I recently had cause to pen an overview of informed consent for psychedelic therapies that won’t be making its intended appearance in a journal article. Happily, I’m due to speak about informed consent at ICPR next week anyway, so this wasn’t in vain and allowed me some time to refresh my memory on the literature.
I include the text of it below, which I may cannibalise for use elsewhere (bulking out my thesis?). It’s meant as a fairly milquetoast survey of the scene, rather than an opportunity to grind any of my own axes, but as such should help orient a reader who has stumbled upon ‘psychedelicethics.com’ who is looking to learn about, well, psychedelic ethics.
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The atypical acute and long-term effects of psychedelic administration both present challenges for the practice of informed consent, which seeks to safeguard patient autonomy and support patient-defined goals for treatment. Heightened vulnerability and suggestibility during acute drug effects, as well as diminished decision-making capacity, represent risks to patient autonomy (Villiger and Trachsel, 2023); subjective effects during psychedelic experiences can include profound perceptual and cognitive changes, including alterations to sense of self and reality (Studerus et al., 2011), which as well as being hard to anticipate, can be challenging for clinicians to describe and for prospective patients to understand; while the potential for longer-term influences on metaphysical beliefs (Timmermann et al., 2021), personality (Weiss et al., 2023) and values (Kähönen, 2023) present particular challenges for deciding whether to undertake treatment.
While the signing of a consent form may be a one-off process that precedes an intervention, informed consent remains important throughout treatment. Under the acute effects of psychedelics, a patient’s decision-making capacity – itself a key requirement of informed consent – can be compromised, complicating how a clinician should respond to some patient requests, perhaps for therapeutic touch which the patient had not consented to prior to the session, or for the termination of the session itself with rescue drugs (Lee, Rosenbaum, and Buchman, 2024). Until the evidence base for outcomes relating to touch and session termination can inform best practice guidelines, scholars affirm the importance of a precautionary mindset that emphasises the need to minimise suspected risks of harm over prospects of undetermined benefits (Devenot et al., 2022a; Jacobs et al., 2024; Lee, Rosenbaum and Buchman, 2024).
Considering the unusual subjective effects and downstream side-effect profile of psychedelics, Smith and Sisti (2020) propose a consenting process which is ‘enhanced relative to that of informed consent procedures used to prescribe other psychotropics’. A third of UK nationals who would not consider a psychedelic-based treatment referenced their unwillingness to undergo a psychedelic ‘trip’ (Jacobs, 2021), suggesting that features of psychedelic treatments that are atypical in medicine are highly salient in patient decision-making processes, and must be included in any valid consenting process.
The difficulty in accurately describing the phenomenology of a psychedelic experience is well-recognised, and the often highly personal and autobiographical hallucinations that can arise cannot be predicted and explained to a prospective patient in advance. Marks et al. (2024) propose that such limitations are acknowledged with patients, while nonetheless making ‘good-faith efforts to fully inform’ them. Expanding on Smith and Sisti’s ‘enhanced consent’, many bioethicists call for the development of diverse resources to better communicate the effects of psychedelic treatment, including preliminary low doses to ‘test the waters’, access to testimony from similar users, multimedia educational materials and virtual reality to simulate some of the acute effects (Villiger and Trachsel, 2023; Jacobs et al., 2024; Marks et al., 2024; Appelbaum, 2024).
Although such efforts could improve comprehension of psychedelic treatments, some argue that the normative standards for informed consent in medicine cannot be met when treatment involves ‘transformative experiences’ (Paul, 2014), and that alternative mechanisms for safeguarding patients should be considered (Jacobs, 2023; Egerton and Capitelli-McMahon, 2023). Informed consent processes are meant to support patients in rationally deciding whether undertaking a potential treatment, with its associated risks and potential benefits, is right for them (Jacobs, 2023). But a rational choice cannot be made to undertake an experience that involves both learning something that can only be learned by having the experience, and changing in response to that experience, whether in terms of self-concept, values, or core preferences. If the subjective experience of a psychedelic treatment is inaccessible or unimaginable to me, the argument goes, or I cannot foresee who I will be or what I will care about after, my consent to treatment cannot be properly ‘informed’. Others are less concerned by this reasoning, pointing to other medical treatments that are ‘transformative’ which we accept informed consent to (Kious et al., 2024), or suggesting that a robust desire to escape the negative status quo of psychopathology can rationally ground a wish to risk a transformation (Villiger, 2024).
More pragmatically, reviews of informed consent forms for psychedelic trials have found that they may be lacking regarding highly salient features of psychedelic therapies, including the use of touch (Harrison, 2023) and the prospect of long-term changes to personality, values and worldview (Rouhe, 2022). While these features should be acknowledged during the consenting process, quite which of the many potential outcomes should be highlighted remains unclear. As for any intervention, clinicians should strive to inform without overwhelming patients (O’Neill, 2017). Detailing every possible complication, however minor and rare, could paradoxically diminish decision-making capacity by inducing patients to focus on irrelevant information or be swayed by the sheer number of negative possibilities rather than likely benefits. A particular difficulty for psychedelic practitioners arises due to the suggestibility-enhancing effects of psychedelics (Carhart-Harris et al., 2015). Devenot et al. (2022b) show that material introduced to patients in advance of drug-assisted sessions can shape acute experience and patient understanding. As such, disclosure of potential outcomes of psychedelic use, crucial to safeguard patient autonomy, may inadvertently make some outcomes more likely by contributing to patient expectations and ‘set’.
As with many dimensions of psychedelic therapies, researchers and clinicians contemplating best practice for informed consent should retain a sense of epistemic humility: in alerting prospective patients about the limitations of our current understanding of psychedelic effects, and in avoiding the premature concretization of consent practices (Appelbaum, 2024).
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Appelbaum, P. S. (2024). Informed Consent to Psychedelic Treatment—A Work in Progress. JAMA psychiatry.
Carhart-Harris, R. L., Kaelen, M., Whalley, M. G., Bolstridge, M., Feilding, A., & Nutt, D. J. (2015). LSD enhances suggestibility in healthy volunteers. Psychopharmacology, 232, 785-794.
Devenot, N., E. Tumilty, M. Buisson, S. McNamee, D. Nickles, and L. K. Ross. (2022a). A Precautionary approach to touch in psychedelic-assisted therapy. Bill of Health.
Devenot, N., Seale-Feldman, A., Smith, E., Noorani, T., Garcia-Romeu, A., & Johnson, M. W. (2022b). Psychedelic identity shift: A critical approach to set and setting. Kennedy Institute of Ethics Journal, 32(4), 359-399.
Egerton, K., & Capitelli-McMahon, H. (2023). Transformative experience and the principle of informed consent in medicine. Synthese, 202(3), 65.
Harrison, T. R. (2023). Altered stakes: Identifying gaps in the informed consent process for psychedelic-assisted therapy trials. Journal of Psychedelic Studies, 7(S1), 48-60.
Jacobs, E. (2021, Jun 4.). Public attitudes to psilocybin-assisted therapy. Drug Science. https://www.drugscience.org.uk/yougov-results-is-the-uk-ready-to-reschedule-psilocybin
Jacobs, E. (2023). Transformative experience and informed consent to psychedelic-assisted psychotherapy. Frontiers in Psychology, 14, 1108333.
Jacobs, E., Earp, B. D., Appelbaum, P. S., Bruce, L., Cassidy, K., Celidwen, Y., … & Yaden, D. B. (2024). The Hopkins-Oxford Psychedelics Ethics (HOPE) Working Group Consensus Statement. The American Journal of Bioethics, 1-7.
Kähönen, J. (2023). Psychedelic unselfing: self-transcendence and change of values in psychedelic experiences. Frontiers in Psychology, 14, 1104627.
Kious, B. M., Peterson, A., & McGuire, A. L. (2024). Are Psychedelic Experiences Transformative? Can We Consent to Them?. Perspectives in Biology and Medicine, 67(1), 143-154.
Lee, A., Rosenbaum, D., & Buchman, D. Z. (2024). Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations. The Canadian Journal of Psychiatry, 07067437231225937.
Marks, M., Brendel, R. W., Shachar, C., & Cohen, I. G. (2024). Essentials of Informed Consent to Psychedelic Medicine. JAMA psychiatry.
O’Neill, O. (2017). Some limits of informed consent. In The Elderly (pp. 103-106). Routledge.
Paul, L. A. (2014). Transformative experience. OUP Oxford.
Rouhe, J. (2022). How informed is the informed consent in clinical trials with psychedelics? A review of the state of patient autonomy in therapeutic studies with psychedelic drugs. [Master’s thesis, University of Eastern Finland]
Smith, W. R., & Sisti, D. (2021). Ethics and ego dissolution: the case of psilocybin. Journal of medical ethics, 47(12), 807-814.
Studerus, E., Kometer, M., Hasler, F., & Vollenweider, F. X. (2011). Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies. Journal of psychopharmacology, 25(11), 1434-1452.
Timmermann, C., Kettner, H., Letheby, C., Roseman, L., Rosas, F. E., & Carhart-Harris, R. L. (2021). Psychedelics alter metaphysical beliefs. Scientific reports, 11(1), 22166.
Villiger, D. (2024). Giving Consent to the Ineffable. Neuroethics, 17(1), 1-16.
Villiger, D., & Trachsel, M. (2023). With great power comes great vulnerability: an ethical analysis of psychedelics’ therapeutic mechanisms proposed by the REBUS hypothesis. Journal of Medical Ethics, 49(12), 826-832.
Weiss, B., Sleep, C. E., Beller, N. M., Erritzoe, D., & Campbell, W. K. (2023). Perceptions of psychedelic personality change, determinants of use, setting and drug moderation: Toward a holistic model. Journal of Psychedelic Studies, 7(3), 200-226.
Psychedelic Ethics 