The IRB has posted revised versions of two of our most popular (can policies be “popular”? Maybe we should call them “the most referred-to”?) policies — IRB Policies 15.1, Elements of Informed Consent, and 15.3 Waivers of Signed Informed Consent Documents and Waivers of Informed Consent Elements. The biggest changes relate to formatting, as we’re (slowly) trying to get our policies into a standard format. We’ve also updated both with information from recent guidance and regulatory changes. For example, in 15.3, we’ve added some language clarifying that the FDA will not object to an IRB waiving the requirement to obtain informed consent in certain minimal risk studies. That guidance, from 2017, was a big step forward in FDA terms, as it had previously been quite inflexible regarding consent waivers (they were hardly ever allowed).
We in the IRB office refer to these policies all the time. We hope our research teams do as well, each time they develop a consent process or plan to request a waiver or alteration of the consent process.