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.
Factorial Structure of Nursing Practices Related to Support for Decision-Making Regarding Consent for Surgery in Elderly Patients with Dementia
Sachiko Matsui, Miwa Yamamoto
Yonago Acta Medica, 22 February 2022; 65(1) pp 70–81
When elderly patients with dementia require highly invasive treatment or surgery for lifethreatening conditions, decisions regarding consent for surgery are made based on informed consent provided by the family, which excludes the patient whose decision-making ability is deemed impaired due to the dementia. This study aimed to clarify the factorial structure of nursing practices related to support for decision-making regarding consent for surgery in elderly patients with dementia.
An anonymous self-administered questionnaire survey was completed by nurses with three or more years of experience working in orthopedic surgery wards at secondary emergency hospitals in the Kinki area. The survey collected data on participant attributes and nursing practices related to decision-making support. Data were analyzed by exploratory factor analysis (promax rotation) using nursing practice items related to decision-making support as variables. Internal consistency was examined.
Participants were 112 nurses including 108 women (96.4%) and four men (3.6%), with a mean age of 38.3 (±SD 9.8) years. Exploratory factor analysis of the nursing practice items related to decision-making support demonstrated the validity of the observed 24 variables, with a Kaiser-Meyer-Olkin value of 0.858 and a significant Bartlett’s test of sphericity (P < 0.001). Five components with eigenvalues of 1 or more were extracted, including “achieving advocacy for elderly patients with dementia through cooperation among medical professionals,” “advice considering the lifestyles and values of patients and their families,” “support with a deeper understanding of elderly patients with dementia,” “support that helps elderly patients with dementia to express their intentions,” and “nurses’ attendance in IC sessions for elderly patients with dementia.” The Cronbach’s α coefficient for the 24 nursing practice items related to decision-making support was high, at 0.926.
The factorial structure of nursing practice related to support for decision-making regarding consent for surgery in elderly patients with dementia included five factors and 24 items. The reliability and construct validity of the factorial structure were also confirmed.
Editor’s note: Yonago Acta Medica (YAM) is a peer-reviewed journal, specializing in medical sciences, published by Tottori University Medical Press, Japan.
Empowering patients with dementia to make legally effective decisions: a randomized controlled trial on enhancing capacity to consent to treatment
Aoife Poth, Susanne Penger, Maren Knebel, Tanja Müller, Johannes Pantel, Frank Oswald, Julia Haberstroh
Aging & Mental Health, 6 January 2022
As our society ages, the incidence of age-related diseases increases and with it the number of medical treatments that require informed consent. Capacity to consent is often categorically questioned in persons with dementia (PwD) without appropriate assessment, depriving them of their right to autonomous decision-making. Supportive structures for PwD that comply with legal requirements are lacking. The EmMa project tried to overcome this shortcoming by developing and testing possible supportive measures to enhance the informed consent process for PwD.
These enhanced consent procedures (ECPs) were tested in a randomized controlled trial with 40 PwD. It was hypothesized that strengths-based ECPs could improve capacity to consent to a drug treatment in PwD as measured with a semi-structured interview.
Against the expectations, no effect of the ECPs on capacity to consent could be found, but the ECPs improved understanding of information in PwD.
To empower PwD in clinical settings, however, all aspects of capacity to consent should be targeted with specific aids that are implemented carefully and selectively. More research on possible aids for ECPs is urgently needed in order to enable ethically and legally robust informed consent. In particular, effective ways to improve both reasoning and appreciation are yet to be found.
Capacity to consent to treatment in psychiatry inpatients – a systematic review
Aoife Curley, Carol Watson, Brendan D. Kelly
International Journal of Psychiatry in Clinical Practice, 23 December 2021
Mental capacity for treatment decisions in psychiatry inpatients is an important ethical and legal concern, especially in light of changes in mental capacity legislation in many jurisdictions.
To conduct a systematic review of literature examining the prevalence of mental capacity for treatment decisions among voluntary and involuntary psychiatry inpatients, and to assess any correlations between research tools used to measure mental capacity and binary judgements using criteria such as those in capacity legislation.
We searched PsycINFO, Ovid MEDLINE and EMBASE for studies assessing mental capacity for treatment decisions in people admitted voluntarily and involuntarily to psychiatric hospitals.
Forty-five papers emanating from 33 studies were identified. There was huge variability in study methods and often selective populations, but the prevalence of decision-making capacity varied between 5% and 83.7%. These figures resulted from studies using cut-off scores or categorical criteria only. The prevalence of decision-making capacity among involuntary patients ranged from 7.7% to 42%, and among voluntary patients ranged from 29% to 97.9%. Two papers showed positive correlations between clinicians’ judgement of decision-making capacity and scores on the MacArthur Competence Assessment Tool for Treatment; two papers showed no such correlation.
Not all voluntary psychiatry inpatients possess mental capacity and many involuntary patients do. This paradox needs to be clarified and resolved in mental health legislation; supported decision-making can help with this task.
Doing research with intellectually disabled participants: reflections on the challenges of capacity and consent in socio-legal research
Journal of Law and Society, 16 December 2021
In this article, I reflect on the praxis of doing qualitative interview research involving intellectually disabled people as participants. I explore the ways in which ethical and legal norms work together to shape what is possible in research with intellectually disabled participants. I use stories from the field to explore issues of recruitment and sampling, working with ‘gatekeeper’ organizations, accessible information and informed consent, and data sharing and open access. As these reflections demonstrate, undertaking fieldwork involving intellectually disabled participants presents multiple challenges for socio-legal researchers. They also show that many of the challenges are surmountable, offering concerns, considerations, and solutions that can, and perhaps should, be considered by all socio-legal researchers who wish to ensure that all of the voices of society are included and reflected in their research.
Doctors’ knowledge regarding decision-making capacity: A survey of anesthesiologists|
Alastair Moodley, Ames Dhai
Clinical Ethics, 6 December 2021
Informed consent for anesthesia is an ethical and legal requirement. A patient must have adequate decision-making capacity (DMC) as a prerequisite to informed consent. In determining whether a patient has sufficient DMC, anesthesiologists must draw on their knowledge of DMC. Knowledge gaps regarding DMC may result in incorrect assessments of patients’ capacity. This could translate to an informed consent process that is ethically and legally unsound. This study examined the DMC-related knowledge of anesthesiologists in a group of four university-affiliated hospitals. The findings suggest that anesthesiologists have several areas of knowledge deficiency regarding DMC and DMC assessment. These findings could inform the development of undergraduate and postgraduate curricula.