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