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Latest update on HRA approval

3 February 2016

From the end of March 2016 the coordinated system for gaining NHS permission (CSP) will be closed for new studies.

The combined form on the Integrated Research Approval System (IRAS) will be adopted across the UK and a new format for site information will be provided. 

Plans for the fourth phase of Health Research Authority (HRA) approval, which will extend to clinical trials and investigations in secondary care, have been confirmed. 

For commercial studies there will be no requirement to submit Site Specific Information (SSI) forms; the HRA says it will continue to test suitable formats for site information for all study types.

The HRA has proposed a proportionate approach for non-commercial single site studies taking place in the NHS in England where the organisation is also the study sponsor. These will be included in plans for the fifth phase HRA approval, expected at the end of March 2016.

The new HRA approval process is being implemented across the NHS in England in a phased approach. The new process involves an assessment by the HRA alongside the ethical review process, providing a single authoritative approval for the NHS. This means that NHS organisations no longer need to duplicate research governance checks and can focus on ensuring there is the appropriate capacity and capability to deliver studies on time.

As of 11 January 2016, a total of 107 studies had been received by the HRA, with approval issued to 62 within a median of 16 calendar days. 

For more information and guidance on applications contact the JRO on randd@uclh.nhs.uk or visit the HRA website.