February 2016
Transition arrangements to the new HRA approval process
Important information for researchers
National guidance for researchers currently applying for or preparing to apply for HRA approval or NHS R&D permission or NHS REC approval is set out below:
- The HRA recommends that all new studies now go through the new HRA approval process except educational studies, research databases, or research tissue banks.
- If you have already started using the separate REC and R&D forms you can easily switch to the new single IRAS form in order to apply for HRA approval. You do this by going into the project filter and selecting the option for HRA approval in question 4 of your application. This will combine the information you have submitted from the 2 separate forms in to the new single IRAS form.
- If you have already started using the separate REC and R&D forms and you have obtained authorisations (eg sponsor in principle), these authorisations will be lost if you switch to the new single IRAS form for HRA approval.
- If you do not wish to use the HRA approval process ie you wish to continue with your separate submissions for REC and R&D approvals, you must submit your application by 31 March 2016.
- If you have already submitted your NHS REC form but not your NHS R&D form; or you have already submitted your NHS R&D form but not your REC form;you cannot use HRA approval and you must submit your application by 31 March 2016.
- SSI Forms are not required as part of HRA approval for NHS sites in England.
- From 1 April 2016:
- The NIHR Coordinated System for gaining NHS Permission (CSP) which is currently used for processing R&D permissions for portfolio studies, will be decommissioned.
- All new and ongoing studies will use HRA approval. If you still have not submitted your R&D form by 31 March 2016 you will have to use the new HRA approval process.
- If you need to add sites or have any amendments to an approved study then you will need to use HRA approval. Guidance will be published shortly on this.
I:\RESEARCH & INNOVATION\HEALTH RESEARCH AUTHORITY\communications\HRA IRAS ADVICE FOR RESEARCHERS FEB 2016.docx