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Rapidly expanding support for psychedelic agents in mental health treatment has introduced unique challenges and essential considerations in the design and implementation of informed consent processes, an analysis concluded.

A review of publicly available psychedelic research-oriented documents identified seven overlooked or underemphasized elements to address in future psychedelic-informed consent processes, Mason Marks, MD, JD, of Harvard Law School in Cambridge, Massachusetts, and colleagues wrote in a special communication .

These include:

• Acute and chronic perceptual changes
• Personality changes and altered metaphysical beliefs
• Role of limited physical touch
• Potential for patient exploitation and abuse
• Data collection and research
• Practitioner disclosures
• Interactive patient education and comprehension assessment

"The unique qualities of these substances, the variety of contexts in which they may be used, and the diversity of clinicians providing them necessitate special informed consent procedures," the authors wrote.

In an , Paul Appelbaum, MD, of the New York State Psychiatric Institute at Columbia University in New York City, wrote that it's "important to recognize that these elements are only part of a complete informed consent process."

"Moreover, the content of that consent process is likely to change as additional knowledge about psychedelic treatment becomes available," Appelbaum wrote.

Research increasingly supports the use of psychedelics like psilocybin and lysergic acid diethylamide (LSD), which act on 5-HT2A receptors, to treat a number of mental health conditions including depression, post-traumatic stress disorder, obsessive-compulsive disorder, and various addiction disorders.

Australia, the U.K., and Canada have loosened restrictions on the use of these substances for research and limited medical use. The FDA has released for studying psychedelics, in addition to granting and breakthrough therapy status for major depressive disorder and priority review for post-traumatic stress disorder, respectively.

Despite these regulatory advances, the study authors noted that informed consent has largely been limited to psychedelics research participants, and "standards for integrating psychedelics into healthcare have lagged," including processes for educating patients and obtaining permission to treat.

Psychedelics are different in many ways from existing treatments for these conditions. Their effects, sometimes altering reality and metaphysical beliefs, are difficult to describe and can vary widely. Psychedelics can also lead to severe adverse events, including hallucinogen persisting perception disorder, that are difficult to predict.

Psychedelics may expose patients to a heightened potential for abuse or coercion by practitioners or others, and because of the unique role of "set" and "setting" in psychedelics -- the degree to which environmental factors and patient expectations may influence outcomes -- the process of informed consent itself and expectations about psychedelics could influence patient experiences.

Appelbaum added that a description of setting and duration should be given. Risks can go beyond changes in perceptions and personality "to include acute and sustained psychiatric symptoms, including severe anxiety and the possibility of triggering manic or psychotic episodes," Appelbaum explained. "Thus, patients will need to be informed about how such short-term reactions will be addressed during and after the treatment session."

The social and regulatory climate in which psychedelics are situated further complicates informed consent, the study authors said. Jurisdictions have different laws around the use of psychedelics, and the substances remain stigmatized or illegal in some places. Psychedelics practitioners may, more so than in some medical fields, be influenced by their personal experience with psychedelics or industry relationships in an emerging field largely funded by private interests or philanthropy.

To address these concerns, the authors stated informed consent must use clear language to thoroughly describe the range of possible effects, including aspects that may seem bizarre or feel mystical, and practitioners should be available to answer patient questions. They must also review the potential for worsening of symptoms or other perceptual changes that are difficult to predict.

Marks and colleagues also noted the importance of discussing the role of limited touch in psychedelic therapy. Physical touch has historically been avoided in therapy models, but clinicians who administer psychedelics commonly use limited forms of reassuring touch, including holding the patient's hands or lightly touching their shoulders. Clinicians should determine ahead of administration -- with code words, or other markers like colored bracelets -- what kinds of physical touch patients consent to.

They should also review the legal status of the psychedelic with the patient, and discuss the potential for legal or social repercussions from data that is shared about patients. Consent should include the disclosure of any existing or potential conflicts of interest.

The authors suggest that tools like virtual reality simulations, role play, and consent quizzes can help patients anticipate what to expect with psychedelics and gain a full understanding of the consent process. Appelbaum suggested that video narratives from other patients on their own experiences could be used as a part of consent.

Informed consent processes for psychedelics, Marks and colleagues suggested, should be incorporated into medical school training, practitioner training programs, FDA risk mitigation and evaluation strategies, and state clinical practice guidelines.

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