If your study involves the NHS in England, you should use HRA Approval. HRA Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance with the independent REC opinion provided through the UK research ethics service.
HRA approval replaces the need for local checks of legal compliance and related matters by each participating organisation in England.
As of 31 March 2016, HRA Approval became the process for applying for approvals for all project-based research in the NHS led from England. This means that:
- HRA Approval will be used wherever the project involves NHS organisations in England.
- Where a project also involves NHS/HSC organisation(s) elsewhere in the UK (i.e. other than in England) the study will be supported through existing UK-wide compatibility systems, by which each country accepts the centralised assurances, as far as they apply, from national coordinating functions without unnecessary duplication.
- Projects that have previously sought or gained NHS Permission for participating NHS organisations in England, or applied for REC review, now come under HRA Approval.
The HRA provides detailed guidance on the process and how to apply, which you should read carefully before submitting an application. The guidance also contains a link through to IRAS, the online application system.
Should you require institutional sign off for an application to HRA via IRAS, a declaration form will need to be completed.
If you are a PhD student, your declaration form will need to be signed off by your Supervisor.
The HRA have provided specific guidance for student research inclucing:
If you are an Academic, your declaration form will need to be signed off by your Departmental Director of Research.
Please return the completed declaration form to the ethics mailbox.
Please remember that once you have received approval from the HRA, you are still required to submit an application via the online ethics system. Please include all documents submitted including the approval letter/notification.
If you are unsure whether you require NHS REC approval, the HRA have created a decision tool that will advise you as to whether or not you will need to complete an application using the IRAS