Tag Archives: health & human services

The Department of Health and Human Services Requests Comments on Proposed Changes to the "Common Rule"

On July 26, 2011, the U.S. Department of Health and Human Services (“DHHS” or the “Department”) published an advance notice of proposed rulemaking (“ANPRM”) soliciting comments on proposed changes to the “Common Rule.”[1] The Common Rule, more formally known as the Federal Policy for the Protection of Human Subjects, is a uniform set of regulations governing the protection of human subjects involved in research that is conducted or supported by certain federal agencies, including, by way of example, DHHS and the Departments of Defense, Education, Agriculture, Commerce, and Veterans Affairs, among others. In addition, many institutions that conduct research under a Federalwide Assurance (“FWA”) voluntarily adopt the Common Rule’s protection for all research performed at the institution, regardless of funding source, including FDA-regulated research.

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