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.
Among the more challenging and controversial issues to be addressed by the NPRM include the following:
- Informed consent for biospecimens and whether such consent should be required for all biospecimens, de-identified samples already collected, and “leftover” samples from clinical procedures;
- Scope of the Common Rule, particularly if it should be expanded to all research conducted by entities receiving federal funding regardless of whether the project itself is federally funded;
- Definition of “research” and whether it should encompass quality improvement, program evaluation and public health activities;
- Harmonization of the Common Rule with other regulatory schemes, particularly the Food and Drug Administration’s Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable and Health Insurance Portability and Accountability Act Privacy Rules; and
- Revisions to Institutional Review Board (IRB) review processes, including use of single, centralized IRBs for domestic sites participating in multi-site trials and required level of, and standards for, review for minimal risk studies.
Stakeholders will have the opportunity to respond to HHS’ proposal through the NPRM’s public notice and comment process and meetings with policymakers in the executive and legislative branch.