Consent-as-Method: Capacity to Consent of Cognitively Disabled People and Research Ethics Review
Hannah Quinn, Rebecca-Eli M. Long
Canadian Journal of Disability Studies, 22 April 2024
Abstract
Informed consent is a core ethical principle informing research conduct. Yet, normative consent culture–often grounded in ableist understandings of capacity, rationality, and independence– exclude people with cognitive disabilities. The adjudication of consent capacity in research can be a source of harm, requiring researchers to enact lateral ableism against research participants and, potentially, themselves. As anthropologists conducting ethnographic research with intellectually and developmentally disabled participants in Canada and the U.S., we argue for the creation of an anti-ableist consent culture in the context of research. In exploring alternative ways of doing consent, we turn to the etymology of “feeling-with”–the collaborative, multi-sensory, and embodyminded experience of giving, getting, and living consent–as this can inform more ethical and anti-ableist notions of consent. We propose “consent-as-method” as part of a larger conversation about the methodological challenges and potentials of doing research as and with people with non-normative bodyminds. Drawing on our research and lived experiences of cognitive ableism, we theorize consent practices that consider disabled people’s felt knowledges of denial of consent capacity and coercion to inform anti-ableist, relational ways of doing consent. We focus on capacity because it structures the kinds of bodyminds that are seen as capable of being consenting subjects. We build on existing scholarship that considers how critically engaging with disability as a lived experience and orientation fundamentally crips our methodological and ethical commitments. Attending to consent capacity through consent-as-method treats consent as not only a means to an end but as an anti-ableist research ethic.

Essentials of Informed Consent to Psychedelic Medicine
Special Communication
Mason Marks, Rebecca W. Brendel, Carmel Shachar, Glenn Cohen
JAMA Psychiatry, 10 April 2024
Abstract
Importance
Interest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system.
Observations
Despite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings.
Conclusions and Relevance
Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.

Informed Consent to Psychedelic Treatment—A Work in Progress
Editorial
Paul S. Appelbaum
JAMA Psychiatry, 10 April 2024
Excerpt
Psychedelic compounds appear to be moving toward approval for clinical use, with early studies suggesting therapeutic efficacy for conditions ranging from depression to alcohol use disorder to traumatic brain injury. However, obtaining meaningful informed consent to psychedelic treatment will be challenging, given the unique effects of the drugs—including what are often described as the ineffable elements of the psychedelic experience, such as ego dissolution. Although some commentators have suggested that informed consent to psychedelic treatment, in the usual sense of that term, is simply unattainable, a growing consensus has coalesced around the notion that with proper attention to content and presentation, clinicians will be able to obtain meaningful and valid consent from patients…

Informed Consent for Psychotherapy: The Moderating Role of Therapeutic Alliance, Prior Knowledge and Autonomous Motivation on Decision-Making and Treatment Expectation
Sönke Ladwig, Franz Pauls, Leonie Gerke, Yvonne Nestoriuc
Clinical Psychology & Psychotherapy, March-April 2024
Abstract
Background
Informed consent is an ethical prerequisite for psychotherapy. There are no routinely used standardized strategies for obtaining informed consent. A new optimized informed consent consultation (OIC) strengthened treatment-relevant aspects. It remains unclear which factors influence the OIC efficacy regarding clinical and decision-related outcomes.
Methods
N = 122 adults were included in a randomized controlled online trial. Participants received an information brochure on psychotherapy (TAU; n = 61) or OIC + TAU (n = 61). The main and interaction effects of group allocation, therapeutic alliance, prior knowledge about psychotherapy and treatment motivation on treatment expectations, decisional conflict and capacity to consent were tested. Floodlight analyses were conducted for significant interactions.
Results
Large interaction effects were shown between treatment motivation and group allocation on treatment expectations (β = -0.53) and between prior knowledge and group assignment on capacity to consent (β = 0.68). The interaction between treatment motivation and group allocation was significant up to a motivation score of 5.54 (range: 1-7). The interaction between prior knowledge and group assignment was significant up to a knowledge score of 14.38 (range: 5-20).
Conclusion
Moderator analyses indicated varying efficacy degrees for the OIC regarding decisional outcomes and expectation. Especially patients with little treatment motivation or low prior knowledge benefited from optimized information about the efficacy and possible side effects of psychotherapy.