Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders

Abstract

Objectives: We aimed to: (A) describe researcher decision-making when including or excluding adults with conditions that have the potential to affect capacity and/or communication in research and (B) explore the underlying values and reasoning of stakeholders in research which falls under the provisions of the Mental Capacity Act, 2005.

Design: The mixed-methods design included semistructured interviews with adults with conditions that have the potential to affect capacity and/or communication, supporters, researchers, research ethics committee members and an online survey with researchers. Triangulation was used to integrate the data and examine the complementarity of the findings.

Setting: England and Wales.

Participants: There were 61 participants who took part in semistructured interviews, of which 39 were adults with conditions with potential to affect capacity and/or communication, 6 were in support roles for adults with conditions with potential to affect capacity and/or communication (including family members and professionals in advocacy organisations), 8 were members of research ethics committees flagged under the Mental Capacity Act to review research where there could be issues of mental capacity and 8 were researchers with experience of working with adults with conditions that have the potential to affect capacity and/or communication. The online survey had 128 participants, researchers with experience of working with adults with conditions that have the potential to affect capacity and/or communication.

Results: All stakeholders were supportive of the genuine inclusion of adults with conditions that have the potential to affect capacity and/or communication in research, and exclusion was seen as a form of discrimination. Many researchers were daunted by meeting the threshold within the legislation for including participants who may lack capacity.

Conclusion: Further training, expertise and resources are required to promote the successful inclusion in research of adults with conditions that have the potential to affect capacity and/or communication.

Keywords: Delirium & cognitive disorders; Health policy; MEDICAL ETHICS; MENTAL HEALTH; QUALITATIVE RESEARCH.