Mental capacity to consent to research? Experiences of consenting adults with intellectual disabilities and/or autism to research

Abstract

Accessible Summary• The NHS Constitution states that all patients should have opportunity to take part in approved research • This study asked clinical researchers how they include people with intellectual disabilities and/or autism in research • Many barriers were identified that relate to making mental capacity judgements • Many researchers agreed new resources that support consent and capacity judgements for research would be helpful and gave some ideas about what could help. AbstractBackground: Adults with intellectual disabilities and/or autism are often excluded from participating in health and healthcare research. Understanding study information, which is an important aspect of demonstrating capacity to give informed consent, can be a particular challenge. This study surveyed clinical researchers to discover: (i) their experiences of assessing mental capacity for research; (ii) what methods they used to facilitate the inclusion of adults with intellectual disabilities and/or autism; and (iii) their views about a proposal to develop new resources to facilitate mental capacity judgements with adults with intellectual disabilities and/or autism for informed consent for research. Methods: Clinical researchers in North East England who conduct research with NHSpatients with intellectual disabilities and/or autism were invited to participate in a 22item self-completed semi-structured questionnaire survey, either online or on paper.Results: Twenty-one clinicians completed the survey (response rate 30.4%).Participants reported on 18 research studies which included people with intellectual disabilities and/or autism. In many studies people who lacked capacity to give informed consent were excluded, and often shortcuts were taken in judging capacity.Limited adaptations to support capacity were used. Respondents welcomed the proposal of developing assistive resources that could support capacity judgements and informed consent to research. Conclusions:To improve access to research for people with intellectual disabilities and/or autism, researchers need robust methods to facilitate informed consent and | 231 HAMILTON eT AL.

Predictors of quality of life for autistic adults

“…Given the subjective nature of QoL it may be, prima facie, that proxy‐reports cannot be a valid substitute for a first person rating. However, adults with intellectual disability are frequently excluded from research due to issues with obtaining valid informed consent [Hamilton et al, ]. As such, this excludes a portion of the autism community from being recognized in QoL research.…”

Can sensory integration have a role in multi‐element behavioural intervention? An evaluation of factors associated with the management of challenging behaviour in community adult learning disability services

“…For example, individuals present with different levels of learning disability, it is associated with other disorders (Smith & Matson, ) and some present with CB. Due to the complexity of the issue and perceived difficulty with gaining consent for participation in studies, there is emerging evidence to suggest that people with a learning disability and autism spectrum disorder (ASD) are specifically excluded from healthcare research (Hamilton et al, ). In addition, the study of sensory integration (Watling & Hauer, ) is a new and developing area, which is also under‐researched amongst adults with learning disability (May‐Benson & Kinnealey, ).…”

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

“…The disconnect between established approaches to providing care for populations who lack capacity, and approaches to the design and conduct of trials involving them, creates a conflict between the care and clinical trial paradigms that acts as a barrier to their inclusion [60]. Person-centred approaches to health care focus on flexibility and relationality through treating people as individuals, respecting their rights as persons, building mutual trust and understanding, and developing relationships [61].…”

“…In stark contrast, there is little explicit attention paid to the concept of person-centredness in trials involving these same populations [62]. Researchers conducting trials with adults with intellectual disabilities and/or autism identified the need to embrace a range of person-centred approaches, particularly around consent processes, to ensure trials are more inclusive [60]. Adopting these approaches, particularly the tailoring of information provision and consent processes, the use of decision aids and visual aids to improve cognitive accessibility, and revisiting consent after data collection, are key to successful trials involving adults lacking capacity [60].…”

“…Researchers conducting trials with adults with intellectual disabilities and/or autism identified the need to embrace a range of person-centred approaches, particularly around consent processes, to ensure trials are more inclusive [60]. Adopting these approaches, particularly the tailoring of information provision and consent processes, the use of decision aids and visual aids to improve cognitive accessibility, and revisiting consent after data collection, are key to successful trials involving adults lacking capacity [60]. A framework for person-centred research has been proposed that aims to move beyond traditional research governance approaches to consent which focuses on the 'protection of vulnerable people' and the signing of a consent form [62].…”