Diverse and inclusive involvement

Diverse and inclusive involvement

These pages cover considerations for involving consumers from groups who are under-represented in clinical trials.

When undertaking consumer and community involvement, it can be tempting to involve the same people – usually those that are well known to you or your organisation. However, wherever possible, it’s important to involve people with a diverse range of skills and experience, particularly people from groups that are under-represented/under served in clinical trials. This is likely to require extra thought, preparation, time and money.

Why diversity and inclusivity matter

Representation is an important principle of generalisable research: if participants in trials don’t reflect the population that is intended to use the intervention being trialled, then outcomes may not be relevant to the whole population, leading to health care that is not optimal for everyone.

Note that this toolkit is about consumer involvement, not participation or recruitment. However, researchers should be mindful of how diverse and inclusive consumer involvement and trial participation interact. While inclusive and diverse involvement does not necessarily translate to diverse participation, it may help. If trials are not designed or implemented with consideration of the needs of the communities or populations that are affected, people from those populations may be less likely to participate in trials. For example, Brijnath et al. (2024) in their study of the experience of ethnically diverse populations in Australian clinical trials found that “Partnering with diverse communities and facilitating access were crucial to recruitment across all groups”.

The MRFF principles of consumer involvement in MRFF-funded research specifically state that consumers should be involved in research “with broad diversity and equity, with the goal of increasing involvement of priority populations through culturally safe and appropriate engagement.”

There should be an expectation of inclusive and diverse consumer involvement in all research, and it is important to engage with consumers and community groups from a place of trust, inclusivity, equity, and mutual respect.

Resources

Further reading

What does diverse and inclusive consumer involvement in trials look like?

Diverse involvement ideally reflects the differences amongst groups that are relevant to your research (Beresford et al. 2017).

  • Explain what it is – what does it mean to have diverse and inclusive consumer involvement in trials?
  • Diverse and inclusive consumer involvement in trials goes beyond visible differences and encompasses the unique experiences, needs, and challenges faced by various communities. In the Australian context, this means engaging consumers and communities from rural, regional, and remote areas who often experience barriers to accessing health and medical research. It also requires addressing intersectionality—how factors such as socioeconomic status, cultural background, disability, and gender identity interact to shape health outcomes. Effective consumer involvement recognizes these complexities and seeks to develop equitable, evidence-based solutions tailored to the populations most impacted by the research.
  • Explain what it isn’t - Diverse and inclusive consumer involvement in trials is not about tokenistic representation or simply ticking a box to satisfy diversity metrics. It goes beyond superficial differences or one-off contributions from a single perspective, and instead strives to engage with consumers throughout the whole trial. It focuses on meaningful engagement that genuinely reflects the diverse experiences, needs, and voices of the communities the research aims to serve. True inclusivity ensures that these perspectives are actively valued, thoughtfully integrated, and ultimately shape the design and outcomes of trials to deliver equitable and impactful solutions.

The UK’s INCLUDE Project (Innovations in Clinical Trial Design and Delivery for the Under-served) identified several groups that are often under-served, or underrepresented, in health research, which need to be considered when designing research.

These groups include:

Groups by demographic factors, for example:

  • Age (eg. extremely young or extremely old populations)
  • Women
  • Ethnic minority groups
  • LGBTQ+
  • Education

Social and economic factors, for example:

  • People working fulltime
  • People in rural or remote areas
  • Socially marginalised people, or people from lower socio-economic backgrounds
  • People who are carers or who look after children

Health status, for example:

  • People with mental health conditions
  • People with physical disabilities
  • Smokers
  • People who are obese

It is important remember that people may belong to more than one of these groups. This intersectionality influences how people experience or access health research, and should considered as part of consumer involvement and trial design and implementation.

Resources

Further reading

How to reach consumers from underrepresented communities

The best way to reach consumers from underrepresented groups is to go to where they are. Often community or advocacy groups will have done the ‘groundwork’ of building trust and ‘activating’ consumers in health involvement. Even then, it is important to take the time and effort to build and maintain trust with community members.

Accessibility: removing barriers to involvement

For some groups, researchers and researcher organisations will need to offer support to increase consumer and community capacity to be involved. It is up to researchers to make consumer involvement accessible.

Some of the accessibility problems people might face include:

  • Poor accessibility, both physical access and access to appropriate resources to participate
  • Lack of incentives to participate
  • Lack of trust in trials or the health system
  • Poor health literacy and lack of understanding of the health system
  • Financial barriers

Resources

Further reading

Involving First nations communities

More information on this important topic to come soon.

Previous Principles of involvement