CNIL MR-001 is the primary data protection framework interventional clinical trials in France where participants give informed consent. Organisations conducting these studies must either apply for direct authorisation from the French data protection authority, the Commission Nationale de l’Informatique et des Libertés (CNIL), or declare that they comply with an applicable Reference Methodology, such as MR-001. This framework has been in place since 2018, but the May 2026 update introduced further complexity to the methodology.