Post-Approval Requirements

This page provides you with the Research Ethics Board (REB) post-approval requirements. 

Jump to: 

• modification requests
• adverse event reports
• annual/final reports

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Projects that have been archived for less than six months may be reactivated following the submission of a modification request for a new end date provided that this does not extend the end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

1. 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.
2. 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.