Institutional Review Boards: Cooperative Research (Proposed Rule) Regulatory Impact Analysis

Institutional Review Boards: Cooperative Research

The proposed rule, if finalized, would require any institution located in the U.S. participating in FDA-regulated cooperative research to rely on approval by a single institutional review board (IRB) for that portion of the research that is conducted in the U.S., with some exceptions. The proposed rule would harmonize our requirements for cooperative research, to the extent practicable and consistent with statutory provisions, with the requirements of the “Federal Policy for the Protection of Human Subjects” (revised Common Rule)1 in accordance with section 3023 of the 21st Century Cures Act of December 13, 2016 (the Cures Act) (Public Law 114-255, 130 Stat 1033). This proposed rule should reduce the administrative and coordination costs of conducting FDA-regulated cooperative research by (1) reducing duplicative reviews; (2) facilitating an earlier start of cooperative research; and (3) reducing the need to reconcile variability in IRB review decisions for cooperative research conducted with a common protocol. Reducing the costs of conducting cooperative research should reduce the costs of FDA-regulated medical product development and facilitate an earlier start of cooperative research which could contribute to a faster introduction of those products into commercial use.

Regulatory Impact Analysis

Institutional Review Boards: Cooperative Research (PDF)

Federal Register: 87 FR 58752, September 28, 2022

Docket: FDA-2019-N-2175