HRA Approval

The Health Research Authority (HRA Approvalis now the route for regulatory approval for all project-based research: portfolio, non-portfolio, commercial and non-commercial, and students projects in the NHS led from England and involving the NHS organisations in England.  

The NIHR Coordinated System for NHS Permission (CSP) closed to new applications on 31st March 2016. 

All studies approved through HRA are issued with an HRA Approval Letter, which provides assurance that the study meets all regulatory and legislative requirements relative to the study type (including ethical approval, where required). This replace existing arrangements for NHS Permission/Assurance granted by R&Ds.  

HRA has issued guidance for studies which require new NHS sites in England, or amendments

Receipt of the HRA approval letter does not mean that all support arrangements are in place locally, this will need to be confirmed by the Sponsor. Sponsors now need to share local information packages with NHS sites (ie. PI and local study team, R&D office and, where applicable, the Local Clinical Research Network (LCRN).

The R&D office will continue to act as a source of advice, guidance and support locally for research and will continue to manage the local implementation of studies – the HRA have provided a useful document clarifying activities that will be undertaken by HRA and those that will continue to be undertaken by local R&D offices as described in Local support functions in primary care R&D following HRA Approval. 

If your project involves NHS primary or community sites in Norfolk and Suffolk,  please contact our research office  for advice on your application and support in setting up your study

Further details on HRA approval can be found on the HRA website or e-mail hra.approvalprogramme@nhs.net

The “HRA Approval: Assessment Criteria and Standards” document below is intended for reference by research sponsors and by other key parties who support researchers seeking HRA Approval.

http://www.hra.nhs.uk/documents/2016/03/hra-approval-assessment-criteria-standards-document.pdf

Guidance for studies in Primary Care settings  can be found in the letter at the end of this page and in the following documents:

http://www.hra.nhs.uk/documents/2016/03/hra-approval-primary-care-settings-principles-study-set.pdf

http://www.hra.nhs.uk/documents/2015/06/2015-06-28-hra-approval-information-general-practice.pdf


The Health Research Authority has an excellent section entitled 'before you apply for approval' which helps sponsors and chief investigators make sure what approvals they will need and how to apply. 


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Clara Yates,
16 Jul 2015, 01:54
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