COGR Letter to FDA Regarding Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

The Council on Governmental Relations (COGR), representing 188 research universities and affiliated institutions, has formally expressed support for the Food and Drug Administration's proposed rule to allow institutional review boards (IRBs) to waive or alter certain elements of informed consent for minimal risk clinical investigations. In their letter, COGR emphasizes that this change aligns FDA regulations with the Common Rule, recommendations from relevant advisory committees, and provisions in the 21st Century Cures Act. COGR contends that the current FDA regulations only permit exceptions to informed consent requirements in specific emergency or life-threatening circumstances, which can result in unnecessary administrative burdens for investigators and IRBs. The proposed regulation, they argue, would streamline the review process for minimal risk research while still ensuring robust protections for human subjects. COGR concludes by expressing appreciation for the opportunity to comment and invites further inquiries about their position.