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, 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). e059036. 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: 25 Apr 2022 08:30
URI: https://ueaeprints.uea.ac.uk/id/eprint/83874
DOI: 10.1136/bmjopen-2021-059036

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