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HHS Proposal To Improve Human Medical Research

 

 

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The HHS’s Office For Human Research Protection (OHRP), while not widely known by the public, is charged with the important job of protecting the “. . . rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS)”.

 

The OHRP provides provides regulatory oversight, guidance, and advice on ethical and regulatory issues involved in biomedical and social behavioral research.

 

 

The last major revision to human research regulations were adopted in 1991; the “Federal Policy for the Protection of Human Research Subjects,” informally known as the “Common Rule”.

 

Regardless of the source of their funding, nearly all academic research institutions in the United States abide by these guidelines.

 

On Friday, the HHS announced an Advanced Notice of Proposed Rule Making (ANPRM) for changes under consideration to the `Common Rule’.

 

First a link and some excerpts from the press release, and then links to the proposed changes. Public comment is being actively solicited over the next 60 days.

 

 

 

News Release

FOR IMMEDIATE RELEASE
July 22, 2011

Contact: HHS Press Office
(202) 690-6343

HHS announces proposal to improve rules protecting human research subjects

Changes under consideration would ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight

The U.S. Department of Health and Human Services announced today that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations – which have been in place since 1991and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research.

The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. The proposed changes are designed to strengthen protections for human research subjects.

(Continue . . .)

 

 

ANPRM for Revision to Common Rule

Information Related to Advanced Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule

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