The University of Waterloo research ethics committees and the Tri-Hospital Research Ethics Board (THREB) established by Cambridge Memorial Hospital, Grand River Hospital, and St. Mary’s General Hospital have agreed to an alternative review model for research involving investigators from both institutions.
The establishment of a coordinated review process is in accordance with the Tri-Council Policy Statement, 2nd edition (TCPS2), outlining institutions may adopt an alternative review model for multi-jurisdictional research. Both institutions however will, as outlined in the TCPS2, “remain responsible for research undertaken within its jurisdiction or under its auspices irrespective of where the research is conducted” (TCPS2, Article 8.1).
The objective of the coordinated review process is to streamline the ethical review for research involving both Waterloo investigators and Tri-Hospital investigators. This will be accomplished by providing a single point of contact at the Principal Investigator’s (PI) home institution.
The coordination of simultaneous review is expected to eliminate the need for consecutive review at both institutions and reduce the time researchers experience obtaining ethics clearance for multi-site research. This process is also expected to aid researchers in handling comments made by one ethics committee that then requires approval as a modification to another ethics committee.
It is expected the Waterloo-THREB coordinated review process will continue to evolve over time as outlined in the Agreement between the two institutions. Future changes to this process shall be made by mutual agreement. Review of the agreement will be undertaken annually.
A researcher submitting an application for the coordinated review process agrees that all information provided, or later requested to provide, can be freely shared between the ethics committees.
All research regardless of the risk level identified is eligible for the Waterloo-THREB coordinated review process.
Principal Investigator and Locally Responsible Investigator:
- All research conducted will require a Principal Investigator (PI) to be named on the application along with a locally responsible investigator at each institution.
- Research that is initiated by a Waterloo faculty member to be conducted at one or more of the Tri-Hospitals is the person that should be listed as the PI for the study on the application form.
- A Tri-Hospital investigator is then listed on the application form as the locally responsible investigator.
- A Tri-Hospital PI may also be the locally responsible investigator for their home institution.
- The initial application form to be used will be the THREB Application Form. This is located on the THREB website.
- Before the initial application can be submitted for review the application must first receive administrative approval from each hospital that is involved in the research.
- This administrative approval process is slightly different at each of the three hospitals.
- Contact information for the administrative process is contained in Part 3 of the THREB Application Form.
- Waterloo investigators also need to create a Form 101 in the Waterloo online application system to ensure the application is assigned a number and a file created.
- Once administrative approval is obtained from the hospital(s), the initial application can be submitted to the PI’s home institution and will be reviewed by both the THREB and a Waterloo research ethics committee. Communication of the combined review results to researchers will be coordinated by the PI’s home institution.
- Ethics clearance to begin the research will be provided through one clearance notification certificate signed by both the Waterloo research ethics committee and the THREB.
Modifications or amendments to an approved and active research study that was reviewed through the coordinated review process will be reviewed using the THREB amendment form.
The review of the modification/amendment will be coordinated by the PI’s home institution.
Notification of research ethics clearance for a modification/amendment will be sent by both ethics committees.
Continuing reviews and renewals of active research studies that were reviewed through the coordinated review process must be submitted by the PI to both ethics committees using the required forms.
Researchers must report all problems that occurred in the research.
- Adverse events of research that was reviewed through the coordinated review process must follow the usual process for reporting adverse events as outlined by each ethics committee. The PI is responsible for notifying their home institution then immediately following up with the other ethics committee.
- Protocol deviations of research that was reviewed through the coordinated review process must follow the usual process for reporting protocol deviations as outlined by each ethics committee. The PI is responsible for notifying their home institution then following up with the other ethics committee.
Letter to THREB as per SOP 4.5
- Incidental findings or unanticipated problems associated with the research that was reviewed through the coordinated review process must following the usual process for reporting unanticipated problems or incidental findings as outlined by each ethics committee. The PI is responsible for notifying their home institution then following up with the other ethics committee.
Study closure/completion of research that was reviewed through the coordinated review process must follow the usual process for closing a study as outlined by each ethics committee. The PI is responsible for notifying their home institution then following up with the other ethics committee.
Researchers are to contact their research ethics office/administrator to discuss the application being submitted for review.
- Waterloo: Julie Joza, Senior Manager, Office of Research Ethics
- THREB: Dr. Michael Coughlin, THREB chair