In August 2022 we received a letter from Mermaids, which was also signed by a number of organisations, raising concerns about a research study we were preparing to review.
The study, titled ‘Outcomes for children referred to Gender Identity Development Service’ is part of the research stream of the Cass Review. The Cass Review is an independent review of gender identity services for children and young people.
We shared our response to this letter in a news article published on 19 August 2022. In our response we said that we would provide a further update once we had reviewed the application.
Like all eligible research applications we receive, this study has been reviewed by one of our Research Ethics Committees, and because this study also involves the use of data without consent, our Confidentiality Advisory Group.
This process is the same that we follow when reviewing any application for health and social care research and has not changed because of the concerns that were raised.
The application was initially reviewed in September 2022 by one of our Research Ethics Committees (REC) and the Confidentiality Advisory Group (CAG). The correspondence from Mermaids was shared with both the REC and CAG Chairs in advance of the application review in order that any concerns raised by Mermaids, within our remit, which had not already been addressed during the review were considered.
These groups are independent bodies who review research applications. Our RECs consider whether the research is safe, ethical and legal, and CAG looks at whether the proposed use of data without consent is in the best interest of patients and the public.
Following the REC and CAG reviews the study was given a provisional opinion - with a request for more information and clarifications on specific parts of the application.
Since our last update the applicants have been considering our feedback and making the necessary changes. This isn’t a quick process and has taken a number of months for them to complete.
The applicants provided complete responses to the outstanding queries which remained pending for the application. The responses gave us the assurance we needed, and HRA Approval has been issued for the study. This encompasses the REC’s favourable ethics opinion and the CAG’s supported outcome.
This case identified that we didn't have a process for managing concerns and considerations submitted prior to REC or CAG review and we are now in the process of putting this in place.