The Food and Drug Administration seems to be on a regulatory roll. First there was the draft guidance about children in research; today (Sept. 28, 2022) the FDA has released a proposed rule about single institutional review board review of multisite research.
Per the federal register announcement of the proposed rule, the change would harmonize FDA’s requirements regarding single institutional review board review with those in the Revised Common Rule.
The actual change is described at the end of the document linked above. The FDA proposes changing language at 21 CFR 56.114, which currently indicates institutions involved in multi-site research may use a single institutional review board arrangement aimed at avoidance of duplication of effort. The proposed language says single institutional review board review is a must, and then lists exceptions to that requirement.