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Noting that the draft guidance on “Key Information and Facilitating Understanding in Informed Consent” for sponsors, investigators, and institutional review boards (IRBs) will likely be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.
At the heart of the matter is lining up new language about the inclusion of “key information” for trial participants in non-federally funded research (overseen by FDA) found in 21 CFR Part 50 in the Code of Federal Regulations with the existing language in 45 CFR Part 46 (the Common Rule) for federally funded research (overseen by OHRP), both labeled as concerning “Protection of Human Subjects.” Riddle says it is important for members of clinical trial teams—and especially for IRBs—to understand what they may or may not need to do in order to prepare their organizations for the change.
“Since 2019, OHRP guidance includes an expectation of, and instructions for, a concise summary of key information for trial participants that is to be found at the beginning of what can be very long and complicated informed consent forms and written at a reading level that should be understandable to the non-medical expert reader,” Riddle explains. “Among other concerns, the reasonably foreseeable risks and benefits of the research should be articulated in this part of the consent. So most of the large academic medical centers that receive both federal funding and non-federal funding for their clinical trials just adopted the OHRP standards for all of their trials, even though those standards really only apply to the federally funded research,” such as from the National Institutes of Health, the Department of Defense, and so on.
When the FDA’s 21 CFR Part 50 did not change along with 45 CFR Part 46, “there was a disconnect between what OHRP and FDA were requiring in terms of the additional elements of informed consent, so even if this key information was included in a consent form for a non-federally funded trial, it was not required,” Riddle says. This key information should help participants to understand the research and encourage them to ask questions about their role in it, he adds.
The guidance harmonization is part of other regulatory changes that are expected in early 2025 concerning single IRB reviews of proposed research, Riddle explains, so sponsors, contract research organizations, and sites with templates for their informed consents are advised to be ready for making updates as even bigger changes are coming down the pike.
Author: Gary Cramer
