What Does ICH E6 R3 Say About Returning Data to Participants?

The most recent ICH E6(R3) final guidance introduces critical updates to Good Clinical Practice (GCP), particularly around informed consent and participant data access. The guidance emphasizes greater flexibility and the use of technology-driven innovations to enhance how patients understand what they are consenting to. A significant update appears in section 2.8 (Investigator Responsibilities), which now requires a clear plan for returning trial-related data to participants when appropriate....