The University of Waterloo research ethics boards and the Waterloo Wellington Research Ethics Board (WWREB) 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, (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).
Objective of the coordinated review process
Research eligible for coordinated review
How to submit an application for co-ordinated review
Requests for modifications/amendments
Continuing review and renewal of active studies
Objective of the coordinated review process
The objective of the coordinated review process is to streamline the ethical review for research involving both Waterloo investigators and 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 board that then requires approval as a modification to another ethics board.
It is expected the Waterloo-WWREB 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 boards.
Research eligible for coordinated review
All research regardless of the risk level identified is eligible for the Waterloo-WWREB coordinated review process.
How to submit an application for coordinated review
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 hospitals is the person that should be listed as the PI for the study on the application form.
- A hospital investigator is then listed on the application form as the locally responsible investigator.
- A hospital PI may also be the locally responsible investigator for their home institution.
Application forms:
- The initial application form to be used will be the WWREB Application Form. This is located on the WWREB 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 WWREB Application Form.
- Waterloo investigators also need to submit an application in the online research ethics 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 WWREB and a Waterloo research ethics board. 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 board and the WWREB.
Requests for modifications/amendments
Modifications or amendments to an approved and active research study that was reviewed through the coordinated review process will be reviewed using the WWREB 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 boards.
Renewing an active study
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 boards using the required submission types.
Waterloo renewal request (through the online system) WWREB annual renewal form
Reporting a problem
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 following up with the other ethics board.
WWREB Unanticipated Problems Form
- 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.
Waterloo protocol deviation form
Letter to WWREB 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 board. The PI is responsible for notifying their home institution then following up with the other ethics board.
Waterloo incidental findings form
WWREB Unanticipated Problems Form
Closing a completed study
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 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)
Who to contact
Researchers are to contact their research ethics office/administrator to discuss the application being submitted for review.
- Waterloo: Heather Root, Senior Manager, Research Ethics