Details

Autor(en) / Beteiligte

• Bunning, Karen
• Jimoh, Oluseyi Florence
• Heywood, Rob
• Killett, Anne
• Ryan, Hayley
• Shiggins, Ciara
• Langdon, Peter E

Titel

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

Ist Teil von

• BMJ open, 2022-03, Vol.12 (3), p.e059036-e059036

Ort / Verlag

England: British Medical Journal Publishing Group

Erscheinungsjahr

2022

Quelle

Electronic Journals Library

Beschreibungen/Notizen

• ObjectivesThis 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.DesignA documentary-based survey was conducted focusing on adults with capacity-affecting conditions and associated communication difficulties. The survey investigated: (1) retrospective studies during the implementation period of the MCA (2007–2017); (2) prospective applications to MCA-approved Research Ethics Committees (RECs) during a 12-month period (2018–19); (3) presentational and linguistic content of participant information sheets used with this population.SettingStudies conducted and approved in England and Wales.SampleStudies 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: (1) 1605 studies; (2) 83 studies; (3) 25 participant information sheets.Primary and secondary outcome measuresThe 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.ResultsThe 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.ConclusionsPeople 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.