HRA Approval: the new process for the NHS in England

HRA Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion provided through the UK research ethics service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England.

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On 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:

  • Research described by any of the IRAS filter question 2 categories, except those for “Research Tissue Bank” and “Research Database”, can apply for HRA Approval if the lead NHS R&D Office is in England.
  • 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.

On this page you will find summarised information about HRA Approval and links to where to find key guidance.

 

How do I apply for HRA Approval?

Like all research projects, before you submit an application for HRA Approval you will need to undertake a number of planning and preparation activities aside from completing an application form. During the preparation phase and before you submit your application we strongly recommend that you refer to our:

You apply for HRA Approval by completing an application form in IRAS, called the “IRAS Form” and electronically submitting this form and your supporting documents to the HRA. To find out more about this process in IRAS, start by referring to the IRAS Help guidance for HRA Approval. 

 

Setting up research sites in England

There are five stages to setting up research sites in England which can be undertaken in parallel to obtaining HRA Approval. The five stages are:

  1. Identify potential sites
  2. Invite those sites to assess whether or not they are likely to be able to put the arrangements in place to deliver the study (the site will need a final version of the protocol)
  3. Invite sites who think they can participate to put the arrangements in place to deliver the study (this stage happens after submission for HRA Approval, the site will need the local information pack and either the HRA Initial Assessment Letter or the HRA Approval Letter (depending on timing of site set up)
  4. Following discussion and agreement with the applicant, the NHS organisation confirms their capacity and capability to deliver the study by either exchanging signed agreements or, for non-commercially sponsored studies, agreeing the Statement of Activities (this stage happens after HRA Approval is in place).
  5. Applicant confirms date at which the study can start/ site initiation date at that NHS organisation.

Further information on setting up new NHS sites in England can be found here.

 

Projects involving NHS led from Northern Ireland, Scotland or Wales with Participating NHS sites in England

Where a project is led from outside England but has English NHS sites, the national R&D coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for English sites and thereby retain existing compatibility arrangements.

 

Does HRA Approval apply to studies that pre-date HRA Approval?

The following studies will be brought under HRA Approval so that NHS sites in England can work with sponsors in the new way:

  • Studies which have already applied for REC review but have not applied for R&D review
  • Studies which have previously obtained NHS/HSC permission and now need to add new NHS sites in England

Please refer to the information provided for pre-HRA Approval studies.

 

What do I do once I get HRA Approval?

When you receive your letter confirming HRA Approval it will be accompanied by guidance about what you should do next.

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 covers what you might need to consider around amendments, progress reports and safety reporting.

 

Amendments to projects

For all projects led from England, whether or not it has HRA Approval, you are expected to notify both substantial and/or non-substantial amendments using the appropriate form.

This section on our website covers what you will need to consider around amendments.

< Page last updated 20 December 2016>