Research sponsorship, ethics and integrity can be complex particularly where human participants or human tissue is involved. If you can't find the answer to your question contact Research Governance.
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 upon the employment status of the Chief Investigator and the nature of the research. The University’s Research Governance Team (email@example.com) 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 a University Research Governance Manager and the Research and Development Office in the relevant Health and Social Care Trust. It must be subject to ethical review by an NHS Research Ethics Committee (ie Office for Research Ethics Committee Northern Ireland (ORECNI) or equivalent).
My research only involves staff from the Health and Social Care Trust – what approval do I need for this?
This research must also be subject to governance review by a University Research Governance Manager 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 an NHS REC/ORECNI for ethical approval?
You should not apply to have your research reviewed by a NHS REC/ORECNI 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.
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.
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 do work with children or vulnerable adults?
Access NI checks are dependent upon 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 (please also note that this policy is under revision pending government review and further clarification should be sought from Nichola McKay in the Legal Services Unit). HSC Trusts may also require Access NI checks for researchers working with their patients or on their premises. Researchers are advised to contact the relevant HSC Trusts for information on this.
I wish to make an amendment to my study – who do I inform?
For a substantial amendment you must complete a notice of substantial amendment and submit your request along with any associated documentation to your sponsoring organisation for approval prior to submitting the request to ethics. Minor amendments do not require a form to be completed but should be notified to your sponsoring organisation and Research Ethics Committee. Guidance on the categorisation of minor and substantial amendments can be found on the NHS Health Research Authority website.
My research is completed – what do I do now?
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 aformentioned bodies within one year of completion of the study.
How long should I store my data for?
The University expects primary data to be securely held for a minimum of five years after the completion of a research project. However, researchers must be aware of and comply with any specific requirements of the funding body relating to longer periods of data retention. For example, several Research Councils require data to be retained for 10 years or even longer for research based on clinical samples or relating to public health. 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 HSC/NHS Trust in which you wish to conduct your research. It is advised that you speak with the Research Governance Manager 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 HRA Defining Research Tool 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.
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