Summary of proposed Common Rule changes

As mentioned in a previous Research News post, the federal Office for Human Research Protections has released a Noticed of Proposed Rulemaking, describing possible changes to the Common Rule (45 CFR 46), the regulation that governs all human subject research done at UAMS.

Some of the proposed changes could lead to significant adjustments in how research is overseen and conducted. These changes could include requiring single-IRB review of multisite studies; simplifying the review of very low-risk research; and requiring subjects’ consent to store their samples for unspecified future research, even if the future research would involve only samples that do not include identifiers.

A recent article in Nature provides a nice — and brief — summary of the proposed changes and the rule revision process. We strongly encourage everyone in the UAMS research community to stay informed of these potential changes. As the article notes, the implementation of a final rule could come sooner than we expect, and could lead to some significant changes in the research climate.