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Human Subjects Division (HSD)

Regulatory Updates

OHRP: HHS Proposal to Improve Rules Protecting Human Research Subjects Published in Today's Federal Register

Jul 26, 2011 at 10:59am

The U.S. Department of Health and Human Services announcement that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects was published as an Advance Notice of Proposed Rulemaking (ANPRM) in the July 26, 2011 issue of the Federal Register.  In that ANPRM, entitled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," the government seeks the public's input on an array of issues related to the ethics, safety, and oversight of human research, before making changes to the regulations.  Those regulations, often referred to as the Common Rule, have been in place since 1991.  The proposed changes in the ANPRM are designed to strengthen protections for human research subjects.  The ANPRM can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm


To be assured consideration, comments must be received no later than 5 p.m. on September 26, 2011.  For additional information about the ANPRM, including how to submit or browse comments, visit http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.