On 16 April 2018, HRA Approval became HRA and Health and Care Research Wales (HCRW) Approval and now applies to all project-based research taking place in the NHS in England and Wales. We are in the process of updating our online guidance to reflect this change. For information on how to prepare and submit an application for HRA and HCRW Approval please refer to the IRAS website.
For information relating to site setup and local processes for the NHS in Wales please refer to the HCRW website.
HRA Approval brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent ethical opinion by a Research Ethics Committee (REC) so that you only need to submit one application. It applies where the NHS organisation has a duty of care to participants, either as patients/service users or NHS staff/volunteers. References to participants include people whose data or tissue is involved in a research project.
This page provides an overview of the HRA Approval process. For detailed guidance, go to the Integrated Research Application System (IRAS).help section. We also recommend you visit our research planning section for help before you begin your IRAS application
HRA Approval applies only to the NHS in England
If your project is led from Northern Ireland, Scotland or Wales and involves NHS/HSC sites then you will not apply to the HRA. You should apply through the appropriate NHS/HSC permission process for that lead nation. Studies with sites in Northern Ireland, Scotland or Wales are supported through existing UK-wide compatibility systems where each country accepts relevant centralised assurances from national coordinating functions to avoid duplication. Guidance is available on IRAS.
Planning your application for HRA Approval
If your project is eligible for HRA Approval there are four main steps that should be completed in the following order:
Once you have completed the steps above, the diagram below shows you the main steps in gaining HRA Approval.
You may receive separate correspondence about your REC opinion. More detailed information on the ethical review part of HRA Approval is available.
We are currently piloting a single HRA Approval validation which incorporates both assessment and ethical review validation. Currently however you may still receive separate validation letters for the assessment and ethical review aspects of your approval.
- The ethical review validation letter will confirm that your application is valid and contain details of the ethical review that will take place.
- The initial assessment letter will confirm that your application is valid and some assessment checks have already been carried out.
To ensure your application is 'valid first time' then you are encouraged to read the information contained in our research planning section.
The HRA Approval: assessment criteria and standards document is intended for reference by research sponsors and by other key parties who support researchers seeking HRA Approval.
It outlines the criteria against which research studies submitted for HRA Approval will be assessed and the standards that these studies will be expected to meet.
It is critical that sponsors understand the content of this document in order to provide appropriate advice and support to their researchers in applying for HRA Approval.
Questions or comments relating to this document and its contents should be emailed to email@example.com.
Before applying for HRA Approval, a sponsor is expected to have identified potential participating sites that will be listed in the IRAS application and in most cases have discussed the project with local researchers and the research management staff supporting them. You can find contact details for Research and Development (R&D) staff at NHS organisations on the NHS R&D Forum website.
NIHR CRN Portfolio
For both commercial and non-commercial studies applying for the NIHR CRN Portfolio, you should complete and submit a Portfolio Application Form (PAF) in IRAS to request inclusion on the NIHR CRN Portfolio prior to your application to HRA Approval.
A PAF will be generated when your responses to questions in the IRAS filter question indicate that the study is led from England and you wish to apply to the NIHR CRN for support. As part of HRA Approval, we will share information about your application with the CRN to allow them to make a decision on NIHR CRN Portfolio eligibility.
For non-commercial studies, you must prepare the Organisation Information Document for each type of research site in your study.
For commercial studies, you must
prepare the draft template agreement you propose to use with sites, the commercial Organisational
Information Document and the costing
template. For studies which are part of the National Institute for
Health Research (NIHR) Clinical Research Network (CRN) Portfolio you must ask
the lead CRN to validate the costing template, at least one week before
application for HRA Approval.
We continually review and improve the approval process to ensure that it meets user needs. If you have any comments or suggestions for improvements, email the HRA Approval team.