In 2025, the U.S. Department of Health and Human Services (HHS) initiated several significant policy changes impacting how clinical trials are conducted in the U.S. This session will explore five major developments: updated informed consent standards prioritizing plain language and accessibility; new HHS-led interoperability efforts to streamline trial data exchange; clarified Internal Revenue Service guidance on taxing participant stipends; a shift from mandated diversity action plans to a voluntary reporting framework; and cross-agency modernization efforts through the HHS Clinical Trials Modernization Working Group. These changes—while intended to promote transparency and innovation—have introduced ambiguity for sites, sponsors, and contract research organizations. Attendees will gain clarity on how to operationalize these updates, navigate compliance challenges, and align processes with the evolving federal landscape in 2026 and beyond.
CEU: 1.00 ACRP
Speakers:
Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare
Sophia McLeod, Advocacy Advisor, Association of Clinical Research Organizations (ACRO)