Central University Research Ethics Committee B
Committee description
Secretaries: Matthew Billington, Email: mjbill2@liverpool.ac.uk, Adam Shaw, Email: Adam.Shaw@liverpool.ac.uk, Frances Thomason, Email: F.I.Thomason@liverpool.ac.uk and Dr Amy Schofield, Email: amyschof@liverpool.ac.uk
Preamble from the University Policy on Research Ethics [1]
The University is committed to maintaining the highest standards of rigour and integrity in its research. As a component of this commitment, the University requires that all research projects which involve human participants or their tissues or their personal information should receive research ethics approval before they commence.
Terms of Reference
The Central University Research Ethics Committees are responsible for receiving details and considering the ethical aspects of University research projects involving human participants, their tissues or their personal data where the degree of ethical risk is flagged as more than minimal, and where they do not fall solely under the remit of another review body.
1. To seek to ensure that University research projects involving human participants, their tissues or their personal information are carried out in accordance with the research ethics principles specified in the Declaration of Helsinki, the University of Liverpool research ethics policy and other relevant ethical guidelines.
2. To approve as proposed; to request further clarification or modification; or to refuse approval of applications and amendments received.
3. To receive regular reports on the progress and outcomes of studies approved by the Committee, where this has been requested as part of the review.
4. To ensure that procedures are in place to monitor any serious adverse effects affecting participants in approved studies.
5. To revoke or suspend an approval already granted if the programme of work does not follow that specified in the proposal, if there are serious adverse events, or if the conduct of the researchers is unsatisfactory.
6. To refer any perceived failure of a Principal Investigator or other researcher to comply fully with their obligations in respect of a proposal to the Research Integrity and Governance Committee for investigation in accordance with the Policy on Misconduct in Research.
7. To approve the terms of reference and membership of, and to monitor as appropriate, any research ethics committees within a Faculty established to consider the ethical aspects of minimal risk projects within specific subject areas.
8. To receive regular reports from approved research ethics committees within the Faculties on projects considered by such Committees. The Committee may audit a sample of applications reviewed by research ethics committees within the Faculties each year.
9. To provide regular reports on decisions reached and issues raised to the University’s Committee on Research Ethics.
Reporting Relationship
The Central University Research Ethics Committees report to the Committee on Research Ethics.
Frequency of Meetings
The Central University Research Ethics Committees usually meet on six occasions during the academic year. Additional meetings may be scheduled where necessary.
Committee members are expected to attend at least 50% of the Committee’s meetings during the academic year.
Quorum
A quorum of 25% membership will be required for each meeting of the Committee. At least one Lay or External Member, and the Chair or Vice-Chair - or an acting Chair nominated by the Chair - must be present.
At the discretion of the Chair, in the event of a meeting not being quorate, the opinion of absent members shall be sought by email and included, as appropriate, in the discussion.
Procedures
(a) The University’s online system for research ethics applications must be used for all applications.
(b) Applications requiring central committee review will be considered by a Central University Research Ethics Committee that is quorate.
(i) Applications will be sent to all members, with a specific member nominated for each application to present the project to the Committee.
(ii) The Principal Investigator will be invited to attend the review meeting to answer questions about the application; and will be expected to demonstrate an awareness and engagement with research ethics principles. Attendance is usually required as it allows for clarification of points of uncertainty and so helps to shorten the review process for all involved. If the Principal Investigator cannot attend, the application will normally be deferred to the next available committee where attendance can be guaranteed. In exceptional circumstances, the Chair may permit an application to be heard in absence.
(iii) If a member of the Committee is an investigator on a project being reviewed, or there is any other potential conflict of interest, the individual should declare the interest and will not be part of the decision concerning that particular project.
(c) Following the meeting, the Committee’s comments will be distributed to the applicants.
(d) On occasion, the Chair may recommend that an application involving more than minimal risk can be considered by a sub-group of the Committee outside of the normal committee cycle; or by a research ethics committee within a Faculty. The decisions of the sub-group or the research ethics committee within the Faculty will be presented to the central Committee for information.
(e) Central University Research Ethics Committee C (formerly known as ‘the Physical Interventions’ Committee) will normally - though not exclusively - review biomedical, healthcare-related, and interventional research.
(f) Only employees of the University may act as the Principal Investigator for applications requesting approval, so a student or honorary staff member must be under the supervision of a member of staff.
(g) The University’s research ethics committees cannot grant research ethics approval retrospectively. In some cases, applications may disclose that the research has already started without first obtaining research ethics approval. This is a breach of the University’s Policy on research ethics, and all such cases will be referred to the University’s Research Integrity and Governance Committee for consideration as part of the University’s Policy on misconduct in research. Such applications should be considered invalid.
(h) All Committee members are responsible for undertaking regular and ongoing training in research ethics.
(i) The University of Liverpool will provide indemnity for members of the Committee.
(j) Administrative support will be provided through the Research Support Office.
(k) These terms of reference and the membership of the Committee will be reviewed annually.
(l) Further information on the processes for University research ethics review can be found within the ‘Procedures’ section of this handbook.