Kate Gallin Heffernan, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Boston office, was featured in a multi-part video Q&A by Andy Studna, in Applied Clinical Trials.

Watch the full series here:

Part 1: “Understanding Executive Orders and Trial Compliance”

Part 2: “The Quiet Risks of Ignoring Executive Orders in Research”

Part 3: “Balancing DEI Reporting with Legal Risk”

Part 4: "Performing Risk Assessments Amid Shifting Federal Guidelines"

Part 5: "How Research Institutions Can Future-Proof Compliance Programs"

Following is a summary:

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.

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