What approvals are needed?
If you are unsure of what approvals you need then the NHS HRA website can help. Alternatively, please contact our research and development team for advice.
To provide a quick summary:
- You normally need to apply for NHS Health Research Authority (HRA) approval. In addition, if your study involves service users you need to apply for Research Ethics Committee (REC) approval too.
- This is done by submitting an IRAS form using the research application website, also known as the Integrated Research Application System (IRAS).
- The HRA and REC provide national-level approval that applies to all NHS sites. The location of the REC is irrelevant.
- The research and development department of each NHS Trust taking part as a research site need to provide an email confirming their agreement for the study to proceed. However, their review is limited to assessing local capacity and capability. It should not duplicate any of the HRA and REC’s review.
- The national review and local research and development reviews may happen in parallel with each other. We recommend this to help minimise delays.
Drafting a research application
You will need to create an account on the Integrated Research Application System (IRAS) website. Then click on ‘new project’ to start drafting your research application.
As well as completing an application form, you will need to upload your study documents onto IRAS before you can submit for approval.
All documents should include a date, version number and IRAS number in the header or footer.
As well as the e-learning available on the IRAS website, our team have created an IRAS top tips guide for using the system.
As you progress with filling in your IRAS application, please keep our research and development team updated on progress – either through meetings or by contacting [email protected]. We will add our sponsor authorisation to your form after reviewing the final version.
Post submission
After submitting your application, please check for any comments from REC and HRA via email. It is important that you respond within the timelines given in their reply.
Once the HRA have confirmed your application is valid, you can begin to share information with the organisations where you would like to carry out the research. Please note, at this stage full approvals have not been granted.
Once a Research Ethics Committee review date has been confirmed, it is recommended that a member of the research team tries to attend via videocall. If this is not possible, the review will still go ahead, and you will receive a letter afterwards with any queries to resolve. The NHS HRA review will happen in parallel with the REC review and does not involve a separate meeting.
Once the national reviews are completed and any queries have been satisfied, you should receive final approval letters.
No research can take place at a study site until:
- National approvals have been issued.
- The site’s research and development department have issued an email confirming local capacity and capability (C&C) for the research to proceed.
- The sponsor has issued a green light email to acknowledge the C&C and confirm that everything is ready for the study to proceed at that site.
