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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 ÉîÒ¹¸£ÀûÕ¾, 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 ÉîÒ¹¸£ÀûÕ¾ 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 ÉîÒ¹¸£ÀûÕ¾ faculty member and conducted at Waterloo, the ÉîÒ¹¸£ÀûÕ¾ 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

• ÉîÒ¹¸£ÀûÕ¾'s application form, located in , will serve as the initial application form
• Waterloo investigators will also need to complete an 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 ÉîÒ¹¸£ÀûÕ¾ and Waterloo research ethics committees

Modifications or amendments to approved or active research studies reviewed through the coordinated review process will be reviewed using ÉîÒ¹¸£ÀûÕ¾'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.

• ÉîÒ¹¸£ÀûÕ¾: Continuing Ethics Review form, via WREM
• Waterloo: (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.

• ÉîÒ¹¸£ÀûÕ¾: Serious Adverse Events form, via WREM 
• Waterloo: A (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.

• ÉîÒ¹¸£ÀûÕ¾: Protocol Deviation form, via WREM
• Waterloo: (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.

• ÉîÒ¹¸£ÀûÕ¾: Serious Adverse Events form, via WREM
• Waterloo: (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.

• ÉîÒ¹¸£ÀûÕ¾: End-of-Study form, via WREM
• Waterloo: (Form 105)