In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders and federal funding policies. She highlighted the confusion and increased scrutiny on research projects, particularly those involving diverse populations. Practical risks include potential legal scrutiny and funding agency actions. Heffernan also emphasized the importance of accurate reporting and careful documentation to avoid false claims. Future-proofing compliance involves thorough portfolio assessments, diversifying funding sources, and strengthening partnerships between academia and industry to support early-stage research and innovation.
ACT: What are some practical risks that sites or sponsors might face if they fail to align with an executive order that hasn’t yet been codified into law?
Heffernan: Right and that is exactly the limbo that I was describing. I think what we’re seeing is concern about just increased scrutiny on their projects by the funding agencies, increased scrutiny to the institution. For example, one thing I’ve seen a lot of clients grappling with is what trials are they publicizing on their websites? Many times, institutions, for good reason, will put forward the available clinical trial opportunities on a public facing website, so that the public is aware of opportunities to participate in research, and they really had to rethink, whether or not the names of these trials, which, again, were all approved and ongoing before the administration took office, and before any of these new policies were articulated, but whether or not putting that out to the public is really going to bring additional scrutiny to their organization that might even go beyond the scope of the name of the trial, and obviously what I’m referring to is trials that by their name, talk about involving or participation by underserved populations, ethnic minorities, or the LGBTQ+ communities, other things that the organization may be aware have become the target of certain executive orders. Again, these are ongoing trials that have IRB approval and that are actively enrolling. I think it’s been a real it’s been a real conundrum, I think, for organizations as to whether or not they remove reference to those types of trials on their website, simply by virtue of the executive orders.
Even going a little bit further when a restriction might not be overtly applicable yet, it might just be in the executive order, it hasn’t yet been codified into law, or an agency has taken action that has been enjoined by the courts, which we’ve seen a lot of as well, we’ve nonetheless seen some not so subtle messaging from the funding agencies that’s off the record to our clients, where, basically, even though the stated law right now is proceed as usual, we have had off the record messaging of, ‘You really better revise this application for funding to remove all references to diversity, or you’re not going to get considered.’