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Supporting Research

Carrying Out Research Across Borders

This toolkit is designed for use by researchers setting up and conducting research in the NHS, or health and social care settings across multiple UK nations

If you have any queries relating to the below content, please contact the relevant organisation in your nation.

Before you begin

  • The UK has a range of organisations working together to support and regulate different aspects of health and social care research; the UK is made up of four nations: England, Northern Ireland, Scotland and Wales
  • This toolkit is designed for researchers setting up and conducting research to take place within more than one UK nation; this decision tool can be used to help you decide whether or not your study is research as defined by the UK Policy Framework for Health and Social Care Research
  • This toolkit highlights the key national differences in legislation and/or processes and provides guidance on how to navigate differences.
  • For further advice or support, please contact queries@hra.nhs.uk; you can also provide feedback by completing this survey
  • Read on for the full content, or request an offline (PDF) version

Contents

This toolkit contains information on:

  • Information dependent on your study
    • Research Ethics Committee (REC) scope
    • Approvals for project-based research in the NHS, health and social care
    • Research involving adults lacking capacity to consent for themselves
    • Research involving prisoners and/or young offenders
    • Social care research
    • Research involving general medical devices and in vitro diagnostic medical devices
    • Accessing identifiable patient data without consent
  • Information applicable to all research types
    • Document provision
    • Contracting arrangements

Research Ethics Committee (REC) Scope

The Governance Arrangements for Research Ethics Committees (GAfREC) is the UK policy document describing the NHS, Health and Social Care Research Ethics Committee (REC) function and specifies when a review by an NHS/HSC REC is required. Annex A sets out the extent of legal requirement for REC review by nation.

This decision tool can be used to determine if your study requires NHS/HSC REC review. For studies taking place in multiple UK nations, please complete the decision tool for each nation.

Approvals for project based research in the National Health Service (NHS) and Northern Ireland’s Health and Social Care (HSC) Service

Study wide review is the process by which all research in the NHS/HSC is reviewed and approved. This brings together the assessment of governance and legal compliance of research in healthcare (and social care in Northern Ireland).

The four nations of the UK take a consistent approach to study wide reviews so that you only need to submit one application on IRAS in most circumstances.

Each participating nation will take assurances from the study wide review conducted by the lead nation (the nation conducting the initial review).

Each participating nation will review your research application against any nation specific laws or regulations and may ask you questions about these but should not ask for information or documents you have already provided.

Key differences in approvals for research in the NHS, Health and Social Care

England and Wales

  • For any research taking place in the NHS in England and/or Wales, you will receive a Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval letter
  • The HRA and HCRW Approval letter will detail any further requirements before you can begin your research, for example the requirement for sites to confirm their capacity and capability
  • Further information about the HRA and HCRW Approval application process, and tips for a successful application can be found on the HRA and HCRW Approval Integrated Research Application System (IRAS) webpage.

Northern Ireland

Scotland

  • For any research taking place in the NHS in Scotland, you will receive R&D permission after the relevant study wide reviews and site assessments and arrangements are complete

For further information about R&D permissions application process, please visit the IRAS page for Scotland submissions or the NHS Research Scotland website.

Are you planning or running a non-CTIMP (non-Clinical Trial of an Investigational Medicinal Product) which will undertake intrusive research involving adults lacking capacity to consent for themselves?

This section is relevant if you plan to recruit living participants aged 16 or over who lack capacity (in any nation), or to retain them in the study following loss of capacity (in England, Wales or Northern Ireland). Intrusive research means any research with the living participants requiring consent in law.

The Mental Capacity Acts in England, Wales and Northern Ireland and the Adults with Incapacity (Scotland) Act only apply to non-CTIMP research. If you are planning or running a Clinical Trial of an Investigational Medicinal Product (CTIMP) involving adults lacking capacity to consent for themselves in any of the four UK nations, please see the principles of consent for further guidance.

National Mental Capacity Act/Adults with Incapacity (AWI) differences

England and Wales

  • Approval is required by an “appropriate body” under section 30 of the Mental Capacity Act 2005 (MCA) for any research, even where the research does not involve NHS patients; further information about the MCA and appropriate bodies can be found on the Health Research Authority website
  • The appropriate bodies are NHS, Health and Social Care Research Ethics Committees (RECs) or Ministry of Defence Research Ethics Committee (MODREC), where the research falls within the remit of MODREC
  • For guidance on the research provisions of the MCA, see chapter 11 of the Code of Practice, available on the gov.uk website

Northern Ireland

Scotland

What this means for the review

If you are conducting a non-CTIMP involving adults lacking capacity to consent in Scotland and at least one other nation, two applications and reviews are required due to the differences in legislation.

One application should be booked to Scotland A REC and the other to a flagged REC in England, Northern Ireland or Wales.

Guidance on documentation requirements can be found on the Health Research Authority decision tool.

Further general guidance can be found on the Integrated Research Application System (IRAS) help page.

Do you plan to include any participants who are prisoners, young offenders or on probation?

For this purpose, a prisoner or young offender is defined as any inmate of the prison systems of England and Wales, Scotland or Northern Ireland. It does not include patients detained under the Mental Health Act at special hospitals or other psychiatric secure units, or juvenile offenders detained in local authority secure accommodation or secure training centres.

Health research involving prisoners or young offenders should relate directly to their health care and be of such a nature that it could only be conducted in this population.

National Differences: Research including prisoners, young offenders or participants on probation

England and Wales

  • The Offender Health Research Network (OHRN) publishes guidance on the various approvals and permissions required to conduct research involving prisoners in England and Wales and may be able to assist with specific queries
  • The ethics application can be booked to any Research Ethics Committee (REC); further information on this service can be found on the Health Research Authority website

Northern Ireland

  • Please contact research.approvals@hscni.net at the earliest opportunity for guidance on the approvals required
  • Ethics applications for health and social care research involving prisoners can be booked to any REC
  • You may also require a separate research application to the Northern Ireland Prison Service

Scotland

  • Scottish healthcare related studies involving prisoners should be submitted to any Scottish REC
  • An application to the Scottish Prison Service should be made separately, with guidance on how to do so available from NHS Research Scotland

Do you plan for your research to take place in the social care environment?

National differences: Social care

England and Wales

  • A favourable ethical opinion is usually required where the study involves health research
  • In England, ethical applications should be made to a flagged social care Research Ethics Committee
  • In Wales, ethical applications can be made to any Research Ethics Committee in the UK
  • Further information can be found on the Health Research Authority website

Northern Ireland

  • Healthcare and social care are integrated under Health and Social Care (HSC) Northern Ireland
  • All social care research taking place within HSC or involving services commissioned by HSC requires submission via IRAS for regulatory review
  • Ethical applications should be made to an appropriately flagged Research Ethics Committee.
  • Multicentre social care research in Northern Ireland requires confirmation of initial support from the Executive Directors of Social Work, which should be applied for
  • For research within the independent sector (not involving the HSC), please contact the Office for Research Ethics Committees in Northern Ireland for advice on approvals

Scotland

  • For Scottish social care research studies, a Research Ethics Committee favourable opinion is only required in the following cases:
    • The study falls within the scope of the Adults with Incapacity (Scotland) Act 2000 (these studies must undergo review at the Scotland A Research Ethics Committee)
    • The study involves NHS patients, or a mixture of both NHS patients and social care users. These studies can be reviewed by any Scottish NHS Research Ethics Committee
    • The study involves linking social care data with NHS data

Will your research involve a medical device or in-vitro diagnostic device?

This would mean your research involves either:

  • A non-UKCA/CE/UKNI marked medical device (including a standalone in-vitro diagnostic or an in-vitro diagnostic being used as a companion diagnostic in a Clinical Trial of an Investigational Medicinal Product (CTIMP))
  • A UKCA/CE/UKNI marked medical device, which has been modified or is being used outside of its current intended purpose (including a standalone in-vitro diagnostic or an in-vitro diagnostic being used as a companion diagnostic in a CTIMP)

National Differences: General medical devices and in-vitro diagnostic medical devices

England, Wales and Scotland

Northern Ireland

The Medicines and Healthcare products Regulatory Agency (MHRA) have published information about the regulation of devices in Northern Ireland.

General medical devices

  • The EU Medical Device Regulations (2017/745) (MDR) applies to clinical investigations of medical devices in Northern Ireland
  • Information on the application process can be found on the IRAS website

In-vitro diagnostic (IVD) medical devices

  • The EU in-vitro Diagnostic Medical Device Regulations (2017/746) (IVDR) applies to performance studies of IVDs in Northern Ireland
  • Information on the application process and the documentation requirements for IVD studies can be found on IRAS; his includes information for standalone IVD studies as well as studies where an IVD is used as a companion diagnostic in a Clinical Trial of an Investigational Medicinal Product

Will identifiable, confidential patient data be accessed outside the care team without prior consent at any stage of the project (including identification of potential participants)?

National Differences: Accessing identifiable data without consent

England and Wales

  • If your project involves access to identifiable patient data relating to people living or receiving care and treatment in England and Wales without consent, you may need to apply to the Health Research Authority (HRA) for agreement to process data without consent and an application should be made to the Confidentiality Advisory Group (CAG)
  • For details of Section 251 of the NHS Act 2006 and supporting Health Service (Control of Patient Information) Regulations 2002, how it regulates the control of identifiable patient data and how it may impact on your research, please refer to the HRA website

Northern Ireland

  • There is currently no legal basis for those outside of the direct care team to process patient/service user identifiable data without consent
  • The Health and Social Care Privacy Advisory Committee can provide advice on any options available to progress your research in Northern Ireland
  • The Health and Social Care Honest Broker Service does not provide identifiable data for consented studies or trials but may be able to offer advice on options to access anonymised data to support your research

Scotland

Providing the UK Local Information Pack

A UK Local Information Pack (LIP) is provided to NHS, Health and Social Care organisations by researchers to ensure that the information given to all research sites is consistent.

Information about the LIP, email templates for sharing the LIP and further guidance can be found in IRAS help.

Information about setting up Participant Identification Centres can be found on the Site Specific Information page of IRAS help.

Providing the UK Local Information Packs (LIPs) to NHS, Health and Social Care sites

England and Wales

  • Applicants will receive an Initial Assessment Letter; LIPs may be shared with sites when the Initial Assessment Letter is received; the LIP should include the Initial Assessment Letter
  • The sponsor should send the LIP directly to the Research and Development (R&D) department, delivery team and local clinical research network (if an NIHR portfolio study) using the England and Wales non-commercial email template or commercial email template as appropriate
  • For Welsh sites, it is expected that the sponsor has a process to translate patient facing documents into the Welsh language if requested by sites or participants

Northern Ireland

  • The sponsor may send the LIP to each participating site’s R&D department and delivery team once the application has been validated and once instructed to do so by the Health and Social Care R&D Approvals Service
  • The LIP should be shared using the Northern Ireland non-commercial email template or commercial email template as appropriate

Scotland

  • NHS Research Scotland Permissions Coordinating Centre make the LIP available to participating R&D departments and the appropriate Network or Portfolio Manager
  • The sponsor is responsible for making the information available to the research teams using the Scotland email template; this covers both non-commercial and commercial studies

Contracting Arrangements

Model contracts are available for many types of research.

These contracts have been developed and are maintained by the Four Nations Contracts Leads Working Group, in partnership with a wide range of stakeholders from across the four nations. As such, contracting expectations and arrangements across the four nations are broadly similar.

For all four nations:

  • In commercially sponsored research, it is mandatory to use the unmodified contract templates appropriate to your study type
  • In non-commercially sponsored research, it is expected that the unmodified contract appropriate to your study type is used; use of bespoke or modified agreements, where an appropriate template exists, is likely to result in significant delay and costly review; any modifications must be highlighted in the application

National differences relating to the way contractual agreements are reviewed and agreed

England and Wales

  • You will need to obtain a waiver from the Health Research Authority and Health and Social Care Research Wales if you wish to use a modified or bespoke agreement (an agreement that differs from a published UK-wide model agreement template)
  • This waiver allows NHS sites to freely negotiate all the contractual terms of the agreement
  • In Wales, you can expect this negotiation to be carried out with a central team

Northern Ireland

  • You will need to obtain a waiver via the Health and Social Care R&D Approvals Service if you wish to use a modified or bespoke agreement (an agreement that differs from a published UK-wide model agreement template)
  • This waiver supports Health and Social Care sites to freely negotiate all the contractual terms of the agreement

Scotland

  • You can expect to carry out a single contract negotiation for all Scottish sites; this will be negotiated with a nominated lead site or central team
  • If your study is single centre, it will be negotiated at the relevant site