Bioethics Blogs

Implications of Common Rule Changes for Minimal Risk and Expedited Review of Social & Behavioral Research

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For the first time in 20 years the U.S. Department of Health and Human Services has proposed changes to Federal Regulations governing protections for people who participate in research.  Any changes will have a substantial impact on the conduct and Institutional Review Board (IRB) approval of social-behavioral research–especially in terms of how IRBs will interpret criteria for “minimal risk” research and expedited review.

At the recent 2014 PRIM&R Advancing Ethical Research conference, Dr. Celia B. Fisher, Director of Fordham’s Center for Ethics Education and a member of the National Research Council’s Committee on Revisions to the Common Rule for Social & Behavioral Science, explained the Committee’s recommendations for regulatory change and its impact on SBR and research involving children and other “vulnerable” populations. Dr. Fisher’s PRIM&R presentation is available for download here.

To read The National Research Council’s Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences please visit their website.

For more information, see the Society for Research in Child Development’s Social Policy Report Preserving and Enhancing the Responsible Conduct of Research Involving Children and Youth: A Response to Proposed Changes in Federal Regulations

 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.