Informed Consent in Mental Healthcare
Book Chapter
Hanfried Helmchen, Jakov Gather
Ethics in Psychiatry, 20 March 2025 [Springer]
Abstract
The right to self-determination is firmly established in various national and international legal documents, as well as in declarations and codes of medical associations. Medical or research-related interventions can generally only be performed with the informed consent of the person concerned. In this chapter, we, firstly, describe the elements of informed consent and elaborate on the concept of shared decision-making and relevant aspects of the professional-patient relationship in mental healthcare. We then discuss why, what about, how, when and by whom patients with mental disorders should be informed and how decision support can be provided. We conclude by pointing out ethical conflicts which may occur in the context of informed consent, including situations in which patients lack mental capacity and, therefore, cannot give informed consent themselves.
Month: March 2025
An Assent Framework for People with Intellectual and Developmental Disabilities and Complex Communication Needs
An Assent Framework for People with Intellectual and Developmental Disabilities and Complex Communication Needs
Original Article
Christopher Tullis, Amarie Carnett
Journal of Developmental and Physical Disabilities, 8 March 2025
Abstract
In both research and practice, gaining assent from participants is an ethical imperative in applied behavior analysis. Recent guidance for including assent-based procedures has been provided in the literature (Breaux & Smith, 2023). However, limitations for decision-making when working with individuals who have developmental disabilities and complex communication needs (CCN) may require further guidance given the range of different considerations, such as use and proficiency with an augmentative and alternative communication system (AAC). Thus, this article provides an overview of considerations for individuals with greater support needs, a framework for evaluating assent in clinical practice, suggestions for measurement, and suggestions for future research.
The following article is referenced in the above:
Assent in applied behaviour analysis and positive behaviour support: ethical considerations and practical recommendations
Review
Cassi A Breaux, Kristin Smith
International Journal of Development Disabilities,1 February 2023; 69(1) pp 111-121
Abstract
The term positive behaviour support (PBS) is used to describe the integration of the contemporary ideology of disability service provision with the clinical framework of applied behaviour analysis (ABA). Assent, the participation consent of those not legally able to consent, has gained recent popularity in the fields of ABA and PBS. The goal of assent-based ABA and PBS is a person-centered approach to assessment, intervention, and all other decision-making. In this model, the learner’s assent withdrawal for participation is honored, whether it be a vocal ‘no’ or a non-vocal expression of verbal behaviour. There is currently a limited subset of studies that mention or utilize assent with learners in ABA or PBS. The lack of published research can make assent-based practices seem to be a choice of the practitioner. The authors of this manuscript seek to further define assent, illuminate the necessity of assent-based practices, and offer assent-based procedures in ABA- and PBS-based intervention.
Re-envisioning autonomy: From consent and cognitive capacity to embodied, relational, and authentic selfhood
Re-envisioning autonomy: From consent and cognitive capacity to embodied, relational, and authentic selfhood
Editorial
Jonathan Lewis
Clinical Ethics, 24 February 2025
Excerpt
… In medical ethics, autonomy at its most basic level has tended to be conceptualized in terms of a patient’s ability to understand, deliberate, and decide. Prevailing legal and ethical paradigms have long held that a patient’s expressed preferences—assuming they satisfy the requisite threshold of mental capacity—ought to be respected unequivocally. This model underpins practices such as advance directives, a framework critiqued by Brock for its narrow focus on cognitive capacity. Empirical findings reported by Toomey et al. suggest that lay judgments about decision-making do not align neatly with this capacity-centric model. Their research indicates that when tasked with deciding for another, individuals are inclined to privilege a person’s treatment preference even when the person fails to satisfy the traditional cognitive requirements for capacity so long as the preference reflects the person’s “true self.” According to Strohminger, Knobe, and Newman, the true self consists of those stable, core attributes—values, traits, and dispositions—that consistently define who a person is across time and circumstance. Their research demonstrates that individuals tend to regard actions as more authentic when they are consistent with these enduring, core attributes (rather than reflecting transient states or external pressures). If we, like most theorists of autonomy, consider authenticity to be a key component of the nature of autonomy, then Toomey et al.’s studies could suggest that a decision may not be genuinely autonomous if it does not resonate with these enduring aspects of the self. In other words, and in the context of medical decision-making, a patient’s choice might satisfy the formal criteria for cognitive capacity but still be considered non-autonomous if it deviates from what is widely recognized as the individual’s deep-seated values, interests, and dispositions (see, e.g., Hawkins and Toomey et al.)…
Challenges to gaining informed consent in a low-income urban community in Ghana: a case study of Tetegu, Weija Gbawe
Challenges to gaining informed consent in a low-income urban community in Ghana: a case study of Tetegu, Weija Gbawe
Case Study
Darrold Cordes, Paul Sefah, Dora Marinova
Discover Sustainability, 20 March 2025
Open Access
Abstract
There is a lack of data describing the physical, social, economic, and environmental conditions of low-income communities in Sub-Saharan African cities. Research to obtain this data requires informed consent from business owners and heads of households. This case study focuses on a small enclave of approximately 150 households and associated businesses and community services in Tetegu, Accra, Ghana. Low-altitude aerial and terrestrial surveys were conducted to identify all structures, business types, and occupancy levels of households. A sample of businesses and households were purposively chosen as potential participants in the study. Interviews were conducted and informed consent procedures were followed in accordance with the ethics approval. Data was collected online using a computer tablet and informed consent was recorded electronically. Language and literacy barriers required considerable patience when presenting the scope of the research and participants’ roles and rights. Distrust of researchers, resentment, indifference, and aggressive behavior towards researchers were encountered. Other challenges included health and safety concerns and the quality of telecommunication services. Informed consent was obtained from more than 30% of households and 10% of businesses. The research outcomes may not represent other urban low-income communities in Accra or other cities in Ghana, West Africa, or Sub-Saharan Africa.
Evaluation of the surgical informed consent for elective and emergency surgeries in obstetrics and gynaecology in Saudi Arabia
Evaluation of the surgical informed consent for elective and emergency surgeries in obstetrics and gynaecology in Saudi Arabia
Research
Maryam Al-Meshkhas, Zahraa Alakrawi, Sumaiah Alrawiai
BMC Medical Ethics, 12 March 2025
Open Access
Abstract
Background
Informed consent (IC) represents one of the fundamental rights of patients in healthcare. An essential aspect of the IC process is providing patients with equal access to information to enable them to make the right decisions. However, failure to obtain IC undermines patient autonomy, lowers patient satisfaction, increases risks, and negatively affects the patient’s trust in healthcare providers. This study aims to evaluate the surgical informed consent (SIC) process from the patient’s perspective both for emergency and elective surgeries in obstetrics/genecology in Saudi Arabia.
Methods
This is a quantitative cross-sectional study. The study population included all hospitalized female patients who had undergone obstetric or gynaecological surgeries, from February 2021 to March 2021. The total sample size was 156 female patients.
Results
Most of the participants were married (96.2%) and unemployed (80.1%). The most performed surgery was caesarean Sect. (84%). Most of the patients were satisfied with their SIC experience which represents over 85%. No significant difference has been found between the elective and emergency surgeries. However, person-in-charge of SIC administration and the time provided to sign the IC were deemed to be significant predictors.
Conclusion
Based on the findings, it is recommended that physician take responsibility for the SIC administration rather than an unknown provider. It is also recommended to provide the patients with adequate time to understand the SIC. Furthermore, ensuring the availability of emotional support is critical for enhancing the patient experience.
Barriers and willingness to express consent to organ donation among the Kazakhstani population
Barriers and willingness to express consent to organ donation among the Kazakhstani population
Research
Aidos Bolatov, Aruzhan Asanova, Gulnur Daniyarova, Vitaliy Sazonov, Yuliya Semenova, Aigerim Abdiorazova, Yuriy Pya
BMC Public Health, 3 March 2025
Open Access
Abstract
Background
Organ donation is a critical component of healthcare, yet donation rates in Kazakhstan remain low. Understanding the socio-demographic factors, knowledge levels, and perceived barriers influencing individuals’ willingness to consent to organ donation is essential for developing effective interventions.
Methods
This cross-sectional study surveyed 1,294 participants across Kazakhstan. The sample was predominantly female (78.3%), urban (79.4%), and well-educated, with a significant proportion having medical backgrounds. Data were collected on socio-demographic characteristics, knowledge about organ donation, and perceived barriers. Comparison methods and binomial logistic regression analysis was used to identify significant predictors of willingness to express consent for organ donation.
Results
Age, ethnicity, family status, and knowledge about organ donation were significant predictors of willingness to donate. Older participants and Russian ethnic group members were less likely to consent, while widowed individuals and those with higher knowledge levels were more likely to express consent. Although several factors did not have significant prediction with willingness to donate in the regression analysis, chi-square and U-tests revealed significant associations for residence, occupation, educational level, and religious affiliation. Key barriers to donation included distrust in the medical system, fears of organ trafficking, and insufficient awareness, particularly among non-medical participants. These barriers were significant deterrents and correlated with lower willingness to donate. However, due to the overrepresentation of urban, educated, and medical-affiliated participants in the sample, findings may not fully reflect the general population of Kazakhstan.
Conclusion
The findings highlight the need for targeted educational campaigns to increase public awareness and address misconceptions about organ donation. Building trust in the medical system and dispelling fears of unethical practices are essential for improving donation rates. The study underscores the complex interplay of socio-demographic factors, knowledge, and perceived barriers in shaping organ donation decisions in Kazakhstan, while also emphasizing the need for future research with a more representative sample.
Community engagement approaches and lessons learned: A case study of the PRECISE pregnancy cohort study in Kenya
Community engagement approaches and lessons learned: A case study of the PRECISE pregnancy cohort study in Kenya
Onesmus Wanje, Angela Koech, Maggie Woo Kinshella, Grace Mwashigadi, Alice Kombo, Grace Maitha, Nathan Barreh, Hiten D Mistry, Rachel Craik, Marianne Vidler, Marie-Laure Volvert, Peter von Dadelszen, Marleen Temmerman, The Precise Network
Fronteirs of Public Health, 24 February 2025
Abstract
Community engagement (CE) has been recommended as an important ethical consideration for health research to enhance informed consent and exchange knowledge between researchers and community members. The purpose of this paper is to describe how CE was developed and delivered for the PRECISE prospective pregnancy cohort study in Kenya. PRECISE enrolled pregnant women in antenatal care, followed them up to the postpartum period, and collected data and biological samples to enable the study of placental disorders in sub-Saharan Africa. Initially CE was aimed at informing the community about the study, establishing community-wide acceptance of the research and addressing concerns about biological sample collection to facilitate participation in the study. CE later evolved to be a platform for mutual learning aiming to deepen the community’s understanding of research principles and informed consent and providing a feedback loop to researchers. We engaged diverse stakeholders including health workers and managers, local administrators, religious and traditional leaders, older women, pregnant women, non-pregnant women and men. We utilized a variety of CE approaches and tools adapting to the specific contextual factors at the study sites. Achievements included widespread understanding of informed consent and research principles, clarification of misconceptions, and dispelling of fears regarding biological sample collection. The relationship with the community was strengthened evidenced by frequent inquiries and active participation in CE activities and the research study. For effective CE, we recommend involvement of community members in the CE team and continuous and adaptive CE throughout the study period.
Informed Consent for Breast Cancer: The Perspective of Physicians in Japan
Informed Consent for Breast Cancer: The Perspective of Physicians in Japan
Review
Erika Suzuki, Hiroyuki Takei
Journal of Nippon Medical School, 2025
Abstract
Informed consent (IC) is closely related to shared decision making (SDM), and SDM can lead to IC. IC is fundamental to medical ethics as described in the Geneva, Helsinki, and Lisbon declarations and is essential for clinical practice, as it provides legal protection for healthcare professionals. IC should be achieved through SDM based on both narrative-based medicine and evidence-based medicine. SDM should also involve healthcare professionals other than physicians (e.g., nurses, pharmacists, social workers). Communication skills for IC are important and are encapsulated in the SPIKES protocol. IC for breast cancer treatment requires explanation of the roles of local and systemic therapy. A documented “do not attempt resuscitation” order should be obtained for end-of-life IC.
Editor’s Note:
The referenced declarations in the abstract are further identified in this article excerpt:
…Medical Ethics and Informed Consent
Three declarations are relevant to medical ethics: the Declaration of Geneva on the physician’s pledge[6], the Declaration of Helsinki on ethical principles for medical research involving human subjects[7], and the Declaration of Lisbon on the rights of the patient[8]. These documents confirm that IC is essential to the provision of medical care. In particular, the content of the explanations given to patients in medical research must be based on the principles of the Declaration of Helsinki and approved by the ethical review committee of each institution[9].
6．World Medical Association. WMA Declaration of Geneva [Internet]. Ferney-Voltaire; World Medical Association: 2024. Available from: https://www.wma.net/policies-post/wma-declaration-of-geneva
7．World Medical Association. WMA Declaration of Helsinki- Ethical Principles for Medical Research Involving Human Participants [Internet]. Ferney-Voltaire; World Medical Association: 2024. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects
8．World Medical Association. WMA Declaration of Lisbon on the Rights of the Patient [Internet]. Ferney-Voltaire; World Medical Association: 2024. Available from: https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient
Updating Winterwerp with Rooman to add a requirement for ‘Real therapeutic measures’ to legal criteria for admission without consent in psychiatry
Updating Winterwerp with Rooman to add a requirement for ‘Real therapeutic measures’ to legal criteria for admission without consent in psychiatry
Brendan D. Kelly
International Journal of Law and Psychiatry, July–August 2025
Open Access
Abstract
Admission without consent and treatment without consent are topics of prolonged discussion throughout the history of psychiatry. These practices raise significant issues pertaining to human rights to liberty, bodily integrity, and treatment. Balancing rights is always challenging, especially when people lack decision-making capacity owing to the impact of mental illness. In 1979, the European Court of Human Rights outlined criteria required to justify lawful admission without consent owing to mental disorder in Winterwerp v. the Netherlands. These criteria were: (a) a competent national authority needs to demonstrate the existence of a true mental disorder based on objective medical expertise; (b) the extent of the mental disorder needs to warrant compulsory confinement, and (c) continued detention needs to be validated by the persistence of the disorder. Since then, the Court has delivered multiple judgements relating to psychiatric committal and detention in various facilities, but the most significant potential addition to the Winterwerp criteria occurred in 2019, in Rooman v. Belgium. In this case, the Court stated, “that there exists a close link between the ‘lawfulness’ of the detention of persons suffering from mental disorders and the appropriateness of the treatment provided for their mental condition”. The Court stressed ‘that, irrespective of the facility in which those persons are placed, they are entitled to be provided with a suitable medical environment accompanied by real therapeutic measures’. On this basis, this paper proposes adding a fourth requirement to the Winterwerp criteria to justify lawful admission without consent owing to mental disorder: ‘(d) real therapeutic measures must be provided’. The absence of ‘real therapeutic measures’ should undermine the legal basis of admission without consent on the basis of mental disorder. This would mean that there could be no involuntary admission owing to mental disorder without treatment being appropriate and available. Such an addition to criteria for involuntary admission in national mental health legislation would protect, rather than erode, human rights, and would more accurately reflect the core purpose of psychiatry: the treatment of mental illness and the consequent alleviation of suffering.
Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers
Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers
Amanda Siriwardana, Brendan Smyth, Meg Jardine
BMJ Open, 18 March 2025
Abstract
Objective
Low-risk pragmatic clinical research such as learning health system research, quality assurance activities and comparative effectiveness studies are approaches to embedding clinical research within routine practice to generate generalisable evidence. Individual written informed consent may present a barrier to the feasibility and inclusiveness of such low-risk clinical research. Within an overarching moral and ethical framework, the form and requirements of consent vary in both clinical practice and research settings according to the context and level of risk. Within some low-risk research settings, waiver of consent may be appropriate.
Analysis
We sought to describe contemporary national and international English-language guidelines pertaining to the use and oversight of waiver of consent in clinical research. We identify 14 guidelines including 1 international, 1 regional and 12 national statements, and summarise the principles in each for circumstances in which a waiver of consent is appropriate.
Conclusion
While complete international harmonisation of policy may be neither realistic nor necessary, there are numerous unifying concordances suggesting a broad consensus on the approach to waiver of consent research.
Center for Informed Consent Integrity 