Proposed Revisions To The Common Rule: Can IRBs Really Enhance Protections While Reducing Burdens?

Abstract

On July 26, 2011, the Department of Health and Human Services (HHS) announced its intention to significantly revise and update HHS regulations regarding human subject research for the first time since 1991, when it originally promulgated what has become known as the Common Rule. HHS further solicited comments to its proposed revisions contained in this Advance Notice of Proposed Rulemaking (ANPRM) through the use of 74 questions. Over 1100 interested parties responded to these questions. HHS is still in the process of reviewing and analyzing the responses. No further action has been taken and, as of this writing, a formal Notice of Proposed Rulemaking (NPRM) has not been issued.