The US Food and Drug Administration is proposing a waiver to the legal requirement on pharma companies to obtain informed patient consent for certain low-risk clinical trials. The proposal would amend a provision of the 21st Century Cures Act to add an exception to the consent requirement.
The proposed rule, if finalized, would allow the institutional review board (IRB) responsible for the review and approval of clinical research to waive or alter certain elements of informed consent, or to waive the requirement entirely, under limited circumstances.