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Consent Waiver for Low-Risk Studies Moves Toward FDA Finish Line

Nov. 18, 2021, 9:19 PM

The FDA is moving ahead with finalizing a long-awaited rule that would allow drug and device companies for the first time to relax consent requirements for some low-risk studies, officials said Thursday.

The proposed rule would allow ethics boards known as institutional review boards (IRBs) to waive the requirement for researchers to obtain informed consent from participants. IRBs can currently only waive informed consent in life-threatening situations or for emergency research, when a patient population has no capacity to consent.

The changes would mark a critical step toward harmonizing the FDA’s requirements for conducting studies with human volunteers (21 ...