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HRA Approval: review process

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On receipt of application for HRA Approval

In the first instance you will receive an update to the Submission History entry on the E-submission tab for your IRAS Form confirming that we have received your submitted application.

Where NHS REC review is required, your application will be checked to see whether it is complete for the purposes of review by the NHS Research Ethics Committee (REC).  In accordance with UK-wide Research Ethics Service procedures, you will be told whether it is valid for NHS REC review no more than 5 working days after submission of your application.

At the same time, we will undertake an initial assessment of your study to ensure that there is sufficient information to undertake a full assessment and identify what further information will be required during full assessment.  The outcome of the initial assessment is

  • A HRA initial assessment letter sent to the applicant which confirms the application has been received, the template agreements/statements of activities and costing templates/schedule of events to be used in the study, information that sites will need to begin to set up the study. This is when you can formally send the local information package to sites. For some studies this step will not be required and a HRA Approval letter will be issued.
  • Initial Assessment information to the REC to provide confirmation of compliance with legislation and the level of insurance being provided.

HRA Approval includes HRA assessment and, where required, NHS REC review.

HRA assessment will assess the study for regulatory compliance and other related matters. For full information on the aspects considered under HRA assessment and the standards that studies are expected to meet, sponsors are strongly encouraged to familiarise themselves with the specific HRA assessment criteria and standards [internal link], to ensure that researchers are supported in developing studies ready for submission.

As we review your application, the HRA assessment team may contact you for more information, to request clarifications, or to discuss some aspect of your project. We will usually attempt to contact you by telephone in the first instance and follow up by email, so please ensure that you provide appropriate contact details and that you check your email regularly following submission of your application to ensure that any issues are resolved promptly.

As part of this process you may be issued with an ‘Initial Assessment’ Letter.

Where NHS REC review is required, this will be carried out as described in the Research Community section [internal link] of this website. As part of the REC review, you will also receive communications from the Research Ethics Service, including notification of the outcome of the NHS REC review.

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Conclusion of review 

Once both HRA assessment and REC review (where required) are complete you will receive notification of the outcome (“HRA Approval” or “not approved”) in the form of a letter and guidance on what you should do next.

You cannot commence your study in the NHS in England until HRA Approval has been issued.

If you have any concerns or queries related to the assessment of your application please contact the HRA Approval team.  Please make sure that in your email you quote the IRAS ID for your study and your preferred contact details (email/phone). If you feel you need to escalate a concern please contact hra.approvalprogramme@nhs.net.

If your query relates specifically to the ethical review please contact the relevant REC Manager [internal link].

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Keeping HRA informed once you have HRA Approval

Once your study has HRA Approval you will need to keep us and the organisations participating in your research informed of any changes to your study. This section on our website [internal link] covers what you might need to consider around amendments, progress reports and safety reporting.

Further information resources for research sponsors, those supporting researchers and NHS organisations

If you are a research sponsor or you are involved in supporting researchers applying for HRA Approval please refer to the HRA assessment criteria and standards document [internal link].

Please also refer to the information about setting up NHS participating organisations in England [internal link].

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Providing feedback on your experience of HRA Approval

We would welcome any feedback or comments that you may have on your experience of seeking HRA Approval. Please submit your comments by email to hra.approvalprogramme@nhs.net