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: There’s growing concern around including DEI-related language in reporting. How can research teams acknowledge diversity-focused efforts without inadvertently increasing their exposure to legal scrutiny, such as False Claims Act risk?
Heffernan: This is a great question, and an area that I think we’ve seen some of the most concern expressed by clients. Many of our clients are in a really challenging position when they have to currently report on the completion of aims within a grant or within a trial project that were previously approved and designed at a time when there was both acceptance of and even really a mandate for diversity centered aspects of federally funded research. One thing that I think is important for organizations to remember, is that it’s really fundamentally important for them to be accurate in how they report out the work that they’ve done. You can really put yourself in a False Claims bind by misrepresenting in any way the work that was done on a grant in a way that’s inaccurate, that said, the way you frame that, the way you phrase it, the way in which organizations can accomplish that type of progress reporting on previously defined scopes that involved diversity efforts and mandates and avoid hot button trigger words. Those are the important considerations that we’re helping clients to navigate.