Trial Participants: Informed Consent, GCP, Patient Involvement

10. Types of Activities Where the Public Can Get Involved

  • Contributing to patient information leaflets to help recruit and inform people by telling them what they need to know in language they will understand.

  • Joining an ethics committee whose job it is to make sure that research carried out respects the dignity, rights, safety and well-being of the people who take part.

  • Being part of an advisory group to a research project which helps to develop, support and advise the project.

  • Helping to design a questionnaire, thinking through approaches to gaining good quality information from people in a research study.

  • Working with others to help communicate research findings to members of the public.

Examples of public involvement in clinical trials:

  1. Patients and carers contributed significantly to the protocol for a large UK-based multicentre NIHR Health Technology Assessment- funded study (MUSTARDD-PD) researching the management of people with mild dementia associated with Parkinson’s disease. People provided constructive ideas around how to raise the subject of dementia with this target population, and suggested alternative wordings to make all the study practicalities much clearer.

  2. The PURPOSE (Pressure Ulcer Programme of Research) team at the Leeds Clinical Trials Research Unit found the pressure ulcer community to be a seldom heard group due to the lack of an existing service user/carer group and the complex health needs of many people in the community. Therefore, a small network of service users, carers and family members with some personal experience of preventing or living with pressure ulcers was formed.
A flexible ‘asset based’ approach to involvement was used to take on various roles depending on skills, needs and the level of commitment the members felt able to give. Preparation workshops supported this process by enabling network members to reflect upon their experience and expertise. Research opportunities are sent out to the network as they arise. They also offer opportunities for people to contribute from home, allowing input from people with work/carer commitments or mobility issues.
  1. The Wales Cancer Trials Unit (WCTU) is strongly committed to public involvement focused on professional working partnerships with the patients. To identify volunteers who are able to contribute effectively and confidently at technically complex meetings, a formal recruitment process was established. Trials staff are involved with the selection and training of new volunteers and the mentoring of existing ones.
A support volunteer’s role includes:

  • Recruiting research partners to trials.
  • Supporting both research partners and trial managers.
  • Reviewing current support systems.
  • Identifying development opportunities for research partners.
  • Ensuring links with the Involving People network.