This session will be a panel discussion covering the combining a new U.S. administration with a flurry of newly updated and released documents, there is a lot to keep track of that impacts daily work. The Declaration of Helsinki, one of the most important documents in clinical research, was just updated in October 2024. Combined with the January 2025 release of the long-awaited ICH E6 (R3), the delayed FDA sIRB mandate, and the FDA's efforts to harmonize regulations with OHRP's Common Rule, this is an exciting yet changing time to be in clinical research