Equitable and accessible informed healthcare consent process for people with intellectual disability: a systematic literature review
Systematic Review
Manjekah Dunn, Iva Strnadová, Jackie Leach Scully, Jennifer Hansen, Julie Loblinzk, Skie Sarfaraz, Chloe Molnar, Elizabeth Emma Palmer
BMJ Quality & Safety, 9 December 2023
Abstract
Objective
To identify factors acting as barriers or enablers to the process of healthcare consent for people with intellectual disability and to understand how to make this process equitable and accessible.
Data sources
Databases: Embase, MEDLINE, PsychINFO, PubMed, SCOPUS, Web of Science and CINAHL. Additional articles were obtained from an ancestral search and hand-searching three journals.
Eligibility criteria
Peer-reviewed original research about the consent process for healthcare interventions, published after 1990, involving adult participants with intellectual disability.
Synthesis of results
Inductive thematic analysis was used to identify factors affecting informed consent. The findings were reviewed by co-researchers with intellectual disability to ensure they reflected lived experiences, and an easy read summary was created.
Results
Twenty-three studies were included (1999 to 2020), with a mix of qualitative (n=14), quantitative (n=6) and mixed-methods (n=3) studies. Participant numbers ranged from 9 to 604 people (median 21) and included people with intellectual disability, health professionals, carers and support people, and others working with people with intellectual disability. Six themes were identified: (1) health professionals’ attitudes and lack of education, (2) inadequate accessible health information, (3) involvement of support people, (4) systemic constraints, (5) person-centred informed consent and (6) effective communication between health professionals and patients. Themes were barriers (themes 1, 2 and 4), enablers (themes 5 and 6) or both (theme 3).
Conclusions
Multiple reasons contribute to poor consent practices for people with intellectual disability in current health systems. Recommendations include addressing health professionals’ attitudes and lack of education in informed consent with clinician training, the co-production of accessible information resources and further inclusive research into informed consent for people with intellectual disability.

A survey of informed consent in patients with dementia in the US and Japan
Iijima Yoshihiko
Nagoya Journal of Medical Science, 31 October 2023;
Open Access
Abstract
This study aimed to confirm the reality of family-focused medical treatment of dementia in Japan and the US. It conducted a questionnaire survey on informed consent from patients with dementia among neurologists and psychiatrists in four prefectures in the Tokai Region (Aichi, Gifu, Mie, and Shizuoka) and dementia specialists in the US. Of the responses, 120 (39.7% response rate) and 20 (5.9% response rate) were obtained, respectively. In obtaining informed consent from patients with dementia, 75 Japanese specialists (62.5%) and 16 US specialists (80.0%) regularly assessed patients’ decision-making abilities. The majority of specialists in both Japan and the US used the Mini–Mental State Examination and Hierarchic Dementia Scale-Revised, which are widely used for cognitive function assessment. In the survey, 27 Japanese specialists (22.5%) and 10 US specialists (50.0%) had different considerations when obtaining informed consent for participation in research, compared to their medical practice. The majority of Japanese and US specialists obtained informed consent from both the patient and their family.

Reproductive psychiatric advance directives: promoting autonomy for perinatal people with serious mental illness diagnoses
Original Article
Emily C. Dossett, Sonja L. Castañeda-Cudney, Michelle T. Nguyen, Melisa Olgun, Jennifer Wang, Keris Jän Myrick, Laurie Hallmark, Elyn R. Saks
Archives of Women’s Mental Health, 10 November 2023
Open Access
Abstract
People with serious mental illness (SMI) diagnoses who become pregnant are particularly vulnerable to symptom recurrence and resulting potential lack of decision-making capacity (Taylor et al. J Psychiatr Res 104:100-107, 2018; Bagadia et al. Int J Soc Psychiatry 66:792-798, 2020). In these situations, prenatal and behavioral health providers have little legally viable guidance on what medical and/or psychiatric care the patient desires (Aneja and Arora Indian J Med Ethics V:133-139, 2020). We created a “Reproductive Psychiatric Advance Directive (PAD),” grounded in Reproductive Justice principles, that promotes patient autonomy by proactively articulating perinatal medical and psychiatric care preferences. We conducted a medical and legal literature review using two sets of terms related to (1) PADs and (2) reproductive health. We convened an expert working group of legal, medical, psychiatric, peer, and advocacy leaders and community-based organizations to develop a Reproductive PAD. Our literature review yielded no results about Reproductive PADs. We created de novo a Reproductive PAD template with sections on medical and psychiatric history, informed consent for critical medical and psychiatric care, family planning and custody preferences, and optional sections on abortion and on electroconvulsive therapy. The Reproductive PAD provides a possible legal mechanism for people of childbearing age with SMI diagnoses to articulate their medical and psychiatric care choices around reproduction and pregnancy. Future research should evaluate the Reproductive PAD as an effective tool for protecting patient autonomy during pregnancy and postpartum and guiding medical and psychiatric providers.

Informed consent practices for acute stroke therapy: principles, challenges and emerging opportunities
Review
Amir Mbonde, Michael J. Young, Adam A. Dmytriw, Quentin J. Moyer, Joshua A. Hirsch, Thabele M. Leslie-Mazwi, Natalia S. Rost, Aman B. Patel, Robert W. Regenhardt
Journal of Neurology, 10 October 2023
Abstract
Importance
Informed consent (IC) plays a crucial yet underexplored role in acute stroke treatment, particularly in the context of intravenous thrombolysis (IVT) and endovascular thrombectomy (EVT). This narrative review examines data on current IC practices in acute ischemic stroke management, specifically for patients treated with IVT or EVT, with the aim of identifying areas for improvement and strategies to enhance the IC process.
Observations
IC practices for IVT vary significantly among hospitals and physicians with the frequency of always requiring consent ranging from 21 to 37%. Factors influencing IC for IVT include patient decision-making capacity, standard of care, time sensitive nature of treatments, legal and moral obligations, risk of complications, physician age and speciality, treatment delays, and hospital size. Consent requirements tend to be stricter for patients presenting within the 3–4.5-h window. The content and style of information shared as part of the IC process revealed discrepancies in the disclosure of stroke diagnosis, IVT mechanism, benefits, and risks. Research on IC practices for EVT is scarce, highlighting a concerning gap in the available evidence base.
Conclusions and relevance
This review underscores the significant variability and knowledge gaps in IC for EVT and IVT. Challenges related to decision-making capacity assessment and the absence of standardised guidance substantially contributes to these gaps. Future initiatives should focus on simplifying information delivery to patients, developing formal tools for assessing capacity, standardising ethical frameworks to guide physicians when patients lack capacity and harmonizing IC standards across sites. The ultimate goal is to enhance IC practices and uphold patient autonomy, while ensuring timely treatment initiation.

[Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model)]
Kochanek M, Grass G, Böll B, Eichenauer DA , Shimabukuro-Vornhagen A , Hallek M, Zander T, Mertens J, Voltz R
Medizinische Klinik, Intensivmedizin und Notfallmedizin, 29 September 2023
Abstract
When conducting clinical trials in intensive care and emergency medicine, physicians, ethics committees, and legal experts have differing views regarding the inclusion of patients who are incapable of giving consent. These different views on the participation of patients who are not capable of giving consent also complicate how clinical trials are prepared and conducted. Based on the results of a literature search, a consensus model (Cologne Model) was developed by physicians performing clinical research, ethics committees, and lawyers in order to provide patients, those scientifically responsible for the study, ethics committees, and probate (guardianship) judges with a maximum of patient safety and legal certainty, while simultaneously enabling scientific research.

Editor’s note: This is a German language publication.

Developing a dementia friendly approach to consent in dementia research
Michelle Pyer, Alison Ward
Aging and Mental Health, 11 September 2023
Abstract
Objectives
This paper explores the process of gaining consent from the perspectives of people living with dementia, their relatives/carers, and service providers. This is developed based on new primary qualitative research and addresses a gap in critical reflection on the practice and ethical process of research consent.
Methods
A qualitative approach was used to conduct this research through the implementation of four focus groups run with people living with dementia (n=12), two focus groups with family members (n=6), two focus groups with service staff (n=5).
Results
Data was analysed thematically, to identify two core themes: consent as a journey and the flexible consent approach. These identified concerns with autonomy, decision making and placing people living with dementia at the centre of the consent process. The journey of consent emerged as central to supporting participation and enhancing the consent process.
Conclusion
The paper presents new evidence about the lived experience of research consent in the field of dementia, presenting the process of collecting consent in research as a flexible process that is best supported through a growing knowledge of participants and participation sites.

Capacity Assessment in Emergency Surgery
Selwyn O. Rogers, Darren S. Bryan
Journal of Clinical Ethics, Fall 2023; 34(3) pp 270-272
Abstract
Informed consent is a necessary component of the ethical practice of surgery. Ideally, consent is performed in a setting conducive to a robust patient-provider conversation, with careful consideration of risks, benefits, and outcomes. For patients with medical or surgical emergencies, navigating the consent process can be complicated and requires both careful and expedited assessment of decision-making capacity. We present a recent case in which a patient in need of emergency care refused intervention, requiring urgent capacity assessment and a modification to usual care.

Why we have duties of autonomy towards marginal agents
Book Chapter
Anna Hirsch
Theoretical Medicine and Bioethics, 12 May 2023 [Springer]
Open Access
Abstract
Patients are usually granted autonomy rights, including the right to consent to or refuse treatment. These rights are commonly attributed to patients if they fulfil certain conditions. For example, a patient must sufficiently understand the information given to them before making a treatment decision. On the one hand, there is a large group of patients who meet these conditions. On the other hand, there is a group that clearly does not meet these conditions, including comatose patients or patients in the late stages of Alzheimer’s disease. Then there is a group of patients who fall into the range in between. At the lower end of this range are so-called ‘marginal agents,’ which include young children and patients in the middle stages of Alzheimer’s disease. They also do not meet the typical requirements for autonomy, which is why they are usually granted fewer autonomy rights. However, some of them are capable of ‘pre-forms’ of autonomy that express what is important to them. These pre-forms differ from mere desires and reflect the identification/authenticity condition of autonomy. They have something in common with autonomous attitudes, choices, and actions – namely, they express the value of autonomy. As I will argue, autonomy is a value worthy of protection and promotion – even in its non-reflexive forms. Against this background, it becomes clear why we have autonomy duties, more precisely positive, autonomy-enabling duties, towards marginal agents and why we should give them as much attention as autonomy duties towards competent patients.

The capacity to consent to treatment is altered in suicidal patients
Research
Emilie Olié, Thomas Catanzaro, Manon Malestroit, Julio A. Guija, Lucas Giner & Philippe Courtet
Annals of General Psychiatry, 9 September 2023; 22(35)
Open Access
Abstract
Background
Many patients with depression refuse treatment. Moreover, suicide attempters often display low perceived need of treatment and impaired decision-making. These observations raise questions about the capacity to treatment consent in depressed suicide attempters (SA).
Methods
In patients with current depressive episode (N = 33 SAs and N = 27 non-SAs), consent capacity was evaluated with the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), insight with the Beck Cognitive Insight Scale, and depression severity with the Beck Depression Inventory (BDI).
Results
The median BDI score in the whole sample (N = 60) was 21 [10;36], and was higher in SAs than non-SAs (27 [11;36] vs. 15 [10:33], p < 0.001). Consent capacity was impaired in 30% (appreciation), 53% (reasoning) and 60% (understanding) of all patients. MacCAT-T sub-scores were lower in SAs than non-SAs (understanding: 4.4 [2.35;5.8] vs. 5.3 [3.13;6]); appreciation: 3 [1;4] vs. 4 [2;4]); reasoning (4 [1;7] vs. 7 [3;8]), and ability to express a choice: 1 [0;2] vs. 2 [0;2]; all p < 0.001). In multivariate analyses, suicide attempt history and depression severity (but not insight) were negatively associated with MacCAT-T sub-scores.
Conclusion
More research is needed on the capacity to consent to treatment of patients with depression, particularly suicidal individuals, to make informed choices about their treatment.

Treatment without consent in adult psychiatry inpatient units: a retrospective study on predictive factors
Giulia Meroni, Othman Sentissi, Stefan Kaiser, Alexandre Wullschleger
Frontiers of Psychiatry, 10 August 2023
Abstract
Background
Coercion is one of the most important challenges in mental health. In Switzerland, forced medication can be applied during an emergency (Art. 435 of the Civil Code) or over a longer period in case of endangerment of others or oneself (Art. 434). We aimed to analyze the predictors of this specific treatment without consent.
Methods
Forced medication prescriptions in the Division of Adult Psychiatry of the Geneva University Hospitals between 2018 and 2021 were retrospectively analyzed. Medication under Article 434 was the main outcome variable. Age, gender, admission mode, main diagnosis, and the Health of the Nation Outcome Scales (HoNOS) score at admission were considered as potential predictors. T-test and Pearson’s chi-square test were used to compare continuous and categorical variables. A logistic regression was performed to find significant predictors of forced medication.
Results
Seventy-one out of 4,326 inpatients were subjected to forced medication under Art. 434. HoNOS global scores at admission were not significantly different in the forced medication group compared to the control group. Aggressive behavior was lower in the former at the univariate level. Forced medication was associated at the multivariate level with female gender, involuntary admission, and psychosis.
Conclusion
Women suffering from psychosis are more at risk of receiving involuntary and repeated medication. The risk of deterioration in psychosocial functioning or behavioral disorganization seems to be the main argument for this coercive measure. Future studies should focus on the patient’s perception of this coercion to prevent it and improve adherence to care. Follow-up after discharge might be useful to evaluate a long-term benefit.