FDA In Brief > FDA In Brief: FDA takes steps to allow greater flexibility for clinical investigators about informed consent in minimal risk situations

FDA In Brief > FDA In Brief: FDA takes steps to allow greater flexibility for clinical investigators about informed consent in minimal risk situations





FDA takes steps to allow greater flexibility for clinical investigators about informed consent in minimal risk situations



Today, the U.S. Food and Drug Administration is proposing to amend its regulations to implement a provision of the 21st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants. The proposed rule, if finalized, would allow the Institutional Review Board (IRB) responsible for the review and approval of the research to waive or alter certain elements of informed consent, or to waive the requirement to obtain informed consent entirely, under limited conditions. To waive or alter informed consent under the proposal, the IRB would ...