Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary (2013)
Chapter: Front Matter
PROPOSED REVISIONS
TO THE COMMON RULE
Perspectives of Social and Behavioral Scientists
WORKSHOP SUMMARY
Robert Pool, Rapporteur
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
Division of Behavioral and Social Sciences and Education
NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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.
This study was supported by Contract/Grant No. 10001076 between the National Academy of Sciences and the National Science Foundation. Other sponsors included the 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. Any 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.
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Suggested citation: National Research Council. (2013). Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Robert Pool, Rapporteur. 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, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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 Academy 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 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 engineers. Dr. C. D. Mote, Jr., 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 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 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 engineering communities. The Council 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.
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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 Fiske (Chair), Department of Psychology, Princeton University
Melissa E. Abraham, Harvard University Medical School and Massachusetts General Hospital
Thomas J. Coates, Center for World Health, University of California, Los Angeles
Celia B. Fisher, Center for Ethics Education, Fordham University
Margaret Foster Riley, School of Law, University of Virginia
Robert M. Groves, Office of the Provost, Georgetown University
Felice J. Levine, American Educational Research Association
Robert Levine, Center for Bioethics, Yale University
Richard E. Nisbett, Department of Psychology, University of Michigan, Ann Arbor
Charles R. Plott, Laboratory for Experimental Economics and Political Science, California Institute of Technology
Yonette Thomas, Office of Research and Compliance, Howard University
David R. Weir, Survey Research Center, University of Michigan, Ann Arbor
Jeanne C. Rivard, Study Director
Robert Pool, Rapporteur
Jennifer Diamond, Program Associate (until May 2013) v
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
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
Acknowledgments
This workshop summary has been prepared by the workshop rapporteur as a factual summary of what occurred at the workshop. The committee’s role was limited to planning and convening the workshop. The views contained in the report are those of individual workshop participants and do not necessarily represent the views of all workshop participants, the committee, or the National Research Council (NRC).
The workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the Report Review Committee of the NRC. 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 charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We thank the following individuals for their review of this report: Nancy Adler, Departments of Psychiatry and Pediatrics, University of California, San Francisco; Wylie Burke, Department of Bioethics and Humanities, University of Washington; Susan Fiske, Department of Psychology, Princeton University; Richard Lempert, Eric Stein Distinguished University Professor of Law and Sociology (Emeritus), University of Michigan, Ann Arbor; Julia Milton, Public Affairs, Consortium of Social Science Associations, Washington, DC; Vimla L. Patel, Center for Cognitive Studies in Medicine and Public Health, The New
York Academy of Medicine; and Gerald S. Schatz, Pellegrino Center for Clinical Bioethics, Georgetown University Medical Center.
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the report nor did they see the final draft of the report before its release. The review of this report was overseen by Matthew Rizzo, review coordinator, and Larry Brown, review monitor. 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 considered. Responsibility for the final content of this report rests entirely with the author and the institution.
Appreciation is extended to Barbara A. Wanchisen, director of the Board on Behavioral, Cognitive, and Sensory Sciences and Robert M. Hauser, executive director of the Division of Behavioral and Social Sciences and Education for their leadership and guidance in moving the project forward; and to the sponsors for making the workshop possible. The 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.
Contents
SESSION 1: REVIEW OF THE EVIDENCE
Previous Reports by the National Academies
Risks and Harms in the Context of Research with LGBT Youth
Calibrating Risk of Harms with Levels of Review
Possible Extensions of the Exempt and Excused Categories
SESSION 3: THE CONSENT PROCESS AND SPECIAL POPULATIONS
Longitudinal Research with Behavioral and Biospecimen Data from Families
Consent in Disaster and Traumatic Stress Research
SESSION 4: DATA USE AND SHARING AND TECHNOLOGICAL ADVANCEMENTS
Archiving and Sharing Confidential Data in the Social Sciences
Data-Based Decision Making for Education
Toward Unified Data Security Requirements for Human Research
SESSION 5: MULTISITE AND MULTIDISCIPLINARY STUDIES
A Single IRB for Multisite Research
Managing Local Precedents—Three Models
International Multisite and Multidisciplinary Studies
SESSION 6: PURVIEW AND ROLES OF INSTITUTIONAL REVIEW BOARDS
Effects of Proposed Changes on Sociocultural Anthropology
Human Subjects Protection in Research Funded by the Department of Justice
