HRA Approval - What you need to know

Studies involving or led from Scotland, Wales or Northern Ireland

The HRA has compatible arrangements in place with national coordinating functions in the Devolved Administrations (DAs, i.e. Scotland, Wales and Northern Ireland ).

If your study is led from England, where the sponsor (or delegate) has indicated that they have a site in a DA, the HRA will share the HRA Approval application with the national coordinating function of the relevant nation (those countries listed in IRAS filter question 3) along with the outcome of the HRA assessment. This is so that each nation does not repeat the study wide review of the study.

  • The national coordinating functions in the DAs will undertake a review of the nation specific elements (e.g. arrangements for adults lacking capacity to consent or use of the Welsh language). If there are queries, they will liaise directly with the sponsor (or delegate).
  • The national coordinating functions will share the outcome of the HRA and their own nation specific elements of their review with the NHS/HSC organisations in their countries. This is called the study wide review.
  • The national coordinating functions may also be in touch to confirm if the sponsor (or delegate) does indeed intend to open sites in their country.
  • R&D permission at each DA NHS/HSC site is requested by the researcher using an SSI form. The DA NHS/HSC site will not issue R&D permission until the national coordinating function has issued their “study wide review” to the NHS/HSC R&D offices.

The HRA will communicate with the sponsor (or delegate) over study wide matters i.e. HRA assessment and REC review leading to HRA Approval. The HRA does NOT act as an intermediary between sponsor (or delegate) and the NHS/HSC organisations which take part in the study.

For example for an English led study with sites in Scotland: Where IRAS project filter 3 indicates that there are sites in Scotland, the HRA will share the study and the outcome of the assessment with NHS Research Scotland (NRS) who in turn make available to participating NHS sites in Scotland. For things where legislation is different in Scotland (such as adults without capacity to consent), NRS will undertake that part of the review on behalf of Scottish sites.

For studies with the lead R&D office in Wales, Scotland or Northern Ireland, you will need to complete the IRAS form (the combined NHS REC and R&D form) in the same way as for studies led from England. (Note: The combined IRAS form was implemented within IRAS for new studies from 28 June 2017. If you have already created separate REC and R&D Forms in IRAS there is no need to switch over so please continue to use the separate forms). Submission instructions are available on the e-submission/submission tabs within the IRAS Form and should be followed as they will change over time as further developments within IRAS are made. A step-by-step guide is available within IRAS Help. The HRA will accept the review that the relevant devolved nation undertakes; and the HRA will perform the England specific assessment for sites in England.

When the study is led from a DA and has sites in England, the lead nation will share the R&D application form and all received documents with the HRA. In practice this means:

  • To issue HRA Approval for the sites in England, the HRA Assessment Team will work with the sponsor (or delegate) to ensure that the study complies with standards in England (e.g. that the arrangements for adults lacking capacity to consent apply in England).
  • The lead nations sponsor (or delegate) should contact the HRA so that they can offer support to complete the Statement of Activities and Schedule of Events so that they can support the set-up of sites in England.
  • Once the Statement of Activity and Schedule of Events are ready and the HRA has issued the Initial Assessment Letter, the researcher liaises directly and simultaneously with the local study team, research management team and (if appropriate) the LCRN team for each NHS site in England. Instructions are available in IRAS Help.

Note: Where a sponsor (or delegate) has already completed an SSI for a site in England before talking to the HRA, the HRA will use some of the information in the SSI to support the creation of the Statement of Activities and Schedule of Events. The HRA would rather sponsors (or delegates) did not waste time completing an SSI but rather that they contact the HRA early. When HRA Approval was first implemented the HRA were aware that may sponsors (or delegates) would have had SSIs already completed so were happy to accept them as a basis on which to work but they are not necessary. A sponsor from Northern Ireland, Scotland or Wales can complete a Statement of Activities and Schedule of Events without approaching HRA for support if they have read the guidance and do not require any further support. (In the future a Local Information Pack will be implemented across the whole of the UK. The aim is that the Local Information Pack will be generated and shared with NHS/HSC organisations (local study team and research management) from within IRAS. There is not yet an implementation date for this.)

Where study is led from Scotland, Wales or Northern Ireland the process for submitting to sites in those nations has not changed, i.e. SSIs are transferred in IRAS to the local study team for completion and the local study team “submit” to the R&D office (although sometimes the sponsor (or delegate) do the submitting). Country specific instructions are provided in IRAS Help.

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.

Note: All formal correspondence from the HRA is sent to the person listed as sponsor contact in IRAS A4 as well as the CI (IRAS A3) and the Lead NHS organisations (IRAS A68-1). This ensures that the right people get the information. The person listed in IRAS A4 should be the main contact for the study.