Involving people with lived or living experience, often called consumers, in the concept development and design of your clinical trial is important. Consumers can help define the research question and focus research on outcomes that are important to them. Many funding agencies require involvement of consumers in the design of clinical trials as there is evidence of the positive effect consumers have on recruitment and retention in clinical trials.

You do not need ethical approval to involve consumers and community members in research and healthcare improvement projects because data is not being collected from them. The people involved are working with you as members of your project team. However, there are ethical considerations you should bear in mind.

• Monash Partners has an online, free module on ethics requirements for Consumer and Community.

A trained and networked Health Consumer Representative is an important member of your team and you need to think about how you would like them to be involved throughout the different stages of your project. It is good practice to have more than one consumer, so they can support each other and provide diverse viewpoints. You may want multiple consumers filling different roles throughout the research cycle e.g. on a steering committee or testing a participant information consent form (PICF).

• The ACTA CCI toolkit outlines different ways to include consumers as does the WAHTN CCI Handbook (Resource 2 p19}. Once you know what skills and experience you are looking for, you can develop a Consumer Expression of Interest form {Resource 17 p36) for recruitment.

There are a number of local registries that provide you with access to consumers and community members who have trained to be involved in health and medical research.

• NSW Regional Heath Partners has created Consumer Connect – a registry to provide you with access to consumers and community members who have expressed interest in commenting on design, participating in or contributing to future health and medical research. You can request a consumer representative here.
• Health Consumers NSW has suggestions on finding consumer representatives and can also help you find one.
• If your project is related to cancer, including health prevention, Cancer Voices provides a matching process to experienced health consumer representatives.
• AHRA CCI Handbook resource 14 outlines a number of different strategies for recruiting consumers {Resource 14 p33)
• ACTA tookit
• Monash Partners module on finding consumers

If you have a person with lived experience of relevance to your project, but no experience of health and medical research, there is training and mentoring available for you and them.

• ACTA’s Consumer involvement toolkit includes training for consumers.
• Health Consumers NSW has a free, online training module for both researchers and consumers on ‘Introduction to Consumer Involvement in Health Research’.
• Your consumers can become a member of Health Consumers NSW for free. Health Consumers NSW has an Online Engagement Site where member consumers can connect and share experiences.
• Cancer Council Australia has online, free modules specifically designed for community members wanting to work with cancer researchers.
• For an international perspective, a 15-minute “Patient Engagement Basics” training for researchers and clinicians is available in multiple languages.

Depending upon your target population, it may be important to find consumers who are less likely to be involved in research (e.g. ethnic minorities, young and working age people, older people, disabled people, people with learning difficulties, those without a university level education, people from lower socio-economic backgrounds). It will take time and face-to-face conversations to develop these relationships, but this will help to ensure a successful project.

Unlike the rest of your team, it is not part of a health consumer’s regular employment to work on your clinical trial. For this reason, remuneration is an important consideration. Many consumers are happy to provide their expertise for free, but you should not assume this. At a minimum, you should offer to reimburse them for out-of-pocket costs like transport and parking for on-site meetings. Some consumers may not be able to fund these costs upfront, so other arrangements such as cab charge may be required. Have these conversations early in the relationship and see here for more information on consumer costs and budgeting.

If you are lucky, you will need to interview Potential Consumers {Resource 15 p34) to determine the most appropriate for the roles available. But remember – two consumers are better than one!

Once you have your consumer representatives, you will need provide them with important information including

• An Induction and Orientation {Resource 23 p43) to the organisation and your project
• Consumer role/position description outlining the type and amount of expected engagement
• Consumer Involvement Agreement {Resource 22 p42) and Conflict of interest declaration and Confidentiality agreement if required. 
• Reimbursement and remuneration processes and timing
  • remuneration claim form template {Resource 24 p44)
• Governance structure for the project and any committees involved, including pictures and roles descriptions of committee or project team members
• Practical information such as meeting frequency and locations, parking, security access, videoconferencing software and contact details of primary contact person
• Terms of Reference {Resource 21 p4) for steering or advisory committee roles or working groups
• Guidelines for raising a concern or complaint
• Information about leaving a project or committee

Some documents will change over time as you tailor the role to a consumer’s particular expertise, or you may wish to co-design some of the materials.  

It may seem like an extra burden or unnecessary costs to involve consumers in your team, but they will add great value to the overall project. The AHRA CCI Handbook has resources for both consumers and researchers to evaluate (p48 resource 27} and reflect (p49 resource 28} on the involvement activities and how to plan for its satisfactory conclusion (p51 resource 29).

Who can help?