Thank you for your interest in conducting research at Cambridge Memorial Hospital and/or Grand River Hospital and/or St. Mary's General Hospital.
All research involving human subjects at these hospitals is reviewed by the Tri-Hospital Research Ethics Board (THREB), except for those studies reviewed by an alternate Board of Record (e.g. the Ontario Cancer Research Ethics Board).
In order to facilitate this review, it is essential that all the necessary documentation be included in your application (see application form and its instructions). THREB meets the first Wednesday of the month except during July and August.
To provide sufficient time for research review, your completed application package 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 on the THREB web page.
The application form has five parts, all of which must be complete.
For retrospective record reviews, a different application form should be used (application for retrospective review of health records) found at the same website.
For collaborative research involving investigators from both the University of Waterloo and any of the three THREB hospitals, there is a co-ordinated review process that can be accessed at the University of Waterloo Office of Research Ethics website (opens in a new tab).
Administrative approval from the hospital(s) involved in the research must be obtained before THREB can review the research.
In general, the THREB requires the original plus five copies (six hard copies in total) of all documents that must be reviewed (except for the investigator’s brochure for clinical trials). In addition, the THREB requests that an electronic copy of the materials be sent to the Administrative Coordinator at the email listed below.
For industry-sponsored studies the cost associated with this review is $3,000 (see part 4 of the application form). Please attach your cheque made payable to “Cashier, St. Mary’s General Hospital”.
Additionally, there is a charge of $400.00 for any amendment or protocol change to an industry-sponsored study that requires the committee to review more than minor changes in the protocol or the consent form. In addition to completing this application package please provide us with information outlining any specific requirements for the final ethics approval letter.
To provide sufficient time for research review, your completed application package must be received by the deadline in the month prior to the meeting, that is, 4:30pm on the second Wednesday of the month. The administrative coordinator of the THREB will strive to notify applicants of THREB decisions by mail or fax within 10 business days of the meeting. Please keep in mind that the administrative support for THREB is a part-time position.
Minimal risk projects for which delegated (expedited) review might be expected can be submitted at any time for review.
Once the protocol has been reviewed and approved by the committee, you will be required to submit the following reports and forms, all of which are available at our website on the THREB web page.
- A progress report and review of the project will be required should the study extend longer than one year from date of approval. You will be sent a reminder letter approximately eight weeks prior to this date.
- The study completion form is submitted to close out the study.
- Send copies of the amendment form along with any amended document containing the proposed changes (e.g. protocol, information sheet/consent form, drug or device brochure, advertisement, study instrument, questionnaire, etc.) and a detailed explanation and justification for each change,
- Use this form to report unanticipated local serious adverse events (SAE) or unanticipated problems related or possibly related to participation in the study. Please provide a summary of the burden or risk(s) to participants and indicate the impact or implications for the consent form. Provide a detailed report of any SAE occurring within CMH and/or GRH and/or SMGH (See THREB SOP#4.5). The THREB does not receive or acknowledge reports of non-local SAEs, rather it requires at least annual DSMB or Sponsor-generated safety reports. (See THREB SOP#4.4 continuing review.)
- The trial can commence once THREB issues a written approval of the trial and, where necessary, administrative approval of contracts or clinical trial agreements have been received
Mail completed applications to:
Shelley Croth, administrative coordinator
Tri-Hospital Research Ethics Board
Kaufman Building, Room K415
Grand River Hospital
835 King Street West
Kitchener, ON N2G 1G3
Phone: 519-749-4300, extension 5367
Email: email@example.com (opens in new window)
The administrative coordinator is in the office normally only on Mondays and Wednesdays, 8:30 am to 4:30 pm. Please do not hesitate to contact her if you require any further information.