informed Consent
4-2 Additional Elements of Informed Consent and Provisions for Waiver or
Alteration
Documentation of Consent and Waiver Conditions
Health and Retirement Survey Design and Content
A-1 Applicability of IRB Regulations
Definition of Research
A-3 Definition of Human Subject
A-4 Research Eligible for Exemption
A-5 Expedited Review (SBES-Related Categories)
A-6 Criteria for IRE Review
A-7 Basic Elements of Informed Consent
A-8 Additional Elements of Informed Consent
A-9 Conditions for Waiver of Informed Consent
A-10 Documentation of Informed Consent and Waiver Conditions
A- 11 Definition of Minimal Risk
. .
X1111
17
20
48
49
51
54
56
57
66
68
82
84
85
126
194
195
196
197
200
203
206
209
211
213
216
OCR for page R18