The U.S. Government has issued a Notice of Proposed Rulemaking (NPRM) based in part on recommendations from this report. The NPRM now more thoroughly addresses behavioral and social science and perspectives and acknowledges benefiting from the guidance provided by this report (NPRM, pg. 34).► Press Release
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.
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.