Ethics review and involvement
Consumer involvement is not research. This page helps to delineate research activities from involvement activities
The NHMRC’s ‘Statement on consumer and community involvement in health and medical research’ recognises that appropriate consumer involvement in research should be encouraged and facilitated by researchers and research organisations because it is likely to improve the design, recruitment, conduct, and translation of research.
Human Research Ethics Committees (HRECs) frequently raise ethical concerns about the design and conduct of research projects they review. Involving consumers in your research will provide the HREC with an assurance that the research is:
- aligned to the needs of the people it is trying to help;
- beneficial in terms of delivering meaningful outcomes for patients;
- conducted in a way that is sensitive to participants’ needs.
Providing information on your consumer involvement activities enables the HREC to consider how consumer involvement has contributed to the ethical probity of the application and/or how your ongoing involvement plans will make your research more patient-centred.
Reassurance that consumers will guide and support your study has the potential to lead to fewer queries and therefore, faster approval.
When is ethics approval required for consumer involvement?
Ethics approval is not required for the vast majority of consumer involvement activities. Even when research methods are used (e.g. surveys, interviews or focus groups), consumer involvement is not research and rarely raises ethical issues. Consumers are not acting in the same way as research participants.
Involving consumers in research advisory, consultative or collaborative capacity does not require ethics approval.
Ethics review may be required if the objectives of the research and consumer involvement are combined as illustrated in the following case study.
You wish to investigate which of two different layouts of your PICF is easier to read for a trial you are planning. You also wish to formally test a hypothesis that Layout A is easier to read than Layout B. You organise focus groups where consumers participate in voice recorded discussions that are thematically analysed.* Your findings suggest a strong preference for Layout A and you publish these findings as transferable knowledge.
In this scenario, a separate ethics application to conduct the focus groups would be required to undertake the study associated with the involvement activity.
*The use of qualitative research methods such as focus groups, does not necessarily mean a project is defined as research. To avoid confusion with research, the term ‘discussion group’ (rather than ‘focus group’) may be preferable.
Where consumers are part of the research team and/or their involvement activity results in direct contact with study participants or access to identifiable data, ethics/governance checks to confirm that the team has adequate training, support, and supervision, would be appropriate.
The Consumer Involvement - Research distinction has many parallels with the Quality Improvement - Research distinction. The NHMRC’s Ethical Considerations in Quality Assurance and Evaluation Activities provides further guidance on whether HREC approval, (or other forms of ethics review for low-risk projects) are appropriate. A Comparison Table providing further information can be accessed here.