Table 1.
Guiding ethical questions for conducting a psilocybin trial in DoC patients
| Research ethics question | Description |
|---|---|
| Does a psilocybin trial involving DoC patients have clinical or social value? | Clinical value concerns whether a trial’s hypothesis is relevant to answering a pressing clinical question. Social value concerns the relevance of a trial’s hypothesis in addressing an important scientific or social problem. |
| Is the proposed psilocybin trial scientifically valid? | A protocol is valid if the study design is appropriate to answer the research question. The use of inappropriate or unreliable methods undermines the study’s potential to produce knowledge of clinical or social value. |
| Is psilocybin administration a therapeutic or nontherapeutic procedure? | Therapeutic procedures have an evidence base sufficient to justify the belief that they may be of direct benefit to research participants. Nontherapeutic procedures are used solely to answer a scientific question. Distinguishing therapeutic from nontherapeutic procedures allows for an accurate risk-benefit analysis of a trial. |
| Does psilocybin administration in DoC patients pose no more than a minor increase over minimal risk? | A key protection for vulnerable participants is the limit set on the risks to which they may permissibly be exposed for scientific purposes. This limit is universally recognized as the minimal risk threshold. It is unethical to apply nontherapeutic procedures in vulnerable participants that exceed this risk threshold. |
| Will research participants be selected fairly? | Fair selection of research participants ensures that the benefits and burdens of research participation are distributed equitably. |
| Will valid surrogate consent be sought for research participation? | Surrogate consent for research is permissible. Safeguards should be put in place to prevent therapeutic misconception or to address the possibility that a participant might regain consent capacity during the trial. |
Framework adapted from Binik and Hey (2019) and Weijer and Miller (2004).