Determining capacity of people living with dementia to take part in research: an electronic survey study of researcher confidence, competence and training needs

Abstract

Abstract Background Researchers are required to determine whether a person has capacity to consent to a research study before they are able to participate. The Mental Capacity Act and accompanying Code of Practice for England and Wales provide some guidance on this process, but researchers have identified that it can be difficult to determine capacity to consent when a person has complex cognitive or communication needs. This study aimed to understand the experiences and opinions of researchers who recruit people with dementia to research projects, to inform the future development of training resources.Methods A mixed method, cross-sectional, electronic survey was circulated via social media and research networks in England and Wales. The survey remained open for ten weeks and included open and closed questions exploring respondents confidence in determining capacity in the context of recruiting people with dementia to consent, their views on training and support they have experienced and their perceptions of future training and support needs.Results 60 respondents completed the survey from across England and Wales. Although 75% of respondents had experience of determining capacity to consent people with dementia to research, only 13% rated themselves as feeling ‘very confident’ in this. Qualitative content analysis of open responses led to the generation of six themes, explaining researchers’ confidence, competence and future training needs in this area: 1. Researcher uncertainties 2. Lack of time, 3. Balancing information complexity with accessibility, 4. Gatekeepers, 5. Existing enablers and 6. Envisioning future training.Conclusions Researchers working with people with dementia would benefit from specific training in undertaking conversations around consent with people with dementia. People with dementia have may have fluctuating capacity, and despite support from caregivers, researchers have little practical guidance on methods of determining a person’s ability to understand or appreciate the information they have provided during the consent process. Given the development of large complex trials within dementia research, there is an urgency to develop specific and practical guidance and training for researchers working with people with dementia and their families.