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

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 must be submitted on the Bannatyne Campus Research Ethics Board  "Request for Amendment/Changes to a Previously Approved Study" 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

Request for Amendment Changes Form 

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

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