Background

Trials involving adults who lack capacity to consent can be challenging to conduct, partly due to the requirement for consultees or legal representatives to be involved in decisions about participation. When someone lacks capacity to provide their own consent, someone else, usually a family member or close friend, is approached to act as a consultee or legal representative. 

​Previous research has shown that family can find it difficult to make decisions about research, and some may experience decisional and emotional burden as a result. This can lead to a higher proportion of families declining participation,  compared to people providing their own consent. In our previous research, families expressed a need for more information about what the role of a consultee or legal representative involves, and wanted more support when making research decisions on behalf of someone who lacks capacity to consent.
Information about being a consultee/legal representative
Family members who are asked to act as a consultee or legal representative on behalf of someone who lacks capacity to consent to a study should be given information about what would be involved. This can come at a difficult time for families as they might be busy providing care for the person or be worried about the person's health. 

​Together with Thinklusive, we have co-produced a video called 'Making Decisions About Research For Others' which explains:
  • what we mean by 'lacking capacity to consent'
  • what a consultee or legal representative is
  • what being a consultee or legal representative involves
  • what a consultee or legal representative would need to think about

The video is in Talking Text format so it is designed to be as easy to understand and accessible as possible.

'Making Decisions About Research For Others' video is available on You Tube and via this link:  ​https://youtu.be/lerIAU4zq2k

CONSULT decision aid for consultees/legal representatives

Decision support interventions, also known as decision aids (DAs), are increasingly being used to support patients making decisions about treatment or uptake of screening. More recently, DAs have been developed for people considering participating in clinical trials. DAs support the decision process by providing information about available options and their associated outcomes, alongside information that enables patients to consider what value they place on particular outcomes and provide structured guidance on steps of decision making.

A decision aid has been developed for family members (or close friends) making decisions about research on behalf of someone who lacks capacity to provide their own consent. The intention of the decision aid is to help families to make a more informed, values-based decision. It was developed in collaboration with lay involvement and stakeholder groups, and informed by theoretical frameworks and empirical research. The decision aid ('Making decisions about research for others') is a short colourful booklet available as a A5 paper copy or as an editable PDF which can be given to family members or friends who are asked to act as a consultee or legal representative.

The booklet is given alongside the information sheets that would usually be given to consultees or legal representative. It contains information about the role of a consultee/legal representative and encourages them to think through what would be involved in taking part in the study, and to consider how it would align with the wishes and preferences of the person they are representing. It helps them to decide whether the person they represent would (or would not) want to take part if they were able to make the decision. To help them to do this, they are encouraged to go through a brief 'values clarification exercise'. There are also spaces to write down any questions they may have or to consider if other people should also be involved in the decision. 

​For more information about accessing the decision aid, please contact: 
Picture
Front cover of the decision aid developed as part of the CONSULT project

Evaluating the decision aid: CONSULT SWAT (study within a trial)

We are also evaluating whether the decision aid effectively supports families of adults who lack capacity to consent to make more informed decisions about research. This is through conducting a ‘Study Within a Trial’ (SWAT) which is a is a self-contained research study that is embedded within a host trial with the aim of evaluating alternative ways of delivering or organising a particular trial process. SWATs can be evaluated across multiple host trials, which enables meta-analysis across different trial contexts. The CONSULT SWAT protocol has been published in Trials and we have completed a mixed-methods feasibility stage of the CONSULT SWAT which has been published in Trials.

We are now seeking to work with trials who are interested in embedding the CONSULT SWAT in their study.
Host trials are eligible if:
  • Trial team anticipates that a reasonable proportion of potential participants will lack capacity to consent
  • Utilises personal consultees or personal legal representatives

But not eligible if:
  • Trial involves recruitment without prior consent (e.g ‘deferred’ consent) only
  • Uses nominated consultees or professional legal representatives only
  • Trial requires participation decision to made urgently or within a short timeframe

The SWAT has been designed to be flexible and to minimise the impact on host trials. For example, randomisation and recruitment processes will be aligned with those in host trials, and there is no separate consent form for participating in the SWAT. We can support trial teams to integrate the SWAT into their trial recruitment pathway, and provide sample text to be added to a protocol and copies of the SWAT information sheets and other materials. 

If you would like more information, or to receive a CONSULT SWAT information pack, please contact: 
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