The first study to ever go through HRA Approval has now been completed.
The study, led by NHS South Norfolk Clinical Commissioning Group (CCG), looked into interagency working across local health agencies, local authorities and the police in safeguarding adults, and involved interviews with members of the local safeguarding adults board. The application was made in May 2015, during HRA Approval’s phased roll-out.
The project was the result of one of the CCG Commissioners being awarded a Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England Fellowship.
Clare Symms, research manager for the CCG, commented:
“There were a whole lot of firsts involved: this was our first CCG-led and sponsored research project, it was a first-time researcher, and we were the first to go through the new HRA Approval process. This was a test for us as sponsor (and as lead R&D office) to understand the system and the HRA was keen to learn from our experiences.
“It all went surprisingly well! As sponsor and lead R&D Office we supported the Chief Investigator to develop the protocol, prepare the HRA application, liaise with local sites and following study completion, to prepare and disseminate the final report. The HRA application process was fairly straightforward. Completion of the new documentation took a bit of getting used to; however this did prompt us to think about aspects of the study earlier that we may otherwise have addressed them.
“HRA arranged a telephone discussion with the Chief Investigator (CI) and I to gain feedback on our experiences from the sponsor and the CI perspectives and I personally found this remarkably useful in helping to gain an understanding of the rationale behind the development of the statement of activities / schedule of events and to explore some of the challenges and misconceptions we had in completion and where more clarity was needed in the instructions for applicants. It was nice to see our feedback being incorporated in the later versions of the documentation.
“If I could give one piece of advice to other sponsors and research teams it would be read the guidance! It may sound obvious but had I recognised the importance of (and hence actually read) the HRA assessment criteria and standards before we submitted we may have got approval even faster than the 11 days it took! We definitely read this now before submitting studies!
“As a result of going through this process we were able to offer advice to local researchers and R&D managers about the process and to encourage others to go through this route. We found it immensely helpful in increasing our understanding of HRA Approval and how we might need to adapt our local systems to support researchers.
“The study is now complete – it finished on time and to target. It was a positive learning experience for all concerned and we are delighted that our study was the first to achieve HRA Approval!”