Contents
1 Aim
Health research authority (HRA) approval is required for studies that take place in the NHS in England. It comprises a review by an NHS research ethics committee (REC) (where required) as well as an assessment of regulatory compliance and related matters undertaken by dedicated HRA staff. In England, it replaces the need for local checks of legal compliance and related matters previously known as the local governance review.
This allows NHS organisations to focus their resources on assessing, arranging, and confirming their capacity and capability to deliver a study. The HRA and the clinical research network (CRN) expects members of the local Research and Development team to collaboratively work with Investigators and Research teams when they have been notified that they have been selected to participate in a new study they expressed an interest in.
This SOP should be used when an Investigator or Research team are completing set up activities as part of the formal capacity and capability assessment so that confirmation of capacity and capability (CC and C) can be issued.
2 Scope
All staff registering research projects conducted within the trust, by either internal or external staff.
3 Link to overarching policy
4 Procedure
4.1 Registration
When a study is registered, a governance contact and where relevant a delivery team contact will be assigned to support through the set up process. However, it is helpful if sponsors or investigators contact Grounded Research as early as possible, ideally before regulatory approvals are applied for. At this point discussions can begin around feasibility, for example does the trust have the services required to run a study, does it have enough eligible patients to meet the recruitment target.
Where the study is RDaSH sponsored or is the lead NHS organisation, it is expected that investigators will engage at the point where they are developing a protocol and applying for funding. However, the steps described below are still required.
Grounded Research Governance team will commence the capacity and capability assessment through collaboratively working with the Research team, investigator, and relevant support services set the new study.
Once the HRA application has been submitted and the validation letter received, the research can be formally registered with Grounded Research using the local information pack (LIP). Further information about the LIP can be accessed on the HRA website here;
4.2 Assess arrange and confirm
- Assessing, assessing whether the NHS organisation has the capacity and capability to participate in the study.
- Arranging, putting any practical arrangements in place to provide the capacity and capability to deliver the study.
- Confirming, confirming that the NHS organisation has the capacity and capability in place to deliver the study and will deliver the study.
4.2.1 Assessing
This will be confirmed by the operational management group, who will consider staff and resource capacity required to deliver the study. The Governance team will ask research nurses and the relevant support departments to review the industry costings template (commercial studies only) or the SoECAT or schedule of events (non- commercial studies only) against the current protocol to check whether they are happy with the activities noted, the timings provided for these and that they relate to the protocol accurately.
4.2.2 Arranging
This includes arranging research panel approval and the internal agreements outlined below. Internal approvals will be organised by Grounded Research and must be in place before CC and C can be issued.
All research (except for those deemed as not requiring CC and C) must be reviewed and approved by the research panel, usually this will be at the monthly research panel meeting but may be conduct outside of the meeting where timings do not allow review at a meeting.
Grounded Research will liaise with support services, for example where the study requires pharmacy or laboratory support and will arrange review and support service approval. In some cases, these activities may need to be sub-contracted to external organisations with an appropriate contract or service level agreement.
The relevant service manager for the area where the research will be conducted must provide confirmation that they have no objection to the research taking place.
Where there are payments made to the trust finance approval will be required.
Where a model contract is used instead of an OID the Contracts team must review and sign off the contract. Senior care group approval is required as well as service manager.
Where there are any concerns around data protection and GDPR input from the Information Governance team will be sought.
4.2.3 Confirming
Once all internal checks are complete an email will be sent by the research governance manager confirming CC and C. The signed model contract or OID is attached to this email. No research activity can take place until CC and C is confirmed.
5 Summary
The trust follow the HRA guidance on registering a research project. Sponsors and investigators are encouraged to contact the research governance manager at the earliest opportunity to ensure there are no delays in the CC and C process.
- Early engagement.
- Submit LIP.
- Assess.
- Arrange.
- Confirm.
- Issue CC and C.
- Open study to recruitment.
6 Appendices
6.1 Appendix A contents of the UK local information pack
In summary the UK local information pack is made up of the following.
6.1.1 Covering email using standard template format
You will need to use the appropriate email template, please refer to the instructions below for sharing the local information pack
6.1.2 Localised organisation information document (non-commercial studies)
The outline organisation information document(s) submitted with the IRAS form application must be localised before sharing with participating NHS or HSC organisations. Refer to the previous section and the guidance provided with the templates for more information.
6.1.3 UK statement of events or schedule of events cost attribution tool (SoECAT)
The schedule of events or SoECAT forms part of the UK local information pack for non commercial studies only.
6.1.4 Relevant contract (commercial studies)
In commercially sponsored studies the relevant model contract(s) or agreement(s) form part of the UK local information pack.
6.1.5 Delegation log
A delegation log is appropriate for studies that are clinical trials (defined as first four categories in IRAS project filter question 2) where the local study activities are managed by a principal investigator (PI). Sponsors may share the template delegation log that will be used in the study as part of sharing the UK local information pack, or they may indicate in the email template used to share the UK local information pack that they will share the delegation log template later (for example, after a site initiation visit). Where used and shared, the delegation log should include known research team names but not signatures (signatures should be put in place during site set up).
6.1.6 Relevant supporting documents
These will include some of the documents that have been submitted or approved with the IRAS form submission and other documents to support study set up at the participating NHS or HSC organisation(s). Information about the documents to include is provided alongside the covering email templates provided.
The sponsor, or authorised delegate, is responsible for sharing the UK local information pack with participating NHS or HSC organisations; the process for doing this depends on where the NHS or HSC participating organisation is located
6.2 Appendix B Email template to share local information pack
Document control
- Version: 2.1.
- Unique reference number: 432.
- Date ratified: 29 January 2024.
- Ratified by: Clinical policy approvals group.
- Name of originator: Research governance manager.
- Name of responsible individual: Research panel.
- Date issued: 9 February 2024.
- Review date: April 2025.
- Target audience: All staff involved in research.
Page last reviewed: April 15, 2024
Next review due: April 15, 2025