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Project Title:

Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences
PIN: DBASSE-BBCSS-12-04        

Major Unit:

Division of Behavioral and Social Sciences and Education
Institute of Medicine

Sub Unit: Committee on National Statistics
DBASSE Committee on Population
Board on Health Sciences Policy
DBASSE Board on Behavioral, Cognitive, and Sensory Sciences

RSO: Rivard, Jeanne

Subject/Focus Area: Behavioral and Social Sciences; Education

Project Scope
This project will be conducted in two phases. In Phase I, an ad hoc committee will plan and conduct a public workshop, following which a designated rapporteur will prepare an individually-authored summary of the event. In Phase II the committee will gather additional data, conduct analyses, and prepare a report with findings, conclusions and recommendations. The workshop summary and report will address prospective revisions to the Common Rule for the protection of human subjects in research 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 Phase II portion of the project and report will address the following objectives:
• 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 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.

The start date for the project is September 30, 2012.

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 Academy of Education, 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 and the Alfred P. Sloan Foundation.

The workshop summary will be issued in summer 2013. The study report will be issued in early winter 2013.

Note (05-15-2013): The Project Scope has been updated for clarity and to include all the sponsors of Phases I and II.

Project Duration: 18 months    

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Committee Membership
Committee Membership

 Meeting 1 - 01/14/2013
 Meeting 2 - 01/15/2013
 Meeting 3 - 03/21/2013
 Meeting 4 - 03/22/2013
 Meeting 5 - 06/18/2013
 Meeting 6 - 08/14/2013
 Meeting 7 - 09/09/2013


Reports having no URL can be seen
at the Public Access Records Office