Use our frequently asked questions (FAQs) to help answer common queries. If you can’t find the answer you are looking for, please contact us (firstname.lastname@example.org)
Only research requires ethical review. There is no requirement for ethical review of service evaluation or audit. The HRA Defining Research Tool (http://www.hra-decisiontools.org.uk/research/) will help you ascertain what category your work falls into. You should also discuss your proposal with the University’s Research Governance Manager for category confirmation (email@example.com).
The Research Sponsor is the organisation taking on the primary responsibility for the insurance and management of the research. The research may be sponsored by the University or the NHS Trust. The sponsorship will depend upon the employment status of the Chief Investigator and the nature of the research. Contact the Research Governance team (firstname.lastname@example.org) to discuss the appropriate sponsorship arrangements for your research.
This research must first be reviewed by the Swansea University Sponsorship Oversight Committee. Following this, the 3 main steps to approval are NHS REC review, HRA approval and NHS Trust confirmation of capacity and capability. For research involving NHS patients, data and premises it must be subject to ethical review by an NHS Research Ethics Committee. For research involving NHS staff only, ethical review may be required at Faculty level through your Faculty Research Ethics Committee or by an NHS REC. Please use the HRA Decision Tools to decide (http://www.hra-decisiontools.org.uk/ethics/; https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/student-research-toolkit/ )
You should not apply to have your research reviewed by an NHS REC until you have secured the appropriate governance approval(s). Your application will not be accepted without sign off by the sponsor and this cannot be secured until all study documentation has been reviewed.
The University does not permit any student to act as Chief Investigator in any research. This applies even if the student is a qualified professional working in the student capacity. In student research the Chief Investigator must always be the student’s supervisor or another member of academic staff, as the University is the employer.
You will need to provide evidence that you are appropriately qualified by education and experience to perform your tasks. This can be evidenced through a CV. Members of the research study team involved in the day-to-day study management and activities are required to have completed Good Clinical Practice (GCP) training. You may also be required to undertake some specific training depending on the type of research study.
We recommend an informal discussion early in the process with informal email confirmation of local PI agreement, as well as laboratory services, surgical teams, etc.
The Swansea University Sponsorship Oversight Committee review will take 10 working days. After this, the NHS REC and/or HRA approval processes can be booked, followed by approximately 8+ weeks to obtain NHS Trust approval.
For both substantial and non-substantial amendments you must complete the amendment tool and submit your request along with any associated documentation to your sponsoring organisation for approval prior to submitting the request to ethics.
For more information go to our Amendments page here
You must notify the sponsoring organisations, the Research Ethics Committee and the funding body (if appropriate) that your study is complete by submitting an end of study declaration. You must also provide a final summary report to all aforementioned bodies within one year of completion of the study. Don’t forget other end of study considerations such as informing participants, publishing results, post-research care, storage of relevant material (HTA) and data storage.
For more information go to our Close of study page here