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.