Altered stakes: Identifying gaps in the informed consent process for psychedelic-assisted therapy trials
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
Abstract Background and aims Psychedelic-assisted therapy (P-AT) has been shown to reduce post-traumatic stress disorder (PTSD), depression, and anxiety symptoms, and is likely to be approved in the United States (US) in the coming years. However, concerns about participant safety in these early trials have surfaced, including allegations of sexual misconduct. This paper aims to illuminate how potential risks have been communicated to P-AT participants via informed consent documents and to suggest how existing policy might be modified given the unique risks involved in P-AT trials. Methods Publicly available informed consent forms (ICFs) were gathered by searching clinicaltrials.gov . Queries were applied to filter trials involving the use of a classical psychedelic (psilocybin, LSD) or psychedelic-adjacent substance (MDMA, ketamine) in tandem with psychotherapeutic intervention and those with a status of “completed,” “recruiting,” or “active.” Results Nineteen ICFs met inclusion criteria and were reviewed to determine what risks, benefits, and safety protocols were communicated to participants in their respective trials. The primary finding from this review of ICFs from P-AT trials revealed that studies were in compliance with federal regulation. However, there were missing elements related to the vulnerability experienced while under the effects of psychedelics that warrant inclusion in future ICFs in P-AT trials. Conclusion Although the ICFs for P-AT trials examined in this study covered several important areas related to risk, benefits, safety, and accountability as required by federal regulations in the US, future research should consider ways to expand this content in order to assure that consent is truly informed prior to enrolling subjects.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it