The primary mandate of the Tri-Hospital Research Ethics Board (THREB) is to determine the ethical acceptability of research proposed by the hospital(s), by researchers having an association with the hospital(s), or research involving patients or staff at Cambridge Memorial Hospital, Grand River Hospital, or St. Mary’s General Hospital, with the exception of research reviewed by an alternate Research Ethics Board of Record* for the hospital(s).
In discharging this mandate, the Tri-Hospital Research Ethics Board (THREB) has the authority to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects that is conducted within the hospital(s), again, with the exception of research reviewed by an alternate Research Ethics Board of Record for the hospital(s).
THREB complies with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), the International Conference on Harmonization Good Clinical Practice Consolidated Guideline (GCP), Part C Division 5 of the Food and Drug Regulations of Health Canada, the provisions of the Ontario Personal Health Information Protection act (PHIPA) and the United States Food and Drug Administration regulations at the Code of Federal Regulations (CFR) Title 21 Part 50 and CFR Title 45 Part 46 and other applicable laws and guidelines.
- To protect the rights, safety and wellbeing of research participants in all health-related research studies conducted under the auspices of Cambridge Memorial Hospital, Grand River Hospital or St. Mary’s General Hospital, with the exception of that research reviewed by an alternate Board of Record for the hospital(s),
- To provide all submitted health-related research protocols appropriate ethical and scientific review in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) and other applicable laws and guidelines,
- To continue review of the ethical and scientific acceptability of research conducted under the auspices of the THREB,
- To provide education regarding research guidelines to the membership of the THREB in order to promote adherence by researchers to the TCPS2 and other accepted standards, as applicable,
- To review submitted proposals for alignment with the mission, vision, and values of the participating hospitals(s),
- To determine that any impact on the resources of Cambridge Memorial Hospital, Grand River Hospital or St. Mary’s General Hospital has been assessed, and
- To prepare and provide an annual THREB summary report to the three hospital boards.
The THREB receives its authority from and reports to the Board of Directors of Cambridge Memorial Hospital, the Board of Directors of Grand River Hospital and the Board of Trustees of St. Mary’s General Hospital.
The THREB will review its Terms of Reference annually and present them to the hospital Boards for approval.
Authority of THREB
The THREB has the authority and responsibility to approve, propose modifications to, or reject research involving human participants, monitor ongoing research and to suspend or terminate any research being carried out within or under the auspices of the member hospitals, with the exception of research reviewed by an alternate Research Ethics Board of Record for the hospital(s).
The member hospitals retain the authority to reject any THREB approved research.
In order for the THREB to retain the independence required of it by the TCPS2, a decision made by the THREB to reject research may not be overruled by member hospitals.
The THREB may establish formal agreements with other institutions or organizations to facilitate review and approval processes of multi-site research projects which are under review by another Research Ethics Board. Such agreements will require a formal decision of the THREB membership and signature of the Chair.
The decisions of the THREB are open to appeal through an appeal mechanism established by the member hospitals.
The THREB must have membership that meets the requirements of the TCPS2, GCP and PHIPA.
The THREB will be comprised, in addition to the Chair, of three representatives from each hospital, approved by the CEOs of their respective hospitals, and including:
- two members who have broad expertise in the methodologies and the areas of science reviewed by the board;
- physician representative(s);
- member(s) from the discipline of ethics;
- two lay members without affiliation to the hospitals, recruited from the community;
- clinical pharmacist(s);
- one executive representative from each hospital;
- member(s) knowledgeable in Canadian law relevant to the research;
- member(s) knowledgeable in privacy issues;
- ad-hoc reviewers as necessary (non-voting).
Membership will be for a renewable three year term. Members will complete relevant training and education as required by the Chairperson.
The Chairperson is approved by the Boards of the three hospitals for a renewable three year term, and must have experience on a Research Ethics Board with education and expertise in research methodology and research ethics.
The Chairperson shall be the THREB’s official spokesperson.
Although attempts will be made to reach consensus on decisions, a vote of the majority present will be taken as the Tri-Hospital Research Ethics Board’s decision provided there is a quorum. Written positions are encouraged to facilitate discussion when a member cannot attend. Committee members must be absent from the meeting for the portion where his/her application (Principal Investigator or Sub-investigator) is being considered or whenever there is a conflict of interest.
A quorum shall be constituted so long as a majority of the total number of voting THREB members is present. For decisions affecting the THREB itself, the quorum must also include at least one representative from each of the THREB hospitals.
Meetings will be held at least nine times a year at a set time. At the discretion of the Chairperson, scheduled meetings may be cancelled or additional meetings called.
- Members must notify the Chairperson if they are unable to attend a meeting
- Frequent unexplained absences will be addressed by the Chairperson
The THREB is bound by Tri-Council Policy Statement, and the respective hospitals’ policies on the release of information. The THREB meeting agenda, minutes, and information contained in research proposals submitted for ethics review are all confidential. Official copies of reviewed proposals will be retained by the THREB Office for as long as legally required.
* A Research Ethics Board of Record is a Research Ethics Board that has been appointed by an institution under whose auspices a research study is being conducted to serve as the primary or sole authority for the research ethics oversight of the study. (See: Canadian General Standards Board: Research Ethics Oversight of Biomedical Clinical Trials.) OCREB is currently an alternate REB of Record for CMH and GRH for multi-centre cancer studies.