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Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators

October 2011 – The CAREB Board of Directors recently filed comments to the Department of Health and Human Services (HHS) in response to an Advanced Notice of Proposed Rulemaking (ANPRM) entitled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (Notice Number HHS-OPHS-2011-0005), published in the July 26, 2011 Federal Register (76 FR 44512).  As a foreign, not domestic body, CAREB has chosen not to comment on all of the specific details proposed in the ANPRM. Instead, comments were provided on areas where, based on CAREB’s collective experience, can provide insight as to best practices.