Abstract
There has been a growing focus on improving the informed consent process for research. However, some people with problems with their memory or understanding may lack capacity to provide consent for themselves. In these situations, a proxy decision-maker (usually a family member) is needed to help make a decision about whether they take part or not. Involving proxies can be challenging, which contributes to people with incapacity being under-represented in research. Our previous study found that it was difficult for some family members to make a decision, and they experienced an emotional and decisional burden as a result. Families thought that greater support when making decisions about research would help. This led us to develop the first decision support tool for family members making decisions about research. This tool was found to be acceptable and we now need to test whether it is an effective form of support. We have also conducted further work to explore how to measure its effectiveness through establishing which outcomes matter, to whom, and why (COnSiDER Study). This project will explore whether the support tool is effective, what factors affect this, and how much it costs. This will be done using a Study Within a Trial (SWAT) which is a self contained research study that is embedded within a host trial/trials with the aim of evaluating a particular trial process.
Aim
This project aims to support the inclusion of adults lacking capacity in research through improving decision-making by the family members involved. This will be achieved through understanding the barriers and facilitators to implementing the novel decision-support tool (CONSULT-ENABLE study), exploring the feasibility of the tool and outcome measures being developed (including CONCORD scale), and establishing whether the decision-support intervention is effective in improving the quality of decision-making by family members (CONSULT SWAT). In addition, we will develop an online toolkit for researchers and practitioners (www.capacityconsentresearch.com) to provide resources on assessing capacity, legal frameworks, signposting to training and other resources, and a mechanism for implementation. In parallel, we will also be exploring how people can be enabled to express their wishes about research participation in advance of any loss of capacity to consent (CONSULT-ADVANCE study).
Project Lead
Project Collaborators
Contact Project Author
URL
Research Area(s)
Study Design(s)
Data Collection Method(s)
Participant(s)
Status
Expected completion date: February 28, 2026