NRC Examining Proposed “Common Rule” Revisions - Consensus Report Planned
August 2, 2013
by Paula Skedsvold
In July, 2011, the U. S. Department of Health and Human Services proposed changes to the federal regulations governing human research protections and sought comments from the public prior to proceeding with regulatory revisions. As DHHS reviewed over 1000 submissions, the Board on Behavioral, Cognitive, and Sensory Sciences of the National Research Council’s Division of Behavioral and Social Sciences and Education began planning for a workshop that would consider the implications of the proposed changes for human research protections in behavioral and social sciences research.
The Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, chaired by FABBS President-Elect Susan Fiske of Princeton University, brought together experts from a range of behavioral and social science disciplines and methods to address six topic areas in a March 2013 workshop:
- Functioning of the Common Rule and IRBs
- Types and Levels of Risks and Harms in SBS sciences
- Consent Processes and Special Populations
- Use of Existing Data and Data Sharing
- Multidisciplinary and Multisite Studies
- Purview and Roles of IRBs
A summary of the workshop is available to the public.
Later this year, the NRC committee will release a consensus report containing a deeper analysis of the issues and recommendations. The consensus panel will identify critical issues, provide guidance to IRBs for addressing these issues, and suggest topics for research to assist in developing best practices and assessing the effectiveness of the rules and their implementation.