FDA Posts Long-Awaited Proposed Rules for IRBs, Informed Consent
It’s been a long time coming, but the FDA has finally published a pair of proposed rules designed to sync the agency’s IRB and informed consent requirements with the Common Rule, the regulation used by most federal agencies to guide human subjects research.
By making this move, the FDA, which has its own separate research regulations, hopes to reduce administrative workloads for sponsors, investigators and IRBs.
The agency’s rules, first proposed in the 21st Century Cures Act, aren’t groundbreaking but they will make strides toward achieving greater IRB review consistency across federally funded and privately funded research, David Forster, WCG’s chief compliance officer, tells CenterWatch Weekly, calling the recently published rules “welcome news” after years of delay.
The proposed rule on protection of trial participants and IRBs would nix the need for continuing reviews, unless IRBs determine otherwise, of trials that have reached a point involving only data analysis (including analysis of identifiable private information or identifiable biospecimens, and/or gathering follow up data from procedures that participants would undergo as part of clinical care). It also would revise recordkeeping requirements for continuing review and update general informed consent requirements with the Common Rule’s provisions.
Additionally, the proposed rule would add a requirement to keep records documenting the IRB’s rationale for continuing review for trials that otherwise don’t require it.
The second proposed rule would usher in new requirements for U.S. institutions taking part in FDA-regulated cooperative research to use single IRBs for all trials done domestically, with two exceptions: cooperative research that must legally use more than single IRB review and research for which the government deems single-IRB review inappropriate. It also proposes new recordkeeping requirements for trials that use outside IRBs.
The two proposed rules are open for public comment until Nov 28.
Read the proposed rule on protection of trial participants and IRBs here: https://bit.ly/3rfxflT.
Read the proposed rule on IRBs and cooperative research here: https://bit.ly/3LS7cL7.