Research governance and ethics

Research Governance at Swansea University

Please note: This page is at an early stage of development and will be subject to change. 

What is Research Governance?

Research Governance is the process by which the University ensures the delivery of high quality research which complies with all relevant legislation.  Further information can be found within the UK policy framework for health and social care in research which was published in November 2017 to replace the four UK Health Departments Research Governance Frameworks (RGFs) previously available. All University research is subject to the UK policy Framework.

Is Research Governance the same as ethics approval for my research project?

All research involving human participants, their tissue or data must receive approval from an ethics committee.  This approval forms part of the research governance process.

If your research involves participants not recruited via the NHS you must receive approval from your College/School ethics committee before your research can begin. There may be circumstances where a University committee does not have the expertise to review a research project and research governance may request a NHS ethics committee to review the project although outside their normal scope.

If your research involves NHS staff, tissues, data, facilities or patients you will need NHS ethics approval and local R&D permission before your research can begin.  You will need to have an agreed Research Sponsor before you can submit these applications to the NHS. 

How does the RGF replacement, the UK policy framework affect me and my research?

The UK policy framework for health and social care research defines the responsibilities for all those involved in the conduct or management of research projects: researchers, students, supervisors, care professionals, funding bodies, research hosts, employers and sponsors of research projects. 

For research which involves human participants or access to NHS resources there are stringent requirements to be followed.  In the case of clinical trials involving drugs or devices there is specific legislation which must be complied with. All research activity taking place in the NHS requires a Research Sponsor to be declared.

For non NHS research under the UK policy framework a Research Sponsor may not need to be declared, although funding bodies often request a Research Sponsor is identified.  The University will still require reasonable assurances that such research will meet the conduct and management requirements of the RGF. 

The University has drafted a Policy for Clinical Research in combination with reviewing policies and procedures relating to research practices.  There will be a number of new or revised systems and procedures to aid compliance with the required legislative standards and best practice.

If after reading the information on these pages you are unsure what requirements need to be met for your research project involving human participants or data please contact Research Governance.


What is a Research Sponsor, Sponsor or Sponsorship?

The Research Sponsor (or Sponsor) takes responsibility for the overall conduct of the research project.  Further information can be found within the UK policy framework for health and social care research.

Please note: the Research Sponsor is not necessarily the same organisation providing the funding for a research project.

Who can act as the Research Sponsor for University research?

If you are a student of or substantively employed by Swansea University you should contact Research Governance in the first instance.  If you are neither a student nor employee of the University please contact your substantive employer or academic institution.  In some instances the University may act as the Sponsor for honorary staff members but this will be assessed on an individual project basis.

The University will usually act as the sole Research Sponsor for the majority of projects.  However, there are now specific instances when co-sponsorship with Abertawe Bro Morgannwg University Health Board will be considered. This will be assessed by Research Governance.  For further information please see the University Research Sponsor flowchart: SU Sponsor Approval Process v2 .

Researchers should not identify the University as sponsor until they have agreement from Research Governance.

When do I need a Research Sponsor?

The University must actively consent in writing if it is to act as Sponsor for research projects involving the NHS or Social Care.  Although there is not necessarily a need to demonstrate the University as a Sponsor for non NHS projects, the conduct of the project should still meet the requirements of the UK policy framework for health and social care research.

Projects involving the NHS

Researchers should complete the ‘Full set of Project Data’ application via the Integrated Research Application System (IRAS).  If your recruitment sites are in Wales (or another devolved nation) you will also need to generate separate Site Specific Information (SSI) forms.

IRAS is a single system for applying for permissions and approvals for health and social care/community care research in the UK – a full list of review bodies are availbe on the website.  Within IRAS, there is an online guide to provide instructions on using the system available via the ‘E-learning’ tab. IRAS will provide the appropriate ethical and local permissions for the project to proceed at individual sites within the NHS and other review bodies as listed.

Please note: We have developed University specific guidance for help in completing the IRAS form.

Projects not involving the NHS

The majority of other research in the University should receive an ethical review by applying to their College/School ethics committee to obtain an agreement to proceed.  The University is currently revising processes for the monitoring and audit of these projects. 

What is the process for requesting the University to be the Research Sponsor?

If you require the University to be the Research Sponsor you will be asked to provide the completed  SU Sponsor Application Form - V2 and project documents for review, as per the Procedure for the Research Sponsor Approval

Alternatively, the researcher should contact Research Governance as early as possible.

This governance review will involve an assessment of staff and costs that will need to be included for the University to accept the role of Research Sponsor.

All projects sent for a governance review should be accompanied by a completed SU Sponsor Application Form - V2. 

Note: The sponsor application form is not required for reviews at the funding application stage.  These projects will receive a more detailed review post award to include the completed Sponsor Application Form.

How long will it take to complete the sponsor review?

An initial sponsor review at the funding application stage will usually be processed within a few days.

For a complete sponsor review of an IRAS application and all the required documents you will need to allow 2 weeks for a review for the majority of projects.

For projects involving drugs or devices, please contact Research Governance at the time of the funding application. Time lines for the complete sponsor review of these projects will be agreed at the time the application is assigned for review (which, depending on workload, may be several days after you send us your full document set).

You should not book your project for an ethics committee review until you have received an ‘in principle’ agreement sponsor letter and reference number from Research Governance. An agreement in principle is subject to the research project receiving all of the required approvals and permissions including Insurance confirmation, Ethics committee favourable opinion, NHS R&D permission and Medicines & Healthcare products Authority (MHRA) authorisation where relevant.

When will a Peer Review be required?

The UK policy framework for health and social care research states that all Health and Social Care research must receive an ‘appropriate independent expert (peer) review’.  

An externally funded project will often have had an expert independent review of the methodology behind the project proposal. However, for projects where there has not been sufficient review of the proposal because there is insufficient expertise on the award panel or they have reviewed a programme or fellowship grant then a separate Peer Review may be necessary.

A separate peer review will not be required for the majority of student projects which have been reviewed by their academic Supervisor and the College’s committee.  Exceptions to this may be if drugs, devices or a physical or mental intervention are being given during the research project. However, evidence of the peer review provided may be requested.

If a governance review establishes that a Peer Review (which may be additional to one provided) is required the researcher will be directed to the Joint Study Review Committee. 

Does the University have Insurance cover for my research project?

The University has a responsibility to protect research participants, staff and students involved in research.  The University has insurance cover in place for the majority of University research projects. 

There are some instances when the University needs to seek clarification from the insurance provider that cover will apply.  You will be advised of these instances during governance or ethical review.  When the University accepts the role of Sponsor you will be issued with evidence of insurance usually as part of the sponsor letter.

Please note: This page is at an early stage of development and will be subject to change.