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Research in the HSC

In accordance with the UK Policy Framework for Health & Social Care Research (2017), Research Governance compliance is required before a research study can commence in Health and Social Care Trusts (HSC) in Northern Ireland.

All research applications must be submitted using the web-based Integrated Research Application System (IRAS).

Before submission you should consider:

  • Make contact with the appropriate HSC Trust Research Office(s) at an early stage
  • Consider feasibility including patient/client population and input from HSC support services (Pharmacy, Laboratory, Radiology etc)
  • Evidence of funding (attribution of research costs)
  • Sponsorship
 

Full guidance is available on the Integrated Research Application System (IRAS) Website

 

Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales now benefit from a consistent package to support study set-up and delivery across the UK.

Part of submission includes a Local Information Pack (LIP) for commercial and non-commercial research. This contains an Organisation Information Document (OID) (which replaces the Site Specific Information form, used previously in Northern Ireland). For more information and guidance on the UK Local Information Pack please visit IRAS Help. A slideshow presentation which explains the procedure is also available to download if you click here.

Examples of completed SoECAT and OID templates are also now available on the Four Nations NHS/HSC Compatibility website on the UK Local Information Pack: Questions and Answers page. 

N.B. Model Participant Identification Centres (PICs) Agreements, to be used as a subcontract between participating NHS/HSC host organisations and PICs, are being developed and will be released shortly. In the interim, please continue to use the current process for recruitment and set up of PICs and do not use the LIP/OID for PICs.

N.B. Research studies involving primary care (General Practitioners, Dentists, Opticians, Community pharmacists), are not the responsibility of HSC Trusts, unless HSC Trusts own the primary care premises or staff involved in the research are employed by HSC Trusts. Further advice can be found by contacting the relevant GP practice, details contained within the Research Site ODS codes section in IRAS, or the Northern Ireland Clinical Research Primary Care Network 
 
 
For further guidance specifically related to NI click on the link below to download a guidance document...

HSC Trust Research Application Guidance (v6)

 

 

Click here to download the UK Framework for Health & Social Care Research

The Health Research Authority and the health departments in Northern Ireland, Scotland and Wales have developed a policy framework, which sets out principles of good practice in the management and conduct of health and social care research in the UK. This applies to health and social care research involving patients, service users or their relatives or carers, including research involving them indirectly e.g. using information that the NHS or social care services have collected about them. It is for organisations and individuals that have responsibilities for health and social care research including funders, sponsors, researchers and their employers, research sites and care providers. Click here to watch a short animation about what the framework is about (please note that this will open "youtube"): https://youtu.be/hV_ccr5p2XU

 

Determine whether your study is research

For the purposes of research governance, ‘research’ means the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods. Although some research projects include evaluation, where a project is considered to be solely audit or service/therapy evaluation, it will not be managed as research within the NHS/HSC or social care. Such projects do not require ethical review by a NHS/HSC or Social Care Research Ethics Committee or management permission through the NHS/HSC R&D office.

To help you decide whether your project is classified as research, the Health Research Authority (HRA) provide guidance (HRA website) and a Decision Tool

 

R&D Application Gateway

The R&D Application Gateway acts as the national co-ordinating function for Northern Ireland, that co-ordinates the study-documentation, and subsequent amendments. The Gateway’s role is to facilitate and support the application process by working in partnership with the HSC Trust R&D Offices and Sponsors/applicants, to ensure that all research applications, including amendments, are managed in a timely and efficient manner.

Please download a set of Frequently Asked Questions if you want to learn more about how the Gateway works.

Contact details Tel:  (028) 7161 1126     Email: research.gateway@hscni.net

 

How long will approval take? 

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-Jun 2016     Jul-Sep 2016      Oct-Dec 2016

Jan-Mar 2017     Apr-Jun 2017     Jul-Sep 2017      Oct-Dec 2017

Jan-Mar 2018     Apr-Jun 2018     Jul-Sep 2018      Oct-Dec 2018

Jan-Mar 2019

 

 

Governance Arrangements for Research Ethics Committees (GAfREC)

The Health Research Authority and the UK health departments in Northern Ireland, Scotland and Wales have published revised Governance Arrangements for Research Ethics Committees

Health and social care research can sometimes involve an element of risk, but it’s essential that this doesn’t compromise the dignity, rights, safety and well-being of the people who take part. To make sure that this is the case, Research Ethics Committees scrutinise research proposals before approving them to go ahead. This policy document sets out when review by a Research Ethics Committee (REC) is required and what’s expected from committees reviewing health and social care research proposals. These governance arrangements cover the principles and standards for RECs, including their composition, management and accountability. Click here to download the new edition of the governance arrangements, GAfREC 2018, issued on 18 June 2018.