The lead nation for a study is based on the location of the lead NHS R&D office. The lead nation will undertake the UK-wide review (in England this is incorporated into the HRA assessment) and share the application and the outcome of the UK-wide review with the other participating nations.
HRA Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance, 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 participating organisations to focus their resources on assessing, arranging and confirming their capacity.
If the lead nation is outside England, and there are NHS sites in England, HRA will accept the study-wide review and complete nation-specific elements before issuing HRA Approval.
In parallel to this activity, individual NHS/HSC participating organisations can be set up.
HRA Approval uses a local information pack for NHS participating organisations in England. The sponsor does not need to obtain detailed information from the local research team before sending the pack below by email to the local research team, the R&D office and Local Clinical Research Network (where relevant). Contact details are available on the NHS R&D Forum website. The details are then completed jointly between all relevant parties and then confirmed in writing.
Local Information Pack: List of Contents
- 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.
When HRA Approval has been issued, the sponsor should send the Approval letter and any revised documents to the local research team, the R&D office and Local Clinical Research Network (where relevant).
- A diagram setting out each step of the site set-up process and the information required for each step is available here. (PDF: “site set up diagram”, v1.0 March 2016).
HRA Approval uses a local information pack for NHS participating organisations in England, the HRA will provide additional support to applicants for studies where the lead NHS R&D office is in Northern Ireland, Scotland and Wales and the study has sites in England – please see information below about cross border arrangements and contact email@example.com for support clearly indicating that your study is sponsored in Northern Ireland, Scotland or Wales.
- Cross-border arrangements for provision of NHS R&D local site-specific information for cross-border studies (PDF: 13 April 2016)
< Page updated 14 April 2016 >