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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

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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.

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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

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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

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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 LabsResearch, 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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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