RESEARCH GOVERNANCE
Research, consent & privacy
✓ Separate platform use from research
People may use the registry without opting into research. Research permission is recorded separately, versioned, and can be withdrawn prospectively.
✓ Pseudonymous participant IDs
The registry uses a stable participant ID rather than a name-based account and repeatedly asks participants not to place identifying details in free text.
✓ Longitudinal follow-up schedule
Episodes support scheduled follow-ups at 24 hours, 7 days, 30 days, 90 days, 6 months, and 1 year.
✓ Privacy-protected community summaries
Community displays use aggregate, research-consented records and suppress small groups below the configured privacy threshold.
✓ Research-only export architecture
The backend supports research-consented, non-withdrawn exports, audit events, data dictionaries, and provenance/version fields.
◐ Validated outcome modules
WHO-5, PCL-5/LEC-5, MEQ-4/CEQ-7, and selected PROMIS domains are being incorporated through a versioned instrument-provenance framework. Exact instrument text is only embedded when reuse terms are documented.
Participant-facing governance documents
Research permission v2.1
Plain-language information about optional research use, risks, benefits, privacy, and prospective withdrawal.
Privacy notice
What the Registry collects, why it is used, how research permission differs from platform use, and how to contact the Registry.
Terms of Use
Eligibility, responsible use, nonclinical boundaries, third-party links, and service limitations.
Safety & Support
Emergency boundaries, crisis resources, technical-support boundaries, and safety-event reporting context.
Baseline → experience → longitudinal outcomes
Still required before journal submission or external research use
Obtain an IRB/human-subjects determination as appropriate; finalize a protocol and statistical analysis plan; document instrument licensing and versions; predefine primary and secondary outcomes; establish adverse-event review and escalation procedures; specify missing-data and attrition handling; complete privacy/security and retention review; document researcher access controls; and establish a formal data-access process.
Federal interoperability readiness
Independent registry, standards-ready architecture
FDA's 2026 public hearing specifically asks about Coordinated Registry Networks, common data elements, adverse-event reporting, interoperability, privacy protection, and longitudinal follow-up. The Registry now maintains a stable internal common-data-element catalog so variables can be mapped to future authoritative standards without changing their scientific meaning.
Boundary: this does not imply FDA, HHS, VA, NIH, White House, or other federal endorsement, certification, sponsorship, or participation.
View the Registry data-standards layer →Research transparency
The registry is observational. Associations in registry data cannot by themselves establish that a psychedelic exposure caused an improvement, worsening, or adverse event. Public-facing summaries should preserve that distinction.