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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. More information is provides on the Research Involving Humans webpage.

Steps To Take Before Applying for REB Review

Which Application To Submit for Review

What Materials to Submit for Review

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Projects that have been archived for less than six months may be reactivated following the submission of a modification request for a new end date provided that this does not extend the end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 must review and provide clearance for any changes or modifications to projects that relate to the researcher’s dealings with his or her participants before changes are implemented. Examples include adding a new survey, recruiting additional participants, or adding a project team member. Such modifications will be submitted through Romeo.

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. Modification requests will not be processed until any overdue annual reports have been submitted. Please see the Romeo Quick Reference Guide for instructions on how to submit a modification request.

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.

Top Tips for an Efficient Review:

The Office of Research Services sees upwards of 400 applications and an additional 400 modification requests per year. To ensure that the review process moves smoothly for all researchers at Laurier, we have devised a list of common issues we see in applications, as well as their solutions.

 

1. The wrong ethics application is submitted to the REB. 

Solution: 

2. Application is incomplete or documents do not contain required information

Solution:
  • Complete all sections carefully, paying attention to the instructions and tips in the yellow boxes you’ll see in the Romeo application.  
  • Review the list of What Materials to Submit for Review.
  • Review Article 3.2 of the TCPS 2 and Informed Consent Guidelines including the informed consent template.
  • Your advisor should carefully review your application before they provide you with approval to submit.  If your application is incomplete, it will be returned and this will slow down the review process.

3. Application and materials are written for wrong audience

Solution:

  • Write your Romeo application for a researcher, but one who may be peripheral to your field of study. Avoid discipline-specific jargon and use procedural writing when you can.
  • Answer the questions carefully without providing unnecessary information.  For example, do not submit a copy of your grant proposal in section 1.5, where you are only asked to provide a succinct summary of the purpose, objectives and aims of the research and to describe your research methodology/design.
  • Write your consent documents (and any other document directed to participants) as if addressing the participant.  Address the participant directly (e.g., “In this study, you will be asked to…”, “You may participate in this study without consenting to the use of your quotations.”, “You will receive a $10 gift card…”).  Do not use jargon and unnecessarily complex terminology.

4. There are inconsistencies between documents

For example, you describe compensation as $25 in the application and recruitment material, but as $40 in the consent document.  Or you list the time commitment as 60 minutes in the application, but as 30 minutes in the consent document.

Solution: Leave time to proofread all materials once you have completed the application.  Many inconsistencies in need of correction slow down the review process for all researchers at Laurier.

5. The instructions in the Consent Document template (meant to help researchers as they prepare their consent document) are left in the final document

Solution: Remove template text/instructions that are intended for you to read as you prepare your consent document.  Where the template says “if applicable” add only the information that is applicable.  Remove all text that is not applicable (e.g., a common mistake is to leave in the written signature lines when you are obtaining online record of consent). 

6. Risks are not adequately identified in section 6, or described to participants in the consent document

Solution: Recognize that most research has real or perceived risks.  Do not hesitate to identify these risks. Some risks may seem negligible, however they may be concerning to a potential participant.  Identifying these risks and taking steps to mitigate them is a critical step in obtaining informed consent.  Correctly identifying real and perceived risks in your initial application will facilitate the REB review.

7. The consent form does not provide a place for participants to record consent for voice recording, or use of quotations, or other optional procedures that are described in your application

Solution: If you have optional procedures in your research design, provide a clear means by which the participant may opt in or opt out.  Please include both options (Consent and do not consent) to your form, as this clearly indicates that participants were given able to choose between two options.

8. Real or perceived Conflict of Interest is not described and risks associated with conflict of interest not discussed 

For example, dual roles of researchers and their associated obligations (e.g., acting as both a researcher and a therapist, health care provider, caregiver, teacher, advisor, family member, coach, consultant, supervisor, student, or employer) may create conflicts, undue influences, power imbalances or coercion that could affect relationships with others and affect decision-making procedures (e.g., consent of participants).

Solution: Become familiar with the TCPS2 guidance on Researchers and Conflict of Interest

9. Researcher leaves inadequate time for REB review and revisions

Solution: Review the REB timelines and prepare a careful application that includes all required attachments. 

10. Research plan does not meet the standards for ethical conduct of research outlined in the TCPS 2 

Solution: Become familiar with the TCPS 2 guidelines as they pertain to your work.  Use the hyperlinked Table of Contents on the Tri-Council Policy Statement Website to find relevant articles, or use control+F to find information in the pdf copy of the TCPS2.

11. Poorly organized response to REB request for revisions

Solution: Follow the instructions for resubmitting your application after you receive feedback from the REB.  A point-by-point revision summary must be attached.  The best way to complete this summary is to cut the comments you received from the REB and paste them into a new Word document.  Then respond in-line to each comment by saying how you addressed each concern and where the revisions were made (e.g., what section of your application did you revise, what additions/deletions/edits were made to consent documents, information letters, advertisements, etc.) Clear and complete responses to the REB review memo leads to more efficient reviews of your resubmission and will prevent unnecessary delays. Revisions to attachments should be clearly identified using either track changes or highlighting.  Clearly identifying revisions allows reviewers to focus on the changes that were made to documents rather than re-reviewing all documentation.