FDA plans amendment to informed consent requirement

The US Food and Drug Administration yesterday proposed amending 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 need to make findings that have been included in a Common Rule waiver provision for minimal risk research for decades. The Common Rule provision has provided appropriate safeguards to protect the rights, safety and welfare of individuals participating in certain minimal risk research for more than 25 years.

The FDA intends to withdraw its related 2017 guidance if this proposed rule becomes final. The agency is also seeking input on the types of minimal risk clinical investigations for which sponsors or investigators would anticipate requesting a waiver or alteration of informed consent from the IRB.