Public involvement should be central to planning your project and should be planned at the earliest opportunity.
For both Confidentiality Advisory Group (CAG) and Research Ethics Committee (REC) applications, you should involve the public prior to submitting your application, and provide each with a summary of what you have done, how and when you have done it, the outcomes, and how it has influenced your project design.
There is separate information about public involvement that Research Ethics Committees (RECs) are looking for which will help the REC with the review of your application. The guidance below provides more information on the CAG expectations.
We strongly encourage you to consider public involvement that will meet both CAG and REC expectations. This may be asking the same group a range of questions that will cover CAG and REC expectations or ask different groups about different elements. Considering both CAG and REC in your public involvement at the earliest opportunity will not only help your application but will benefit the design and success of the project.
There are a number of ways you can involve the public. If you need help to decide how to involve the public please read the guidance on our resources page.
If you are still unsure about how to plan and involve the public in a way that meets CAG expectations after reading this guidance, you can contact us at cag@hra.nhs.uk.
What is CAG-specific public involvement?
CAG expects to see evidence of public involvement that specifically tests the public acceptability of using confidential patient information without consent for the purpose of your application.
What this means in practice is providing a public group with a plain language summary of your project that includes the purpose of the project, how confidential patient information is used without consent and the safeguards that will be in place. You should seek views on these specific topics.
Who do I need to involve?
When involving the public around topics specific to your CAG application, you should ensure that you involve members of the public who are representative of the people whose confidential patient information will be used without consent.
People from different demographic groups and geographical locations may have different views on the use of confidential patient information without consent for your project so it is expected that you include people who reflect these differences. This does not mean that you are expected to undertake public involvement at each site or location where confidential patient information will be accessed, but the following points should be considered when planning who you need to involve.
- Include people with lived experience of the health condition or social care situation. This should include people with a range of demographic characteristics appropriate to the focus of the study. Where there is no specific health condition (such as healthy volunteer applications) you should include people who are representative of the demographic and geographical variations of the project cohort.
- Consider which population data you will be using and whether different populations or communities might have different views about the use of their confidential patient information. For example, rural communities, communities with higher deprivation scores or geographical areas with a high proportion of a particular socio-economic group may have different views from others.
- A proportionate number of people in relation to the size of the cohort whose confidential patient information will be used without consent. There is no definitive number or formula for calculating how many people is enough but please see the HRA principle on involving enough people for further information.
It is good practice to have a core public group who can support your project (for example review of patient facing materials, direction of the project), but frequently this should be supplemented with wider public involvement, as above, to ensure wider public support. If you need help to find the right people to involve please read our guidance on our resources page.
The views of the public over use of data can change over time. You may also use data from different populations during your research. This could affect the perspectives you need to consider during your research, so CAG-specific public involvement is not a one-off activity.
What do CAG expect to see in my application?
The evidence that you gather from this CAG-specific public involvement should be included in your application. This could include minutes of meetings, slides or questionnaires shared. It should demonstrate:
- The demographics of who you have involved, how many and why their involvement is relevant
- How you have involved people, such as focus groups or meetings
- What questions or topics were used
- The number and types of responses you received i.e. both positive and negative and what changed because of this feedback
- How you plan to continue this specific public involvement for the duration of CAG support