Tri-Hospital Research Ethics Board
The Tri-Hospital Research Ethics Board (THREB) is a shared research ethics board serving St. Mary’s General Hospital, Cambridge Memorial Hospital and Grand River Hospital. THREB reviews all research involving human subjects at these hospitals, except for research reviewed by an alternate Board of Record for one of the hospitals (e.g. the Ontario Cancer Research Ethics Board).
In order to facilitate this review, all the necessary documentation must be included in the application (see forms below).
THREB meets the first Wednesday of the month except during July and August. A completed application package including the signed original and five copies (six copies in total) must be received by the second Wednesday of the month prior to the meeting date. A checklist outlining the required steps is included as the first part of the application form.
Minimal risk studies that may receive delegated (expedited) review instead of full board review have no deadline for receipt.
The primary responsibility of the THREB is to make decisions concerning the ethical acceptability of research proposed by the hospital(s), by researchers having an association with the hospital(s), or any research involving patients or staff at the hospital(s). For purposes of review by THREB, research is defined as “an undertaking intended to extend knowledge through a disciplined or systematic investigation” (Tri-Council Policy Statement 2).
THREB is mandated to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects that is conducted within the hospitals, again with the exception of research reviewed by an alternate Board of Record for the hospital(s). THREB complies with guidelines from:
- The Tri-Council Policy Statement Ethical Conduct for Research Involving Humans 2 (2010)
- The Good Clinical Practice: Consolidated Guideline of the International Conference on Harmonization
- Division 5 Health Canada Food and Drug Regulations
- Relevant Canadian health and privacy legislation
THREB also endeavors to facilitate compliance with the human subject requirements of two US federal agencies: The Food and Drug Administration and the Office for Human Research Protections, US Dept of Health and Human Services.
Additional administrative review
While THREB reviews all research, administration departments at each hospital also review research for financial, resource, and contractual implications (see administrative approval form application part 3).
Please note: Each hospital has a unique process for administrative review and approval. This process must be completed before THREB review can be initiated. It is up to the Investigator to make contact with the relevant institutions to determine their requirements. Contact information for administrative review at the three hospitals can be found below and in the administrative approval form (application part 3).
St. Mary’s Research Proposal Approval Process is as follows:
- Research proposal is received by the Hospital Chair, Research Committee
- Chair, St. Mary’s Research Committee reviews documentation
- Research Proposal is placed on St. Mary’s Research Committee agenda
- Research Committee reviews proposal, implications for St. Mary’ and provides administrative approval to proceed to THREB
- Chair, St. Mary’s Research Committee, signs off on administrative approval and advises researcher that study may proceed to THREB
- Research proposal is reviewed by THREB
Cambridge Memorial Hospital Sandra Hett, Vice President, Clinical Programs and Chief Nursing Executive 700 Coronation Boulevard, Cambridge, Ontario N1R 3G2 Telephone: 519-621-2333 extension 2416 firstname.lastname@example.org
Grand River Hospital Sarah Laferriere, Research Office Administrator Grand River Hospital 835 King Street West, Kitchener, Ontario, N2G 1G3 Telephone: 519-749-4300 extension 2876 email@example.com firstname.lastname@example.org
St. Mary’s General Hospital Melody Vallerand, Administrative Assistant to VPs and CFO, 911 Queen’s Boulevard, Kitchener, Ontario N2M 1B2 Telephone: 519-749-1038 email@example.com
Both the administrative review and the research ethics board review must be completed and any outstanding issue resolved prior to the research being initiated.
For more information, or to send an application and other forms, contact:
Laurie Dietrich, THREB Administrative Coordinator, Tri-Hospital Research Ethics Board Grand River Hospital, Kaufman Building room K415, 835 King Street West, Kitchener, ON N2G 1G3 Phone: 519-749-4300, extension 5367 Fax: 519-749-4282 E-Mail: firstname.lastname@example.org
You can reach the THREB Chairperson, Dr. Michael D. Coughlin at: email@example.com
More information is available under the following links:
- General information and guidelines for investigators
- Meeting dates for 2016
- Terms of reference, St. Mary’s General Hospital Research Committee
- Procedures for renewal and continuing review (SOP#4.4)
- Procedures for reporting SAEs and unanticipated problems (SOP#4.5)
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2)
- Good Clinical Practice Guidelines (GCP)
- Website to access TCPS2 Tutorial
- THREB Annual Report
In general, the THREB requires the original and five copies (six packages in total) of all documents that must be reviewed. To provide sufficient time for review, completed application packages and other items for review must be received by the second Wednesday of the month prior to the THREB meeting date. Please email an electronic copy of the submission to firstname.lastname@example.org.
- Application form for project review (revised October 2016)
- Application for retrospective review of health records (revised October 2016)
- Administrative approval form (application – part 3) (revised October 2016)
- St. Mary’s General Hospital Data Agreement
Forms for continuing review
- Annual renewal progress report form (revised October 2016)
- Amendment review request form (revised October 2016)
- Study completion form (revised October 2016)
- Unanticipated problems – SAE report form (revised October 2016)
- Confidentiality agreements (revised January 2014)