Inclusion of people with learning disabilities in clinical research: Results of the HOLD study

Adults with learning disabilities have poorer health outcomes than those who do not. They are typically excluded from clinical research, and funding formulas do not allow for sufficient reasonable adjustments to be made. This study aimed to better understand how to improve inclusion of adults with learning disabilities in clinical research, and what adjustments are most needed to allow this to happen.

Twelve focus groups were conducted for 53 participants. Seven focus groups included 25 people with learning disabilities, four family members and four carers, and five focus groups included 18 health and social care professionals. Ten focus groups were conducted face to face and two virtually. All participants lived or accessed a service within Hampshire or Isle of Wight.

Data was analysed using reflexive thematic analysis. Key themes were ensuring informed consent, adequate information about potential risks to participation and how to report these risks should they occur and ensuring the availability of trusted support staff to aid participation. Examples of adjustments included offering longer appointments, flexibility with scheduling appointments, using an accessible location and having research staff with skills in working with people with learning disabilities. In addition, researchers should consider reimbursing additional support staff costs that would otherwise be borne by the participant. These adjustments could help shift clinical research away from excluding individuals with learning disabilities, towards more equitable participation. This would ensure people with learning disabilities are not only appropriately protected within clinical research studies, but also meaningfully included.