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HHS seeks input on human-research regs


By Paul Barr
Posted: July 24, 2011 - 12:01 am ET
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HHS announced it is contemplating how it could improve its regulations overseeing research on human subjects and is seeking public input on the matter.

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Changes to the rules—known as the Common Rule—would relate to the ethics, safety and oversight of human research and would be designed to strengthen protections, according to HHS. The potential changes were published in an advance notice of proposed rulemaking called Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (PDF).

“The adoption of the Common Rule two decades ago was a landmark event to ensure ethical practices and the safety of those individuals who participate in research,” said Dr. Howard Koh, assistant secretary for health, in a news release. “The changes under consideration offer the promise of updating and enhancing those protections to keep pace with current challenges.”

Among the issues HHS is seeking comment on are: revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk; using a single institutional review board review for all domestic sites of multi-site studies; and establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.

Comment will be accepted for 60 days after publication in the Federal Register, which according to HHS would be July 25 and would make comment due Sept. 23.


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