HRA Approval - What you need to know

How to apply for HRA Approval

Before you apply, discuss the study with your sponsor. The HRA expect the sponsor to ensure that the study is well planned and ready to be rolled out across the NHS, including the identification of participating sites and active discussion of the study with local researchers and research management staff.  More information for sponsors is available on the HRA website in ‘Before you apply for HRA approval’.

Applications for HRA Approval are made via IRAS using the new combined IRAS Form, which replaces the REC and NHS R&D forms, this is submitted electronically to the HRA and REC for review.

When preparing your application, you may find it useful to read the information in HRA Assessment to understand the criteria used to assess your application.

If applying for HRA Approval, don’t apply to NIHR CSP. Also if applying for HRA Approval, you no longer need to submit Site Specific Information (SSI) forms for NHS sites in England. Currently SSI forms are required for sites in Northern Ireland, Scotland and Wales. SSI Forms remain required for non NHS sites across the UK.

The following text summarises and adds helpful tips to the IRAS guidance.

1. IRAS project filter

On IRAS it’s critical to select the correct study category on the project filter, as this means that the appropriate questions and forms will appear for completion. Please use the Question Specific Guidance (green ‘i’ buttons) on IRAS to help you understand the categories. The project filter relies on you knowing when to select IRAS form and hence which studies are eligible, see Do I need HRA Approval?.

Select ‘IRAS form’ in question 4 of the project filter.

There may be other approvals that you need for your study, most of which are applied for via IRAS, these will appear if you’ve got the study category right. Your sponsor will be able to advise.

If you choose the wrong category the HRA will return your form and you will need to start again.

2. Check the IRAS Form has appeared by clicking on ‘Navigate’ and ‘Project Forms’, and that no REC or NHS R&D Forms have been generated.

3. If you are running your study through the NIHR Clinical Research Network in England, discuss the study with them and make a formal application to them electronically via the IRAS Portfolio Application Form (PAF), before applying for HRA Approval. A PAF will be generated when you indicate in the project filter that your study will be led from England and you will apply to the NIHR CRN for support (Project filter question 5b).

4. Complete the IRAS project dataset and prepare your supporting documentation as normal. This includes uploading supporting study documents to the checklist in IRAS.

5. If a non-commercial study, complete the Statement of Activities and Schedule of Events. The purpose of the Statement of Activities is to provide clarity about delivery of the study at the site; where there is no other formal agreement in place the Statement of Activities can also be used as a simple agreement between the sponsor and the site. The purpose of the Schedule of Events is to give very clear information to participating sites about what activities will be undertaken at the site and how the costs of those activities are managed in the NHS.

In some instances the Statement of Activities is sufficient to constitute the site agreement. Where this is not sufficient the NIHR Model agreements should be used and where they are modified this should be highlighted and the rationale for the modification given.

The HRA are trialling these templates so please provide them with feedback. You will need help from your research/proposal admin/legal office to complete the Statement of Activities.

You will need help from the NHS R&D office to identify the costs involved for the Schedule of Events form. It doesn’t require you to identify costs in pounds and pence, but does need you to attribute costs to NHS definitions.

It may be that more than one Statement of Activities and/or Schedule of Events is needed (e.g. if you have a number of different types of site involved in your research). Further guidance is included at the end of each template.

You’ll need to upload these templates to your IRAS application and type them in the Checklist using ‘other’. If you need to do more than one version of each form please include each document in a new row in the ‘other’ section of the Checklist by using the ‘add new row’ button.

6. Remember if eligible for the NIHR CRN portfolio, apply for this before submitting the IRAS Form for HRA Approval.

7. Obtain the required electronic authorisations for the IRAS Form, by selecting the Authorisations tab for the form and following the instructions provided.

8. Check the IRAS Form before submission to make sure it is complete. Once you have obtained the authorisations don’t amend any part of the IRAS Form as this will invalidate the electronic authorisations. This is a common reason for rejection.

9. Instructions on how to submit the application are in the e-submission tab of the IRAS Form. Please read them carefully. Submission is started by contacting the Central Booking Service (CBS). You should receive an email confirming that your application has been booked for HRA Approval. You can enter the REC booking information on the first page of the IRAS Form, but remember don’t amend any other part of the IRAS Form as this will invalidate your electronic authorisations.

10. On the same day as you have booked your application via CBS, electronically submit your application for HRA Approval via the E-submission tab for the IRAS Form. Supporting documentation is electronically submitted along with your IRAS Form by uploading the files to the relevant rows on the Checklist tab of your IRAS Form.

11. Confirmation of receipt of your application for HRA Approval will be via an update to the Submission History entry on the E-submission tab of your IRAS Form.

For studies with the lead R&D office in Wales, Scotland or Northern Ireland, you also need to complete the IRAS Form.  Submission instructions are available on the IRAS Form e-submission tab and will involve e-submission to the REC and immediately afterwards emailing the IRAS Form and accompanying documents to the lead nation. See IRAS Help for information for each country. The HRA will accept the review that the relevant devolved nation undertakes; and the HRA will perform the assessment for sites in England. See Studies involving or led from Scotland, Wales or Northern Ireland.

If your study has non-NHS sites you may need to complete non-NHS Site Specific Information (SSI) forms in IRAS, HRA guidance is available on their website under Site Specific Assessment.

Note: All formal correspondence from the HRA is sent to the person listed as sponsor contact in IRAS A4 as well as the CI (IRAS A3) and the Lead NHS organisations (IRAS A68-1). This ensures that the right people get the information.  The person listed in IRAS A4 should be the main contact for the study.