The University of Waterloo research ethics committees and the Western University Research Ethics Boards 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 Western 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 committee that then requires approval as a modification to another.
- Waterloo and Western 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-Western 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 committees.
All research regardless of risks level identified is eligible for the Waterloo-Western 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.
- For Western contact Erika Basile, Director, Research Ethics, and at Waterloo contact Julie Joza, Senior Manager, Office of Research Ethics.
- The REB administrators at each institution will then contact the other administrator to begin setting up requirements for a coordinated ethics review between the committees.
- All research conducted between Waterloo and Western 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.
- For example, if the research is initiated by a Waterloo faculty member and conducted at Western the Waterloo faculty members is the person that is to be listed as the PI on the application form. A Western investigator is then listed on the application form as the locally responsible investigator. The PI may also be the locally responsible investigator for their home institution.
- The initial application form to be used for this collaborative review process will be the Western application form. This is located on the Western website.
- Waterloo investigators will also need to populate an application form (i.e., Form 101) in Waterloo’s online application system to ensure the application is assigned a number at Waterloo and a file created.
- Ethics clearance to begin the research will be provided through one clearance notification certificate signed by both the Waterloo and Western research ethics committees.
Modifications or amendments to an approved and active research study that was reviewed through the coordinated review process will be reviewed using the Western 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 projects 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 follows 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.
- 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.
Completion of research that was reviewed through the coordinated review process must following 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: Heather Root, Senior Manager, Research Ethics or Karen Pieters, Manager, Research Ethics
- Western: Erika Basile, Director, Research Ethics