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HRA Approval: Guidance for sponsors/chief investigators working collaboratively with NHS organisations in England

This page explains how sponsor/CIs are expected to work with NHS organisations which may be selected to participate in the study.

 

Sections on this page:

 

HRA Approval

HRA Approval is the new 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.

This allows these participating NHS organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study. Please refer to HRA Approval programme [internal link] information for more details. HRA Approval applies only to the NHS in England. Studies with sites in Northern Ireland, Scotland or Wales 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.

 

HRA Approval: HRA’s review process

For details of our review process for HRA Approval, NHS organisations in England can refer to:

 

Initial discussions with NHS organisations participating in research

Before finalising the IRAS Form, you are strongly advised to have preliminary discussions with potential participating NHS organisations in order to understand if those organisations have the potential to participate. It is at this stage that potential participating organisations can assess their capacity and capability to participate in the study. To start this discussion, the minimum information that you should send to the potential participating NHS organisation is the version of the protocol that will be submitted for HRA Approval.

Some sponsors may require a formal assessment phase and may undertake a site selection visit to determine if the organisation will be invited to participate in the study.

Organisations that have agreed that they might be able to participate in the study should be identified on Part C of the IRAS Form. If additional participating organisations are identified after initial submission then these can be added by the appropriate notification of amendment after HRA Approval.

For studies eligible for support from the NIHR Clinical Research Network, (external link) the CRN may be able assist in identifying potential NHS organisations in England.


NHS organisations acting as host organisations for research delivery

For studies that have HRA Approval, sponsors/chief investigators or those otherwise supporting study set up, and NHS organisations are expected to work collaboratively so that the participating organisations can confirm that arrangements are in place, that they have the capacity and capability to deliver the study, and that they are ready to start the study.

In limited exceptional cases, the HRA will be clear in the HRA Approval letter that some or all participating English sites will not need to provide formal confirmation of the capacity and capability [pdf] to deliver the study, because the site is expected to take part in the study, unless it specifically declares that it will not. In such circumstances, unless the participating organisation requests additional time, or opts out of the study, it will normally be assumed to have confirmed participation in the study within the timescale indicated in the HRA Initial Assessment letter or Approval letter.

You are responsible for providing study documents simultaneously to study delivery teams and research management functions supporting participating organisations (and to the Local Clinical Research Network, where applicable), in order to facilitate study set-up and conduct.

 

Putting arrangements in place to deliver the study

Once you have made an application for HRA Approval and have received the HRA Initial Assessment letter (or HRA Approval Letter where no Initial Assessment letter needs to be issued), you can work with participating organisations to put the local arrangements in place to deliver the study. You may choose to set up sites after HRA Approval if that suits your study delivery plan better. The timing of engagement with sites is determined by the study delivery plan that you, as sponsor/chief investigator, have in place.

HRA Approval is testing the use of a new local information pack for NHS participating organisations in England.

For sites in England you should send the following local document package simultaneously to the study delivery team and the research management team supporting them (and to the Local Clinical Research Network, where applicable) once you have received the HRA Initial Assessment letter (or HRA Approval Letter where no Initial Assessment letter is issued). Click here for contact details for R&D staff and the relevant Local Clinical Research Network.

  • Copy of IRAS Form (combined REC and R&D form) as submitted for HRA Approval
  • Protocol
  • Any amendments
  • Participant information and consent documents
  • Statement of Activity relevant to the participating NHS organisation (non-commercially sponsored only) or delegation log (commercially sponsored only) – only containing information known to sponsor
  • Relevant template contract/model agreement (if needed in addition to Statement of Activity)
  • Costing template (commercially sponsored only) or Schedule of Events (non-commercially sponsored only)
  • 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 document versions

In addition, if it is planned that researchers who are not employed by the participating organisation will deliver research activities locally, you should work with the research management function for the site to put HR arrangements in place in accordance with the HR Good Practice Resource Pack (Research Passport guidance) (external link).

The HRA Initial Assessment or HRA Approval Letter will provide information relevant to study set up. Any cost negotiations that are required with the participating organisation can be finalised at this stage.

 

Confirming that an NHS organisation will participate in a study

Once all the arrangements have been put in place to provide the capacity and capability to deliver a study, the participating NHS organisation will provide you with confirmation of this by email, indicating that they are ready to start the study. The actual date at which you wish to start research activities at the site should have already been agreed and may be dependent on a site initiation visit or similar that you wish to conduct.

Participating NHS organisations in England should provide confirmation to you as outlined in the HRA Approval letter. This will usually be by mutual agreement of the Statement of Activities or by signature of the template agreement – this will be made clear in the HRA Approval letter. The HRA will provide a suggested template email that participating NHS organisations in England may choose to use to accompany this agreement.

 

Participating NHS Organisations in Scotland, Wales or Northern Ireland

Please follow the guidance relating to the coordinated permissions systems in the devolved administrations. Sponsors are expected to have discussed the project with local researchers at the participating sites and the relevant R&D office. For participating organisations in Northern Ireland, Scotland and Wales, the instructions in IRAS for submitting NHS SSI forms should be followed.

 

Participating non-NHS Organisations

If your study includes non-NHS research sites, you may need to generate and submit non-NHS Site Specific Information (SSI) forms in IRAS. Please refer to the section within this website on Site Specific Assessment for more information.

 

< HRA Approval: NHS organisation guidance; version 4.0, dated 14 April 2016 >