U.S. Department of Health and Human Services Extends Comment Period for Proposal to Revise Substantially the Human Research Subject Protection Regulations
02 September 2011Health Alert
On 1 September 2011, the U.S. Department of Health and Human Services (HHS) extended the deadline for comment on its Advance Notice of Proposed Rulemaking (ANPRM) to modernize and enhance regulations that govern research on human subjects. These regulations, originally promulgated by HHS in the late 1970s, are often referred to as the Common Rule. They are applicable to research conducted, regulated or supported by federal agencies, and to other private sector entities that file an "assurance of compliance" with the regulations. Manufacturers of pharmaceutical products and medical devices, and those who conduct clinical investigations of drugs and devices that are regulated by the FDA, encounter the same requirements with slight modifications as part of FDA's regulation of clinical investigations. HHS issued the ANPRM on 26 July 2011. In response to concern that such substantial proposed revisions required additional time to review, HHS has extended the comment period by one month. Comments are now due 26 October 2011.