Please click on the relevant topic below to access information on the process for the approval of research in the HSC
The Research Governance Framework for Health and Social Care (HSC)
While research is essential to the successful promotion and protection of health and wellbeing, and to modern and effective HSC services, proper governance of research is also essential to ensure that the public can have confidence in, and benefit from, quality research. All four UK nations have created their own versions of the Research Governance Framework.
Currently, the Health Research Authority is leading a UK-wide project with the aim of creating a replacement Framework for Research. If possible this would be a harmonised UK-wide document, and the process is expected to complete early in 2015.
Following an initial comments period held to capture the feedback of key stakeholders (NI comments can be downloaded below), the UK policy framework for health and social care research went out for formal consultation. The policy framework are available at the link below:
The current Research Governance Framework for Health and Social Care sets out standards that apply to all research undertaken by, or on behalf of, HSC and the Department of Health, Social Services and Public Safety (DHSSPS).
HSC Trust Governance Permissions and the HSC R&D Application Gateway
HSC R&D Division provides the funding to support Research Offices in each of the five HSC Trusts. These offices are responsible for providing research governance permission for research studies involving secondary care in Northern Ireland.
Researchers wishing to conduct research in the HSC in Northern Ireland must obtain management permission (also referred to as R&D approval) for each HSC research site.
The following guides provide instructions and contact details on how to do this: HSC Trust Research Governance Permission Guidance for Applicants
For multi-centre studies (studies involving more than one HSC Trust in Northern Ireland or with one or more UK nations), the HSC R&D Application Gateway has been established to coordinate research governance permission, working closely with the HSC Trust R&D Offices in Northern Ireland and the other national research co-ordinating centres in the UK. The Gateway is not responsible for granting permission, this is the responsibility of HSC Trusts, but rather coordinates the submission of a multi-centre application. Applicants must make contact directly with the Gateway to submit multi-centre study applications.
For a single centre study (involving only one HSC Trust in Northern Ireland) the submission of application is made directly to the HSC Trust Research Office.
HSC Trusts Combined Metrics - Time to Approval
The documents below contain combined metrics for the 5 HSC Trusts in NI relating to the time for research governance approvals. These reports are issued by the Trust Research Office Managers.
Cross-border arrangements for provision of NHS R&D local site-specific information for cross-border studies
The 4 Nations have reviewed the information required for study approval/confirmation of capacity and capability at the local NHS site level. This is with the aspiration of coming to a common UK position, that supports the timely set-up of studies and that meets the needs of sponsors, research sites, NHS patients and service users. An update is provided below:
For Northern Ireland, Scotland and Wales: We are working with colleagues across the UK to develop a UK-wide Local Information Pack that will be incorporated into IRAS and will replace the current Site Specific Information (SSI) Form. More details will be available in due course.
For England: We are building on the experience of using the Statement of Activity and Schedule of Events templates in England and working in collaboration with colleagues in Scotland, Wales and Northern Ireland to develop a UK-wide Local Information Pack that will be incorporated into IRAS. More details will be available in due course.
In the meantime the existing interim arrangements continue to apply.
· Site Specific Information (SSI) forms will continue to be used for setting up studies in the devolved administrations (DAs).
· The above includes research studies that are sponsored/led from England with research sites in a DA, where the DA will continue to use SSI forms.
· Where research studies are sponsored/led from a DA with sites in England, the HRA will accept SSI forms.
· For DA-led studies, the HRA Approval team will facilitate the completion of any additional information requirements in England in order to review the study and will confirm with the sponsor that the information is correct.
· Sponsors from a DA (or authorised delegates) are advised to contact the HRA at the earliest opportunity so that the HRA Approval team can facilitate the review of the research study for English sites.
The above arrangements will be reflected in updates to operational guidance documents, including the HRA Approval Q&A.
Amendments made during a research study
Amendments to a study, after HSC/NHS Research Governance Permission has been granted, should be notified to HSC/NHS organisations. This applies to both substantial and non-substantial amendments.
The amendment should be notified in parallel with ethical and regulatory review so that the implications of the amendment can be assessed and necessary arrangements made.
Please note that the Sponsor/Chief Investigator is responsible for providing details of the amendment, including copies of revised documents, to all participating investigators and study teams.
Amendments must be notified using the appropriate forms and all documentation should be submitted to the lead National Coordinating Function (See leaflet). For Northern Ireland lead studies ALL amendments should be submitted via email to: firstname.lastname@example.org.
For further information on amendments including forms and categorisation of amendments please see the HRA website: http://www.hra.nhs.uk/research-community/during-your-research-project/amendments/
Governance Arrangements for Research Ethics Committees
A revised version of Governance Arrangements for Research Ethics Committees (GAFREC) has been agreed by the four UK Health Departments. This document is the policy of the UK Health Departments, describing what is expected from the research ethics committees that review research proposals relating to areas of the UK Health Departments’ responsibility. It also explains when review by these committees is required.
The policy covers the principles, requirements and standards for research committees, including their remit, composition, functions, management and accountability. It also describes the Research Ethics service in which the research committees operate, and the review they provide.
This harmonised edition came into effect on 1 September 2011 (Updated April 2012). It revises and replaces editions of the policy previously issued separately in England and Scotland in 2001. It also applies to Wales and Northern Ireland.
Guidance on the main changes to the Remit of RECs under the harmonised GAfREC:
Please click here for a link to The Office of Research Ethics Committees for Northern Ireland