The National Research Council’s Board on Behavioral, Cognitive, and Sensory Sciences has released a report based on a March 2013 workshop that explored the implications of proposed revisions to current regulations for protecting human participants, while at the same time advancing behavioral and social sciences.

• Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions
• The types and levels of risks and harms encountered in research in social and behavioral sciences, and issues related to the severity and probability of harm
• The consent process and special populations, because new rules have been proposed to improve informed consent
• Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because of possible revisions applying standards for protecting the privacy of healthcare data when incorporated into research data
• Multidisciplinary and multisite studies, because of possible revisions to the regulations that would allow multisite studies to be covered by a single IRB
• The purview and roles of IRBs, because of possible revisions to categories of research that could entail changes in IRB oversight

The workshop stemmed from a July 2011 advance notice of proposed rulemaking from the U.S. Department of Health and Human Services, issued with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised.

AERA Executive Director Felice J. Levine was a member of the workshop committee, and serves on the NRC’s Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences.

Related:

“NRC Holds Workshop on Common Rule, Webcast Available Online,” AERA Highlights, April 2013

“NRC Panel to Examine Common Rule—Executive Director Levine Appointed,” AERA Highlights, January 2013