Psychedelic-assisted therapy is moving from research to clinical and community practice faster than governance frameworks are being built. The evidence is clear on what makes these services safe. Most institutions are not implementing them.
FDA Breakthrough Therapy designations for psilocybin (2018, 2019), the NEJM psilocybin trial, and the JAMA Psychiatry RCT establish clinical legitimacy for psychedelic-assisted therapy. Johnson, Richards and Griffiths (2008) established the foundational governance principle: adverse events in clinical psychedelic contexts are shaped more by the quality of set, setting, and supervision than by the pharmacological properties of the compounds. The governance infrastructure of the session determines the safety profile of the intervention.
Foundational safety guidelines across eight domains. Persisting adverse reactions rare when followed.
RCT. GRID-HAMD response 71% at week 4 (≥50% symptom reduction), waiting-list controlled. Session protocol governance central to safety profile.
Landmark NEJM comparison trial. No serious adverse events under structured session protocols.
The prototype organizes reflection across six proposed governance dimensions. It does not produce a validated institutional score, audit, accreditation, or certification.
Written contraindication criteria reviewed annually; preparation protocol ≥2 sessions; physical setting standards documented and inspected annually; minimum facilitator training hours documented with scope of practice agreement; three-tier adverse event classification; ≥3 integration sessions within 30 days post-session.
The full tier operationalization — PIONEERING through EARLY STAGE, with specific observable criteria for all six dimensions — is documented in the Framework Foundation.
Psychedelic therapy programs · Retreat centers · Harm reduction organizations · Indigenous ceremony facilitators (with M13 governance) · Festival medical teams · Mental health clinics expanding into psychedelic-assisted therapy
And anyone entering a session. Participants, clients, and their families — the set, setting, and supervision this governs are what separate a safe experience from a harmful one for you.
M3 (Psychedelic Harm Reduction Governance) is the module that started the space law conversation. Johnson, Richards and Griffiths (2008) established that adverse events in psychedelic contexts are shaped more by set, setting, and supervision governance than by pharmacological properties. In long-duration spaceflight, psilocybin and related compounds have documented potential for addressing the depression, PTSD, and psychological distress that astronauts face on extended missions. The governance infrastructure for therapeutic psychedelic use in off-Earth clinical contexts does not yet exist. This module is the foundation for building it.
Review the module scope and proposed dimensions. The assessment remains an educational prototype; no email report or institutional finding is active.