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This report, chaired by BBCSS chair Susan Fiske, is the product of a consensus study to inform the efforts of the federal government in revising regulations 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.
Withing 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.
► Press Release
On January 19, 2017, the U.S. Department of Health and Human Services and 15 other federal agencies published the long-awaited revisions to the "Common Rule," which regulates the protection of research participants. The new rule includes a statement that the rule-making benefitted from guidance provided by the 2014 NRC report Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences, and the 2016 report Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century.
More detailed information on the final rule can be accessed on the website of the Office of Human Research Protections and the website of Public Responsibility in Medicine and Research (PRIM&R) that includes summaries of changes.
The new rules support greater flexibility for researchers and Institutional Review Boards (IRBs) in today's behavioral and social sciences, while affording the greatest protection for research participants. IRB's have a year to comply with the new rules. Susan T. Fiske, chair of the NRC committee report and member of the National Academy of Sciences, commented that the imprint of the committee's report can be seen in new rules that allow for:
- Designating a single IRB for cooperative research.
- Improving consents by simplifying them, removing "legalese", and requiring investigators to provide participants with a better understanding of the research to assist in their decision-making.
- Allowing for the use of broader consent for the future use of identifiable private information and identifiable biospecimens.
- Defining vulnerable populations more rationally. For example, the definition removed pregnant women and "handicapped", and replaced "mentally disabled" with individuals with impaired decision-making capacity.
- Exempting low-risk studies such as: questionnaires, surveys, or interviews; "benign behavioral interventions"; and secondary research with certain types of identifiable information or biospecimens for which consent is not required (e.g., that which is publically available).
- Clarifying that "exempt" means exempt from IRB review. Together, the first two categories above capture 80% of BBCSS research.
- Benign behavioral interventions are defined as "brief in duration, harmless, painless, not physically invasive, not likely to have a significant lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing". Examples include: playing online games, solving puzzles under various noise or conditions, or deciding how to allocate a nominal amount of received cash between themselves and someone else.
View the video related to the report
The report Proposed 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. Read more about this report
Susan Fiske (Chair), Princeton University
Melissa E. Abraham, Massachusetts General
Thomas J. Coates, University of California,
Celia B. Fisher, Fordham University
Margaret Foster Riley, University of Virginia
Robert M. Groves, Georgetown University
Patricia K. Hammar, PKH Enterprises
Julia I. Lane, American Institutes for Research
Rena S. Lederman, Princeton University
Robert J. Levine, Yale University
Felice J. Levine, American Educational
Bradley A. Malin, Vanderbuilt University
School of Medicine
Richard E. Nisbett, University of Michigan
Charles R. Plott, California Institute of Technology
Yonette F. Thomas, Association of
David R. Weir, University of Michigan
Jeanne Rivard, Senior Program Officer
Jatryce Jackson, Program Associate