11/03/2022
Photo by Rodeo Project Management Software on Unsplash
Section 3023 of the 21st Century Cures Act (Cures Act) requires harmonizing the human subject protection regulations between U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA). The Federal Policy for the Protection of Human Subjects, also known as the “Common Rule,” specifies the requirements for the protection of human subjects in HHS sponsored clinical trials. A final rule published to the Federal Register on January 19, 2017 revised the Common Rule, and an amendment delayed the effective date to January 22, 2018 and the compliance date to June 19, 2018. Another amendment established a transition period from the compliance date until January 21, 2019.
In efforts to harmonize with the revised Common Rule, the FDA recently published two proposed rules. The first, Institutional Review Boards: Cooperative Research, requires multisite clinical trials in the US to use the same centralized Institutional Review Board (IRB) to reduce administrative burden and is in line with the revised Common Rule requirement for the same. The second, Protection of Human Subjects and Institutional Review Boards, changes the organization of the informed consent form to first present the most important information that helps the participant understand the clinical trial before the other details. This proposed rule also revises FDA’s Investigational Device Exemption (IDE) regulations related to submitting progress reports to IRBs.
The FDA is also working towards finalizing a previously published proposed rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, that is also linked to harmonizing with the Common Rule. Read our blog on this proposed rule HERE.
Comment on the proposed rules through November 28, 2022.
The revised Common Rule and the FDA proposed rules advance the HHS and FDA closer to harmonizing human subject protection regulations as required under the Cures Act. Once the regulations are harmonized, the regulatory burdens of two requirements for human subject protections will be minimized. For now, if a study is subject to both sets of regulations and they differ, the stricter regulations must be followed.
Follow the history of the HHS Revised Common Rule in these blogs:
Additional Delay in Timing of the Compliance to the Updates to the Common Rule
Common Rule Revisions Delayed by Published Interim Final Rule
Common Rule Changes and their Effects, as Proposed by the NPRM
-The Clinical Pathways Team
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