Disabilities | Free Full-Text | Applying the ‘Human Rights Model of Disability’ to Informed Consent: Experiences and Reflections from the SHAPES Project

By inergency On Jan 28, 2024

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Demographic changes occurring across the European Union mean that, by 2050, the population aged 65 years or more will increase to almost 130 million [1] (p. 16). By 2070, it is estimated that 30% of the European population will be aged 65 or more, up from approximately 20% currently, while the proportion of the population over 80 years is projected to double [2] (p. 10). In the last 50 years, life expectancy has increased by about 10 years for both men and women [2] (p. 7). However, longer lifespans are associated with a greater prevalence of chronic diseases and physical, sensory, and cognitive impairments, which, in interaction with social and environmental barriers, may give rise to disability [3,4]. Relatedly, according to the European Commission’s Report on the Impact of Demographic Change, people aged over 65 account for the majority of the 50 million EU citizens who suffer from two or more chronic conditions [2] (p. 18). Therefore, while Europeans are living longer, the promotion of higher quality of life and more years spent in good health and well-being is crucial.

The SHAPES Project

The promotion of continuing health, active ageing, and independent living is at the core of the Smart and Healthy Ageing through People Engaging in Supportive Systems (SHAPES) Project. SHAPES is a response to the European Commission’s funding call, Trusted digital solutions and Cybersecurity in Health and Care (H2020-SC1-FA-DTS-2018–2020). SHAPES is a four-year project (November 2019–October 2023) that endeavours to build, pilot, and deploy a large-scale, pan-European platform and care ecosystem that will provide a range of supports to older persons, including older persons with disabilities, to facilitate healthy and independent living. The SHAPES Platform is designed to be a standardised, interoperable, and scalable platform for the integration of smart technologies. The SHAPES Platform has three core functions: to collect and analyse data relating to individuals’ health, environments, and lifestyles; to identify needs on an ongoing basis; and to provide reliable, trustworthy, and affordable recommendations and solutions in return. Individual technological solutions in the SHAPES projects, such as social robots, aim to specifically address users’ requirements and expectations regarding supporting and extending older adults’ independent living and active and healthy ageing at home. With this shared objective, the project brings together thirty-six partner organisations and research institutions, across fourteen European countries, with expertise in health, social sciences, IT development, robotics, health and social service provision, advocacy, ethics, and law.

The SHAPES Platform will be co-developed based on ethnographic research of older adults’ lifeworlds; organisational, structural, and sociotechnical perspectives on integrated care delivery; and a set of technological requirements to accommodate an open and interoperable ecosystem of digital technologies designed to support and extend the independent living of older individuals, including older individuals with disabilities. Subsequently, commencing in the final quarter of 2022, the SHAPES Platform will undergo validation via a multidisciplinary, large-scale piloting campaign. Pilots will involve over 2000 older adults across fifteen pilot sites in ten states (nine EU Member States and Northern Ireland), including six reference sites of the European Innovation Partnership on Active and Healthy Ageing. Pilots will be conducted with multiple technology use-cases across seven themes:

(1): Smart Living Environment for Healthy Ageing at Home;
(2): Improving In-Home and Community-based Care;
(3): Medicine Control and Optimisation;
(4): Psycho-social and Cognitive Stimulation Promoting Well-being;
(5): Caring for Older Individuals with Neurodegenerative Diseases;
(6): Physical Rehabilitation at Home;
(7): Cross-border Health Data Exchange Supporting Mobility and Accessibility for Older Individuals.

SHAPES operates within defined ethical and legal frameworks to protect both researchers’ and participants’ fundamental rights, privacy, and personal data. SHAPES adopts an inclusive and person-centred approach. Furthermore, it is informed by the human rights model of disability, which underpins the United Nations (UN) Convention on the Rights of Persons with Disabilities (CRPD) [5]. The CRPD is the leading international law instrument on the rights of persons with disabilities, affirming that persons with disabilities must enjoy all human rights and fundamental freedoms and recognising their human dignity (Article 1 CRPD). By adopting a social-contextual perspective on disability [6], the CRPD recognises attitudinal and environmental barriers as being the source of disablement. The CRPD places the focus on persons with disabilities as the subjects of rights, rather than being considered as objects of rights, charity, or medical interventions [7] (e.g., p. 316). Central to this is Article 12 CRPD which enshrines the principle that persons with disabilities must be given equal recognition before the law. In particular, States Parties are obliged to recognise that persons with disabilities “enjoy legal capacity on an equal basis with others in all aspects of life” (Article 12(2)). Article 12 CRPD encompasses both legal personality (i.e., being able to bear rights and duties under law) and the capacity to act. While many national regimes still consider a person not to have legal capacity where a cognitive or psychosocial disability is considered to impair an individual’s decision-making or “mental capacity”, the Convention differentiates between mental capacity and legal capacity (CRPD Committee, General Comment, para 15). Mental capacity refers to the individual’s psychological abilities, whereas legal capacity refers to the legal recognition of the individual and their decisions. Furthermore, and for the purpose of this article, it is worth recalling that Article 25 CRPD, which provides for the equal right to health, states that healthcare providers must not discriminate against persons with disabilities, including on the basis of free and informed consent (CRPD, Article 25(d)).

Consistent with its purpose and ethos, the project is seeking inclusive participation in the design and development process, in particular in the piloting of the SHAPES Digital Technologies, i.e., the set of technologies, systems, and mobile applications that are part of the SHAPES Platform. The research conducted includes participants living across 10 EU Member States (Czech Republic, Cyprus, Finland, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden) and the UK, whether in their own homes or in residential care facilities, experiencing permanent or temporary impairments and neurodegenerative diseases impacting on their cognitive functioning, such as Alzheimer’s disease or dementia. As well as such specific populations, the SHAPES research cohorts of older adults may conceivably also include individual participants who have a history of acquired brain injury, stroke, transient ischaemic attack, or other health conditions that may have precipitated cognitive impairment, or that may do so in the future. The project seeks to align with the human rights model of disability and to realise a participatory approach that will permeate its various facets including, inter alia, SHAPES governance, research and piloting, and the development and deployment of the Integrated Platform. SHAPES aims to take into consideration the ability of each individual to make decisions concerning their participation, and endeavours to implement the human rights approach and the paradigm shift in legal capacity brought about by the CRPD. This has required us to reflect in particular on our approach to informed consent, in order to ensure full and cognisant participation of older persons with disabilities in the project.

The above-mentioned factors—pan-European research, inclusive ethos, the human rights model of disability, participatory research, inclusion of persons who may have cognitive impairment, and so on—make the experience of constructing the SHAPES Project’s informed consent process a valuable one. This article discusses the challenges and the strengths related to the inclusive participation sought in SHAPES, with the involvement of service recipients usually referred to as “vulnerable adults”, paying particular attention to informed consent. In that regard, the whole SHAPES Project recognises that the concept of vulnerability is “an open-textured, ambiguous and elusive notion which is used in many different disciplines” [8] (p. 780). If understood as exposure to risk, it is argued that vulnerability is a universal experience [9]. This may be contrasted with the view that certain groups within society are inherently vulnerable by virtue of certain characteristics. However, Herring considers that acknowledging that individuals’ experiences of vulnerability are not equal allows us to reconcile these ostensibly competing schools of thought [10]. SHAPES uses the term “individuals experiencing vulnerability”, linking the idea of vulnerability to the inherent vulnerabilities of human beings [9], but also to structural inequalities and barriers faced by specific cohorts.

There is a wealth of research on informed consent in social and health science [11,12,13]. There is also an array of research on informed consent in research taking place in residential care facilities [14]. While building on that research, this article aims to adopt a disability perspective and uses the human rights model of disability and the CRPD as part of the theoretical framework. In light of that connection, this article aligns with CRPD terminology and prefers the term “persons with disabilities”/“older persons with disabilities”, albeit using the term “vulnerable adults” when referring to research on informed consent.

Further to these introductory remarks, Section 2 briefly recalls the human rights model of disability. Section 3 briefly highlights the growing scholarship on participatory research, as well as “patient” and public involvement (PPI) of vulnerable adults in research. Section 4 focuses on informed consent and the participation of persons whose legal capacity is restricted by national law, while Section 5 examines how this issue may be addressed, with reference to the inclusive approach adopted in the SHAPES Project.

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