New Multi-Jurisdictional Research Application and Guidance

Dec. 3, 2024
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As of January 7, 2025, Wilfrid Laurier University will adopt a Single Research Ethics Board (REB) Review model for multi-jurisdictional research, in line with the latest version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (TCPS 2, 2022). This new model streamlines the process for multi-jurisdictional research by allowing Laurier's Research Ethics Board (REB) to document and accept the ethics approval for minimal-risk projects from other institutions that are eligible to hold Tri-Agency funding, which are listed below:

Researchers involved in multi-jurisdictional projects should understand when the document and accept process from Laurier’s REB is necessary.

This model simplifies the review process for minimal-risk research by eliminating the need for duplicate ethical reviews across institutions, provided the project has already received approval from a recognized institution.

Researchers collaborating on minimal-risk projects that have been approved by institutions not eligible to hold Tri-Agency funding and not governed by the TCPS 2  (e.g., international institutions) should first contact the REB to determine whether the project is eligible for review via the document and accept process before submitting any material. This step is essential to ensure that the project meets all necessary ethical requirements before proceeding with the appropriate application form.

What is multi-jurisdictional research?

Multi-jurisdictional research refers to collaborative projects is involving investigators from different institutions or organizations. These projects may include the primary collection of data and the secondary use of data. A key requirement is that the projects must be undergo an initial ethics review by one institution’s board, called the Board of Record.

Defining the Board of Record

The Board of Record is the REB that performs the initial review of a multi-jurisdictional research project. This will generally be the REB where Lead Principal Investigator (PI) is based. The Lead PI is typically the researcher who:

  1. Is the PI of the grant that funds the project;
  2. Is the principal designer of the research protocol; and/or
  3. Is affiliated with the main location of the research activities (if data collection is being conducted on a post-secondary education campus).

Laurier will function as the Board of Record for research projects where the Laurier researcher is the Lead PI. It will not perform the initial review for projects where the Laurier researcher does not have this role.  Note: Depending on the nature of the project and the expertise required for the review process, the relevant REBs, in consultations with each other, may determine that the ethics review should be transferred to a different Board of Record to ensure appropriate oversight.  These consultations will be completed by the REBs.

When the Document and Accept Process is Required in Multi-Jurisdictional Projects Approved by another TCPS 2-Governed Institution

Laurier’s REB will document and accept the ethics approval from other TCPS 2-governed institutions for minimal-risk projects, when Laurier researchers (including faculty, staff, and students) are involved in formal research activities relating to a project. These activities include:

  1. Recruiting participants and collecting informed consent

Example: A Laurier researcher is recruiting participants using flyers posted around campus, is the contact point for those participants, and is collecting consent to participate.

  1. Any form of data collection

Example: Laurier researchers are interviewing participants recruited by any member of the research team.

  1. Data analysis and/or data storage of an identifiable or coded dataset

Example: Laurier researchers are storing a dataset that includes identifiable data to conduct analysis on, including having access to a dataset stored in a cloud storage solution (e.g., OneDrive).

Reminder: coded data is a dataset where direct identifiers are removed and replaced with a code such as a participant number or pseudonym.

When the Document and Accept Process is Not Required in Multi-Jurisdictional Projects Approved by another TCPS 2-Governed Institution

The document and accept process is not necessary when Laurier researchers are only tangentially involved in the project. This includes activities where Laurier researchers:

  1. are only involved in the conceptual design of the methodology,

Example: a Laurier researcher designs an experimental paradigm for a research project, but is not involved in recruitment, data collection, or the analysis of identifiable or coded data.

Reminder: coded data is a dataset where direct identifiers are removed from the information and replaced with a code.

  1. are part of the initial exploratory phase of the project (TCPS 2 Article 10.1),

Example: a Laurier researcher engages in discussions with members of a community about the feasibility of a research project, but not in any other phases.

  1. distribute recruitment material on external researchers’ behalf,

Example: a Laurier faculty or staff member disseminates recruitment material (posters, emails to a listserv) only.

  1. are receiving an anonymized or anonymous dataset, or

Example: a Laurier researcher is analyzing a dataset that they cannot identify the participants in.

Reminder: anonymized data is a dataset that has had all identifiers removed, and these identifiers cannot be re-associated with the dataset. Anonymous data is a dataset that never had identifiers associated with it.

  1. are reviewing research dissemination material

Example: a Laurier researcher is reviewing infographics, presentations, and other knowledge mobilization materials related to a research project.

Submitting to the Laurier REB

If the Laurier REB is not the Board of Record, but the document and accept process is required, researchers can submit a “Multi-Jurisdictional Ethics Application” on Romeo after the application receives approval from the Board of Record. This submission involves:

  1. A short intake application form
  2. The submission of all documentation from the original approval: the approval letter, a copy of the approved application, and all research-related materials (e.g., recruitment, consent, and data collection materials)
  3. The TCPS 2 CORE certificates of all Laurier researchers listed on the project

We will strive to document and accept these applications within 5 business days of receipt.

 

If the Laurier REB is the Board of Record, the standard ethics application process applies. While Laurier is implementing the single REB review model, other institutions may not follow this model and may have their own requirements. It is the external researchers’ responsibility to follow their own institutional guidelines for review and approval for multi-jurisdictional projects.

This type of application is subject to the same review timelines as all other Romeo applications. For more information on our timelines, please see our website.

Continuing Review of Multi-Jurisdictional Research Projects

Annual Reports

Researchers must complete the online "Annual/Final Progress Report on Human Research Projects" form annually and upon completion of the project.  ROMEO will automatically keep track of these annual reports for you. When you have a report due within 30 days (and/or an overdue report) it will be listed under the 'My Reminders' quick link on your ROMEO home screen.

Modification Requests

If the Laurier REB is the Board of Record, researchers must submit a Request for Ethics Clearance of a Revision or Modification form for any changes that affect the ethical conduct of the study and alter the originally approved protocol in a significant way, such as changes in the research design, participant recruitment procedures, data collection methods, or the informed consent process.

If the Laurier REB is not the Board of Record, modification requests should only be submitted when changes directly affect Laurier’s involvement (e.g., Laurier research team changes, Laurier students start being recruited when they were not before, funds are being transferred to Laurier etc.), the risk level of the project changes from minimal to higher than minimal risk, or the PI changes such that the Board of Record changes.

If you have any questions about whether a modification request should be submitted for your multijurisdictional research project, please contact the REB@wlu.ca.

Higher than Minimal Risk Projects

The guidance described above pertains only to minimal risk projects. Higher than minimal risk projects are subject to the standard full-board review process. Please contact REB@wlu.ca if you have any questions.