Research Ethics Board Review
Activities Requiring Research Ethics Board Review
As outlined in the Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS2), research involving human participants and research involving human biological materials require ethics review and clearance by a research ethics board (REB) before the research commences.
Therefore, research involving human participants and/or human biological materials conducted by Laurier students, faculty and staff requires review and clearance by the REB.
If you are an undergraduate student conducting minimal risk research as part of your coursework, the review may be delegated to your departmental Research Ethics Committee.
Steps To Take Before Applying for REB Review
Romeo is Laurier’s online application system for REB review of research involving human participants. It must be used for review of all research projects by faculty, staff, graduate students, or undergraduate students when their supervisors will be using their data.*
Romeo provides access to all of your approved projects for future reference. Romeo is used for the submission of new projects, annual/final reports, modification requests, and adverse event reports.
See the Romeo Quick Reference Guide for instructions on registering with and using Romeo.
*Note: If you are an undergraduate student and your supervisor will not be using your research data as a part of their own research, the research is considered minimal risk, and does not involve Indigenous Peoples, including First Nations, Inuit and Métis peoples of Canada, the Romeo system will not be used to submit an application. See Which Application to Submit for Review for more information on the review process you should follow.
The TCPS 2: CORE 2022 (Course on Research Ethics) tutorial provides an introduction to and examples of important principles from the TCPS 2. All Laurier individuals listed on an REB project (e.g., principal investigators, co-investigators, research assistants and supervisors) will need to complete the CORE tutorial and submit their certificate(s) of completion with their REB project.
REB projects will not be reviewed by the REB until all Laurier investigators listed on the project have completed the tutorial. Please ensure that the certificates for all those named on the project are uploaded into the Romeo system at the time of submission.
For further details about this requirement, refer to Policy 11.13: Ethics Review of Research Involving Humans.
The Secretariat on Responsible Conduct of Research (Secretariat) has launched a new version of the Tri-Council Policy Statement 2: Course on Research Ethics (TCPS2: CORE) tutorial, the TCPS2: CORE-2022. While it is advised that all faculty, students, and staff engaging in research with human participants complete this new tutorial as soon as possible, it is not presently a requirement to do so. Laurier’s Research Ethics Board (REB) will continue to accept the older version of the TCPS2: CORE tutorial until further notice.
- If your research involves primary data collection, submit the Non-Psychology Ethics Application form available on Romeo.
- If you are a researcher in Waterloo’s Psychology Department ONLY, submit the version on Romeo labelled Psychology Ethics Application.
- On August 1, 2023, we launched a companion document to assist researchers in filling out the new application.
Internal Researchers:
If your research project has received REB clearance from another institution, Laurier’s REB will review the application submitted to the other institution (including all associated materials and clearance letter) if it meets the following criteria:
- The application clearly outlines the aspects of the project that are specific to Laurier, i.e. any research activities taking place at Laurier or utilizing Laurier resources
- Laurier researchers (and their role in the project) are identified on the application.
Please note that a full-time Laurier faculty or staff member on an active employment contract will need to serve as the local Principal Investigator for the purposes of the Laurier REB application.
If the above criteria are met, please e-mail the full application package to the REB. The full application package should include the following documents. All documents should be clearly labelled.
- REB clearance letter (and clearance for any related modification requests, if applicable)
- Final approved application (and any related modification requests, if applicable)
- Please ensure that the aspects of the project that are specific to Laurier are clearly outlined in the application and that Laurier researchers and their role in the project are identified.
- Final approved research materials (e.g., recruitment materials, consent, surveys, interview questions).
- TCPS 2 certificates for Laurier investigators.
- The full name, affiliation, and e-mail address of anyone that should have access to the online Romeo file. If they do not already have an account, they will need to self-register for a Romeo account to be added to the file. This access is required for the local Laurier PI as well as the external PI listed on the application under review and any other research project team member that requires access to the application and to receive e-mail correspondence related to the application.
External Researchers:
An external researcher is a researcher not employed by Laurier who wishes to access Laurier resources to conduct research. Such projects will need to be reviewed and approved by the Laurier REB. External researchers will first need to obtain REB approval from their home institution before the REB at Laurier will review their research.
Further, external researchers will need to identify a full time Laurier faculty member (adjunct or Contract Teaching Faculty (CTF) appointments do not qualify) as the principal investigator on their REB application to Laurier; external researchers can only be listed as co-investigators, not as the principal investigators on Laurier applications. Please contact the REB for further guidance on this process.
Effective October 15, 2024, the agreement between Laurier and the University of Waterloo (UW) to jointly review minimal risk research projects will end due to updated TCPS 2 multi-jurisdictional review guidance. If you are conducting research with a collaborator from UW, please see the following updated processes:
- If the UW faculty member is the lead Principal Investigator (PI) on the project and the Laurier faculty member is a collaborator or co-investigator: UW is the reviewing REB and the Laurier researcher must complete the ‘Applications Approved at Another Institution’ process (see above) at Laurier after UW approval is granted. We will do our best to review these applications within 5 business days of receipt.
- If the Laurier faculty member is the lead PI and the UW faculty member is a collaborator or co-investigator: Laurier is the reviewing REB and the Laurier researcher must submit the Psychology/Non-Psychology Ethics Application form for review. Subsequently, the UW collaborator must complete the ‘multi-jurisdictional review’ process at UW after Laurier approval is granted.
If you have any questions about your project, contact REB@wlu.ca.
If your department has a Research Ethics Committee (REC) in place and the project is an undergraduate research activity, then it may be eligible for departmental REC review. This is the only application not administered through the Romeo system. Completed applications are submitted to the appropriate departmental REC and not the University REB. Please see Before You Apply for application criteria and Departmental Ethics Review for a list of departmental REC contacts and downloadable forms.
The Human Research Ethics Coordinator, Psychology and Research Ethics Coordinator coordinate any necessary clearances with the Waterloo Region District School Board (WRDSB).
Local school boards have additional requirements that may not be part of the ethics review process at Laurier (e.g., consent is needed from principals, valid police checks for all researchers, and a separate research ethics application and review process from the school board’s Research Ethics Committee).
Contact Mary Neil (Psychology Applicants) or Samantha Moeller (Non-Psychology Applicants) and see WRDSB Research and Evidence-Based Practice Department for additional details.
COVID-19 Research Restriction Updates
Applications to the WRDSB are currently being accepted.
Researchers who have general inquiries about external research, wish to submit an application to advertise or distribute information about a research opportunity to WRDSB schools or departments, or wish to submit an application are asked to contact Julie Scott by email at julie_scott@wrdsb.ca.
WRDSB Research Review Deadlines 2023-24
Ethics Application Deadline (Romeo) |
Research Application Deadline (WRDSB) |
Estimated Start Date of Project |
September 18, 2023 |
October 30, 2023 |
Beginning of January 2024 |
November 20, 2023 |
January 15, 2024 |
Beginning of March 2024 |
February 16, 2024 |
March 30, 2024* |
Mid-September 2024 |
*Note: this deadline is for applications to conduct research at the beginning of the 2024-25 school year. Approved projects may begin no earlier than mid September.
Every project that involves collecting information from human participants needs a consent/information letter. Such documents inform participants about your project, explain what they will be asked to do as participants and set out their rights and responsibilities. For more information and a downloadable template, see Informed Consent Guidelines.
If you have surveys or questionnaires or interview guides, they need to be attached to your application. If you are using an unstructured interview or focus group, attach a list of topics or questions that will be covered during the interview or focus group.
If you are recruiting participants with a poster, letter, or email, or telephone call, attach a copy of the materials used in the recruitment process. Researchers must list their REB tracking number on their recruitment materials. For more information and downloadable templates, see General Ethics Guidelines.
A debriefing statement/script must be submitted when researchers are using deception or concealment. Deception is the act of deliberately misleading participants. Concealment is the act of keeping information from participants without deceiving them.
This statement/script must be prepared in order to remove any misconceptions about the project that participants may have and to re-establish trust that might have been lost; be sure to explain why the deception or concealment was necessary. The participant must be assured that the deception or concealment was neither arbitrary nor capricious. In the interest of the right to withdraw at any time, participants would be allowed to remove their information from the research once the deception or concealment has been explained to them. For more information and a downloadable template, see Informed Consent Guidelines.
To be consistent with the TCPS 2 Definition of Principal Investigator, “The researcher who is responsible for the ethical conduct of the research, and for the actions of any member of the research team at a local site”, students will not be able to be listed as a PI on a Romeo application.
Full-time faculty, contract teaching faculty who are on an active teaching contract, staff will still be able to act as PIs on ethics applications.
While a student can start and edit all sections of an application, they will not be able to be listed as a PI when it comes to the final submission to the REB.
If a student generates a new Romeo application, they will be defaulted to the PI. The student can draft the application but will need to change the PI to their supervisor for their review and approval before submitting to the REB.
To change the PI to the supervisor, please follow the below instructions:
- Navigate to the Project Team Info tab of your application.
- Click “Change PI” in the top left corner of the tab.
- Search for a full time or contract teaching faculty member or staff member.
- Click Select next to their name.
If a Romeo application is submitted with a student listed as the PI, the application will be returned for revisions.
Alternatively, a supervisor can generate the application in ROMEO and add the student as a student co-investigator or principal student investigator so that the student can fill out the remainder of the application. The final approved version must be reviewed, approved, and submitted by the PI (supervisor) in order to be reviewed by the REB. This new process will also remove the requirement of students having to submit a screenshot of their supervisor’s approval with every new application.
All Laurier investigators listed on the application are required to attach their TCPS 2 CORE certificates to the application.
The Secretariat on Responsible Conduct of Research (Secretariat) has launched a new version of the Tri-Council Policy Statement 2: Course on Research Ethics (TCPS2: CORE) tutorial, the TCPS2: CORE-2022. You may find the updated tutorial and further information on their website.
The new tutorial is designed to reflect the current TCPS 2 (2018) policy and to enhance the learning for researchers. The updated tutorial consists of nine modules and a knowledge consolidation exercise:
Module A1 – Introduction
Module A2 – Scope of TCPS 2
Module A3 – Risks and Benefits
Module A4 – Consent
Module A5 – Fairness and Equity
Module A6 – Privacy and Confidentiality
Module A7 – Conflicts of Interest
Module A8 – Research Ethics Board Review
Module A9 – Research Involving Indigenous Peoples
Knowledge Consolidation Exercise
While the modules are numbered in the suggested order of completion, they can be completed in any order and ach module now concludes with a 4-5 question quiz. The final knowledge consolidation exercise consists of 25 multiple-choice questions that will be randomly selected from a question pool.
In order to obtain the new CORE-2022 certificate of completion, users will need to obtain 80% correct on the final exercise. You may retake this exercise as necessary. This course is self-paced and should take approximately 4 hours to complete. It is possible to complete this tutorial in multiple sessions.
CORE-2022 will be compliant with Web Content Accessibility Guidelines 2.0 (WCAG 2.0) to ensure accessibility for all users.
While it is advised that all faculty, students, and staff engaging in research with human participants complete this new tutorial as soon as possible, it is not presently a requirement to do so. Laurier’s Research Ethics Board (REB) will continue to accept the older version of the TCPS2: CORE tutorial until further notice.
Post Clearance Review Requirements
REB Clearance Periods
The Research Ethics Board (REB) grants approvals for a one-year period at a time and has a four-year maximum clearance period for projects involving human participants. You are required to submit annual reports to maintain clearance and may request a one-year extension when submitting your annual report (for up to a maximum of four years). You must submit a final report upon completion of the project to close and archive it on the Romeo system. Once the four-year maximum renewal period has passed, you must submit your final report and a new application for REB review if you plan to continue the project beyond the maximum approval period.
Projects that have been archived for less than six months may be reactivated following the submission of a modification request for a new end date provided that this does not extend the end date beyond four years from the original date of REB clearance. Projects that have been marked as expired for less than six months may be reactivated following the submission of the required annual report with a request to re-activate the file and extend the end date provided that this does not extend the end date beyond four years from the original date of REB clearance. If a project has been marked as archived or expired for six months or more, it cannot be reactivated and a new REB application must be submitted for review and clearance.
Please note that the REB may grant exceptions to this maximum approval period on a case-by-case basis if justification is provided (e.g., requesting an extension due to a leave or COVID-19 related delays or requesting an extension related to a grant extension).
Modification Requests
The REB recognizes that researchers will, over the course of their research study, have reason to request a modification to approved research protocols. Article 6.16 of the TCPS2 (2022) provides guidance on handling modifications:
In general, it is not the size of the change that dictates the ethics review process, but rather the ethical implications and risk associated with the proposed change. In case of doubt on the potential impact of the change to approved research on the level of risk to participants, researchers should consult with their REBs. Changes that substantially alter the nature of the approved research may be assessed as a new research project and require a new REB review.
Researchers must submit a Request for Ethics Clearance of a Revision or Modification form for any changes that may affect the study's adherence to ethical norms. For submission guidelines, visit Romeo User Guidelines, particularly the "How do I submit a modification request to an approved project" section.
Modification requests must include a clear and detailed summary of all requested changes. If these changes require revisions to previously approved research materials (e.g., consent form, recruitment ad) then revised copies of these documents must be submitted for review. Any revisions to previously approved documents should be made using track changes (or highlighting or underlining the changes in the document) to facilitate the review process.
Types of Changes
- Minor Changes Minor changes do not impact participant risk, safety, comfort, privacy, or confidentiality. Examples include:
- Adjustments to session duration or study length
- Minor wording modifications for clarity on research instruments or interview guides
- Removal of items from research instruments or guides
- Switching to an updated version of a published instrument
- Using a similar alternative instrument
- Changes in funding sources
- Major Changes Major changes affect participants or the research process in significant ways. Examples include:
- Changes to recruitment methods or materials
- Alterations to the research location
- Modifications to participant population or inclusion/exclusion criteria
- Changes in study procedures
- Updates to data management practices (e.g., changes in storage, retention, destruction, or personnel access)
- Adjustments to compensation/incentives
- Updates on conflicts of interest
All modifications, whether minor or major, must be approved by the REB before implementation, unless immediate action is required to ensure participant safety (TCPS2 2022, Article 6.16). In cases where immediate changes are made to address an urgent risk, researchers must notify the REB immediately via an Adverse Event Report. Research must cease until the report is reviewed.
REB Considerations for Modifications
- New topics or instruments added to an existing protocol should be relevant to the research question/purpose as described in Section 2 of the application. The REB may request a new application if the modification significantly deviates from the approved scope.
- If a modification increases the risk to participants, the REB may require a new submission for a more comprehensive review.
- There is no limit to the number of modifications, but multiple major changes may significantly alter the research nature, potentially requiring a new application.
Note for Pilot Studies
According to Article 2.1 of the TCPS2 (2022), pilot studies can result in:
- Termination if the main study is deemed infeasible
- Continuation with modifications to the study design
- Continuation without modifications if the main study is feasible
The design and criteria for pilot studies may vary by discipline. Researchers must clearly state the purpose of pilot studies in their ethics application. Pilot studies are distinct from initial exploratory research phases that may involve individual or community contact but do not require REB review (Article 6.11).
Modification requests will not be processed until any overdue annual reports have been submitted.
Adverse Event Reports
Researchers are required to report all unanticipated occurrences associated with their research to the REB immediately following their occurrence with an adverse event report. This includes but is not limited to any undesirable experience or response by a study participant (emotional, psychological, or physiological in nature) related to study participation or as a result of the research procedures.
Annual/Final Reports
All REB projects require the completion of a final report and projects lasting longer than a year also require the completion of annual report(s). You will receive email reminders that a report is due within 60 and 30 days of the due date and you can also monitor projects that have reports due on Romeo.
Projects with overdue annual/final reports are automatically marked as expired. The REB will notify Research Finance when an REB project, tied to a research account, has been marked expired. In such cases Research Finance will freeze the funds associated with this project.
Once you indicate that the project is inactive (i.e. contact with participants is complete) in an annual/final report, the project will be archived in the Romeo system.