Multimedia consent to improve decisional capacity among youth living with HIV: findings from a randomized controlled pilot trial
Research Article
Tiffany Chenneville, Serena Wasilewski, Eric Sumpter, Kaitlyn Ligman, Kemesha Gabbidon, Carina A. Rodriguez
Ethics & Behavior, 31 May 2024
Abstract
This pilot randomized controlled trial explored the feasibility, acceptability, and potential utility of an intervention to improve the decisional capacity (DC) for research consent/assent among youth living with HIV (YLWH). We randomly assigned 30 YLWH aged 13–24 to a control (paper-based) or intervention (multimedia) consent/assent condition. Using a between- and within-subjects design, participants completed a demographic questionnaire and measures of DC, acceptability/feasibility, and voluntary self-consent perceptions after undergoing a hypothetical consent/assent process for a biomedical HIV study. Findings suggest participants found the intervention feasible and acceptable. Participants in the intervention condition scored higher on a DC measure; however, scores did not meet the predetermined cutoff score for adequate DC in either group. The potential implications of these findings for research with youth, including YLWH, are discussed.

Determining capacity of people with dementia to take part in research: an electronic survey study of researcher confidence, competence and training needs
Research
Sarah Griffiths, Victoria Shepherd, Anna Volkmer
BMC Medical Ethics, 28 May 2024
Open Access
Abstract
Background
Researchers are required to determine whether a person has capacity to consent to a research study before they are able to participate. The Mental Capacity Act and accompanying Code of Practice for England and Wales provide some guidance on this process, but researchers have identified that it can be difficult to determine capacity to consent when a person has complex cognitive or communication needs. This study aimed to understand the experiences and opinions of researchers who recruit people with dementia to research projects, to inform the future development of training resources.
Methods
A mixed method, cross-sectional, electronic survey was circulated via social media and research networks in England and Wales. The survey remained open for ten weeks and included open and closed questions exploring respondents’ confidence in determining capacity in the context of recruiting people with dementia to consent, their views on training and support they have experienced and their suggestions for future training and support needs.
Results
60 respondents completed the survey from across England and Wales. Although 75% of respondents had experience of determining capacity to consent with people with dementia to research, only 13% rated themselves as feeling ‘very confident’ in this. Qualitative content analysis of open responses led to the generation of six themes, explaining researchers’ confidence, competence and future training needs in this area: (1) Researcher uncertainties, (2) Lack of time, (3) Balancing information complexity with accessibility, (4) Gatekeepers, (5) Existing enablers and (6) Envisioning future training.
Conclusions
Researchers would benefit from specific training in undertaking conversations around consent with people with dementia. People with dementia may have fluctuating capacity, and despite support from caregivers, researchers have little practical guidance on methods of determining a person’s ability to understand or appreciate the information they have provided during the consent process. Given the development of large complex trials within dementia research, there is an urgency to develop specific and practical guidance and training for researchers working with people with dementia and their families.

Consent and Inclusion of People Living with Dementia (PLWD) in Research: Establishing a Canadian Agenda for Inclusive Rights-Based Practices
Amanda Grenier, Deborah O’Connor, Krista James, Daphne Imahori, Daniella Minchopoulos, Nicole Velev, Laura Tamblyn-Watts, Jim Mann
Canadian Journal on Aging, 20 May 2024
Abstract
Background
People living with dementia (PLWD) may want to participate in research, but the guidelines and processes enacted across various contexts may prohibit this from happening.
Objective
Understanding the experiences of people with lived experiences of dementia requires meaningful inclusion in research, as is consistent with rights-based perspectives. Currently, the inclusion of PLWD in Canadian research is complex, and guidelines and conceptual frameworks have not been fully developed.
Methods
This research note outlines a three-year proof-of-concept grant on the inclusion and consent of PLWD in research.
Findings
It presents a brief report on some of the contradictions and challenges that exist in legislation, research guidelines, and research practices and raises a series of questions as part of an agenda on rights and inclusion of PLWD in research.
Discussion
It suggests conceptual, legal, and policy issues that need to be addressed and invites Canadian researchers to re-envision research practices and to advocate for law and policy reform that enables dementia research to align and respect the rights and personhood of PLWD.

Framework to elicit consent from lightly sedated mechanically ventilated intensive care patients in nursing practice
Yoko Onishi, Yoshiko Murai, Emiko Nakajima
Japan Journal Of Nursing Science, 2 May 2024
Abstract
Aim
The study aimed to ascertain a framework of nursing practices to elicit consent from lightly sedated ventilated patients.
Methods
Study participants were nurses working in intensive care and critical care wards, whose observations and semi-structured interviews were assessed using a modified grounded theory approach.
Results
A total of 15 concepts were generated, from which three categories and three subcategories were generated. Category 1: Nurses taking the lead in providing assistance by sharing signs of change while continuing the invasive treatment, working to maintain the patient’s life, alleviation of pain, promotion of awareness of the current situation, and acclimating them to the treatment environment as the basis for building a relationship between patients and nurses. Category 2: Searching for points of agreement and reaching a compromise involves the nurse drawing out the patient’s thoughts, hopes, and expectations, and transforming the relationship into a patient-centered one by sharing goals with the patient in order to achieve them. Category 3: Organizing collaboration within care supported the patient’s ability to move safely while maintaining the patient’s pace to achieve shared goals, and guided the patient’s independent actions.
Conclusions
Even when patients recover from an acute life-threatening situation, their physical sensations remain vague and their functional decline continues. Rather than simply eliciting consent from patients, the structure of nursing practice to elicit such response from patients involves drawing out the patient’s thoughts, hopes, and expectations, as well as guiding the patient toward goals that they have created together with the nurse and utilizing the patient’s strengths to achieve these goals.

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.