Health Research Authority (HRA) approval is the new process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion provided through the UK research ethics service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.
What are the key changes to the old process?
- A single information package will be used combining the REC and R&D Form.
- In England, site-specific information (SSI) forms will not be required.
- For non-commercial studies, new additional documentation is required. The HRA have introduced Schedule of Events and Statement of Activities.
- For commercial studies, The Schedule of Events and Statement of Activities templates are not used. Instead, a completed NHIR Industry Costing’s Templates & template agreement should be submitted to the HRA.
- Studies with HRA Approval should not begin until the relevant Trust R&D office has confirmed capacity and capability to perform the research. In regards to GOSH/ICH the R&D office will issue a ‘Notice of No Objection’. For HRA Approval studies this confirmation will be given through the exchange of written contracts/agreements or agreeing the new Statement of Activities. For NHS organisations in Northern Ireland, Scotland and Wales there is no change.
What studies will be applicable?
- HRA approval should be requested wherever the research project involves NHS organisations in England
- ALL studies except for ‘Research Tissue Bank’ and ‘Research Database’ should apply for HRA approval if the lead Trust R&D office is in England.
- Projects that have previously gained NHS Permission for participating NHS organisations in England will come under HRA Approval for amendments and addition of new sites.
What do I need to do?
For studies that are eligible for HRA approval, and have GOSH/ICH as the sponsor, the applications for HRA Approval are made electronically via IRAS using the new combined IRAS Form. You will need to liaise with the R&D office (Research.Governance@gosh.nhs.uk) in regards to the submission.
For those studies that have gained HRA approval the associated NHS sites are required to assess, arrange and confirm capacity and capability to perform the research. When completed, for GOSH, a ‘Notice of No Objection’ will be issued from the R&D office. You are not able to commence the study at GOSH until this has been issued.
The R&D office will provide assistance and guidance for PIs/researchers undertaking the processes above.
Please note that it is still a requirement that all research undertaken at GOSH and ICH needs to be registered with us, please contact Research.Governance@gosh.nhs.uk for further advice.