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Research Governance Arrangements

If you are undertaking research in the NHS/HSC it is important that you are aware of the governance and ethical arrangements for research.

(You will also find below information on some of the important Regulatory Authorities involved in health and social care research)

 

The UK Policy Framework for Health and Social Care Research

**Click here to download a copy of the framework.**

 

This policy framework sets out principles of good practice in the management and conduct of health and social care research in the UK. It applies to health and social care research involving patients, service users or their relatives or carers. This includes research involving them indirectly, for example using information that the NHS or social care services have collected about them.

These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public. It is for organisations and individuals that have responsibilities for health and social care research. This includes funders, sponsors, researchers and their employers, research sites and care providers.

The Health Research Authority and the health departments in Northern Ireland, Scotland and Wales have developed the policy framework following public consultation. It replaces the separate Research Governance Frameworks in each UK country with a single, modern set of principles for the whole UK.

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

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

From 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.

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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.

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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

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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. 

GAfREC changes Remit REC 2011 08

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Regulatory Authorities

Health Research Authority (HRA)

The Health Research Authority (HRA) was established in December 2011 to promote and protect the interests of patients in health research and to streamline the regulation of research. The HRA works, with partners such as NIHR and the devolved administrations including HSC R&D Division, to make the UK a great place to do health research, to build confidence and participation in health research, and so improve the nation’s health. Patients, participants and the public share an interest with researchers and sponsors in ensuring good, ethical research is carried out, subject to proportionate regulation. It is leading on work to fundamentally review the Research Governance Framework, with partners in the devolved administrations.

The HRA is developing significant changes to the regulatory processes for health research to simplify the current complex arrangements. This will make it easier to do good research, whilst providing a robust and integrated system for research that patients and the public can trust.

A new system of HRA Approval integrates the review undertaken by the HRA’s research ethics committees with an assessment on behalf of the NHS, eliminating the duplication and variation that currently exists across the NHS. At present, this project is dealing with research ethics and R&D approvals in England only, but HRA is working closely with the devolved administrations to ensure any UK-wide issues are considered.

To help people find out more about the latest research studies, and to make the results of research available to other researchers and the public, the HRA is also ensuring that information about research studies and their results are registered.

The Office of Research Ethics Committees for Northern Ireland (ORECNI)

The Office of Research Ethics Committees for Northern Ireland is responsible for maintaining a Research Ethics Service to protect the rights, dignity and welfare of research participants within the HSC System/NHS, and to protect the rights of researchers to perform ethical research and legitimate investigation.

Medicines and Healthcare products Regulatory Agency (MHRA) 

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.

It protects and improves the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC), and the Clinical Practice Research Datalink (CPRD).

The MHRA is an executive agency of the Department of Health.

Human Fertilisation and Embryology Authority (HEFA)

The Human Fertilisation and Embryology Authority (HEFA) is the UK's independent regulator overseeing the use of gametes and embryos in fertility treatment and research.

It licenses fertility clinics and centres carrying out in vitro fertilisation (IVF), other assisted conception procedures and human embryo research, monitors UK fertility clinics and all UK research involving human embryos, and provides impartial and authoritative information to the public.

HFEA is an executive non-departmental public body of the Department of Health.

Human Tissue Authority (HTA)

The Human Tissue Authority (HTA) is a watchdog that supports public confidence by licensing organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions.

It also gives approval for organ and bone marrow donations from living people. The aim is to set standards that are clear and reasonable, and in which both the public and professionals can have confidence.

The Human Tissue Authority (HTA) has the interests of the public and regulated organisations at the centre of its work. It aims to maintain confidence by ensuring that human tissue is used safely and ethically, and with proper consent.