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Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences
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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.
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 - Howard University |
| Dr. David R. Weir - University of Michigan |
| For more information, see the complete record at the National Academies' Current Project site |
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NRC Staff Contact: Manu Sharma, Senior Program Assistant, 202-334-1747
Jeanne Rivard, Senior Program Officer, 202-334-2967 Revisions to the “Common Rule” in Relation to Behavioral and Social Sciences Workshop National Academy of Science (NAS) Building 2101 Constitution Ave NW Lecture Room Washington, DC Thursday March 21 8:15 a.m. Registration 8:45 a.m. - 5:30 p.m. Workshop Sessions 1-4 Friday March 22 8:15 a.m. Registration 8:45 a.m. - 2:30 p.m. Workshop Sessions 5-6 ? View the agenda for the workshop. ? View the Webcast of this event. This 2-day workshop addressed prospective revisions to the Common Rule for the protection of human subjects in research that are of particular relevance to the behavioral and social sciences. Topic areas included: 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. All powerpoints from the workshop can be viewed by session and speaker below. Session 1: Review of the Evidence Session 2: Risks and Harms - Richard Campbell, University Illinois at Chicago, Institute for Health Research and Policy (Discussion of the issues in the context of research on aging, health, racial, ethnic, and socioeconomic disparities; and suggestions for calibrating levels of review to levels of risk)
- Brian Mustanski, Northwestern University Feinberg School of Medicine (Discussion of issues in the context of sexuality and health research with LGBT youth; participants' appraisals of risk and benefits in behavioral and social science research)
- Steven Breckler, American Psychological Association (Discussion of the issues in the context of broader perspective of the behavioral and psychological sciences, providing a framework for assessing rish of harm, and critiquing the ANPRM proposals for calibrating level of review to the level of risk)
- Charles Plott, California Institute of Technology (Discussion of the nature of risks in relation to economic, decision, and political sciences)
Session 3: Consent Process and Special Populations - Sally Powers, University of Massachusetts, Amherst (Discussion of the issues in the context of research on biopsychosocial factors hypothesized to contribute to depression in family systems; particular focus on "complex consents")
- Roxanne Cohen Silver, University of California Irvine (Discussion of the issues in the context of research on factors, effects, beliefs, and predictors of disaster and trauma; with particular focus on the process of consent, versus the form, to protect participants and advance research that can take place during or immediately after traumatic events)
- Celia Fisher, Fordham University, Center for Ethics Education (Discussion of the issues in the context of research with the biospecimens; and addressing issues related to the various forms of consent for different types of research)
Session 4: Data Use and Sharing and Technological Advancements Session 5: Multi-disciplinary and Multi-site Studies Session 6: Purview and Roles of Institutional Review Boards Prior Common Rule Events: Planning Meeting: A two day planning meeting was held in DC January 14-15, 2013 to gather information. View the agenda for the January 14th, 2013 open meeting. View the public agenda for the January 15th, 2013meeting.
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