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How are adults with capacity-affecting conditions and associated communication difficulties included in ethically sound research? A documentary-based survey of ethical review and cruitment processes under the research provisions of the Mental Capacity Act (2005) for England and Wales
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Bunning, Karen, Jimoh, Oluseyi Florence, Heywood, Rob, Killett, Anne, Ryan, Hayley 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 cruitment processes under the research provisions of the Mental Capacity Act (2005) for England and Wales. BMJ Open, 12 (3). e059036. doi:10.1136/bmjopen-2021-059036 ISSN 2044-6055.
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Official URL: http://dx.doi.org/10.1136/bmjopen-2021-059036
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 mplementation 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: | Journal Article | ||||||
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| Subjects: | B Philosophy. Psychology. Religion > BF Psychology R Medicine > RZ Other systems of medicine |
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| Divisions: | Faculty of Social Sciences > Centre for Educational Development, Appraisal and Research (CEDAR) | ||||||
| Journal or Publication Title: | BMJ Open | ||||||
| Publisher: | BMJ | ||||||
| ISSN: | 2044-6055 | ||||||
| Official Date: | 31 March 2022 | ||||||
| Dates: |
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| Volume: | 12 | ||||||
| Number: | 3 | ||||||
| Article Number: | e059036 | ||||||
| DOI: | 10.1136/bmjopen-2021-059036 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 4 March 2022 | ||||||
| Date of first compliant Open Access: | 1 April 2022 | ||||||
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