21 Nov New Informed Consent Expectations Should Aid Participants’ Understanding, May Catch Professionals Off Guard

By James Riddle, ACRP

Sometimes in the realm of evolving clinical research regulations, the maxim about “be careful what you wish for” can more accurately be phrased as “be aware of it when you get what you asked for.” Such is the case with recently proposed U.S. Food and Drug Administration (FDA) guidance updating the agency’s expectations for the contents of informed consent forms for clinical trial participants, says an expert who will explain the history behind the updates and their ramifications for stakeholders at the ACRP 2025 conference in New Orleans in April. 

Noting that the draft guidance on “Key Information and Facilitating Understanding in Informed Consent” for sponsors, investigators, and institutional review boards (IRBs) will likely be finalized by the time he presents on it at the conference, James Riddle, MCSE, CIP, CPIA, CRQM, Senior Vice President, Global Review Operations, at Advarra, says that the big news from the document is that it finally harmonizes certain informed consent practices of the FDA and the Office for Human Research Protections (OHRP). Although this represents a long-anticipated move on the parts of these two branches of the U.S. Department of Health and Human Services, Riddle adds that new expectations framed in the guidance may catch some research professionals off guard, coming as they are in the midst of other, perhaps splashier, regulatory changes that are getting more attention. Read more…