Table 4

Key findings and relationship to data sets

	Data set
	Qualitative interviews			Researcher survey
	Adults with conditions that have the potential to affect capacity/communication	Supporters	Researchers	Closed questions	Open questions
Key finding
Quality of research
1. Adults with conditions that have the potential to affect capacity and/or communication should be included in research to ensure that research is of high quality, comprehensive and representative of the lived experience and needs of this population.	A=1	A=1	A=1	A=2 PA=1	A=2
2. Exclusion means it is it not possible to do high quality research about the impairing condition.	A=1	A=1	PA=1	A=1	A=2
Equality and rights
3. Inclusion in research promotes advocacy, autonomy and gives people a voice.	A=1	S	A=1	A=2	PA=2
4. Participation in research offers benefits to the individual such as sense of achievement, feeling useful, increasing confidence.	A=1	S	S	PA=1	PA=1
5. Exclusion from research is discrimination, leading to a lack of recognition of needs and issues.	A=1	A=1	A=1	A=1 PA=2	A=2 PA=4
6. People who cannot communicate are thought not to understand and not noticed.	A=1	S	S	S	PA=1
7. Including adults with impairments of capacity or communication in research is important to reduce discrimination and is an ethical issue.	A=1 PA=1	S	PA=1	A=1	PA=3
8. Researchers excluded adults with impairments of capacity or communication as they could not provide responses needed.	D=7	D=4	D=1	A=1	D=4 PA=1
9. Having communication difficulties does not mean someone lacks capacity.	PA=1	S	S	S	A1
10. Some researchers felt discouraged to include participants who lack capacity within research studies.	S	S	S	PA=1	A=1
11. Some researchers said they felt uncomfortable if they had to exclude adults with impairments of capacity or communication from research studies.	PA=1	S	S	PA=1	A=1
Mental Capacity Act (MCA) (2005)
Consultee process
12. Researchers, supporters and gatekeepers, and adults with conditions that have the potential to affect capacity and/or communication were concerned about consultees speaking for someone else. They should not engage in direct decision-making.	A=1	A=1	S	S	A=1
13. If the consultee process is used, the participant should be involved as much as possible in the process.	A=1	S	PA=1 D=1	S	S
14. If the consultee process is used the consultee should be someone who knows the participant very well.	A=1	S	S	S	S
15. The consultee process could be beneficial if it leads to more inclusion of adults with conditions that have the potential to affect capacity and/or communication.	A=1	D=1	PA=1 D=1	S	D=3
16. Finding a consultee is burdensome, time-consuming and may cause delays.	S	PA=1	A=1	PA=1	A=1
Code of practice
17. The code of practice is not much used by researchers.	S	S	A1	S	S
Exclusion
18. Those who lack capacity to give consent for particular studies continue to be excluded from research because research is often focused on those who have capacity.	D=4	D=2	D=1	A=1	A=1 D=4
19. Adults with conditions that have the potential to affect capacity and/or communication are excluded because researchers cannot meet the requirements of the MCA. Research cannot be carried out successfully with those who have capacity.	D=2	D=2	D=1	A=1	A=2 D=2 PA=1
Research practice
Gatekeeping
20. People in gatekeeping roles do not necessarily see themselves as having this role.	S	A=1	S	S	S
Researcher knowledge
21. More must be done to make sure that adults with conditions that have the potential to affect capacity and/or communication can participate in research. Researchers must be knowledgeable in order to adapt processes, methods and communication appropriately.	A=1	A=3	A=1	A=2	S
22. Some researchers were both familiar and confident with the consultee process.	S	S	A1	PA=1 D=1	A=1 D=2
23. Researchers were aware that potential research participants should be supported to make autonomous decisions about taking part in research.	S	S	A=1	S	S
24. Some researchers were confident about including people with conditions that have the potential to affect capacity and/or communication in research. Those that were confident tended to have had experience of working with adults with conditions that have the potential to affect capacity and/or communication in research.	PA=1	S	S	S	A1
25. Researchers indicated that it was important to work within an MDT inclusive of clinical and research staff to support the inclusion of adults with conditions that have the potential to affect capacity and/or communication in research.	S	S	S	S	A1
MCA
26. A majority of researchers rated their knowledge of the MCA as good or excellent.	S	S	D=2	A=1	D=4 PA=1
27. Health-related research is a diverse activity, and researchers in different fields have varying levels of understanding of the MCA.	S	S	A=1	PA=2	PA=4
28. It was not generally understood that under the MCA people should be actively supported to make autonomous decisions.	S	S	A=1	S	S
29. Researchers were aware that under the MCA capacity is decision specific.	S	S	A1	S	S
30. It was not generally understood that under the MCA people judged to lack capacity to give consent should still be actively involved in the decision-making process where a consultee is used.	D=1	S	A=1	S	S
31. There were some researchers who were confident about their ability to work with a consultee.	S	S	PA=1	A=1	A=1 D=2
32. Some researchers had a poor understanding of the MCA.	S	S	A=1 PA=1	A=1	A=2 D=1 PA=2
33. Some researchers were not confident in their ability to work with a consultee. They did not understand what a consultee was and what role they had in research. They confused this with other roles such as making treatment decisions, mediation, advocacy and translation.	S	S	D=1	A=1	A=2 D=1
34. Some researchers said they understood the MCA in clinical settings better.	S	S	PA=2	PA=1	A=1
35. Researchers had learnt about the MCA in teaching and personal study. They said that training in the MCA was important.	S	S	S	PA	A=1
36. Researchers who were less confident said that they were concerned with how to assess capacity and would seek support from others.	S	S	S	S	A1
Health research authority approval processes
37. Applying for an ethical opinion when including participants who lack capacity is difficult.	S	S	PA=1	A=1
38. Researchers are concerned that the HRA is too focused on written information and the use of signatures.	S	S	A=1	S	S
Research methods and engagement
39. Researchers tended to use observational research designs with adults with conditions that have the potential to affect capacity and/or communication, which supporters and gatekeepers thought were more engaging.	PA=1	A=1	S	A=1	S
40. A range of methods were used to engage the public in research including coproduction, user group engagement and community engagement.	PA=1	PA=1	S	A1	S
Resources
41. Researchers exclude adults with conditions that have the potential to affect capacity and/or communication because they do not have enough time to include them.	D=2	D=2	D=1 PA=2	A=1	A=1 PA=3 D=4
42. Researchers excluded adults with conditions that have the potential to affect capacity and/or communication due to a lack of funding.	D=2	D=2	D=1	A=1	D=3 PA=2
43. Researchers excluded adults with conditions that have the potential to affect capacity and/or communication due to a lack of training or resources.	D=3	D=2	D=1	A=1	D=5 PA=1

A, agreement; D, dissonance; HRA, Health Research Authority; MDT, multidisciplinary team; n, number of key findings; PA, partial agreement; S, silence.