The Food and Drug Administration (FDA) has made it official — it will allow waivers/alterations of informed consent processes for certain studies, according to a new rule to take effect this month.
You may recall the FDA issued a guidance in 2017 saying it would not object to consent waivers/alterations on certain minimal risk studies. A final rule issued Dec. 31, 2023, formalizes that guidance in regulation.
The regulation does differ in one important way from the earlier guidance. The FDA has added the criterion pertaining to identifiable information or specimens to its conditions to grant a waiver or alteration. Specifically, the FDA will require that if a study for which an investigator requests a consent waiver/alteration involves identifiable information/biospecimens, the study could not be practicably carried out without the requested waiver. Note that this language matches that in the Revised Common Rule, thereby supporting FDA’s intention to harmonize its regulations with the Common Rule to the extent feasible.
As is standard with Federal Register notices, the most interesting part is the preamble, which gives background on the FDA’s decisions about the final rule. However, if you don’t feel like reading two dozen pages of tiny, single-spaced type, here’s a summary of the rule’s highlights published by a different organization.
This rule change which entail changes to IRB Policy 15.3 and to parts of CLARA. We’re working on those changes and will add another blog post once we’re done. Assuming we remember to do so.