Prioritize participant wellbeing over research aims

The manuals converge strongly on the principle that participant safety and wellbeing take precedence over scientific objectives, protocol completion, recruitment, or data collection. Across the extracts, the manuals recommend continuous attention to risk, support for participants during vulnerable phases, and readiness to pause, modify, or stop participation when distress, medical symptoms, or psychiatric destabilisation emerges. They also agree that participation remains voluntary and that additional clinical care or follow-up may be needed when safety is compromised. Where they differ is mainly in emphasis and operational detail. The MAPS materials place particular weight on withdrawal, termination, and follow-up procedures, including support after withdrawal, attempts at required evaluations, and escalation to the study physician and Medical Monitor. The ayahuasca and ibogaine safety guideline focuses more on prevention in clinical settings, including screening, setting, staffing, avoiding unnecessary stimulation or unsafe isolation, and excluding candidates when risk cannot be adequately managed. The ayahuasca trial guidance and the MAPS manual both mention using the least intrusive intervention consistent with safety, but the trial guidance is more explicit about responding to severe distress and ensuring access to additional clinical care if needed. The MAPS manual also specifically notes that therapists assess stability before allowing departure after sessions, while the other extracts frame safety more broadly during screening, treatment, and follow-up.