Submission and Review Procedures for Changes to the Protocol (Amendments) and Responses to Conditional Approvals

Until further notice please follow these instructions for sending in amendments, responses to conditional approvals, protocol deviations, etc. that qualify for delegated review. Annual review and final reports are to be submitted as instructed on the forms via the Annual Study Status Portal and Final Study Status Portal.

For Tabled responses, annual and amendments requiring full board review go to the Submission Requirements page. Do not follow these instructions for submitting any new study.

Resumption of in person visits or contact:

COVID-19 Research Recovery Team (CRRT) approval is required for any protocol that includes in person visits or an amendment requesting resumption of in person visits via a Request to Undertake Research Involving Human Participants at On- or Off-Campus Research Sites.  If applicable, indicate in your REB submission that the CRRT submission has been completed.  Protocols requiring in-person visits will require Departmental Review or Dean approval as outlined on the University of Manitoba Office of Research website. CRRT approval is a separate process from the REB approval of an application.

The application/amendment must also include Standard Operating Procedures on mitigation strategies for preventing the spread of COVID-19 and a COVID-19 Risk information included in the consent form or via the University of Manitoba COVID-19 Consent Appendix.

Step by step instructions for submitting:

  1. Email submissions to bannreb@umanitoba.caDo not send in submissions to staff e-mail addresses.

  2. Subject line must be formatted as follows:  Ethics numbers (include both the HS# and BREB or HREB #), submission type (e.g. response to conditional approval, amendment, protocol deviation, change in study personnel form, etc.).

  3. If the study is a COVID Clinical Trial also add "COVID Clinical Trial" to subject line

  4. All changes/modifications to documents must be marked for ease of review.

  5. Tracked change documents MUST be saved in ALL MARKUP format prior to sending.

  6. Any documents that have been modified must have a new version date added to document itself (usually inserted in the footer of each page).

  7. If the study involves in person contact the University of Manitoba COVID-19 Consent Appendix must be submitted for approval.

 

 


Amendments/Changes to an Approved Protocol

Researchers are obliged to follow the procedures outlined in the protocol/proposal approved by the Research Ethics Board (REB). If the researcher or sponsor recognizes the need for modification to the protocol/proposal he/she is obliged to file a protocol amendment with the REB prior to implementing the change.

This guideline outlines:

  1. The necessary information that is required of the applicant when submitting a request to the REB; and
  2. details the operating procedures of the Bannatyne Campus REBs review process related to amendments.

Examples of amendments that require REB review include, but are not limited to, changes in: key personnel (e.g. principal investigators, co-investigators, study physicians); research protocol objectives; advertising materials (flyers, radio spots, etc.); research procedures; participant populations (e.g., age range); location where research will be conducted; consent/assent form; recruitment procedures; date for completion of study; procedures for monitoring safety data. etc.


Tips when submitting Amendments/Changes to a protocol

Complete and review the Bannatyne Campus REB “Submission Requirement Checklists for Amendments, Additions or Changes to Approved Studies Delegated Review or Full Board Review.

All changes, with the exception of changes in personnel, must be submitted on the Bannatyne Campus Research Ethics Board Amendment Form (pdf).

For changes in study personnel complete Change in Study Personnel Form (pdf). A checklist of required documents is outlined on the form. 

Additions to amended documents must be underlined or in bold text and any deletions indicated by strikethrough.

Remember to revise the version date in footer of each page of amended consent forms or title page on supporting documents.


When are NOL's required for amendments?

If a "No Objection Letter" (NOL) from Heath Canada (HC) was received for the initiation of the clinical trial, then a copy of the "NOL" from HC for proposed changes to the protocol must be submitted before the REB will approve the proposed amendment or an appropriate justification from the sponsor is outlined in the submission.


SUBMISSION REQUIREMENTS
The submission requirements page will provide a quick reference to the various documents required for ethics review.

REQUIRED FORMS FOR HREB AND BREB

Amendment Form (pdf)

Checklist for Full Board Review of Amendments, Changes or Additions (pdf)

Checklist for Delegated Review of Amendments, Changes or Additions (pdf)