Valid informed consent and decision-making capacity in clinical trials
Vittoria Sorice, Louise Burton, Amy Neal, Jodie Bradder
Nursing Times, 1 August 2022; 118(8)
There are ethical and legal requirements involved in the consent process for research involving human participants. The Mental Capacity Act 2005 introduced a framework outlining how choices should be made by, and on behalf of, people lacking decision-making capacity. This ensures vulnerable groups are protected from being enrolled into clinical studies without their informed consent, and gives people access to studies that are of benefit to themselves and the field of clinical research.
Promoting the Values for Surrogate Decision-making
JAMA, 23 June 2022; 328(3) pp 243-244
The process of making medical decisions used to be straightforward. Clinicians selected the treatment course they determined would best promote the patient’s interests. More recently, in response to increased emphasis on individual autonomy, it is the patient, in consultation with their clinicians and loved ones, who makes medical decisions. This approach respects patients who are able to make their own treatment decisions. However, it poses a challenge for the many adult patients who are unable to understand the information relevant to the decision in question, reason in light of this information and their own values, make a voluntary decision on this basis, or communicate their decision…
Inclusion of older adults and reporting of consent processes in randomized controlled trials in the emergency department: A scoping review
Lauren T Southerland, Katherine K. Benson, Austin J. Schoeffler, Margaret A. Lashutka, Soo Borson, Jason J. Bischof
Journal of the American College of Emergency Physicians Open, May 2022
Conducting research in the emergency department (ED) is often complicated by patients’ acute and chronic illnesses, which can adversely affect cognition and subsequently capacity to consent for research, especially in older adults. Validated screening tools to assess capacity to consent for research exist, but neither the frequency of use nor which ones are used for ED research are known.
We conducted a scoping review using standard review techniques. Inclusion criteria included (1) randomized controlled trials (RCTs) from publication years 2014–2019 that (2) enrolled participants only in the ED, (3) included patients aged 65+ years, and (4) were fully published in English. Articles were sourced from Embase and screened using Covidence.
From 3130 search results, 269 studies passed title/abstract and full text screening. Average of the mean or median ages was 55.7 years (SD 14.2). The mean number of study participants was 311.9 [range 8–10,807 participants]. A few (n = 13, 4.8%) waived or had exception from informed consent. Of the 256 studies requiring consent, a fourth (26.5%, n = 68) specifically excluded patients due to impaired capacity to consent. Only 11 (4.3%) documented a formal capacity screening tool and only 13 (5.1%) reported consent by legally authorized representative (LAR).
Most RCTs enrolling older adults in EDs did not report assessment of capacity to consent or use of LARs. This snapshot of informed consent procedures is potentially concerning and suggests that either research consent processes for older patients and/or reporting of consent processes require improvement.
(Re)Conceptualising ‘good’ proxy decision-making for research: the implications for proxy consent decision quality
BMC Medical Ethics, 18 July 2022; 23(75)
People who are unable to make decisions about participating in research rely on proxies to make a decision based on their wishes and preferences. However, patients rarely discuss their preferences about research and proxies find it challenging to determine what their wishes would be. While the process of informed consent has traditionally been the focus of research to improve consent decisions, the more conceptually complex area of what constitutes ‘good’ proxy decision-making for research has remained unexplored. Interventions are needed to improve and support proxy decision-making for research but are hampered by a lack of understanding about what constitutes decision quality in this context. A global increase in conditions associated with cognitive impairment such as dementia has led to an urgent need for more research into these conditions. The COVID-19 pandemic and subsequent necessity to conduct research with large numbers of critically ill patients has made this need even more pressing. Much of the empirical research centres on the desire to improve decision accuracy, despite growing evidence that authenticity is more reflective of the aim of proxy decisions and concerns about the methodological flaws in authenticity-focused studies. Such studies also fail to take account of the impact of decision-making on proxies, or the considerable body of research on improving the quality of healthcare decisions. This paper reports a concept synthesis of the literature that was conducted to develop the first conceptualisation of ‘good’ proxy decisions about research participation. Elements of decision quality were identified across three stages of decision-making: proxy preparedness for decision-making which includes knowledge and understanding, and values clarification and preference elicitation; the role of uncertainty, decisional conflict, satisfaction and regret in the decision-making process; and preference linked outcomes and their effect. This conceptualisation provides an essential first step towards the future development of interventions to enhance the quality of proxy decision-making and ensure proxy decisions represent patients’ values and preferences.
Guiding Principles and Common Pitfalls of Capacity Assessment
Dede Ukueberuwa O’Shea, Nicolette Gabel, Sarah Aghjayan, Maximilian Shmidheiser, Ross Divers
A Casebook of Mental Capacity in US Legislation, 2022 [Routledge]
Psychologists must consider many complexities of professional practice and individual rights when conducting capacity assessments. This chapter reviews principles and standards that guide psychologists in conducting these evaluations. This chapter provides an overview of foundational abilities of an individual’s decisional capacity according to contemporary models, followed by a discussion of the widely accepted assumptions of decisional capacity assessment: inclusivity, decision-relativity, all-or-nothing assessment, value neutrality, and independence from diagnosis. In conducting capacity assessments, psychologists will also benefit from an understanding of the key bioethics principles of autonomy, beneficence, nonmaleficence, justice, informed consent, and voluntarism. This chapter then reviews specific standards of ethical practice relevant to capacity determinations that are outlined by the American Psychological Association (APA) and medical organizations. This chapter provides details on informed consent procedures in the context of evaluating decisional capacity, as well as standards that describe the need to practice within boundaries of competence, handle third party request for services, cooperate with other professionals, maintain confidentiality and make ethical disclosures, and limit conflicts of interest. Finally, this chapter discusses common pitfalls that psychologists may face when conducting capacity assessments and outline recommendations for best practices in gathering information and working with patients of diverse histories.
Research Ethics and Intellectual Disability
Kevin Mintz, David Wasserman
The Disability Bioethics Reader, 2022 [Routledge]
This chapter focuses on the exclusion of people with cognitive disabilities from research that is not related to their disabilities. Wasserman and Mintz argue that despite real limitations with regard to consent (most people with cognitive disabilities will only be able to assent), denying people with cognitive disabilities the ability to participate in research is largely unjustifiable. Moreover, it has effects that ought to be avoided namely, moral harm of persons with cognitive disabilities and increased vulnerability to abuses and violations when they do participate in research. Wasserman and Mintz argue that there is no good reason to exclude people with cognitive disabilities on the basis of their limitations, especially because people of similar cognitive ages are able to participate in research.
Inclusion of people living with Alzheimer’s disease or related dementias who lack a study partner in social research: Ethical considerations from a qualitative evidence synthesis
Kate de Medeiros, Laura M. Girling, Nancy Berlinger
Dementia, 1 March 2022
Because use of a study partner (proxy decision-maker) to give informed consent on behalf of someone living with Alzheimer’s disease or related dementias (ADRD) is common in nearly all clinical research, people living with ADRD who lack a study partner are regularly excluded from participation. Social research presents different opportunities and risks than clinical research. We argue that guidelines developed for the latter may be unduly restrictive for social research and, further, that the automatic exclusion of people living with ADRD presents separate ethical challenges by failing to support extant decision-making capacity and by contributing to underrepresentation in research.
The study objective was to identify key components related to including cognitively vulnerable participants who lack a study partner in social research.
Research design/Study sample
We conducted an adaptive qualitative evidence synthesis (QES) and subsequent content analysis on 49 articles addressing capacity and research consent for potentially cognitively compromised individuals, to include people living with ADRD, who lack a study partner.
We identified four major topic areas: defining competency, capacity, and consent; aspects of informed consent; strategies to assess comprehension of risks associated with social research; and risks versus benefits.
Based on findings, we suggest new and ethically appropriate ways to determine capacity to consent to social research, make consent processes accessible to a population experiencing cognitive challenges, and consider the risks of excluding a growing population from research that could benefit millions.
The Capacity to be an Expert: Considerations of decision-making assessment for geriatric psychiatrists
Greg Sullivan, Greg Lannuzzi, Joel Kamper
The American Journal of Geriatric Psychiatry, April 2022; 30(4) pp S13-S14
Obtaining valid consent for treatment is predicated on a patient’s ability to make an informed decision, and capacity decisions involve a balance between respecting patients’ autonomy with protecting those with cognitive (and other) impairments. Given the importance of informed consent and the low rates with which clinical teams identify incapacity, it is critically important for geriatric mental health providers to competently identify and evaluate patients with capacity concerns. This need is particularly acute for complex cases, where the presence of medical and cognitive comorbidities can make capacity determination challenging.
Furthermore, while statutes often provide physicians with a legal means for civil commitment of patients lacking decisionmaking capacity, these mechanisms typically mandate the presence of a contributory mental illness. However not all conditions which affect medical decision-making capacity are psychiatric. Hospitalized medically ill patients frequently request discharge prior to being medically appropriate to do so, placing themselves at risk. To proceed with discharge respects a patient’s right to autonomy at the expense of patient safety and provider liability. To detain the patient against their wishes may be medically justifiable, but can be detrimental. State statutes provide little guidance about how to proceed in this situation, and geriatric providers should be aware of the pertinent legal and practical considerations for clinicians facing this arduous decision.
An additional challenge to geriatric mental health involves sexual decision-making and questions of incapacity. Supporting the need for intimacy remains a vital element of long-term care, and great responsibility rests upon the care team to ensure that autonomy, the right to sexual expression, and freedom of intimacy are allowed. However while these principles must be respected, they may present unique challenges in settings where one or more of the participants are diagnosed with a neurocognitive disorder and in long-term care settings. In these instances the traditional elements of informed consent required to demonstrate decision-making capacity must be expanded and adapted.
Negotiating Research Participant Consent With, for and by Adults With Developmental Disabilities in Interaction With Their Third-Party Consent Providers
Nick Boettcher, Camille Duque, Bonnie M. Lashewicz
International Journal of Qualitative Methods, 13 March 2022
We illuminate third-party research participant consent with, for, and by adults with developmental disabilities by examining consent as an iterative, ongoing process. We use an instrumental case study of three adults with developmental disabilities who, together with their third-party consent providing parents, participated in a broader conversation and video analysis study of how family members are part of decision-making by adults with developmental disabilities. Adults with developmental disabilities comprising our case demonstrated discomfort that left us with questions about the relational nature of third-party consent. We performed a directed content analysis of transcripts and video data corresponding to moments of discomfort, resulting in categories of one- distress, two- non-disclosure, and three- evasion. Our findings illustrate ambiguities where consent was at stake and where there appeared to be no ultimate “Yes” or “No” interpretation. We conclude that expressions of resistance to research participation by adults with developmental disabilities displayed in our data were assertions of autonomy that occurred in relation, yet ran counter to, the agendas of researchers and third-party consent providing parents. We offer recommendations for researchers in the developmental disability field and for qualitative researchers more broadly who might encounter similar ambiguities amidst the relational workings of consent. Greater analytic attention to the relational dynamics of consent has potential to expand ethical commitments of qualitative researchers beyond the limited range of meanings offered in ethics board approvals and signed consent forms.
New injectable antiretroviral therapy for HIV facilitates novel treatment pathways for persons without capacity to consent to medical treatment
Kirbie Storrier, Calina Ouliaris, Duncan George
Australasian Psychiatry, 13 March 2022
The development of new injectable antiretroviral therapy facilitates treatment for Human immunodeficiency virus (HIV) positive individuals who lack capacity to consent, posing a safety risk to both themselves and the wider community. We consider pathways to enforce treatment and propose an algorithm to determine the most appropriate legal instrument for application.
Legislative safeguards in mental health and guardianship legislation provide oversight and protection for those who suffer from illness and require coercive treatment. These frameworks have utility in the treatment of HIV patients who lack capacity to consent to treatment.