Abstract
ObjectiveTo investigate how people with communication and understanding difficulties, associated with conditions such as dementia, autism and intellectual disability, are represented in research guidance supplementary to the Mental Capacity Act (MCA: 2005) in England and Wales.MethodsA documentary survey was conducted. The sample comprised the MCA Code of Practice (CoP: 2007) and 14 multi‐authored advisory documents that were publicly available on the Health Research Authority website. Textual review of key words was conducted followed by summative content analysis.ResultsRepresentation of people with communication and understanding difficulties was confined to procedural information and position statements that focused mainly on risk management and protection. Whilst a need to engage potential participants was recognized, guidance provided was imprecise.ConclusionsTensions exist between the protection versus empowerment of people with communication and understanding difficulties in research. The development of structured, evidence‐based guidance is indicated.Patient or public contributionPeople with communication and understanding difficulties and carers participated in a working group to explore, discuss and interpret the findings.
Highlights
Including adults with communication and understanding difficulties in ethically sound research are a complex proposition
The Research Governance Framework for Health and Social Care in England and Wales[5] requires that research participants reflect the diversity of the wider population and advises against the routine exclusion of under-researched groups, including those with disabilities.[6]
Researchers are responsible for ensuring that their research complies with the requirements of the Mental Capacity Act (MCA) (2005), and that people with capacity-affecting conditions are included appropriately.[7]
Summary
Including adults with communication and understanding difficulties in ethically sound research are a complex proposition. Gaining consent is a fundamental prerequisite for involving human beings in research.[8] Founded on the principle of respect for autonomy,[9,10,11] it formally recognizes people's interest in making decisions, acting voluntarily, and understanding and processing appropriate information relating to these decisions Certain conditions, such as dementia, autism and intellectual disability, may affect the individual's decision-making capacity.[12,13] Another common characteristic of these conditions is communication and understanding difficulties, which may pose challenges and complicate assessments of capacity.[14,15] People with capacity-affecting conditions make up a significant proportion of the UK population. This is an international concern for legal systems across the globe.[53,54] The research question was as follows: How does the CoP (2007), as the operational document of the MCA (2005), and HRA research guidance support the representation of people with communication and understanding difficulties in research?
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