Consultees, Advocates and Proxies in End of Life Research

The project was about how we can support people to be involved in research when they might have challenges with communication, thinking or use of language. We aimed to understand how they can best be supported by other people to do this.

Background

Clinical research helps us improve health and care. To improve health and care for everyone, we need to involve a range of people in research. Some people can make decisions about being involved in research. Some might need help to make a decision. A small number of people cannot make any decisions about research.  Being unable to make a decision is called “lacking capacity”.

When people lack capacity their family, friends and/or paid staff might be asked about research. If research involves a new drug of treatment, friends, families or paid staff might be asked to decide whether the person who lacks capacity should be in the research project. In this study, we aimed to find out what information and support friends, families and paid carers required to be involved in decisions about research involving people who lack capacity.  

Project Aims

Broadly, this project aimed to understand how can be proxies be supported to involve adults with impaired capacity in research.

To do this, we undertook a scoping review to determine:

  • Who should act as a nominated /personal consultee and/or legal representative for intrusive research in England and Wales? 
  • What constitutes ‘best practice’ for the use of consultees and/or legal representatives in supporting the involvement of adults with impaired capacity in research 
  • What role do volunteers/independent advocates play in supporting ethically sound research for those with impaired capacity? 
  • What support or training do all potential proxies (personal, professional and legal representatives) require to support involvement of adults with impaired capacity in ethically sound research?  

Project Activity

  • Scoping Review
  • Stakeholder Engagement
  • Dissemination Activities (guidance for RECs, development of consultee training module)

Outputs

  • Overcame some of the structural barriers to adults with impaired mental capacity to inclusion in clinical research

Papers and resources

For more information about this research, visit the project’s website page

Read the paper, titled 'Proxy decision-making about participation in palliative care research: A scoping review'

Read the PCIEP report- long version

Read the PCIEP report- short version

Read the conference presentation abstracts, titled' OP-4 Understanding the scale of exclusion for people unable to consent to research towards the end of life: a scoping review'

Watch the recording, Developing Inclusive Practices around Consent and Mental Capacity in Palliative Care Research

Read the workshop report, 'titled Inclusive Practices around Mental Capacity & Consent in Palliative Care Research'

P-050 Involvement of Dying People with Impaired Capacity in Clinical Research: A Delicate Ecology: Presented at the 2024 International Clinical Trial Methodology Conference

Who was involved? 

  • Clinical Lead / Lead Investigator: Dr Caroline Barry (corresponding researcher), Norfolk and Norwich University Hospital (NNUH) and University of East Anglia (UEA)
  • Miriam Craske, Senior Research Associate
  • Heather Edwards, Public Representative
  • Dr Clara Yates, Norfolk and Waveney ICB
  • Prof Karen Bunning, UEA
  • Prof Rob Heywood UEA
  • Alex Howard, AAH Software
  • Victoria Shepherd, University of Cardiff
  • Guy Peryer, UEA
  • Dr Martyn Patel, NNUH & UEA
  • Matthew Hawkes, UEA

Contact

Caroline Barry, caroline.barry@nnuh.nhs.uk