Informed consent responsibility

The manuals converge on the idea that informed consent is a prerequisite to participation, and that facilitators have an active responsibility in securing it. In the MDMA-assisted therapy manual, this is framed as an ethical and regulatory duty before treatment in an approved clinical trial. The 5-MeO-DMT best-practices model also centres participant autonomy, with the facilitator supporting informed self-selection rather than pressuring participation. The sources also overlap in treating consent as more than a signature, since it depends on clear communication about what the work involves. The 5-MeO-DMT clinical pharmacology review emphasises explaining benefits, limits, risks, and uncertainty, including acute adverse effects, subacute reactivations, and rare psychosis risk. The Conclave manual similarly stresses explaining the practitioner’s methods and container clearly, so participants can judge whether the setting, facilitator, and dosage approach fit their needs. They differ in emphasis and context. The MDMA manual is specific to investigational psychotherapy research and highlights formal informed consent before MDMA-assisted therapy in a clinical trial. The 5-MeO-DMT sources place more weight on participant readiness, autonomy, and risk communication, and one source explicitly notes that therapeutic evidence is preliminary and largely observational, with controlled clinical evidence still limited.