Coordinated Review

Principal Investigator and Locally Responsible Investigator

• The principal investigator (PI) is to contact his/her research ethics office/administrator to discuss the application being submitted for coordinated review
• At Western, contact Erika Basile, Director, Research Ethics; at Waterloo, contact Julie Joza, Senior Manager, Office of Research Ethics
• REB administrators at each institution will then contact their counterparts to initiate coordinated ethics review
• All research conducted between Waterloo and Western investigators requires a Principal Investigator (PI) be named on the application, in addition to a locally responsible investigator at each institution
• For example: if research is initiated by a Western faculty member and conducted at Waterloo, the Western faculty member is listed as PI on the application form; a Waterloo investigator is then listed as the locally responsible investigator. The PI may also be the locally responsible investigator for their home institution

Application Forms

• Western's application form, located in WesternREM, will serve as the initial application form
• Waterloo investigators will also need to complete an Application form within Waterloo’s online application system to ensure the application is assigned a number at Waterloo, and a file created
• Ethics clearance to begin research will be provided through one clearance notification certificate signed by both Western and Waterloo research ethics committees

Modifications or amendments to approved or active research studies reviewed through the coordinated review process will be reviewed using Western's Amendment form, found in WREM. 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.

• Western: Continuing Ethics Review form, via WREM
• Waterloo: Continuing Review form (Form 105)

Researchers must report all problems that occurred in the research, including:

Adverse events of research 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 his/her home institution and immediately following-up with the other ethics committee.

• Western: Serious Adverse Events form, via WREM 
• Waterloo: Adverse Events form (Form 106)    

Protocol deviations of research 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 his/her home institution and following-up with the other ethics committee.

• Western: Protocol Deviation form, via WREM
• Waterloo: Protocol deviation form (Form 107)

Incidental findings or unanticipated problems associated with research 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 his/her home institution and following-up with the other ethics committee.

• Western: Serious Adverse Events form, via WREM
• Waterloo: Incidental Findings form (Form 108)

Completion of research 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 his/her home institution, then following-up with the other ethics committee.

• Western: End-of-Study form, via WREM
• Waterloo: Study Closure form (Form 105)