Most research studies that need advice from the Confidentiality Advisory Group (CAG), also need a Research Ethics Committee (REC) opinion. Applying for these has always been two separate processes. The HRA manages both; we’re colleagues who ‘sit next to each other’ (mostly virtually of course) so could we align these processes better?
That’s the question we asked ourselves as part of wider work to streamline our processes and make things easier for the people that we support.
We want to smooth the way for people who need Regulation 5 (section 251) support following CAG advice by aligning the CAG and REC application routes.
Why are we testing a new process?
CAG became part of the HRA in 2013. We regularly review how we work, and recently we did a more detailed review to identify potential improvements. We identified an opportunity to join the dots in our own processes by making our separate reviews work better together.
Currently, for a study that needs both CAG and REC review there is no need to submit at the same time. What we’ve seen is that applications that are submitted at the same time tend to go through more quickly. Even though this is quicker, applicants have told us that it can be difficult to manage the multiple communications from the two processes.
Often CAG applications come in for review after the study already has a REC favourable opinion. If CAG asks for changes this may mean a REC amendment, which can lead to further delays.
What will change?
We’re trialling a new approach to align both CAG and REC reviews. Our aim is to make the time for the aligned approvals quicker than doing it separately and simplify the process for applicants. We also hope that giving one set of joined up communications to applicants will be more manageable for them.
We need you!
We’re asking research applicants who are preparing an application to CAG if they would be willing to try out this new aligned process with us. They need to have not started the REC approval process yet. We are looking for around 10 applicants so we can get a good range of experience to see what works and what doesn’t.
While this will be beneficial for everyone who uses CAG, we particularly want to hear from applicants who are developing AI or data driven research. We know that different complexities can arise from those types of study and want to be sure we have considered all aspects.
What’s in it for you?
The benefits of the new process will be a quicker timeline and we’ll be aligning your reviews in a managed way. You’ll get coordinated communications from us – one set of queries and responses. This should remove the need for extra amendments.
In return we’ll ask you to feedback to us on the process so we can make further improvements.
Think you might be able to help us to align our reviews? Please contact cag@hra.nhs.uk
Paul Mills, Confidentiality Advice Service Manager