HRA Approval - What you need to know

Working with individual NHS sites in any UK nation

You can identify sites at any time: before you apply for HRA Approval, after you have applied but before Approval is obtained, or sites can be added after HRA Approval as amendments. The HRA recommend that, where possible you have planned your project sufficiently to ensure that all sites are listed at the beginning even if you do not start work at all sites immediately. Further guidance is provided in IRAS Help.

Sites can begin to make an assessment of their capacity and capability to deliver your study before HRA Approval has been applied for or awarded, but the local research team and NHS R&D office will need the final version of the protocol. It’s up to the Chief Investigator and sponsor to determine the timetable for site set up.

The sponsor (or delegate e.g. trial manager) should always communicate simultaneously with the local research delivery team and research management team (R&D/R&I) which supports that NHS organisation. For NIHR CRN Portfolio studies the Local Clinical Research Network (LCRN) that provides support should also be copied in to any documentation so that everyone involved in supporting that study has the same information at the same time. This ensures there is no confusion about who has received which documents.

The HRA detail five steps to setting up a site in England: Identify, Assess, Arrange, Confirm and Site Initiation. A flowchart with more details of these steps can be found on the HRA website.

During the Identify and Assess stages, the sponsor (or delegate) may well send the site a protocol and other information to help the site and the sponsor (or delegate) assess whether or not it likely that the NHS organisation will want or be able to run the study.

The trigger for the Arrange part of study set up is when the sponsor (or delegate) sends the whole Local Information Pack simultaneously to the local study team and the research management team of the NHS organisation they wish to work with. It is expected that this is not the first time the NHS organisation has heard of the study, the sponsor should engage with organisations to enable them to undertake the assess phase of the process.

The Local Information Pack can be sent when the sponsor (or delegate) chooses after they have received the HRA Initial Assessment Letter. This is so that the HRA can confirm that the basic information is in place and there is some level of quality or information provided that is useful to the NHS (particularly confirmation of what type of contract and funding will be used). By exception, if there is a significant delay within the HRA in providing the Initial Assessment Letter, it would be pragmatic for the Local Information Pack to be sent after submission for HRA Approval but before the Initial Assessment Letter is issued but this would not be the norm.

You should send the following Local Information Pack to the study delivery team and NHS R&D office (and local CRN if relevant) at the participating NHS site after you have received the HRA Initial Assessment Letter:

  • Copy of IRAS Form (combined REC and R&D form) as submitted for HRA Approval
  • Protocol and amendments
  • Participant information and consent documents (without local logos/ headers)
  • Relevant model agreement
  • Commercial studies only – NIHR Costing template (validated) and delegation log (including known research team names but not signatures)
  • Non-commercial studies only – Statement of Activity and Schedule of Event templates (including known information)
  • Any other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study
  • Copy of HRA Initial Assessment Letter (if one is issued) and (when issued) HRA Approval Letter and final documents

Where site researchers are not employed by the NHS site, the applicant should work with the NHS R&D office for that site to put HR arrangements in place in accordance with the research passport guidance.

NHS SSI forms are not required for studies going through HRA Approval.

NHS site level information requirements for cross border studies currently differ and is explained in IRAS Help:

If a study is led from England and has sites in a devolved administration, the statement of activities and schedule of events are required by English sites, and NHS SSI forms by NHS sites in the devolved administrations. Note: in Wales the SSI is submitted to Health and Care Research Wales and not the site directly). The agreement of the site to participate will come back directly to the researcher from that site.

If a study is led from a devolved administration, the HRA will accept NHS SSI Forms which have been inadvertently created and work with sponsors to obtain the information that is required by sites in England. However, the HRA prefer you to contact them directly to provide information rather than completing an SSI for the English site. See Studies involving or led from Scotland, Wales or Northern Ireland.

To add sites for studies that were pre-HRA Approval:

  • When as new site is added to an already up and running pre-HRA Approval study it should be provided as an amendment to the lead nation. This has not changed. The lead nation will inform the other countries in which there are new sites. If a new country is added, they will share the study wide review with that new country.
  • If the study had a study wide review under the old system, this continues to be valid. If the new site is in England, HRA Approval will be issued on the basis of the old review but for non-commercial studies, the sponsor (or delegate) will need to use a Statement of Activities and Schedule of Events instead of the SSI.

Over the next 6 months, the four UK nations have committed to review site level information requirements. This will include the implementation of the Local Information pack on a UK wide basis with the aspiration of coming to a common UK position that supports the timely set-up of studies. For more information please see the NHS Research Scotland website.

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.