The practice of electroconvulsive therapy without patient consent: a French naturalistic study
Original Article
Chevalier, S. Lespagnol, J. Charron, L. Cheval, S. Bulteau, A. Sauvaget, A. Laurin
Ethics, Medicine and Public Health, 2025
Abstract
Introduction
Free and informed consent is essential in care, though it may be impossible to obtain in psychiatry due to the impairment of discernment caused by mental illness. In this context, the law authorizes coerced care, including electroconvulsive therapy (ECT), a highly effective treatment that can at least partially restore discernment. However, the practice of ECT without consent is poorly documented, as is the question of reassessing consent during ECT. We need to take stock of the situation in order to improve practices.
Method
We conducted a monocentric observational retrospective chart-based study at Nantes University Hospital (France) involving 162 patients treated by ECT between 2018 and 2022.
Results
Our results showed that 36% of patients were treated by ECT without their consent, but with the agreement of a close relative (32% spouse, 31% child). ECT without the patient’s consent was mainly carried out in patients hospitalized under restraint, with a manic or mixed state, suffering from a catatonic or dementia syndrome. Despite an efficacy rate of 97%, only 3% of patients regularized their consent at the end of the ECT course. Surprisingly, 21 patients were treated with ECT without their consent, with the agreement of a third party, while in open hospitalization, and 26 patients were treated with ECT with their consent while in restricted hospitalization.

Exploring consent as an aesthetic experience through applied theatre with people living with dementia
Karoline Dalby, Lilli Mittner, Rikke Gürgens Gjærum
Nordic Journal of Art & Research, 31 December 2024
Abstract
    The process of giving or obtaining consent is typically seen as a series of language-based actions, either documented on a written form or communicated verbally. However, both methods can present challenges when engaging with individuals living with dementia. This paper explores how to understand consent as an aesthetic experience through applied theatre practices.

We draw on data from 12 applied theatre sessions in a residential care home in Northern Norway (2019–2021). The study design was practice led and situated in everyday-life practices at the care home. Through writing field stories collectively, based on a mixture of notes, video recordings, and embodied experiences, we analysed how people gave their consent to engaging in creative activities beyond using spoken and written language.

We find consent in four key elements that play a major role when we work co-creatively with people living with dementia:1) trust; 2) attunement; 3) sensibility; and 4) mutuality. Consent as an aesthetic experience is thus highly embodied, processual, and relational.

Our paper is written within an emerging discourse of relational perspectives in dementia research. It promotes the perception of people living with dementia as creative citizens who can equally contribute to art and research.

Facing the new diagnostic and treatment options of Alzheimer’s disease: The necessity of informed consent
Jonas Karneboge, Julia Haberstroh, Katharina Geschke, Julia Perry, Katrin Radenbach, Frank Jessen, Ayda Rostamzadeh
Alzheimer’s & Dementia, 30 December 2024
Abstract
With advances in biomarker-based detection of Alzheimer’s disease (AD) and new treatment options with disease-modifying treatments (DMTs), we are heading toward a new conceptualization of diagnostics and therapy in the early stages of AD. Yet consensus guidelines on best clinical practices in predictive AD diagnostics are still developing. Currently, there is a knowledge gap regarding counseling and disclosure practices in early symptomatic disease stages, its implications for dementia risk estimation, and DMTs with associated risks and benefits. The crucial feature is the capacity of patients with (mild) cognitive impairment, eligible for DMTs, to consent. This perspective aims to (1) discuss the current challenges in assessing capacity to consent and (2) highlight the importance of a supported (informed) decision-making process. Measures to facilitate informed decision-making of patients constitute an ethical approach to enhancing the quality of care in this evolving therapeutic landscape.
Highlights
This perspective: Explores biomarker-based early symptomatic AD detection and the implications for patient care. Emphasizes supported decision-making in DMTs for MCI and dementia patients. Discusses the need for standardized tools to assess the capacity to consent. Aligns diagnostic and treatment approaches with ethical care standards. Enhances patient autonomy in the evolving AD therapeutic landscape.

Obtaining Informed Consent of Vulnerable Populations for Participating in Social and Education Sciences Research
Karen S. Voytecki, Gregory L. Hassler
International Conference on Social and Education Sciences, 17-20 October 2024; Chicago, USA
Abstract
Obtaining informed consent is the foundation of ethics in clinical research involving human participants. Individuals who provide informed consent acknowledge they understand all aspects of the research including the nature of the study, the risks and benefits of participation, the participant’s rights, study procedures, research duration, confidentiality, and voluntariness. The process of obtaining informed consent from research study participants contains legal and ethical procedures. The “Common Rule” identifies “vulnerable subjects” for research purposes as “children, prisoners, individuals with impaired decision-making capacity, or economically or educational disadvantaged persons.” This social and education sciences research article explores a pragmatic approach for Institutional Review Boards (“IRBs”) to review research protocols involving individuals with disabilities and/or those who are educationally-disadvantaged as study participants. Consideration is also given to Universal Design for Learning (UDL) principles in relation to appropriate and effective accessibility options to IRB materials. As a direct result, a process is formed for obtaining informed consent of vulnerable participants in social and education sciences research.

Obtaining Informed Consent From People With Dyslexia: The Role Of Easy Language
Marija Jozipović, Mirjana Lenček
Croatian Journal of Rehabilitation Research, 19 December 2024
Open Access
Abstract
Obtaining informed consent is a standard procedure in research practice. However, it is not sufficient, even if an individual chooses to participate voluntarily in research process, for the researchers to be able to claim that they have obtained informed consent. The consent must be of sufficiently ‘high quality’: it must not only be informed, but also valid, i.e., it must contain the following three elements: adequate information, voluntariness, and competence. Although preparing informed consent is a difficult process in general, it is particularly challenging when working with certain populations, such as clinical groups who have language and literacy difficulties, e.g., dyslexia. A lack of understanding of the basis and specific characteristics of this disorder can have negative effects on people with dyslexia (PwD) such as in the form of unwanted misunderstandings, psychological stress, negative effects on their learning processes, as well as unethical treatment in the research process. Studies have shown that PwD can be particularly vulnerable to research that might exploit, imply, or attribute unsafe practices to them and their difficulties, especially in connection with research recommendations that require written informed consent. Easy language refers to the language adaptation of a text to facilitate both reading and comprehension, particularly for PwD. Therefore, the use of the easy language guidelines for language adaptation and graphical adjustment is important when obtaining informed consent from PwD.

The ethical inadequacy of uninformed surrogate consent: advancing respect for persons in clinical research
Robert R. Harrison
Theoretical Medicine and Bioethics, 10 November 2024
Abstract
In clinical research, decision-making capacity is often equated with unspecified conceptions of autonomy, and autonomy is often equated with personhood. On this view, the loss of decision-making capacity is seen as a loss of autonomy, and the loss of autonomy subsumes a loss of personhood. An ethical concern arises at the intersection of those philosophical considerations with the legal considerations in informed consent. Because persons with inadequate decision-making capacity cannot provide legally effective consent, enrollment in research can occur only if a surrogate gives permission on the person’s behalf. Federal regulations and resulting institutional policies allow permission from surrogates empowered under state law to consent to medical treatment procedures, typically in a hierarchy of legislatively prioritized relationships lacking regard for what the surrogate actually knows about the current research-related values and preferences of the potential subject. As a result, the research enterprise often countenances reliance on surrogates who have no relational or informational basis for an enrollment decision that aligns with the values and preferences of the subject. Arguing from the perspective that losing decision-making capacity does not alter the moral status of persons, and that respect for persons rather than respect for autonomy is the central ethical obligation, I assess the ethical implications of allowing persons with no knowledge of the values and preferences of the potential subject to make enrollment decisions, concluding that reliance on uninformed surrogates is not an ethically defensible approach to enrolling subjects in clinical research.

Electroconvulsive therapy and informed consent: navigating clinical efficacy and patient rights
Conference Presentation
Anghel Claudia
Beyond borders: united for mental health 2024; Chişinău, Moldova, 10-13 October 2024
Abstract
Electroconvulsive Therapy (ECT) remains a highly effective treatment for severe mental health disorders, such as treatment-resistant schizophrenia and major depressive disorder. However, its use raises important ethical and legal concerns, particularly regarding informed consent. Balancing the clinical efficacy of ECT with patients’ rights to make informed decisions about their treatment is a complex challenge for mental health professionals. Informed consent is crucial, requiring that patients fully understand the potential benefits, risks, and side effects of ECT before agreeing to the procedure. Mental health care providers must ensure that patients are not only informed about the short- and long-term effects of ECT but also supported in their decisionmaking process. This includes addressing any cognitive impairments or mental health symptoms that may impact their capacity to give informed consent. Additionally, legal guardians or family members may be involved in the consent process, especially when patients are unable to provide it themselves. Ultimately, navigating the delicate balance between ensuring the clinical success of ECT and respecting patient autonomy is essential for ethical practice. Continued research into improving patient education and consent processes can help to understand the efficacy of ECT and the rights of them receiving this treatment.

Anosognosia in Alzheimer’s Disease: Clinical Psychology and Medico-Legal Issues. Informed Consent in Healthcare
Tomasello Letters, Miriana Ranno, Claudia Pitrone
New Medical Innovations and Research, 28 March 2024
Abstract
    Insight or deficit awareness have been used interchangeably to refer the lack of knowledge or recognition of one’s deficit. Our aim was to investigate whether this lack could influence Alzheimer’s disease patients’ ability to understand and do.

Disease awareness is a phenomenon that in recent years is obtaining an increasing interest in a clinical and research point of view. It has important implications on patient care and management. The present study is aimed to contribute to the comprehension of disturbing awareness in patients with Alzheimer disease, and provided a starting point on a complex disease linked to medical and psychological scopes but also involve Bioethics and Law.

Informed consent and decision-making skills
   Informed consent is a fundamental prerequisite of every medical act and the autonomy of a patient, in the fullness of his ability to decide on treatments and possible therapeutic treatments. Presupposition of informed consent, beyond the information (well given and well understood) and freedom (absence of conditioning factors or at least awareness of their presence), is the ability to decide. The ability to decide on medical treatment is inherent in the legal concept of capacity to act (Art. 2 of the CC). The definition, proposed by Wong et al. (1999) (10), provides an indication of the relationships between the ability of the individual and the society around him: “capacity is what distinguishes a person, who is able to make a decision and whose choice must be respected, regardless of the reasonableness of the choice, by a person for whom decisions must be made by others”. There are cases where a person may no longer be able to manage his or her current account but may be able to give his or her consent to simple medical treatment. The ability to decide must be presumed, until proven otherwise. Dementia is, therefore, a risk factor for incapacity, but it does not inevitably involve it. The ability (or inability) is always relative to a certain task. For example, a person may be able to make a decision for simple medical treatment but not be able to discern complex alternatives with different risk/benefit profiles…

The Ethical Importance of Assent in Adults with Decisional Incapacity
Videocast
David Wendler
NIH Webinar, 17 October 2024
Description
Our speaker for this session is Dr. David Wendler, senior investigator, and head of the section on research ethics in the NIH Clinical Center Department of Bioethics.

Topics addressed:

• Ethical background about why it is important to consider whether obtaining assent/respecting dissent in adults who are unable to provide consent for research is appropriate
• When is obtaining assent appropriate vs. not?
• How would they conduct such an assent process
• The difference between assent and dissent

Capacity to consent: a scoping review of youth decision-making capacity for gender-affirming care
Systematic Review
Loren G. Marino, Katherine E. Boguszewski, Haley F. Stephens, Julia F. Taylor
BMC Medical Ethics, 8 October 2024
Open Access
Abstract
Background
Transgender and gender expansive (TGE) youth often seek a variety of gender-affirming healthcare services, including pubertal suppression and hormone therapy requiring that TGE youth and their parents participate in informed consent and decision making. While youth must demonstrate the ability to understand and appreciate treatment options, risks, benefits, and alternatives as well as make and express a treatment choice, standardized approaches to assess the capacity of TGE youth to consent or assent in clinical practice are not routinely used. This scoping review identified the currently available data regarding adolescent capacity to consent to gender-affirming medical treatments.
Methods
Articles relevant to assessing adolescent capacity for clinical decision-making were identified using OVID Medline, Web of Science, and PubMed. Articles were reviewed and thematically analyzed.
Results
Eight relevant articles were identified using three tools for measuring adolescent clinical decision-making capacity: Measure of Understanding, Measure of Competence, and MacArthur Competence Assessment Tool (MacCAT). These studies explored hypothetical treatment decisions, mental health treatment decisions, HIV treatment decisions, genetic testing decisions, and gender-affirming medical decisions. Only one study specifically examines the capacity of TGE youth to consent to medical treatments. Age was correlated with capacity in most, but not all studies. Other studies found cognitive measures (IQ, literacy, numeracy) may impact important aspects of capacity (understanding and reasoning).
Conclusions
For clinicians caring for TGE youth, tools such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) may prove useful, in conjunction with consideration of youth developmental abilities and utilization of shared decision-making practices. A standardized, collaborative approach to assessing TGE youth capacity would benefit TGE youth and their parents, and allow clinicians to more easily resolve ethical concerns.

Editor’s Note: After assessing the observations and arguments made in this paper, we are reaching out to the corresponding author for clarification.