How are adults with capacity-affecting conditions and associated communication difficulties included in ethically-sound research? A documentary-based survey of ethical review and recruitment processes under the research provisions of the Mental Capacity Act (2005) for England and Wales

Bunning, Karen ORCID: https://orcid.org/0000-0002-7396-9205, Jimoh, Oluseyi Florence, Heywood, Rob, Killett, Anne, Ryan, Hayley, Shiggins, Ciara and Langdon, Peter E. (2022) How are adults with capacity-affecting conditions and associated communication difficulties included in ethically-sound research? A documentary-based survey of ethical review and recruitment processes under the research provisions of the Mental Capacity Act (2005) for England and Wales. BMJ Open, 12 (3). ISSN 2044-6055

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Abstract

Objectives: This study aimed to determine the characteristics of ethical review and recruitment processes, concerning the inclusion of adults with capacity-affecting conditions and associated communication difficulties in ethically-sound research, under the provisions of the Mental Capacity Act (MCA, 2005) for England and Wales. Design: A documentary-based survey was conducted focusing on adults with capacity-affecting conditions and associated communication difficulties. The survey investigated: (i) retrospective studies during the implementation period of the MCA (2007-2017); (ii) prospective applications to MCA-approved Research Ethics Committees (RECs) during a 12-month period (2018-19); (iii) presentational and linguistic content of participant information sheets used with this population. Setting: Studies conducted and approved in England and Wales. Sample: Studies focused on adults with the following capacity-affecting conditions: acquired brain injury; aphasia after stroke; autism; dementia; intellectual disabilities; mental health conditions. The sample comprised: (i) 1,605 studies; (ii) 83 studies; (iii) 25 participant information sheets. Primary and secondary outcome measures: The primary outcome was the inclusion/exclusion of adults with capacity-affecting conditions from studies. The secondary outcome was the provisions deployed to support their inclusion. Results: The retrospective survey showed an incremental rise in research applications post-MCA implementation from 2 (2012) to 402 (2017). The prospective survey revealed exclusions of people on the bases of: ‘lack of capacity’ (n=21; 25%); ‘communication difficulties’ (n=5; 6%); ‘lack of consultee’ (n=11; 13%); and ‘limited English’ (n=17; 20%). REC recommendations focused mainly on participant-facing documentation. The participant information sheets were characterised by inconsistent use of images, typography and layout, volume of words and sentences; some simplified language content, but variable readability scores. Conclusions: People with capacity-affecting conditions and associated communication difficulties continue to be excluded from research, with recruitment efforts largely concentrated around participant-facing documentation. There is a need for a more nuanced approach if such individuals are to be included in ethically-sound research.

Item Type: Article
Additional Information: Data availability statement: Data are available upon reasonable request. The ASSENT team hold all data sets used in this article: retrospective survey data were generated using the HRA public database (https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/); prospective survey data were generated centrally by HRA and passed to the team for analysis; PIS survey data were generated by the research team. Data sets are available by application to UEA: k.bunning@uea.ac.uk. Ethics approval: The study was approved by a Social Care REC (18/IEC08/0042.)
Uncontrolled Keywords: brain injuries,dementia,ethics,mental health,neurodevelopmental disorders,stroke,survey,medicine(all),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Faculty of Social Sciences > School of Law
Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 03 Mar 2022 14:30
Last Modified: 23 Oct 2022 03:37
URI: https://ueaeprints.uea.ac.uk/id/eprint/83874
DOI: 10.1136/bmjopen-2021-059036

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