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 Wales Research Governance Framework (RGF) for Health and Social Care*.  All University research is subject to the RGF. 

* Work is underway to complete a UK Policy Framework for research governance

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 affect me and my research?

The RGF 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 RGF a Research Sponsor may not need to be declared, although funding bodies often request a Research Sponsor is identifed.  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 below 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 or Sponsorship?

The Research Sponsor takes responsibility for the overall conduct of the research project.   Further information can be found within the RGF.

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

Who can act as the 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 would 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.

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 RGF.

Projects involving the NHS

Researchers should complete the relevant application via the Integrated Research Application System (IRAS).  There is an online guide to provide instructions on using IRAS available via the E-learning tab. This will provide the appropriate ethical and local permissions for the project to proceed at individual sites within the NHS.

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 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  SU Sponsor Application Form - V2 .  This is not applicable for reviews as 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 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 review. 

For projects involving drugs or devices, please contact at the time of the funding application.  For all other clinical research projects please send your documents for sponsorship review when they are prepared.  Time lines for the review process 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) approval where relevant.

When will a Peer Review be required?

The RGF states that all Health and Social Care research must be peer reviewed.

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 Peer Review may be necessary. 

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 intervention are being given during the research project.

If a governance review establishes that a Peer Review 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 when required.