Cover: Proposed Directions of Change to the Common Rule for Protecting Human Research Participants

Proposed Directions of Change to the Common Rule for Protecting Human Research Participants

RAND Responses

Published Dec 2, 2011

by Tora K. Bikson, Susan Adler, Sandra H. Berry, Rebecca L. Collins, Christopher R. Corey, Michael D. Greenberg, Patrick P. Gunn, Brian A. Jackson, Scott Joiner, Susan G. Straus

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In July 2011, an Advance Notice of Proposed Rulemaking (ANPRM) was published in the Federal Register titled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators." The notice proposes several directions of change in the Common Rule that regulates Institutional Review Board (IRB) protection of human research participants. Members of RAND's Human Subjects Protection Committee, which serves as its IRB, prepared comments responding to the ANPRM and sent them to the Federal Register on October 25, 2011. This document contains that response. Because a large percentage of comments are likely to come from institutions heavily oriented toward clinical-biomedical research, RAND's purpose in publishing its response is to help ensure that the social-behavioral science implications of the proposed changes are also taken into consideration.

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