PROPOSED REVISIONS
TO THE COMMON RULE

for the Protection of Human Subjects in the
Behavioral and Social Sciences

Committee on Revisions to the Common Rule for the Protection of
Human Subjects in Research in the Behavioral and Social Sciences

Board on Behavioral, Cognitive, and Sensory Sciences

Committee on National Statistics

Committee on Population

Division of Behavioral and Social Sciences and Education

NATIONAL RESEARCH COUNCIL
                          OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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PROPOSED REVISIONS TO THE COMMON RULE for the Protection of Human Subjects in the Behavioral and Social Sciences Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences Board on Behavioral, Cognitive, and Sensory Sciences Committee on National Statistics Committee on Population Division of Behavioral and Social Sciences and Education

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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 Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropri- ate balance. This study was supported by the Bill & Melinda Gates Foundation, the Alfred P. Sloan Foundation, and the National Academy of Education. Opinions, findings, conclusions, or recommendations expressed in this publication are those of the author and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13:  978-0-309-29806-3 International Standard Book Number-10:  0-309-29806-7 Library of Congress Control Number: 2014933435 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2014 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Research Council. (2014). Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Committee on Revisions to the Common Rule for the Protection of Hu- man Subjects in Research in the Behavioral and Social Sciences. Board on Behav- ioral, Cognitive, and Sensory Sciences, Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society 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 Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone 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 en- gineers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. C. D. Mote, Jr., is presi- dent 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 Insti- tute 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 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 engineering communities. The Coun- cil is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON REVISIONS TO THE COMMON RULE FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH IN THE BEHAVIORAL AND SOCIAL SCIENCES SUSAN T. FISKE (Chair), Department of Psychology and Woodrow Wilson School of Public and International Affairs, Princeton University MELISSA E. ABRAHAM, Harvard University Medical School and Massachusetts General Hospital CELIA B. FISHER, Center for Ethics Education and Department of Psychology, Fordham University ROBERT M. GROVES, Office of the Provost, Georgetown University PATRICIA K. HAMMAR, PKH Enterprises, LLC JULIA I. LANE, American Institutes for Research and BETA, University of Strasbourg, CNRS RENA S. LEDERMAN, Department of Anthropology, Princeton University FELICE J. LEVINE, American Educational Research Association ROBERT J. LEVINE, Department of Internal Medicine and Center for Bioethics, Yale University BRADLEY A. MALIN, Department of Biomedical Informatics, Vanderbilt University RICHARD E. NISBETT, Department of Psychology, University of Michigan, Ann Arbor CHARLES R. PLOTT, Department of Economics and Political Science, California Institute of Technology MARGARET FOSTER RILEY, School of Law, University of Virginia YONETTE F. THOMAS, Association of American Geographers and Department of Public Health Sciences, Miller School of Medicine, University of Miami DAVID R. WEIR, Survey Research Center, University of Michigan, Ann Arbor JEANNE C. RIVARD, Study Director JENNIFER DIAMOND, Program Associate (prior to June 2013) JATRYCE JACKSON, Program Associate v

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BOARD ON BEHAVIORAL, COGNITIVE, AND SENSORY SCIENCES JOHN T. CACIOPPO (Chair), Department of Psychology, University of Chicago LINDA M. BARTOSHUK, Department of Community Dentistry and Behavioral Sciences, University of Florida RICHARD J. BONNIE, Institute of Law, Psychiatry and Public Policy, University of Virginia JENNIFER S. COLE, Department of Linguistics, University of Illinois at Urbana-Champaign ALICE H. EAGLY, Department of Psychology, Northwestern University SUSAN T. FISKE, Department of Psychology and Woodrow Wilson School of Public and International Affairs, Princeton University DANIEL R. ILGEN, Department of Psychology, Michigan State University NINA G. JABLONSKI, Department of Anthropology, Pennsylvania State University JAMES S. JACKSON, Institute for Social Research, University of Michigan, Ann Arbor JONATHAN D. MORENO, Department of Medical Ethics and Health Policy and Department of History and Sociology of Science, University of Pennsylvania MICHAEL I. POSNER, Department of Psychology, University of Oregon (Emeritus) MARCUS E. RAICHLE, Mallinckrodt Institute of Radiology, Washington University in St. Louis VALERIE F. REYNA, Human Neuroscience Institute, Cornell University RICHARD M. SHIFFRIN, Department of Psychological and Brain Sciences, Indiana University JEREMY M. WOLFE, Brigham and Women’s Hospital, Departments of Ophthalmology and Radiology, Harvard Medical School BARBARA A. WANCHISEN, Director JATRYCE JACKSON, Program Associate MICKELLE RODRIGUEZ, Program Coordinator vi

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COMMITTEE ON NATIONAL STATISTICS 2013-2014 LAWRENCE D. BROWN (Chair), Department of Statistics, The Wharton School, University of Pennsylvania JOHN M. ABOWD, School of Industrial and Labor Relations, Cornell University MARY ELLEN BOCK, Department of Statistics, Purdue University DAVID CARD, Department of Economics, University of California, Berkeley ALICIA CARRIQUIRY, Department of Statistics, Iowa State University MICHAEL E. CHERNEW, Department of Health Care Policy, Harvard Medical School CONSTANTINE GATSONIS, Center for Statistical Sciences, Brown University JAMES S. HOUSE, Survey Research Center, Institute for Social Research, University of Michigan, Ann Arbor MICHAEL HOUT, Department of Sociology, New York University SALLIE ANN KELLER, Virginia Bioinformatics Institute at Virginia Tech, Arlington, VA LISA LYNCH, The Heller School for Social Policy and Management, Brandeis University COLM A. O’MUIRCHEARTAIGH, Harris School of Public Policy Studies, University of Chicago RUTH D. PETERSON, Department of Sociology (emerita) and Criminal Justice Research Center, Ohio State University EDWARD H. SHORTLIFFE, Biomedical Informatics, Columbia University and Arizona State University HAL S. STERN, Donald Bren School of Information and Computer Sciences, University of California, Irvine CONSTANCE F. CITRO, Director vii

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COMMITTEE ON POPULATION LINDA J. WAITE (Chair), Department of Sociology, University of Chicago CHRISTINE BACHRACH, School of Behavioral and Social Sciences, University of Maryland, College Park JERE R. BEHRMAN, Department of Economics, University of Pennsylvania JASON H. BOARDMAN, Department of Sociology, University of Colorado at Boulder PETER J. DONALDSON, Population Council, New York, NY KATHLEEN MULLAN HARRIS, Carolina Population Center, University of North Carolina at Chapel Hill MARK D. HAYWARD, Population Research Center, University of Texas, Austin CHARLES HIRSCHMAN, Department of Sociology, University of Washington HILLARD S. KAPLAN, Department of Anthropology, University of New Mexico WOLFGANG LUTZ, World Population Program, International Institute for Applied Systems Analysis, Laxenburg, Austria ROBERT D. MARE, Department of Sociology, University of California, Los Angeles SARA MCLANAHAN, Center for Research on Child Wellbeing, Princeton University BARBARA B. TORREY, Guest Researcher, National Institute on Aging, National Institutes of Health MAXINE WEINSTEIN, Center for Population and Health, Georgetown University DAVID R. WEIR, Survey Research Center, Institute for Social Research, University of Michigan, Ann Arbor JOHN R. WILMOTH, Population Division/DESA, United Nations THOMAS J. PLEWES, Director viii

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Acknowledgments 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 (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 confiden- tial to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: George Alter, Inter-university Consortium for Political and Social Research, University of Michigan, Ann Arbor; Cynthia M. Beall, Department of Anthropology, Case Western Reserve University; Laura J. Bierut, School of Medicine, Washington University in St. Louis; Christine L. Borgman, Information Studies, University of California, Los Angeles; James M. DuBois, Bander Center, Albert Gnaegi Center for Health Care Ethics, St. Louis University; Daniel Gilbert, Department of Psychology, Harvard University; Jonathan B. Imber, Department of Sociology, Wellesley College; Alan F. Karr, Direc- tor’s Office, National Institute of Statistical Sciences; Randall Lutter, Frank Batten School of Leadership and Public Policy, University of Virginia; and Monika S. Markowitz, Office of Research Integrity and Ethics, Office of the Vice President for Research, Virginia Commonwealth University. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before ix

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x ACKNOWLEDGMENTS its release. The review of this report was overseen by Matthew Rizzo, University of Iowa, Department of Neurology, and Lawrence D. Brown, Department of Statistics, The Wharton School, University of Pennsylvania. Appointed by the NRC, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully con- sidered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. The second, and current, phase of this project was sponsored by the Bill & Melinda Gates Foundation, the Alfred P. Sloan Foundation, and the National Academy of Education. The committee would first like to extend a special thanks to Ed Dieterle, Daniel Goroff, and Gregory White in particular for their assistance as the program officers within the respec- tive foundations. The committee would also like to express its apprecia- tion to the sponsors of the first phase of this project, the workshop, for their participation and ongoing collaboration. The phase one sponsors included the National Science Foundation, American Academy of Political and Social Science, American Economic Association, American Sociological Association, NORC at the University of Chicago, Population Association of America, Russell Sage Foundation, University of Michigan Institute for Social Research, and Westat. The committee also wishes to thank a number of individuals who pre- sented important content and contextual information for our consideration as speakers in the phase one workshop. These speakers included George Alter of the University of Michigan; Susan Bouregy of Yale University; Lois Brako of University of Michigan, Ann Arbor; Steven Breckler of the American Psychological Association; Richard Campbell of the Uni- versity of Illinois at Chicago; Constance F. Citro of the National Research Council; Thomas J. Coates of the University of California, Los Angeles; Roxanne Cohen Silver of the University of California, Irvine; Celia B. Fisher of Fordham University; Rena Lederman of Princeton University; Taylor Martin of Utah State University; Brian Mustanski of Northwestern Univer- sity, Feinberg School of Medicine; Pearl O’Rourke of Partners HealthCare; Charles R. Plott of the California Institute of Technology; Sally Powers of the University of Massachusetts, Amherst; Jeffery W. Rodamar of the U.S. Department of Education; and Laura Stark of Vanderbilt University. This committee is also grateful to Thomas J. Coates for contributing his time and critical participation as a committee member for the first phase of this project. Appreciation is also extended to Barbara Wanchisen, director of the Board on Behavioral, Cognitive, and Sensory Sciences, and Robert M. Hauser, executive director of the Division of Behavioral and Social Sci- ences and Education, for their leadership, guidance, and oversight of and

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ACKNOWLEDGMENTS xi support for the study; and program assistants, Kelly Arrington and Jatryce Jackson, who provided administrative and logistic support over the course of the study. We wish to extend our appreciation as well to Robert Katt for his extensive assistance in editing multiple drafts of the report. Finally, we thank the executive office reports staff of the Division of Behavioral and So- cial Sciences and Education, especially Yvonne Wise and Eugenia Grohman, who provided valuable help with the editing and production of the report, and Kirsten Sampson Snyder, who managed the report review process.

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Contents Summary 1 1 Introduction and Background 13 Introduction, 13 Background, 20 Conclusion, 29 References, 29 2 Rationales, Definitions, and Procedures Related to Research Not Involving Human Subjects and the Proposed Excused Category of Research 33 Introduction, 33 Clarifying the Scope of the Regulations, 40 Excused Research, 48 Clarifying the Distinction Between Excused and Expedited Research, 55 Annex 2.1, 56 References, 57 3  Determining Minimal Risk in Social and Behavioral Research 59 Defining Minimal Risk, 60 Avoiding Overestimation and Underestimation of Harm, 65 xiii

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xiv CONTENTS Expedited Review, 76 Research Involving Greater than Minimal Risk and Requiring Full Board Review, 81 Streamlining Expedited and Full Board Review, 82 Establishing an Empirical Knowledge Base for Level of Risk, 83 References, 84 4 Informed Consent 89 Flexibility in Informed Consent, 91 Informed Consent for Pre-existing Data, 102 References, 104 5 Informational Risk in the Social and Behavioral Sciences 109 Informational Risk in Research, 112 Balancing the Risks and Benefits in Research, 114 Why Not HIPAA as the Mandated Data Security and Information Protection Standard?, 116 Data Protection Plans—Current and Future Guidance, 119 Facilitating Data Sharing and Use, 125 Data Protection for Primary and Secondary Qualitative Data, 129 References, 131 6 Improving the IRB Process 135 The Scope of Federal Regulatory Authority, 135 Innovative Practices, 137 Conclusion, 145 Annex 6.1, 146 References, 147 APPENDIXES A Federal Policy for the Protection of Human Subjects (“Common Rule”) 149 B Table of Committee-Recommended Levels of IRB Review and Oversight 153 C Acronyms 159 D Biographical Sketches of Committee Members 161