What are the objectives?

1. To examine perspectives of researchers and service users on the challenges experienced to recruit individuals with declining capacity to research studies.

2. To identify in research studies the solutions used to manage processes of consent for individuals with impaired capacity.

3. To obtain a consensus on the priority of solutions proposed to facilitate processes of consent

4. Synthesise the findings of the review and stakeholder consultation to develop best practice guidance on processes of consent for participants with impaired, declining, or lack of capacity to consent for themselves.

Why is this important?

The evidence base for palliative and EoLC is limited with few trials of interventions or services. Patients with palliative needs commonly experience deterioration in their level of capacity associated with, for example, disease progression and nearness to death. Inclusion of these patients in research on treatments and interventions for palliative care is vital to identify best clinical practice and cost-effectiveness. This research study draws on examples of best research practice on processes of consent for adults with impaired mental capacity associated in particular with nearness to death.

What will happen?

A parallel study design involving three components to identify, appraise and synthesise best research practice:

1. Systematic literature appraisal to understand the processes of consent that research studies have incorporated to enable the inclusion of adults lacking capacity to consent themselves. Running parallel to this will be a short electronic survey to researchers undertaking research involving adults with impaired/fluctuating/diminishing/lack of capacity to capture literature which may not have been published or received limited attention.
2. Face-to-face consultation with stakeholders on the solutions emerging from the literature and using Nominal Group technique to generate and prioritise recommendations on best research practice. The recommendations are presented in an on-line consensus survey. The synthesis of the findings from the respective components inform the initial draft methods guidance on processes of consent for adults lacking capacity.
3. An expert ‘think-tank’ workshop to critically consider the first draft methods guidance, particularly areas of contention/uncertainty. The final synthesis of the findings will form Methods Guidance on Processes of Consent for Adults Lacking Capacity