March 2, 2015

Human Subjects Research Protections Proposed Rule Finally Moves Forward for White House Review

From: Sidley Austin

On February 24, the Office of Management and Budget’s Office of Internal Regulatory Affairs (OIRA) accepted for review the Department of Health and Human Services’ (HHS) notice of proposed rulemaking (NPRM) governing the protection of human subjects in research, also known as the “Common Rule.” This NPRM, entitled the “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” follows the advanced notice of proposed rulemaking (ANPRM) issued by HHS in July 2011. Once OIRA’s review is complete, the draft NPRM will be returned to HHS for final modifications and release for public notice and comment.

The Administration has taken nearly four years to build internal consensus and solicit external feedback for the various proposals raised in the ANPRM. However, the Administration will likely now move quickly to issue the NPRM and finalize the rule, which it believes will have a significant and positive impact on numerous Administration priorities — increasing data privacy and security for patients, modernizing clinical trials and reducing adverse events, harmonizing and streamlining regulatory requirements and advancing precision medicine.

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