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HRA Approval implementation 31 March 2016

Last updated on 16 Mar 2016

From 31 March 2016 HRA Approval will be the process for applying for approvals for all project-based research in the NHS led from England. For any new studies that are led from outside England but have English sites, the NHS permissions coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for English sites and thereby retain existing compatibility arrangements.

Student studies led from England which require REC review or are taking place at more than one NHS organisation will be included in HRA Approval from 31 March 2016.

This completes the phased roll out that has been underway since May 2015. NIHR CSP will be closed to new applications before the end of March. The timing of the closure of CSP has been agreed between the NIHR Clinical Research Network, the HRA and the devolved administrations.

Studies which have already applied for REC review but have not applied for R&D review, or need to add new NHS sites in England, or have new amendments, should be brought under HRA Approval so that NHS sites can work with sponsors under the new arrangements.

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