Version : 2010
Note to researchers
Ongoing research shall be subject to continuing ethics review based on the associated risks to the participants. The REB ethics approvals are valid for a maximum of one (1) year. The research must be reviewed at least annually and until it is completed. The Principal Investigator must submit an annual progress report prior to the expiration date of the REB’s Certificate of Ethics Approval.
All research involving humans at Health Canada and the Public Health Agency of Canada must be reviewed and approved by the Research Ethics Board. Approval must be obtained in writing before the research begins.
Protocol REB Number:
Project Title:
Provide a short abstract of the project:
Principal Investigator:
Name:
Position:
Branch:
Department/Agency:
Address:
Telephone:
Facsimile:
E-Mail:
Departmental Contact:
Name:
Position:
Branch:
Department/Agency:
______
SignatureDate
Annual Update Information
Date on which original project was approved by REB:______
1.When did this project begin?______
2. What is the anticipated completion date of this project?______
3. Is this project continuing?
Yes No If no, go to question 6 and continue.
4. What is the funding status of this project?
FundedDivision ______Funding Period ______
Funding Sought Division ______
Unfunded
5a.Pleaseprovide a brief narrative on the status of this project (a description of what has occurred since the REB’s last ethics approval):
5b.Substantive or preliminary results should be provided.
6.Please provide the following details on enrolment of participants:
(a) Number of participants that have completed this project: ______
(b) Number of participants currently enrolled in the project: ______
(c) Are there any additional participants still required for the project?
Yes How many?______No. N/A
(d) Have there been any participants that have voluntarily withdrawn
from this project:
Yes How many?______No. N/A
7.Have there been any changes to this protocol that have not been approved by the Research Ethics Board?
Yes No
(If yes, changes to previously approved protocols must be submitted for an ethics review by completing theAmendment Request Form – Appendix Dand sending this form to the REB Secretariat).
8. Since original ethics clearance, have any participants experienced any adverse effects as a result of their participation in this project?
Yes No N/A
a) If yes, please describe these in detail and how the situations were resolved (attach additional pages, as necessary.)
b) What procedures/safeguards are now in place to protect the participants from these risks?
I certify that the above information is accurate.
______
Signature, Principal InvestigatorDate
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
Tunney’s Pasture
Ottawa, Ontario, K1A 0K9
Phone number (613) 941-5199
Fax (613) 941-9093
Email:
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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