Lack of assent to dental examination in children with intellectual disabilities: Dentists’ practices in Europe and ethical issues
Original Article
Ariane Camoin, Isabelle Blanchet, Lionel Dany, Pierr Le Coz, Bérengère Saliba-Serre, Corinne Tardieu
Special Care in Dentistry, 19 March 2024
Abstract
Aim
(1) To determine the repartition of criteria which can be considered as marks of lack of assent by the child with
intellectual disabilities from the dentist’s point of view and whether that influences the decision to examine the patient or not. (2) To explain the decision of practitioners and determine the ethical implications of these practices.
Methods
An anonymous and structured questionnaire was distributed online using the scenario of a 9-year-old child with moderate cognitive impairment with eight different oppositional behaviours. The practitioners were asked about their perception of the patient’s lack of assent and about their decision to perform the dental examination or not.
Results
The proportion of them who performed a dental examination despite the patient’s refusal represented between 13% and 28.8% of the population of respondents.
Conclusion
There was an ambivalence among the practitioners who carried out a dental consultation when children were uncooperative. They adopted a teleological point of view. It calls for us to reflect on the ethical principles of autonomy and beneficence.

Reliability of clinical judgment for evaluation of informed consent in mental health settings and the validation of the Evaluation of Informed Consent to Treatment (EICT) scale
Original Research
Nicola Di Fazio, Donato Morena, Federica Piras, Fabrizio Piras, Nerisa Banaj, Giuseppe Delogu, Felice Damato, Paola Frati, Vittorio Fineschi, Stefano Ferracuti, Gabriele Sani, Claudia Dacquino
Frontiers of Psychology – Quantitative Psychology and Measurement, 26 February 2024
Excerpt
The competence assessment to give informed consent in the legal and healthcare settings is often performed merely through clinical judgment. In the present pilot study, we evaluated the reliability of clinical judgment in the mental health field, with a focus on assessing the general competence of outpatients with schizophrenia. Moreover, we tested a new scale (“Evaluation of Informed Consent to Treatment” -“EICT” Scale) suitable as a standardized assessment tool. The scale assesses four dimensions of competence, Understanding, Evaluating. Reasoning and Expressing a choice. Thirty-four outpatients with schizophrenia were evaluated for their competence to consent by five referring clinicians with different backgrounds (psychiatrist, forensic psychiatrist, geriatrician, anesthetist, and medico-legal doctor). Correlation analyses were conducted between the scores obtained by the clinicians on a modified version of the Global Assessment of Functioning scale (GAF) designed specifically to subjectively assess functioning in each of the four competence dimensions. Moreover, two validated competence scales (Mac-CAT-T, SICIATRI-R), and a neuropsychological battery were administered along with scales for evaluating neuropsychiatric symptoms severity and side effects of medication…

Are Psychedelic Experiences Transformative? Can We Consent to Them
Brent M. Kious, Andrew Peterson, Amy L. McGuire
Perspectives in Biology and Medicine, 20 February 2024; pp 143-154
Abstract
Psychedelic substances have great promise for the treatment of many conditions, and they are the subject of intensive research. As with other medical treatments, both research and clinical use of psychedelics depend on our ability to ensure informed consent by patients and research participants. However, some have argued that informed consent for psychedelic use may be impossible, because psychedelic experiences can be transformative in the sense articulated by L. A. Paul (2014). For Paul, transformative experiences involve either the acquisition of knowledge that cannot be obtained in any other way or changes in the self. Either of these characteristics may appear to undermine informed consent. This article argues, however, that there is limited evidence that psychedelic experiences are transformative in Paul’s sense, and that they may not differ in their transformative features from other common medical experiences for which informed consent is clearly possible. Further, even if psychedelic experiences can be transformative, informed consent is still possible. Because psychedelic experiences are importantly different in several respects from other medical experiences, this article closes with recommendations for how these differences should be reflected in informed consent processes.

Giving Consent to the Ineffable
Original Paper
Daniel Villiger
Neuroethics, 15 February 2024; 17(11)
Open access
Abstract
A psychedelic renaissance is currently taking place in mental healthcare. The number of psychedelic-assisted therapy trials is growing steadily, and some countries already grant psychiatrists special permission to use psychedelics in non-research contexts under certain conditions. These clinical advances must be accompanied by ethical inquiry. One pressing ethical question involves whether patients can even give informed consent to psychedelic-assisted therapy: the treatment’s transformative nature seems to block its assessment, suggesting that patients are unable to understand what undergoing psychedelic-assisted therapy actually means for them and whether it aligns with their values. The present paper argues that patients often have sufficient knowledge to give informed consent because they know that they want to change their negative status quo and that psychedelic-assisted therapy offers an effective way to do so. Accordingly, patients can understand what the transformative nature of psychedelic-assisted therapy means for them and a make a value-aligned choice even if they are unable to anticipate the manifestation of a psychedelic experience.

Barriers and Facilitators of Surrogates Providing Consent for Critically Ill Patients in Clinical Trials. A Qualitative Study
Original Research
Dustin C. Krutsinger, Shannon I. Maloney, Katherine R. Courtright, Karsten Bartels
Chest, 20 February 2024
Abstract
Background
Enrollment into critical care clinical trials is often hampered by the need to rely on surrogate decision-makers. To identify potential interventions facilitating enrollment into critical care clinical trials, a better understanding of surrogate decision-making for critical care clinical trial enrollment is needed.
Research Question
What are the barriers and facilitators of critical care trial enrollment? What are surrogate decision makers’ perspectives on proposed interventions to facilitate trial enrollment?
Study Design and Methods
The authors conducted semi-structured interviews with 20 surrogate decision-makers of critically ill patients receiving mechanical ventilation. The interviews were recorded and transcribed verbatim, and analyzed for themes using an inductive approach.
Results
Twenty surrogate decision-makers of critically ill patients participated in the semi-structured interviews. Thematic analysis confirmed previous research showing that trust in the system, assessing the risks and benefits of trial participation, the desire to help others, and building medical knowledge as important motivating factors for trial enrollment. Two previously undescribed concerns among surrogate decision makers of critically ill patients were identified, including the potential to interfere with clinical treatment decisions and negative sentiment about placebos. Surrogates viewed public recognition and charitable donations for participation as favorable potential interventions to encourage trial enrollment. However, participants viewed direct financial incentives and prioritizing research participants during medical rounds negatively.
Interpretation
This study confirms and extends previous findings that health system trust, study risks and benefits, altruism, knowledge generation, interference with clinical care and placebos are key concerns and barriers for surrogate decision-makers to enroll patients in critical care trials. Future studies are needed to evaluate if charitable giving on the patient’s behalf and public recognition are effective strategies to promote enrollment into critical care trials.

A survey on service users’ perspectives about information and shared decision‐making in psychotropic drug prescriptions in people with intellectual disabilities
Original Research
Gerda de Kuijper Josien Jonker, Rory Sheehan, Angela Hassiotis
British Journal of Learning Disabilities, 1 February 2024
Open Access
Abstract
Background
In people with intellectual disabilities and mental disorders and/or challenging behaviours, rates of psychotropic drug prescription are high. In clinical treatments and evaluations, all stakeholders should be involved in a process of shared decision-making (SDM). We aimed to investigate the perspectives of clients and their carers on clients’ treatments with psychotropic drugs.
Methods
We conducted a survey among adults with intellectual disabilities in a Dutch mental healthcare centre providing community, outpatient and inpatient care. Data were collected between January and June 2022. Questions focused on experiences with the provision of information, treatment involvement and SDM and participants’ wishes in this regard.
Findings
Respondents (57 clients and 21 carers) were largely satisfied with the overall care from their clinicians, and with how information on the pharmacological treatment was provided verbally, but written information was insufficient or not provided. Seventy per cent of clients and 60% of carers reported being involved in medication decision-making. However, over 75% of participants desired greater involvement in SDM and over 60% in medication reviews.
Conclusions
Service users and representatives were satisfied about the treatment and verbal information on their psychotropic drug use. The provision of written information, the SDM process and ongoing evaluation of psychotropic medication use could be improved.

Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations
Research Article
Andrew Lee, Daniel Rosenbaum, Daniel Z. Buchman
The Canadian Journal of Psychiatry, 17 January 2024
Excerpt
…Given that psychedelics can induce powerful nonordinary states of consciousness and increase suggestibility, challenges surrounding the informed consent process in [Psychedelic-Assisted Psychotherapy] PAP have begun to receive attention. For example, Smith and Sisti suggest that a process of “enhanced consent” be undertaken prior to PAP, characterized by special attention to the shifts in personality and values that can follow a psychedelic experience, the possible mental health side effects of psychedelics, and the possible use of therapeutic touch during treatment. However, Jacobs argues that owing to the particular effects of psychedelics—namely, mystical and ego-dissolution experiences which can occur acutely after administration and longer-term shifts in identity and values—the typical standards for informed consent may not be feasible.

Issues of capacity and consent during the psychedelic experience have received less attention. Individuals using psychedelics often experience profound acute changes to their sensorium along with alterations in mood, detachment from the body, and distortions of their sense of self, time, and reality. Consequently, it may be difficult for patients to appreciate the risks and benefits of terminating the session during the psychedelic experience. It may also be difficult for observers to predict or interpret the internal process and distress of patients during sessions, as their observable behaviour may not be representative of their inner experience…

Informed consent for capacity assessment
Shaun T. O’Keeffe, Mary Donnelly
International Journal of Law and Psychiatry, January–February 2024
Abstract
In this paper we examine the role of informed consent to capacity assessment, focussing primarily on the two jurisdictions of England and Wales, and Ireland. We argue that in both jurisdictions, a capacity assessment should be regarded as a distinct intervention, separate from the ‘original’ intervention at issue, and that specific informed consent to the assessment should generally be sought in advance. As part of this, we consider what information should be provided so as to ensure informed consent. Having established a baseline requirement for informed consent, we also recognise that informed consent to assessment will not always be possible, either because the person is unable to understand the information about assessment or because the person refuses to be assessed and so, in the final part of the article, we explore how to proceed when informed consent is either not possible or not forthcoming, including an analysis of the implications of the statutory presumption of capacity.

Capacity to consent to treatment in severe eating disorders
Research Article
Giovanna Parmigiani, Lorenzo Tarsitani, Fabiano Grassi, Gabriele Mandarelli, Stefano Ferracuti
International Review of Psychiatry, 12 January 2024
Abstract
Eating disorders represent a disabling, deadly and costly condition, whose principal treatment is constituted by weigh restoration and psychotherapy. Partial or total refuse of treatment is very common, leading some authors to question their decision-making capacity (DMC) to consent to treatment. However, very few studies have investigated treatment DMC, leading to contrasting results. Forty-five women were enrolled at the Psychiatric and Eating Disorders Unit of the University Hospital Policlinico Umberto I of Rome. Psychiatric symptoms severity (Brief Psychiatric Rating Scale Expanded, BPRS-E), treatment DMC (MacArthur Competence Assessment Tool for Treatment, MacCAT-T), depressive symptoms (Hamilton Depression Rating Scale, HAM-D), anxiety symptoms (Hamilton Anxiety Rating Scale, HAM-A), symptoms and psychological characteristics of eating disorders (Eating Disorder Inventory, EDI-3) and Metacognitive beliefs (Metacognitions Questionnaire 30, MCQ-30) were assessed. Sixty-seven percent of the total sample showed low treatment DMC; specifically, 70.4% of patients affected by Anorexia Nervosa, 72.7% of patients affected by Bulimia Nervosa, and 42.9% of patients affected by Binge Eating Disorder. Specific psychopathological symptoms enhance or hamper patients’ decisional capacities. Clinicians should be aware of the risk of impaired DMC in this vulnerable group of patients and pay attention at those factors suggesting the need of an in-depth evaluation.

A systematic review exploring challenges of informed consent processes in antipsychotic prescribing
Review Article
Jemima Thompson, Lisa M. Grünwald
Psychosis, 19 December 2023
Abstract
Introduction
Informed consent is the process whereby individuals make decisions about their medical care. Information provision, presumption of capability and absence of coercion are three fundamental assumptions required to provide informed consent. Informed consent may be complex to achieve in the context of antipsychotic prescribing. This systematic review aimed to explore challenges relating to informed consent processes in antipsychotic prescribing in the UK.
Method
This was a systematic review of the literature relating to informed consent in antipsychotic prescribing in community settings. Data were analysed using Framework analysis.
Results
Twenty-eight articles were included. Information provision has been perceived as lacking for a long time. Capacity has often not been assumed and loss of capacity has sometimes been viewed as permanent. Power imbalances associated with prescriber status and legal framework surrounding the Mental Health Act can blur lines between coercion and persuasion.
Discussion
Challenges relating to process of informed consent in antipsychotic prescribing have persisted throughout the last few decades. People prescribed antipsychotics need to be made aware of their effects in line with current research. Further research is required to develop models for best practices for informed consent.