Study Amendment

Any changes made to study documents or research processes that are approved by the Research Ethics Board (REB) must be approved by the REB prior to being implemented.

Note: Changes to investigator’s brochures (IBs) should be submitted as updated safety information.

Please follow these instructions to make changes to your approved study processes or documents:

Submit completed study amendment package

  1. Complete the amendment request form in full, with an original signature of the Unity Health Lead Applicant.
    • In lieu of an original signature, the submission email can be sent by the PI or by a research team member with the PI cc’d.
    • Include a relevant explanation for each change being made.
    • Include amended versions of all approved documents that are impacted by the change.  One clean and one tracked changes version of all amended documents must be provided.
  2. Submit an electronic copy of the complete submission to researchethics@unityhealth.to, with the subject line “REB <REB Number> – Amendment”.

Review of study amendment package by the Research Ethics Board

  1. Protocol amendments are reviewed on a first-come, first-served basis. The same factors that affect the length of time for initial study approval also impact protocol amendment review and approval.
  2. The contact person for the amendment will typically be the Research Ethics Coordinator that worked on the original application. If you don’t have a Research Ethics Coordinator, please email researchethics@unityhealth.to.
  3. During review of the application the Research Ethics Coordinator will contact you with any clarifications that are needed prior to approving the amendment.
  4. There are sometimes cases where an amendment requires review by the full board. If this occurs, your Research Ethics Coordinator will let you know and inform you of the next steps.

Approval of the study amendment application

  1. Once the review is complete and all concerns have been addressed, your amendment application will be approved.
  2. Your approval letter will be sent to you via email.

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