Top Tips for an Efficient Research Ethics Review

Print | PDF

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 created a list of common issues we see in applications, as well as their solutions.

The wrong ethics application is submitted to the REB

Solution: 

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.

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.

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.

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). 

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.

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.

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. 

Researcher leaves inadequate time for REB review and revisions

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

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.

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.
    • Cut the comments you received from the REB and paste them into a new Word document.
    • 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

The application was submitted by a student and not a faculty member.

Solution: All individuals added to a ROMEO application can edit the application. However, 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:

  1.  Navigate to the Project Team Info tab of your application.
  2. Click "Change PI" in the top left corner of the tab.
  3. Search for a full time or contract teaching faculty member or staff member.
  4. 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.