Multi-jurisdictional research and research ethics review | Research

In January 2023, a new version of the TCPS2 was released resulting in changes to Chapter 8: Multi-Jurisdictional research for researchers in collaborative partnerships. REBs affiliated with an institution eligible to receive and administer Tri-Agency funds are encouraged to adopt a model of single ethics review for multi-jurisdictional research that is deemed to be minimal risk. The Panel on Research Ethics has provided additional guidance to support the implementation of a single ethics review model.

The Research Ethics Boards at the University of Waterloo have adopted the recommendation. Waterloo's multi-jurisdictional single review model for minimal risk research began on March 18, 2024. Although the single REB review model is recommended, it is not required. Other institutional REBs may choose to not participate in the single REB review model.

Regardless of where the research is conducted, and which REB reviewed the research, researchers must remember the responsibility for the ethical conduct of the study remains with the researchers and their institutions (i.e., reviewer REB's institution and non-reviewing REB's institution).

Multi-jurisdictional projects must meet one or more of the following criteria:

The research team includes investigators (i.e., faculty, staff, students) affiliated with a non-University of Waterloo institution.
Members of the research team hold multiple institutional affiliations.
The research project involves combining data from several projects independently conducted by investigators affiliated with different institutions into one overall project.
The research involves collecting data or recruiting participants at different institutions using the institution's resources (e.g., email lists, space).
The research requires collaborating with a community, non-Waterloo institution, or organization (e.g., local schools, hospital, public health, Indigenous community).

Eligibility for a single REB review

The following criteria must be met for a REB to conduct a single review for multi-jurisdictional research:

The research is defined as minimal risk research. More than minimal risk studies are not eligible for single REB review, unless an official REB review agreement is in place between those institutions.
The reviewing REB must be affiliated with an institution eligible to receive and administer Tri-Agency funds from one or more of the following:

New applications

Steps to take if you are the lead Principal Investigator (PI)

Discuss with your non-Waterloo research team members if they would like to pursue this ethics review model.
Contact Research Ethics to discuss your study and things to consider for a single REB review according to Chapter 8, TCPS2, 2022.
Complete the appropriate ethics application in the online system.
- Name all non-Waterloo collaborators in the external investigator section.
- Name all the locations and institutions in the study sites section and include REB contact information, if known.
- In the other details section of the ethics application, identify the external research team members who would like to be involved in a single REB review and explain their role in the project.

Single REB review is recommended, not required. The other REB(s) may agree, or they may decline a single ethics review.

Steps to take if you are NOT the lead Principal Investigator (PI)

Contact Research Ethics and provide the following information:
- Name of lead PI and their institution
- Name of reviewing REB and contact information
- Title of study and REB # from the reviewing REB
- Funder
- Your role in the study
Research Ethics will confirm the risk level with the reviewing REB and send you instructions for what you need to do to allow Waterloo to document and accept the reviewing REB's review.

Single REB review for multi-jurisdictional minimal risk research is only possible if the reviewing REB is affiliated with an institution eligible to administer Tri-agency funds.

Amendments to existing applications

Role of the Waterloo lead Principal Investigator

Update your existing research ethics application and submit for review the proposed change by following the modifications process.
Co-investigators at the other institutions should connect with their REB to ask what is needed, such as providing updated study documents.
Ensure the amendment submission includes any local context issues or requirements from the co-investigator’s REB or institution.

Role of Waterloo local investigator - lead principal investigator is located at another institution

The following applies if the University of Waterloo’s REB has documented and accepted the ethics review from another REB (i.e., the reviewing REB). The application type in the research ethics system will be checked as “Project has been reviewed by another Canadian institution – document and accept application”.

Update your existing “document and accept” research ethics application, including an upload of any revised study documents, and submit.
Waterloo’s REB needs to be informed about changes as Waterloo’s REB remains accountable for the research occurring under its auspices regardless of location.

Amendments are to be submitted when there are significant changes to the protocol. Examples of when an amendment is needed include changes to:

team members and their roles
- If you add new University of Waterloo team members make sure to upload their TCPS 2 2022 certificate
risk level of the project
recruitment to now include University of Waterloo students, staff or faculty
in-person data collection will now occur on the University of Waterloo campus
funding especially funding held by members of the Waterloo research team
procedures such as adding a new phase to the project

Contact Research Ethics if you are unsure if the change requires a submission at UWaterloo.

Annual Reports

Prior to the study expiration date, the Waterloo researchers will receive an email notification. This notification will ask for a continuing review report (i.e., renewal report) or to complete a closure report if the study is completed. These reports may only be submitted by the individual named as the Waterloo Principal Investigator.

If a University of Waterloo REB has documented and accepted the ethics review of another REB, the continuing review by the reviewing REB must remain active. This means a renewal at Waterloo may not be submitted if the ethics application has been closed or suspended by the reviewing REB.

Reporting Problems

If the University of Waterloo has documented and accepted the ethics review of another REB, events such as protocol deviations, adverse events, incidental findings, and unanticipated problems should be reported to the reviewing REB following their procedures. The reviewing REB will notifify Waterloo's REB, as appropriate.

If Waterloo is the reviewing REB, please follow the instructions for reporting problems.

Frequently asked questions

Question: How do I determine if I am the lead Principal Investigator (PI) for the study?

Response: The lead PI is often named in the grant as the lead PI for the research team. Typically, the lead PI's institution will receive funding for the project and send funds to other institutions as per the agreement. If you are not sure if you are the lead PI based on this definition, please contact Research Ethics to discuss.

Question: All the investigators I am working with reside in a country outside of Canada and have already received ethics clearance from their institutions. Does this qualify for a single REB review?

Response: No, because the other investigators are from a country outside of Canada. If you are unsure how to proceed with a review at Waterloo involving international collaboration contact Research Ethics to discuss next steps.

Question: I am working with the lead researcher who resides at another Canadian institution on a multi-jurisdictional project. Waterloo will receive a sub-grant for students to address particular objective in the research and for their thesis work. Can a multi-jurisdictional review be facilitated?

Response: Discuss with the lead PI what they intend for their research ethics application to cover, then contact Research Ethics. A discussion is needed to clarify the Waterloo students' projects and ensure they receive an ethics review.

February 5, 2025