The FDA will formally propose on November 15, 2018 to amend its regulations to allow an alteration or waiver of informed consent for FDA-regulated clinical investigations. This new found exception for informed consent is limited to research that is minimal risk and provides appropriate safeguards for the rights, safety, and welfare of research participants. Interestingly, the FDA has initially chosen to not harmonize with the revised Common Rule criteria for waiver of informed consent that will soon become fully effective (January 21, 2019) and instead has opted to adopt the waiver criteria found in current Common Rule.
The FDA, however, has requested comments on whether this is the right choice and, specifically, if in the waiver context, specific additional justification, i.e., not practicable, must be provided to use identifiable research materials. The FDA’s proposed rule is definitely worth the read. It provides a nice summary of the legal requirements previously confronting the FDA regarding exception to informed consent and provides instructive additional context for how best to apply the waiver criteria. The unpublished rule can be found here.