Applying the ‘Human Rights Model of Disability’ to Informed Consent: Experiences and Reflections from the SHAPES Project

Applying the ‘Human Rights Model of Disability’ to Informed Consent: Experiences and Reflections from the SHAPES Project
Richard Lombard-Vance, Evelyn Soye, Delia Ferri, Emma McEvoy, Malcolm MacLachlan, Sari Sarlio-Siintola
Disabilities, 14 January 2023; 3(1) pp 28-47
Abstract
Understanding the complexity of informed consent processes is critically important to the success of research that requires participants to test, develop, or inform research data and results. This is particularly evident in research involving persons experiencing neurodegenerative diseases (e.g., Alzheimer’s disease, dementia) that impair cognitive functioning, who according to national law are considered to have a diminished capacity, or to lack the capacity, to consent to research participation. Those who would potentially benefit most from applied research participation may be excluded from participating and shaping data and outcomes. This article offers insights into challenges faced by the Smart and Healthy Ageing through People Engaging in Supportive Systems (SHAPES) Project in obtaining the consent of older persons, including older persons with disabilities. The promotion of continuing health, active ageing, and independent living is central to SHAPES, requiring project partners to reflect on traditional informed consent approaches to encourage the full, cognisant participation of older persons with disabilities. We examine how this issue may be addressed, with reference to the inclusive approach of SHAPES. In respecting the inalienable legal capacity of all legal persons, SHAPES uses the UN Convention on the Rights of Persons with Disabilities (CRPD) and the human rights model of disability as part of the theoretical framework. A novel, inclusive, representative informed consent framework was designed and is detailed herein. This framework provides significant opportunity to advance the inclusion of persons with disabilities or those experiencing neurodegenerative diseases in innovative research and is readily transferable to other research studies. The SHAPES approach is a substantial contribution to research on informed consent, demonstrating the utility of the human rights model of disability in facilitating the full research participation of target populations.

Reification and assent in research involving those who lack capacity

Reification and assent in research involving those who lack capacity
Anna Smajdor
BMJ, 26 December 2022
Open Access
Abstract
In applied ethics, and in medical treatment and research, the question of how we should treat others is a central problem. In this paper, I address the ethical role of assent in research involving human beings who lack capacity. I start by thinking about why consent is ethically important, and consider what happens when consent is not possible. Drawing on the work of the German philosopher Honneth, I discuss the concept of reification—a phenomenon that manifests itself when we fail to observe or respond to our fellow humans’ need for recognition. I suggest that assent is a way of responding to this moral need for recognition, which exists independently of cognitive capacity. I will look at the circumstances in which consent cannot be obtained from human beings, and ask whether some of the same ethically important considerations that underpin the need for consent might be achieved through seeking assent. I discuss the ways in which this might be beneficial for researchers, for prospective research participants and for society at large.

Assessment of cognitive function among adults aged ≥ 60 years using the Revised Hasegawa Dementia Scale: cross-sectional study, Lao People’s Democratic Republic

Assessment of cognitive function among adults aged ≥ 60 years using the Revised Hasegawa Dementia Scale: cross-sectional study, Lao People’s Democratic Republic
Research
Sengchanh Kounnavong, Manithong Vonglokham, Somphou Sayasone, Vanthanom Savathdy, Emiko Masaki, Ryoma Kayano, Bounfeng Phoummalaysith, Boungnong Boupha, Nobuyuki Hamajima
Health Research Policy and Systems, 29 November 2022; 20(121)
Open Access
Abstract
Background
Rapid population ageing remains an important concern for health, social and economics systems; thus, a broader assessment of cognitive decline among adults aged ≥ 60 years is essential. It is important to regularly collect reliable data through validated and affordable methods from people living in different areas and in different circumstances to better understand the significance of this health problem. This study aimed to identify the prevalence of cognitive impairment and the related risk factors by reassessing the scoring of the Revised Hasegawa Dementia Scale among older adults in the Lao People’s Democratic Republic.
Methods
A community-based cross-sectional investigation was conducted in rural and urban settings in six districts of three provinces in the country from January to July 2020. In total, 2206 individuals aged 60–98 years (1110 men and 1096 women) were interviewed in person using a pretested Lao version of the Revised Hasegawa Dementia Scale and the WHO STEPwise approach to noncommunicable disease (NCD) risk factor surveillance (the STEPS survey tool). The adjusted odds ratios (AORs) and 95% confidence intervals (95% CIs) were estimated using a logistic model.
Results
The study found that 49.3% (1088/2206) of respondents (39.7% [441/1110] of men and 59.0% [647/1096] of women) had scores associated with some level of cognitive impairment. In addition to age, the following factors were significantly associated with cognitive impairment: having no formal education (AOR = 9.5; 95% CI: 5.4 to 16.8, relative to those with a university education), living in the northern region of the country (AOR = 1.4; 95% CI: 1.1 to 1.9, relative to living in the central region), living in a rural area (AOR = 1.5; 95% CI: 1.2 to 1.8), needing assistance with self-care (AOR = 1.8; 95% CI: 1.2 to 2.7) and being underweight (AOR = 1.5; 95% CI: 1.1 to 2.2). Factors associated with no cognitive impairment among older adults include engaging in moderate-intensity physical activity lasting for 10 minutes and up to 1 hour (AOR = 0.6; 95% CI: 0.5 to 0.8) and for > 1 hour (AOR = 0.6; 95% CI: 0.4 to 0.8).
Conclusions
Using the Lao version of the Revised Hasegawa Dementia Scale, this study found that more than half of adults aged ≥ 60 years had cognitive impairment, and this impairment was associated with several risk factors. The limitations of this study may include possible overdetection due to the cutoff point for the assessment of cognitive decline used in the Revised Hasegawa Dementia Scale, given that the participants were not familiar with the instrument. However, the study results can be used to help inform health policy in the Lao People’s Democratic Republic regarding the urgent need for a routine data collection system and for providing an environment that addresses and reduces the identified risk factors for cognitive decline to mitigate their impact.

Capacity to Consent of People with Dementia: a Narrative Review from an Ethical Perspective

Capacity to Consent of People with Dementia: a Narrative Review from an Ethical Perspective
Urfa Khairatun Hisan, Nurul Qomariyah, Kristina Elizabeth
Jurnal Profesi Medika, 2022
Abstract
People with dementia have impairment to execute daily life activities by presenting as a deterioration of mental processes, such as memory, thinking, reasoning, and judgment. Many participants in dementia research may lack the capacity to provide informed consent. Additional safeguards are needed for dementia research participants’ protection because of their vulnerability. Only after carefully weighing the risks and possible benefits for the participants in the research may it be decided to use vulnerable participants. The intention to prevent harm pushes against the removal of autonomy. This dilemma is the driving force behind this article’s narrative review of the capacity to consent problems in dementia research. For this critical narrative review, we conducted a thorough search of Scopus, PubMed, and Wiley Open Library for literature addressing the ethical and legal issues on the capacity to consent of people with dementia. We outline the dilemmas and difficulties that surround them including the related ethical principles, the informed consent process, capacity to consent, and safeguards for the participant in research involving people with dementia.

Editor’s note: Jurnal Profesi Medika is an Indonesian journal published by by the Faculty of Medicine UPN Veteran Jakarta

Importance of decisional capacity tools in obtaining informed consent in clinical settings

Importance of decisional capacity tools in obtaining informed consent in clinical settings
Original Article
Miroslav Radenković
Bioethics, 24 November 2022
Open Access
Abstract
Informed consent represents a specific protocol for obtaining consent from a fully informed human subject to take part in clinical research. Still, informed consent is not only required for clinical trials but it also represents a critical precondition before enrolment in standard everyday medical procedures. Relevant fundamental criteria for obtaining informed consent must be followed, and that is that patient must have the decisional capacity to reach autonomous decision. The patient must be adequately informed and not coerced. Evaluating decisional capacity is crucial to providing the required level of care. The decision of which decisional capacity tool to use can be challenging because of various dissimilarities among the instruments. In this paper, four widely documented instruments have been evaluated, namely, the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the Hopkins Competency Assessment Test (HCAT), the Structured Interview for Competency/Incompetency Assessment Testing, Ranking Inventory (SICIATRI), and the Capacity Assessment Tool (CAT). Some of them include a fully structured interview; semi-structured forms characterise others. Most of them are adaptable for different scenarios, and yet, some are tailored for specific treatment decisions. Some evaluate all four components of decisional capacity, while others do not. Although a broad range of capacity assessment tools is available, it has been shown that they notably improve the accuracy of capacity evaluations. Given that many pathological conditions could result in impaired decisional capacity, physicians must be able to correctly and consistently assess the capacity for which education and previous experience are pivotal.

Working in a gray area—Healthcare staff experiences of receiving consent when caring for persons with dementia

Working in a gray area—Healthcare staff experiences of receiving consent when caring for persons with dementia
Dementia, 15 November 2022
Research Article
Lena Östlund, Marie Ernsth Bravell, Linda Johansson
Abstract
Background
Every person has the right to autonomy, and to be involved in decisions about their care. When persons with dementia have difficulties in expressing what they want, their autonomy is challenged. Staff should strive to involve the person in care decisions, to obtain consent and to avoid the use of coercion and restraints. However, care without consent exists and coercion and restraints are being used. In order to improve care, further knowledge is warranted.
Aims
The purpose of this study was to explore staff’s experiences of obtaining consent when caring for persons with dementia.
Methods
In total 14 focus group interviews were conducted with staff with experience of dementia care who work in either home care or residential care in Sweden. An inductive qualitative content analysis was used to analyze the collected data.
Results
Three categories were generated describing staff experiences of consent in dementia care: the person as the decision-maker, the staff as the decision-makers, and the viability of the consent. Overall, staff found it difficult to know if they really had consent from the individual. Even if the person verbally gave consent, it was challenging to know if the person really understood what they had consented to. Common to all three categories was the significance of the relationship between the person with dementia and staff: getting to know the person, recognizing the person’s response in terms of their facial expressions and body language as well as being able to explain and justify specific actions to the person.
Conclusion
Staff need better conditions in dementia care, including training and time to reflect on how to obtain consent. A person-centered approach can be one way to develop care and ensure that persons with dementia are allowed autonomy and to share in making decisions.

Appropriate inclusion of adult research participants with intellectual disability: an in-depth review of guidelines and policy statements

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

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

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

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.