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What Does ICH E6 R3 Say About Returning Data to Participants?
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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. This shift acknowledges the growing importance of transparency and participant rights in clinical trials. However, the guidance does not explicitly assign this responsibility to sponsors, despite them often being the ones who restrict access to participant data. While this change is a major step forward in ethical research practices, its practical enforcement remains uncertain without direct sponsor obligations.
These updates reflect a broader shift toward patient-centric clinical trials, but questions remain about how effectively they will be implemented.
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