Impairment of capacity/communication: assent-based inclusion
Research type
Research Study
Full title
Development of an assent-based process for the inclusion of adults with impairments of capacity and/or communication in ethically-sound research
IRAS ID
244132
Contact name
K Bunning
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Our project is called ASSENT and is funded by the Nuffield Foundation for a period of 30-months, starting in April 2018. The project is about how adults who have impairments of either capacity or communication, or both, (AwICC) are included and considered in research. The project is concerned with the ethical and governance frameworks for research in England and Wales. Research involving human beings is essential for developing new knowledge. Gaining informed consent from people taking part is necessary for research to take place. As life expectancy increases, so there are more people who have dementia or who have had strokes. Improved neonatal care means that premature babies, who have an associated risk of developmental disability, are surviving in greater numbers. These things all contribute to an increase in the proportion of vulnerable people who require some kind of support in decision-making. There are ethical questions about whether it is appropriate to include such people in research. The Mental Capacity Act (MCA: 2005) informs legal, ethical and regulatory frameworks governing capacity and consent. Even with this guidance some researchers and ethics committees find it easier to err on the side of caution and exclude people who seem unable to give informed consent. This results in the under-representation of these groups in research, which negatively impacts the development of medical, educational and social interventions. We will investigate current policy in relation to the Mental Capacity Act (2005) and how it is interpreted in practice. Drawing on our findings, we will develop guidance that recognises the interests and preferences of AwICC, identifies practical strategies and resources to support their involvement, and provides enhancements to the MCA Code of Practice within the context of existing legislation. We will work with AwICC and their supporters throughout the project.
REC name
Social Care REC
REC reference
18/IEC08/0042
Date of REC Opinion
13 Dec 2018
REC opinion
Favourable Opinion