FDA Finalizes Relaxed Consent Requirements for Low-Risk Studies

The FDA finalized a long-awaited rule that relaxes consent requirements for when a clinical investigation poses no more than minimal risk to human subjects.

The final rule (RIN 0910-AH52), released Wednesday, allows ethics boards, also known as institutional review boards, to waive the requirement or alter certain informed consent elements under limited conditions for certain FDA-regulated minimal risk clinical investigations.

Previously, IRBs could only waive informed consent for life-threatening situations, by presidential waiver for certain military operations under specific conditions, or for emergency research.

The FDA’s rule now allows an exception from the requirement when a clinical investigation ...