Appropriate inclusion of adult research participants with intellectual disability: an in-depth review of guidelines and policy statements
Review
Klara Meierer,Pascal Borry, Virginia Sanchini
Accountability in Research, 7 September 2022
Abstract
The history of human-subject experimentation has shown the need for safeguards to protect participants from abuse. Balancing participant protection with adequate representation of the adult intellectual disability population in research presents an important challenge. Our study aimed to analyze guidance on the appropriate inclusion of adults with intellectual disability who are or are not able to consent to biomedical research participation. Terminology, consent and type of ethically acceptable research provisions relevant to adult participants with intellectual disability were comprehensively reviewed in a selection of 17 international and national ethical research guidelines and statements. Most guidelines and statements recommend that adult participants with intellectual disability who are unable to consent be included when it is not possible to conduct the same research with adults capable of independent decision-making, or when there is therapeutic benefit and only minimal risk. Instead of naming specific requirements, the Australian statement stands out by asserting the “individual right” to participate. Assent requirements for incapacitated adults are not explicitly mentioned in most documents reviewed. There appears to be room for further description of the importance of careful capacity assessments and solid assent requirements in ethical research guidance documentation to promote meaningful participation of adults with intellectual disability.

Surrogate consent for surgery among older adult patients
Samuel M. Miller, Nupur Nagarkatti, Vanita Ahuja, Eric B. Schneider, Sanjay Mohanty, Ronnie A. Rosenthal, Lisa M. Kodadek
Surgery, 2 February 2022; Academic Surgical Congress Presentation
Abstract
Background
Surrogate consent for surgery is sought when a patient lacks capacity to consent for their own operation. The purpose of this study is to describe older adults who underwent surgical interventions with surrogate consent.
Methods
A descriptive analysis was performed using data from the American College of Surgeons National Surgical Quality Improvement Program Geriatric Surgery Pilot collected from 2014 to 2018. All patients included were ≥65 years old and underwent a surgical procedure. Demographic and preoperative health characteristics were evaluated to examine differences between those with and without surrogate consent.
Results
In total, 51,618 patients were included in this study, and 6.6% underwent an operation with surrogate consent. Surrogate consent was more common among older patients (median age 83 vs 73, P < .001), female patients (7.7% vs 5.3%, P < .001), patients undergoing emergency as opposed to elective procedures (21.9% vs 1.6%, P < .001), patients with cognitive impairment (50.5% vs 2.4%, P < .001), and patients who were dependent on others for activities of daily living (41.9% vs 4.1%, P < .001). Nearly half of patients with a diagnosis of cognitive impairment signed their own consent.
Conclusion
Surrogate consent was more common among patients who were older, female, had a higher comorbidity burden, and had preoperative disability. Nearly half of patients with documented cognitive impairment signed their own consent. These results indicate that further research is needed to understand how surgeons determine which patients require surrogate consent.

Inclusive Design: Exploring Accessible Informed Consent for People With Aphasia
Masters Thesis
Geena June Stanley
Auckland University of Technology, Master of Design, 2022
Abstract
This research explores how information design and typographic approaches can help create accessible participant information sheets for people with aphasia to ensure they can be included in research. There are worrying statistics that individuals with communication impairments post-stroke are often excluded from research due to perceptions of vulnerability, and that they do not have the decision-making capacity to provide informed consent. These exclusions have the potential to create health disparities for people with aphasia and contribute to existing generalisations in stroke research that can have a negative impact on the care they receive. Participant information sheets were prototyped using a human-centred design approach by adhering to the information design principles of accessibility and inclusiveness. The prototypes were presented to people with aphasia for feedback to ensure the readability, comprehension, and design preferences were appropriate and accessible to the targeted audience. The outcome of the research was a refined set of prototype participant information sheets that ensure greater accessibility to research for people with aphasia. This research found that implementing information design and typographic principles to participant information sheets for people with aphasia can facilitate their inclusion in research through their readability.

Valid informed consent and decision-making capacity in clinical trials
Discussion
Vittoria Sorice, Louise Burton, Amy Neal, Jodie Bradder
Nursing Times, 1 August 2022; 118(8)
Abstract
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
Viewpoint
David Wendler
JAMA, 23 June 2022; 328(3) pp 243-244
Excerpt
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
Open Access
Abstract
Objective
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.
Methods
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.
Results
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).
Conclusions
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
Victoria Shepherd
BMC Medical Ethics, 18 July 2022; 23(75)
Open Access
Abstract
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
Book Chapter
Dede Ukueberuwa O’Shea, Nicolette Gabel, Sarah Aghjayan, Maximilian Shmidheiser, Ross Divers
A Casebook of Mental Capacity in US Legislation, 2022 [Routledge]
Abstract
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
Book Chapter
Kevin Mintz, David Wasserman
The Disability Bioethics Reader, 2022 [Routledge]
Abstract
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
Research Article
Kate de Medeiros, Laura M. Girling, Nancy Berlinger
Dementia, 1 March 2022
Open Access
Abstract
Background
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.
Purpose
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.
Results
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.
Conclusions
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.