In accordance with the UK Policy Framework for Health & Social Care Research (2017), confirmation of research governance compliance is required before a research study can commence activity in any Health and Social Care (HSC) Trust in Northern Ireland (NI). The UK Study-wide governance criteria, which can be accessed on the HRA website here, outlines the standards against which research studies will be assessed. The UK study-wide governance criteria is intended for reference and use by research sponsors when preparing their study protocol and supporting documentation.
For each study, the lead Nation (usually where the Chief Investigator is based) performs a series of core checks that apply across all participating Nations. Additionally, each participating nation performs checks relative to its own legislation. Further guidance on the key legislative differences across the UK can be sought by emailing the Approvals Service on the contact details below.
Planning a study
Before making an application and in order to initiate the assessment of participating site capacity and capability (C&C), research sponsors are expected to have initiated communications with each potential participating HSC Trust. It is essential that Sponsors liaise with the R&D Office in each HSC Trust as well as the proposed study delivery team. You can find contact details for Research and Development (R&D) staff at HSC/NHS organisations on the NHS R&D Forum website here and the details for the six HSC R&D Offices are below.
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Participating Sites |
Research Office contact |
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Belfast Health and Social Care Trust |
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Northern Ireland Ambulance Service Health and Social Care Trust |
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Northern Health and Social Care Trust |
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Southern Health and Social Care Trust |
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South Eastern Health and Social Care Trust |
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Western Health and Social Care Trust |
Further Information on planning your study is also available in the research planning section on the HRA website.
Submitting an application for governance review
All applications for regulatory review are made using the UK’s online integrated research application system (IRAS).
You will be asked a series of questions that will help identify what regulatory reviews each study requires e.g. Research Ethics Committee or Medicines and Healthcare Products Regulatory Agency (MHRA) approval, and the system will route the submission accordingly.
Details on the various approvals that may be required can be found on the HRA website here. However please note that HRA Approval applies to England and Wales only.
For detailed information on how to prepare and submit an application please refer to the IRAS website. If you are a student, it is essential that you confirm that your research is eligible to be undertaken with the NHS/HSC by completing the student research toolkit here and attaching the relevant declaration form to your IRAS application.
What to expect during the study-wide review process
In NI, the responsibility for governance review of study submissions has recently transitioned from the HSC Trusts to the HSC R&D Approvals Service. The HSC R&D Approvals Service has a remit for research involving secondary care only (including social care). To discuss the arrangements for primary care research in Northern Ireland, please contact the Northern Ireland Clinical Research Network (NICRN)
The process of governance review will differ slightly depending on the lead nation. The lead nation for a study is based on the location of the study’s lead R&D office.
Northern Ireland as Lead Nation
Once you have made your submission in IRAS, the HSC R&D Approvals Service will get in touch to advise whether the application includes all the necessary documentation for the governance review to commence (this is a separate process to REC validation).
When the submission is deemed complete, you will be instructed to share the Local Information Pack (LIP) with participating HSC organisations in Northern Ireland for them to commence their capacity and capability assessment in parallel with the continuing governance review.
An Approvals Assessor will be in touch with you throughout the governance review to keep you updated on the process and to ask for clarification on any queries that arise. If documents are updated as a result of any governance queries, you will need to update the LIPs and resend to sites to ensure that they have access to the most current document set for the study for their review. If these updates are made after any regulatory body approval is already in place, an amendment may be required.
Once the study-wide review is complete and any queries have been resolved, the HSC R&D Approvals Service will notify participating organisations in Northern Ireland and also the coordinating functions in each participating Nation so that they may continue with their Nation-specific assessment and processes.
Northern Ireland as a Participating Nation
Once the lead nation informs you that the submission is valid/complete, or when you add a Northern Ireland site to a study via an amendment, the Local Information Pack (LIP) should be sent to participating HSC organisations in Northern Ireland.
The process of sharing the LIP is the trigger for the HSC R&D Approvals Service to commence the Northern Ireland specific governance review. This assessment is not a repeat of the study-wide governance review performed by the lead nation but is a set of specific checks to ensure that any legislative and/or infrastructure differences in Northern Ireland have been considered within the study.
An Approvals Assessor will be in touch with you throughout the Northern Ireland participating nation review to keep you updated on the process and to ask for clarification on any queries that arise. If documents are updated as a result of any Northern Ireland participating nation queries, depending on the timing of review, a study amendment may be required.
Once the review is complete and any queries have been resolved, the HSC R&D Approvals Service will notify the participating HSC Organisations to support their continuing process of assessing capacity and capability (C&C).
HSC Site setup
Sponsors are strongly recommended to have preliminary discussions with potential participating HSC organisations (including the organisation’s Research and Development (R&D) office) before submitting the IRAS form in order to understand if those organisations have the potential to participate. It is at this early feasibility stage that potential participating organisations can begin to 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 HSC organisation is the version of the protocol or protocol synopsis that will be submitted for regulatory review.
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HSC Trusts |
Research Office contact |
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Belfast Health and Social Care Trust |
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Northern Ireland Ambulance Service Health and Social Care Trust |
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Northern Health and Social Care Trust |
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Southern Health and Social Care Trust |
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South Eastern Health and Social Care Trust |
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Western Health and Social Care Trust |
Organisations that have agreed that they might be able to participate in the study must be listed on 'part C' of the IRAS form. If additional HSC participating organisations are identified after initial submission then these must be added by the appropriate notification of amendment.
The process for setting up HSC sites in Northern Ireland will differ slightly depending on the lead nation. The lead nation for a study is based on the location of the study’s lead R&D office.
Setting up HSC sites in Northern Ireland in studies where the lead site is in Northern Ireland
The HSC R&D Approvals Service will instruct you to share the local information pack (LIP) with HSC organisations once your submission is confirmed valid/complete. This will support discussions to continue in relation to the local site requirements for the delivery of the study. Guidance for the Local Information Pack is provided in IRAS Help
Setting up HSC sites in Northern Ireland in studies where the lead site is in another Nation
You should send the local information pack (LIP) to HSC organisations once your submission is confirmed valid/complete by the lead nation. This will support discussions to continue in relation to the local site requirements for the delivery of the study. Guidance for the Local Information Pack is provided in IRAS Help
Once all the local arrangements have been put in place to deliver a study, the participating HSC organisation will provide you with confirmation of this via email, indicating that they are ready to start the study. The actual date for the commencement of research activities at the site should have already been agreed and may be dependent on a Sponsor site initiation visit or upon a greenlight confirmation.
In addition, if researchers who are not employed by the participating HSC organisation will deliver research activities locally, you should work with the R&D Office at the earliest opportunity for the site to put HR arrangements in place in accordance with local requirements.
Study amendments
As there is currently no central research governance review of amendments in Northern Ireland, and so each participating organisation is individually responsible.
Further details on how to amend your research approval can be found on IRAS help here with examples of what constitutes a substantial and non-substantial amendment on the HRA website here.
NHS/HSC Research Ethics Committee Review
The process of Research Ethics Committee review is separate to that of governance review. Details in relation to the Office of Research Ethics Northern Ireland (ORECNI) can be accessed via the HSC Business Service Organisation website here. Further details in relation to the REC review process can be accessed on the HRA site here
Contact
Please email the HSC R&D Approvals Service at Research.Approvals@hscni.net if you have any questions about the process of research governance review.
For queries in relation to other Nation’s processes, the relevant R&D coordinating function can provide advice. Details of the coordinating functions in England, Scotland and Wales are as below:
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Nation |
Coordinating Centre |
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England |
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Scotland |
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Wales |