News       Events

Approval for Research in HSC

Please click on the relevant topic below to access information on the process for the approval of research in the HSC

Single form replaces separate ethics and R&D application forms on a UK-wide basis

Improving consistency for cross-border research within the UK

Research Governance Framework for Health and Social Care

HSC Trust Governance Permissions & HSC R&D Application Gateway

HSC Trusts Combined Metrics - Time to Approval

Arrangements for provision of NHS R&D local site-specific information for cross-border studies

Amendments made during a research study

Governance Arrangements for Research Ethics Committees

 

__________________________________________________________________________________

Single form replaces separate ethics and R&D application forms on a UK-wide basis

From the evening of 28 June 2017 a combined IRAS form that merges the REC and R&D forms will be used across the UK. Already in place for projects where the lead NHS R&D office is based in England, the single IRAS form should be used for projects where the lead NHS/HSC R&D office is based in Northern Ireland, Scotland or Wales.  

The streamlined single system is a result of the work of the Four Nations NHS/HSC Compatibility Programme and contributes to making it easier for applicants to undertake research in the NHS/HSC.  Adoption of the single IRAS form UK-wide will save time and effort for applicants and sponsors and help build UK-wide consistency.

For projects led from Northern Ireland, Scotland, or Wales, although a single form will replace the separate REC and R&D forms, this single IRAS form will continue to be separately submitted for ethical review (where applicable) and review against NHS/HSC standards as per current processes.  The single electronic submission of the IRAS form and accompanying documents for both ethical review and for review against NHS/HSC standards will remain in place for projects led from England. 

Over the coming year more work will be carried out to further streamline the application process, so that the current submission functionality for projects led from England is extended to projects led from Northern Ireland, Scotland and Wales.

Applications for Research Tissue Banks, Research Databases and for research projects not taking place in the NHS/HSC will continue to use the REC Form. Applications for studies where the lead NHS R&D office is based in England are not affected by this change.

Applicants are encouraged to read the advice and guidance within IRAS and to seek support from their lead NHS/HSC R&D office.

 

_______________________________________________________________

Improving Consistency for cross-border research within the UK

The Four Nations Policy Group has agreed priority areas where they can collaborate to make it easier for researchers to undertake cross-border research in the UK.
 
Good practice guidance on amendment submission for projects taking place in the NHS/HSC has been agreed across the four UK nations and is available on the HRA website at the following link: http://www.hra.nhs.uk/news/2017/03/30/improving-consistency-cross-border...
 
The guidance explains and clarifies:
 
  • the categorisation system used across the NHS/HSC to identify which amendments require action by NHS/HSC R&D offices and which do not

  • what kind of activities do not need to be notified as amendments

  • good practice for grouping amendments together

  • good practice for new site amendments

  • the process for submitting amendments – which varies depending on which UK nation the lead NHS/HSC R&D office for the study is based.

 
The guidance can be accessed without the need to log in to IRAS.
 

 

__________________________________________________________________________________

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:  

www.hra.nhs.uk/about-the-hra/consultations-calls/uk-policy-framework-health-social-care-research-consultation-active

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, NI.

 

 

__________________________________________________________________________________

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.

HSC R&D Application Gateway, 
Tel:  (028) 7161 1126, 

 

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.

Jan-Mar 2016

Apr-June 2016

Jul-Sep 2016

Oct-Dec 2016

Jan-Mar 2017

 

 

__________________________________________________________________________________

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

A clear UK-wide process for amendments across NHS/HSC will mean applicant guidance and amendment implementation will be clearer across the UK. Some initial guidance clarification has already been published. 

 
 
 

__________________________________________________________________________________

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:

GAfREC changes Remit REC 2011 08

Please click here for a link to The Office of Research Ethics Committees for Northern Ireland