HEALTH SERVICES RESEARCH STUDIES RESTRICTEDTO RECRUITING NHS STAFF
After HRA Approval – guidance for sponsors and investigators
This page sets out important guidance for sponsors and investigators on the conduct and management of health services research with HRA Approval that is outside of the remit of the NHS Research Ethics Service (see GAfREC for further information on this remit). Please read the guidance carefully.
A failure to follow the guidance could lead to the Health Research Authority (HRA) and Health and Care Research Wales (HCRW) reviewing the Approval status of the research.
1. Further communications with the HRA and HCRW
1.1 Further communications during the research are generally the responsibility of the sponsor. However, the sponsor may delegate responsibility to the chief investigator (CI) or another representative.
2. Commencement of the research
2.1 It is assumed that the research will commence within 12 months of the date of HRA/HCRW Approval.
2.2 The research should not commence at any non-NHS organisation until the local principal investigator (PI) or research collaborator has obtained management permission or approval from the organisation with responsibility for the research participants at the site.
2.3 The research should not commence at any NHS organisation in England and Wales until the site confirms their capacity and capability to undertake their role in the research (except when advised otherwise). Details of how capacity and capability should be confirmed are provided in the HRA/HCRW Approval letter.
2.4 The research should not commence at any NHS organisation in Northern Ireland or Scotland until the processes specific to each nation have been undertaken and the relevant management permissions have been issued.
2.5 Should the research not commence within 12 months of HRA/HCRW Approval, the sponsor should send a written explanation for the delay via e-mail to firstname.lastname@example.org or email@example.com. A further written explanation should be sent after 24 months if the research has still not commenced.
2.6 If the research does not commence within 24 months, the HRA and HCRW may review the approval status.
3.1 For health services research, registration is strongly recommended for reasons of transparency but it is not currently a condition of HRA/HCRW Approval.
4. Duration of HRA/HCRW Approval
4.1 Once issued, HRA/HCRW Approval generally applies for the duration of the research. The conclusion of the research is defined as the final date or event specified in the protocol, not the completion of data analysis or publication of the results. If it is proposed to extend the duration of the study beyond that specified in the application form, the HRA and HCRW should be notified.
5. Working with participating NHSorganisations in England and Wales
5.1 Unless specifically advised, CIs and sponsors should provide all necessary documentation and work in partnership with participating NHS organisations in England and Wales to assess, arrange and confirm that participating organisations have the capacity and capability to undertake the research. The study documents should be sent to both the local study team and the research management function of the participating organisation (e.g. the R&D office), and the Local Clinical Research Network (LCRN) where applicable. In certain cases, participating organisations willnot be expected to confirm capacity and capability to participate and / or receive study documents. Such instances will be clearly indicated and explained the HRA/HCRW Approval letter.
5.2 Where some or all participating NHS organisations in England and Wales arenot expected to provide formal confirmation of capacity and capability (see HRA/HCRW Approval letter for fulldetails), the HRAand HCRW encourages the organisations to confirmby email to the CI and sponsor that the researchmay proceed in advance of the no-objection deadline.
5.3 Where formal confirmation of capacity and capability is expected, sponsors should arrange with participating NHS organisations in England and Wales to have an agreement in place which outlines the roles and responsibilities of each party. This agreement should be proportionate to the study type and study activities undertaken locally and may take the form of agreeing the content of a Statement of Activities (where this approach is agreed by the HRA and HCRW). Wherever model agreements are applicable, it is encouraged that unmodified templates are used. The fully executed agreement or Statement of Activities will be taken as confirmation that the organisation is ready to participate in the research. Confirmation of the type of agreement to be used in a study (or for different types of site in a study) is provided in the HRA/HCRW Approval letter.
5.4 There is no expectation for CIs, sponsors or principal investigators to complete or submit site level forms to participating NHS organisations in England or Wales. If asked to do so, the CI or sponsor should notify the HRA immediately at firstname.lastname@example.org or HCRW at email@example.com. We will work with these organisations to achievea consistentsystem.
6.1 If it is proposed to make an amendment to the research, the CI should email a notice of amendment to the HRA by email to firstname.lastname@example.org or HCRW at email@example.com (whoever is acting as the lead nation).
6.2 HRA/HCRW will categorise both substantial and non-substantial amendments in line with UK wide policy on the handling of amendments. Following categorisation the HRA or HCRW will confirm approval for the amendment by email. The amendment should not be implemented at NHS organisations in England or Wales until HRA/HCRW approval for the amendment has been issued.
7. Conclusion or early termination of the research
7.1 The sponsor should notify the HRA or HCRW in writing that the research has ended within 90 days of its conclusion. The conclusion of the research is defined as the final date or event specified in the protocol, not the completion of data analysis or publication of the results.
7.2 If the research is terminated early, the sponsor should notify the HRA or HCRW within 15 days of the date of termination. An explanation of the reasons for early termination should be given.
7.3 Reports of conclusion or early termination should be submitted in the form prescribed by the HRA.
8. Review of HRA/HCRW Approval
8.1 The HRA and HCRW may reviewthe Approvalstatus at any time in the light of any relevant information it receives.
8.2 The sponsor may at any time request that the HRA and HCRW reviews the Approval status, or seek advice from the HRA and HCRW on any issue relating to the research.