On July 26, 2011, the U.S. Department of Health and Human Services (HHS) issued an advance notice of proposed rulemaking (ANPRM) entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” (Volume 76, Number 143, page 44512). The comment period was to close on September 26, 2011, however, in light of numerous requests, HHS has extended it by 30 days. Thus the comment period now ends October 26, 2011. Due to the wide-ranging potential impact of the proposed changes on human subjects research conducted domestically, this extension gives sponsors, investigators, institutional review boards, contract research organizations and others likely to be affected by the sweeping proposed changes much needed additional time to fully review and comment on the ANPRM.
For additional information about the ANPRM, please click here.