The use of psychedelics in psychiatric care raises multiple challenging ethical issues. “Some of these issues arise with many novel or experimental treatments. However, others are distinctive to psychedelics,” asserts Jacob M. Appel, MD, JD, MPH, HEC-C, director of ethics education in psychiatry at Icahn School of Medicine at Mount Sinai and an attending physician at Mount Sinai Health System.
One recent issue is that some states are making psychedelics available for supervised use outside of the conventional healthcare system. Yet psychedelics remain illegal for non-research purposes under federal law. “Informed consent for the use of a product that may be decriminalized at the state or local level, but is still illegal under federal law, is complex,” says Appel.
One question is to what degree patients must be informed of the risk of arrest or prosecution. At a minimum, researchers should be certain that subjects understand that participating in a research protocol does not absolve someone from the legal consequences of using an illicit substance. “Unfortunately, many potential subjects believe that admission into a clinical trial is a metaphorical ‘get out of jail free’ card, and it is not,” according to Appel.
In addition, there are significant uncertainties about short-term and long-term clinical responses to psychedelic exposure. This makes it difficult to know how much information is sufficient.
“Achieving the right balance is not easy,” says Appel. Researchers must ensure that a study participant is adequately informed while, at the same time, avoiding overwhelming the person with too much information.
Psychedelics have received substantial recent attention from the scientific, clinical, and lay communities for the treatment of psychiatric conditions, observes Rebecca W. Brendel, MD, JD, director of the Center for Bioethics at Harvard Medical School. “While studies continue toward FDA [Food and Drug Administration] approval, some states, such as Colorado and Oregon, have already implemented pathways for use outside the medical system,” says Brendel.
Psychedelic compounds cause variable responses in different individuals and environments. “This makes informed consent both essential and challenging. Once clinically approved within the medical system, novel attributes of the compounds themselves will require clinicians to engage in informed consent processes that specifically include elements unique to psychedelic substances,” argues Brendel.
Brendel and colleagues analyzed the challenges involved in designing informed consent processes for psychedelics.1 One concern is that participants may experience short- or long-term perceptual disturbances or personality changes. There also is a need for researchers or clinicians to communicate the privacy risks involved with psychedelics. The authors recommend explaining to participants that there is a risk that data could be misused or mistakenly released. That could potentially result in negative occupational, social, or legal outcomes for patients or clinical trial participants. To convey complex information on psychedelics, the authors recommended using role playing, simulations, or open-ended consent quizzes. “We recommend interactive education and assessment of comprehension as part of the informed consent process,” offers Brendel.
REFERENCE
- Marks M, Brendel RW, Shachar C, Cohen IG. Essentials of informed consent to psychedelic medicine. JAMA Psychiatry 2024; Apr 10. doi: 10.1001/jamapsychiatry.2024.0184. [Online ahead of print].
The use of psychedelics in psychiatric care raises multiple challenging ethical issues.
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