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 three 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). It can be found at the same webpage.
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 (Application Form-Part 3) from the hospital(s) involved in the research must be obtained before THREB can review the research.
The completed application package should include:
- The hard copy of the original application form (all 3 parts) with appropriate signatures
- 2 additional collated hard copies of the completed Application Form Part 2
- 3 hard copies of the study protocol
- 3 hard copies of consent forms (if applicable)
- 3 copies of the study budget
- 3 copies of supplemental materials (e.g. questionnaires, etc.)
- 3 copies of any recruitment materials
- 1 hard copy of any Investigator Brochure (if relevant)
- 1 electronic copy (PDF) of the entire package (excepting any Investigator Brochure) sent to the THREB Administrative Coordinator
For industry-sponsored studies the cost associated with this review is $3,000 (see part 4-1 of the application form). Please attach your cheque made payable to “Cashier, St. Mary’s General Hospital, ATTN: THREB”.
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.
- An annual progress report and renewal form 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 must be submitted to close out the study.
- An amendment form must be submitted for any changes to a previously approved study. Send copies of the amendment form along with any amended documents 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 the unanticipated problem 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, clinical trial agreements and or research data transfer agreements have been received.
Mail completed applications and other forms 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.
You can reach the THREB Chairperson, Dr. Michael D. Coughlin at: firstname.lastname@example.org