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Monday, November 24, 2014 
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Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences
Project Scope

This project focuses on prospective revisions to the Common Rule for the protection of human research participants that are of particular relevance to the behavioral and social sciences. The work of the committee is intended to inform the current efforts of the federal government to update the Common Rule (45 CFR 46), last revised in 1991. The project is being condView the agenda and the report brief.ucted in two phases. In Phase I, an ad hoc committee of the National Research Council planned and conducted a public workshop. In Phase II the committee will be gathering additional information, deliberating, and preparing a consensus report with findings, conclusions and recommendations.

The objectives of the project are to:
Identify issues raised in the proposed rulemaking which the panel identifies as critical and feasible for the federal government to address for the protection of participants and for the advancement of the social and behavioral sciences.


For each issue, provide guidance for IRBs and researchers as needed to include: techniques for addressing issues, specific examples and best practice models to illustrate how the techniques would be applied to different behavioral and social sciences research procedures.
Identify topics for research emerging from the proposed rulemaking that will assist in developing best practices for implementing the new human research protections and assessing the effectiveness of the rules and their implementation by IRBs and researchers.

Phase I of the project is sponsored by the National Science Foundation with additional support from the American Academy of Political and Social Science, American Economic Association, American Sociological Association, National Opinion Research Center, Population Association of America, Russell Sage Foundation, University of Michigan Institute for Social Research, and Westat.

Phase II of the project is sponsored by the Bill and Melinda Gates Foundation, the Alfred P. Sloan Foundation, and the National Academy of Education.


Members

Dr. Susan Fiske (Chair) - Princeton University
Dr. Melissa E. Abraham - Massachusetts General Hospital
Dr. Thomas J. Coates - University of California, Los Angeles
Dr. Celia B. Fisher - Fordham University
Ms. Margaret Foster Riley - University of Virginia
Dr. Robert M. Groves - Georgetown University
Ms. Patricia K. Hammar - PKH Enterprises
Dr. Julia I. Lane - American Institutes for Research
Dr. Rena S. Lederman - Princeton University
Dr. Robert J. Levine - Yale University
Dr. Felice J. Levine - American Educational Research Association
Dr. Bradley A. Malin - Vanderbilt University School of Medicine
Dr. Richard E. Nisbett - University of Michigan
Dr. Charles R. Plott - California Institute of Technology
Dr. Yonette F. Thomas - Association of American Geographers
Dr. David R. Weir - University of Michigan

For more information, see the complete record at the National Academies' Current Project site


Report from Phase 1
 
CommonRuleCoverLProposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary is based on a workshop that explored the implications of proposed revisions by NIH and alternative approaches for protecting human participants while at the same time advancing behavioral and social sciences. This report summarizes the presentations and discussions that took place at the workshop among experts from a range of social and behavioral science disciplines.

Download the report


  
Report from Phase 2
  
Common Rule Consensus CoverProposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences is the product of a consensus study to inform the efforts of the federal government in revising regulations (the “Common Rule”) that protect human participants in research. Several of the proposals put forth by the Department of Health and Human Services in their July 2011 Advance Notice of Proposed Rulemaking (ANPRM) were endorsed by the committee. Within the context of social and behavioral sciences the committee recommends revising the Common Rule and amending specific proposals in the ANPRM in relation to, for example, key definitions (human subjects research and minimal risk), categories of review required by Institutional Review Boards, and consent processes. The committee also offers examples and strategies for operationalizing the proposed new procedures.

Download the report
  
Public Briefing
January 30, 2014

View the agenda and the report brief.

View the archived webcast below




Past Meetings

September 9-10, 2013
August 14-15, 2013
June 18-19, 2013


March 21-22, 2013
A workshop on the Proposed Revisions to the Common Rule for the Protection of human subjects in research that are of particular relevance to the behavioral and social sciences was held in mid-March.  Numerous speakers in six sessions focused on topics important to the proposed revisions including: review of the evidence, types and levels of risks and harms, consent process and special populations, data use and sharing, multi-site and international studies, and IRB purview and roles. 

More information about the workshop (including webcast and presentations)

January 14-15, 2013
The committee met to plan the March workshop and received input from federal agencies, professional associations, and academic/research organizations.


Staff

Jeanne Rivard, Senior Program Officer, 202-334-2967
Jatryce Jackson, Program Associate, 202-334-3868
The National Academies