ANNUAL RENEWAL OF ETHICS APPROVAL APPLICATION

Document Sample
ANNUAL RENEWAL OF ETHICS APPROVAL APPLICATION Powered By Docstoc
					     UNIVERSITY OF TORONTO
     Office of the Vice-President, Research and Associate Provost
     Ethics Review Office


                  ANNUAL RENEWAL OF ETHICS APPROVAL APPLICATION


PRINCIPAL/PRIMARY INVESTIGATOR:
Please indicate the level of research, Faculty ο Post-Doctoral ο Doctoral ο Master’s ο Undergrad. ο

Name
Department
Mailing Address                                               Postal Code
Phone                          Fax                    Email

Student Number


FACULTY SUPERVISOR/SPONSOR: (if applicable)
Name
Department
Mailing Address                                 Postal Code
Phone                Fax                  Email


PROJECT TITLE:




Protocol Reference #:                                 Original Approval Date:
Previous Reference #: ______________                  Previous Renewal Date: ________________

Please answer the following questions:

1. What is the funding status of this project?

       ο Funding ongoing        Agency: ________________ Funding Period: _____________
             ο Year 1          ο Year 2     οYear 3      ο Year 4     ο Other

       ο Application pending Agency: ________________ Funding Period: ______________

       ο Unfunded

2. Have there been any changes to the study protocol or consent form documents since the most
   recent approval? ο NO     ο YES

       If YES, please describe changes on a separate piece of paper and append revised
       documents to this form. Revised procedures may not be used until approved.
3. Have there been any changes in research personnel?        ο NO              ο YES
   If YES, please list former/new personnel and position:



4. What is the current status of the study?
   ο Human subjects are currently being recruited/participating. Provide start/end date:
   ο Human subjects will be recruited/participate. Provide start/end date:
   ο Human subject involvement has been completed.
   ο The study is closed. (Please complete the Study Completion Report)
   ο The study is withdrawn.

5. How many subjects are currently in the study?

6. How many subjects have completed the study?

7. Did any subjects withdraw? ο No             ο YES    (please describe circumstances below,
   use additional pages(s) if necessary)



8. Since receiving original ethics approval, have any ethical concerns arisen or have any human
   subjects experienced adverse events as a result of their participation in the study?
   ο No       ο YES (please describe in detail, use additional page(s) if necessary)

9. Provide a brief summary of study progress and results (use additional page(s) if necessary).




My signature certifies that the above information is correct and that no unapproved
procedures will be used on this study.

Signature of Principal/Primary Investigator:                        Date:

       AND (if applicable)

Signature of Faculty Supervisor/Sponsor:                            Date: