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

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.