RESEARCH GOVERNANCE

Research, consent & privacy

Current registry architecture. This page describes what the application currently implements and what still requires formal governance before publication-quality human-subjects research. The registry does not claim IRB approval or a security certification.

✓ 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 Research permission is recorded separately, versioned, and can be withdrawn prospectively.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The backend supports research-consented, non-withdrawn exports, audit events, data dictionaries, and provenance/version fields.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.

Baseline → experience → longitudinal outcomes

Registry ID→Baseline profile & screenings→Episode context→Acute assessment→24 h→7 d→30 d→90 d→6 mo→1 yr

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.