# Participant and Public Involvement Plan — v0.8

## Purpose

The clinical and methodological team will not be the sole judge of which harms matter. Participant/public contributors will review outcome relevance, clarity, burden, interpretation, and omitted experiences before registration.

## Proposed panel

- Two adults with lived experience of depression treatment decisions, psychedelic clinical research, or caregiving.
- No requirement that contributors support or oppose psychedelic therapy.
- Conflicts, advocacy roles, industry relationships, and prior publications are disclosed.

## Questions for review

1. Are the prespecified outcomes understandable and important?
2. Are clinically “non-serious” but highly distressing events represented?
3. Are delayed or persistent experiences represented?
4. Are rescue medication, prolonged observation, restraint, transfer, and loss of functioning described in a participant-relevant way?
5. Could the public-facing language be misread as recreational-safety advice?
6. Which interpretation boundaries are missing?

## Boundaries

Contributors review content and interpretation. They do not determine eligibility for specific studies, extract numerical data, or adjudicate risk of bias unless separately qualified and appointed to those roles.

## Documentation

Each recommendation receives a disposition: accepted, modified, deferred, or declined with rationale. Material changes after registration become protocol amendments.