CONSULT SWAT
Research type
Research Study
Full title
Supporting consultees and legal representatives who are making decisions about research on behalf of adults lacking capacity to consent: a randomised Study Within a Trial
IRAS ID
308609
Contact name
Victoria Shepherd
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
Some people with problems with their memory or understanding may lack capacity to consent to take part in a research study. In these situations, a family member is usually involved to help decide whether they should take part or not. Some family members find it difficult to make a decision, and they may experience an emotional burden as a result. A decision aid for family members making research decisions has been developed (a booklet called ‘Making decisions about research for others’). We now need to test it to see whether it is an effective form of support. This will be done using a Study Within a Trial (SWAT) which is a self-contained research study that is embedded within host trials with the aim of evaluating a particular trial process.
The first stage of the project is a feasibility stage. The decision aid will be piloted with 20 family members in one host trial. They will be randomised to receive the decision aid alongside the usual information about the study, or usual information alone. Participants will complete a questionnaire about their decision-making (CONCORD Scale). We will use the findings to refine the second stage of the project.
Stage two is a randomised SWAT to evaluate the effectiveness of the decision aid in up to four host trials. Host trials will be selected based on the population, setting and design of the study. As in stage one, family members will be randomised to receive the decision aid or not. We will compare questionnaire responses from those who received the decision aid and those who did not to see if it increased knowledge and helped decision-making. We will interview some family members and researchers to explore issues such as how the intervention was used. We will also look at resources and costs involved.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0121
Date of REC Opinion
28 Jun 2022
REC opinion
Further Information Favourable Opinion