Table 5 MORECare_Capacity statement solutions on recruiting adults with impaired mental capacity at the end of life in research

Ethics

1. Researchers should design all aspects of the study in the context of potential risk, burden, and benefit of study participation.

2. Institutional review boards and research ethical committees should have transparent decision-making processes to ensure consistency on ethical approvals for studies from various health specialties involving adults across the mental capacity trajectory.

3. The individuals (e.g. relative, friend, formal carer, nursing home staff, healthcare staff) who can act as a consultee to advise on whether the individual would have wanted to participate in the research study had they had capacity should depend on the nature of the study, rather than legal restrictions.

4. Researchers should be able to demonstrate a clear process of consent for potential participants with compromised capacity that details how the researchers will tailor the consent process to maximise an individual’s ability to consent for themselves and when and how they will seek an opinion from a consultee.

Maximising individual autonomy

5. Clinicians should engage in research participation conversations with patients at the early stages of illness, discussing varying levels of risk, burden, and benefit, and document the person’s preferences and wishes in for example an advance directive.

6. Individuals who are likely to lose capacity should be asked to designate a consultee whose opinion on their participation in a research study will be sought if the individual loses capacity.

7. For individuals who have capacity to consent in the moment, but overtime may not remember the discussion, process consent should be adopted whereby researchers re-confirm the individual’s wish to participate at each data collection time point.

8. Researchers should check for non-verbal (e.g. agitation) and verbal cues (e.g. ‘I’m unsure why you are asking me’) that may indicate a wish to withdraw during the study.

Involving consultees

9. Personal consultees should be present in research participation conversations with patients at the early stages of illness.

10. Where possible, to improve social support, personal consultees/family members should be engaged in the (enhanced) informed consent process for adults with impaired capacity.

11. The nature and extent of the responsibility of a consultee acting on behalf of a patient should be clarified.

12. Establish a national body to provide support and information to family members/informal carers acting as personal consultees.

Tailoring recruitment process to need

13. Researchers should incorporate in the study design research participation information and (where applicable) data collection tools in multiple formats (e.g. verbal, written, electronic).

14. Studies where potential participants are expected to be adults across the mental capacity trajectory should incorporate multiple consent processes (e.g. personal and professional consultees, informed and process consent).

Time

15. When possible, potential participants should be allowed time for further discussions regarding their research participation decision.

16. The study design should allow time proportionate to the risk, burden, and benefit of participation for consent or consultee decision (before or after research participation if consent is deferred).

17. Researchers should build in the time required to engage with and train clinical staff who will be involved, and those who might act as professional consultees in the study.

Enhancing the research culture and infrastructure

18. Health and social care practitioners should recognise research as a core clinical activity in a similar way as teaching and training.

19. Clinicians should be supported and provided with training to ensure they are confident in their skills to discuss research studies with patients (and/or family members) during routine clinical contact.

20. Health and social care practitioners should support adults across the mental capacity trajectory at all stages of the research study by considering the person’s best interests and individual wishes and preferences to uphold individual autonomy and minimise the risk of harm, and enable family members to act as a personal consultee by ensuring sufficient information and understanding about the role.