Definition of research governance

Research ethics is about ensuring that a study is carried out appropriately and that it takes account of the safety, well-being and feelings of the people involved. The main areas of concern are likely to be voluntariness, informed consent, risk of physical or psychological harm, anonymity and confidentiality.

Any study involving human subjects should be designed with ethics in mind. All such studies should be evaluated by an appropriate committee to ensure that all of the necessary issues have been identified and addressed. Please see below and also refer to the university’s Policy and Procedures for further information.

All research on human subjects carried out by staff and students of the University must adhere to the Research Governance Policy and Procedures, approved by the Senate in June 2005.

Briefly, this means that researchers need to go through a prescribed process including identification of an appropriate Chief Investigator (CI), peer review, assessment by a faculty/school/research institute Research Governance Filter Committee and then, where necessary and depending upon the category of the research, possible further scrutiny by the University Research Ethics Committee (REC).

The main steps are:

• Draft a research proposal, identify the CI and carry out a risk assessment of the study
• Identify the research category – A or B?
• Submit form RG1 for peer review
• Submit forms RG1 and RG2 for Filter Committee assessment
• For category B research, submit RG1, RG2 and RG3 for further review by the University REC

Once you have successfully completed all of these stages and agreed to the University’s requirements regarding the conduct of the research, the Research Governance section will be in a position to provide you with confirmation of the University’s approval to proceed and a statement of indemnity.

You will be required to provide regular reports on the progress of your study, and a final report once it has been concluded.

This is more complicated, but arrangements are in place and help is at hand from the Research Governance section of the Research Office.

The Research Governance Framework (RGF) for Health and Social Care requires all NHS and HPSS organizations to have research management procedures in place. This means that to access these organizations, the University, its staff and its students need to be in a position to comply with their requirements.

The University has drawn up agreements with some HPSS trusts and is working with others to enable research to take place.

The main steps are:

• Contact the Trust or other host organization to discuss preliminary proposals and complete any initial paperwork (for example, a project outline form) and identify an appropriate CI
• Submit the proposal for peer/scientific review as agreed by the host organization and the University
• Complete the ORECNI/national application form
• Either follow host organization review procedures or submit to an appropriate school/faculty/research institute Research Governance Filter Committee for consideration
• Contact Research Governance to discuss who will act as sponsor
• Submit the application to ORECNI
• Arrange final approval with the host organization and the Research Governance section

Once you have successfully completed all of these stages and agreed to the host organization and University requirements regarding conduct of the research, you will be provided with confirmation of approval to proceed and a statement of indemnity.

You will be required to provide regular reports on the progress of your study and a final report once it has been concluded. The host organization might also require additional management tasks to be completed.

For a detailed description of gaining access to Trusts in NI for research see HSC Permissions Guidance.

“Sponsor” is the title given – in the RGF (see 4 above) - to the organization responsible for assuring the quality and conduct of the research. The sponsor is required to ensure that peer and ethical review have taken place and that monitoring procedures are implemented, among other tasks. The sponsor might also be required to carry indemnity for the study. The University can act as sponsor or as co-sponsor with other organizations. A full description of the role of sponsor can be found in the RGF.

There are many sources of information relating to the area of research ethics and governance. Some can be accessed through links from this site. The most important are the University’s own Policy and Procedures and associated documentation, the RGF and other research management information produced by individual HPSS trusts and other bodies (for example, the Royal Group of Hospitals, Belfast City Hospital and others).

You must follow the procedures for dealing with adverse events where appropriate. If the problem is not related to the conduct of the study, then contact the Research Governance section for advice.

A list of Filter Committees are available on this web site.

You can access the University REC through the Research Governance section, using the University’s application forms. You must not apply direct to the REC as all studies should be reviewed locally by peer review and/or a Filter Committee before being submitted for consideration by the University REC. You can find the REC schedule of meetings on the Research Governance website

You need to submit one original set plus 16 copies of all paperwork to the University REC through the Research Governance Section

Information on applying to ORECNI can be found at www.orecni.org.uk. When applying, you must ensure that you use the ORECNI/national application form. Before submitting your application you must ensure that the steps listed under 4 (above) have been followed. On no account should applications be submitted to ORECNI without appropriate review having been carried out.

Peer review should be carried out by individuals who are independent of the study but are qualified to comment on the science or methodology being used. Peer review might be conducted by University or trust staff or, in the case of a grant application, by someone appointed by the funding body. The University’s Policy and Procedures allow Filter Committees to carry out peer review as part of their assessment of a project, subject to workload. Filter Committees are also expected to maintain a list of people who can be approached to conduct peer review.

The University has taken the decision that a student should not be Chief Investigator unless exceptional circumstances apply. This is for reasons of accountability, experience and expertise. In studies involving the NHS or HPSS, where it is likely that honorary contracts will be required and limits on insurance might be imposed, it is unlikely that students will meet the criteria.