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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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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.

www.nap.edu

Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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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.

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.

International Standard Book Number-13: 978-0-309-28823-1
International Standard Book Number-10: 0-309-28823-1

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 2013 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

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.

Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

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.

www.national-academies.org

Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

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

Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

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

Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
×

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

Page viii Cite
Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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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.

Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Page viii Cite
Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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Suggested Citation:"Front Matter." National Research Council. 2013. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18383.
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On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics.

Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary focuses on six broad topic areas:

1. Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions.

2. The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm, because the ANPRM asks for input on calibration of levels of review to levels of risk.

3. The consent process and special populations, because new rules have been proposed to improve informed consent (e.g., standard consent form, consent for future uses of biospecimens, and re-consenting for further use of existing research data).

4. Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data.

5. Multidisciplinary and multisite studies, because the ANPRM proposed a revision to the regulations that would allow multisite studies to be covered by a single IRB.

6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight.

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