FAQs
What is a sponsor?
The Research Sponsor shall be the individual, organisation or group taking on the primary responsibility for the initiation and management of the research
Who will sponsor my research?
The research may be solely sponsored by the University or the Health and Social Care Trust, if relevant, or may be co-sponsored with another organisation. The sponsorship will depend on the employment status of the Chief Investigator and the nature of the research. The University’s Research Governance Officer should be contacted to ascertain the most appropriate sponsorship arrangements for your research.
My research involves the patients and clients of the Health and Social Care Trust, how do I get approval for this work?
This research must be subject to governance review by the University’s Research Governance Officer and the Research and Development Office in the relevant Health and Social Care Trust. It must be subject to ethical review by the local Health and Social Care Trust Research Ethics Committee, Office for Research Ethics Committee Northern Ireland (ORECNI).
My Research only involves staff of the Health and Social Care Trust, what approval do I need for this?
This research must also be subject to governance review by the University’s Research Governance Officer and the Research and Development Office in the relevant Health and Social Care Trust. However ethical review is only required at School level, through your School Research Ethics Committee.
When do I apply to ORECNI for ethical approval?
You should not apply to have your research reviewed by ORECNI until you have secured the appropriate governance approval(s). ORECNI will not accept your application without sign off by the sponsor and this cannot be secured until all study documentation has been reviewed.
Who can peer review my research?
Peer reviews must be conducted by persons not directly involved in the research, but knowledgeable in the area and research active. The requirements for peer review vary depending on if it is staff or student research. Requirements can be viewed in the University’s Research Governance Framework [add link]
Who provides indemnity for my research?
If you are a QUB staff member or a QUB student the University will provide your indemnity. Proof of this will be provided in the letter of sponsorship we provide you with when governance approval is agreed for your research.
How do I secure Access NI Checks if I wish to work with children or vulnerable adults?
Access NI checks are dependent on whether the activity you are involved in is a regulated activity and whether the frequency and intensity tests are met. Please refer to the University’s Safeguarding Children and Vulnerable Adults Policy for guidance on these issues.
I am a PhD student and I want to work with Trust patients and/or data or on Trust premises – do I need an honorary contract?
Yes. Your supervisor should be able to advise you how to secure this. Alternatively you should contact the Research and Development Office in the relevant Health and Social Care Trust and they will advise.
I wish to make an amendment to my study, who do I inform?
You must complete an amendment request form and submit your request form and associated amended documentation to the sponsoring organisation for approval prior to submitting the request to ethics. You must not action any amendments until ethical approval has been obtained unless the amendment is in relation to an urgent safety measure.
My research is completed – what do I do now?
You must notify the sponsoring organisations, the ethics Committee and the funding body (if appropriate) that your study is complete by submitting an end of study declaration [add link]. You must also proved an end of study summary report to all aforementioned bodies within one year of completion of the study.
How long should I store my data for?
Funder stipulations
Clinical Trials of Investigational Medicinal Products – 15 years
All other clinical trials – 5 years
Any other human subject research – 3-5 years (depending on the nature of the work)
In all cases it must be ensured that the appropriate storage facilities are available to meet these requirements.
Who do I need to contact in the Health and Social Care Trusts?
In order to discuss governance approval you must contact the Research Manager of the relevant Trust in which you wish to conduct your research. Contacts can be viewed on the following table [Add link]. It is advised that you speak with the Research Governance Officer in the University before contacting the Trust Research Managers and he/she will advise you on due process.
Can a student act as Chief Investigator?
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.
Is my project research, service evaluation or audit?
Only research requires ethical review. There is no requirement for ethical review of service evaluation or audit. The Defining Research [Add link] tool will help you ascertain what category your work falls into. You should also discuss your proposal with the University’s Research Governance Officer for confirmation of which category your work falls into.
