Performing Risk Assessments Amid Shifting Federal Guidelines

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: How can research teams perform meaningful risk assessments to ensure feasibility before applying for or drawing down federal funds?

Heffernan: Like the reporting on past aims and progress reports on diversity aims, this has been another area where we've had clients really struggling, in part because everyone right now is obviously doing what they can to ensure that they remain eligible for as much of their federal funding as possible. The motivation is to make the certification in order to be able to draw down the funds. However, it is really important that organizations are looking at those certifications really carefully, that they are taking whatever reasonable, good faith effort steps they can to make sure that they are accurately representing that certification. We've seen a lot of different scopes of certification, so sometimes it's limited to the funds that are actually being drawn down in that no particular moment, and it relates to whether or not the funds themselves are being used to further aims that are not aligned with the government's priorities. That's an easier diligence thing, obviously, because you're looking at just whether or not that project itself has any elements that might cause concern with respect to the stated policies of the funding agency and the administration. I think the harder ones are the ones that ask you to represent what you've sort of done, everything you can to make sure that your entire program at the organization is in line with the executive orders, which again, begs the question, they're not laws. Essentially you're getting a backdoor certification to compliance with something that's not a binding law. I think that's deeply troubling to me as a lawyer in terms of a process for implementing that type of requirement, but what we've said as a practical measure for clients is do your best to make sure you're documenting all the efforts that your organization is taking across the board to evaluate its programs and to make sure that it is compliant with the law, and make sure that those efforts have been undertaken and fairly documented, so that you have something to stand on if it's challenged.