Amendment request form
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If a researcher wishes to make any changes to the original REB-approved research, she/he must notify the REB by submitting an Amendment Request Form (Appendix D). Researchers may only implement changes to their study protocols once the amendment has been reviewed and approved by the REB and a Certificate of Ethics Review has been provided.
Amendment Application Form
Version date: 2014
Note to Researchers
Conflict of Interest: Please confirm with your signature below that any conflicts of interest (actual, apparent, perceived, or potential) relating to this project have been disclosed in this application, for the Research Ethics Board (REB)’s review.
Amendment: Researchers proposing any changes to an approved research project must obtain the approval of the REB before proceeding with these changes, except when necessary to eliminate an immediate hazard to a participant. The REB must then be immediately notified and the modification submitted for consideration immediately thereafter. Such modifications may include, but are not limited to, changes in research design, participant population, or consent procedures. Prior to making any study amendments or modifications, this form must be submitted to the REB Secretariat.
At the discretion of the REB Chair, these modifications may be reviewed via an expedited process. However, significant revisions will require that the proposal be reviewed by the REB at an upcoming REB meeting.
- Protocol REB Number:
- Project title:
- Principal Investigator:
- Please describe the proposed study amendment or modification with rationale. Is it Minor ex., administrative changes such as deleting the name of a co-investigator, change in sponsorship/study budget, or Major ex., adding an intervention such as additional blood tests or obtaining consent.
- Science Review: In general, not needed for minor amendments but may be needed for major amendments. If this amendment has been scientifically reviewed, please attach a copy of the reviews.
- What follow-up action for study participants who are already enrolled in the study do you recommend?
- Inform study participants ASAP
- Revise the consent/assent forms (Please enclose)
- Other (please describe)
- No action Required
- For impact analysis and Divisional / Departmental Approval
- Signature of Head
Documentation: The documentation required for an ethics review of the modified research projects to be submitted by the applicant, may include:
- signed and dated application form; and
- the documentation that has been modified by the researcher.
The Application and all supportive documents should be forwarded to:
Manager, Research Ethics Board Secretariat
70 Colombine Driveway
9th Floor, Room 941C
Brooke Claxton Building, Postal Locator: 0909C
Ottawa, Ontario, K1A 0K9
Phone number (613) 941-5199
Fax (613) 941-9093
The Research Ethics Board (REB) aims to adhere to the principles and practices stated in the Canadian Tri-Council Policy Statement (1998) and the Declaration of Helsinki.
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