The University of Waterloo research ethics board and the Research Ethics Board at Conestoga College have established an alternative review model for research involving investigators from both institutions.
The establishment of this 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, p. 98).
The objective of the coordinated review process is to streamline the ethical review process for Waterloo and Conestoga College researchers. 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 board that then requires approval as a modification to another.
- Waterloo and Conestoga College researchers seeking ethics review from their home institutions are eligible to apply for a simultaneous coordinated review.
- Researchers wishing to use this process are to contact their respective research ethics office/administrators for guidance on this process.
- The Waterloo-Conestoga College coordinated review process will continue to evolve over time as outlined in the Ethics Review Agreement between the two institutions. Future changes to this process shall be made by mutual agreement.
- 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 boards.
All research regardless of risks level identified is eligible for the Waterloo-Conestoga College collaborative review process.
Principal Investigator and Locally Responsible Investigator:
- The principal investigator (PI) is to contact their research ethics office/administrator to discuss the application being submitted for coordinated review.
- All research conducted between Waterloo and Conestoga College investigators will require a Principal Investigator (PI) to be named on the application along with a locally responsible investigator at each institution to be identified and named on the research ethics application.
- The initial application form to be used for this collaborative review process will be the Waterloo application form if the PI is from Waterloo.
- If the PI is from Conestoga College the Conestoga College application form will be used.
- For technical reasons, the Waterloo investigator will need to create a record in the Waterloo online application system to ensure the application is assigned a number and a file created.
- Ethics clearance to begin the research will be provided through one clearance notification certificate signed by both the Waterloo and Conestoga College research ethics boards.
- Application form in Waterloo’s online application system
- Conestoga College application to involve human participants in research
Modifications or amendments to an approved and active research study that was reviewed through the coordinated review process will be reviewed by making an amendment request using the Waterloo online system if the PI is from Waterloo. If the PI is from Conestoga College the Conestoga College change request form will be used.
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 boards.
Waterloo amendment request (through the online system)
Continuing reviews and renewals of active research projects that were reviewed through the coordinated review process must be submitted by the PI to both ethics boards using the required forms.
Waterloo renewal request (through the online system)
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 board. The PI is responsible for notifying their home institution then immediately follows up with the other ethics board
- 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 board. The PI is responsible for notifying their home institution then following up with the other ethics board.
- 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 board. The PI is responsible for notifying their home institution then following up with the other ethics board.
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 board. The PI is responsible for notifying their home institution then following up with the other ethics board.
Waterloo study closure request (through the online system)
Researchers are to contact their research ethics office/administrator to discuss the application being submitted for review.
- Waterloo: Karen Pieters, Manager, Research Ethics
- Conestoga College: Research Ethics Board Coordinator