ANNUAL RENEWAL APPLICATION FORM

  1. TITLE OF RESEARCH PROJECT

Protocol Reference #: Original Approval Date:

Previous Reference #:Previous Renewal Date:

2. INVESTIGATOR INFORMATION

Investigator:

Title (e.g., Dr., Ms., etc.): / Name:
Department (or organization if not affiliated with U of T):
Mailing address:
Phone: / Institutional E-mail:

Level of Project

Faculty Research CBR/CBPR Research
Post-Doctoral Research
Student Research: Doctoral Masters Course-based

Faculty Supervisor/Sponsor:

Title: / Name:
Department (or organization if not affiliated with U of T):
Mailing address:
Phone: / Institutional E-mail:
  1. LOCATION(S) WHERE THE RESEARCH WILL BE CONDUCTED:

University of Toronto

Hospital specify site(s)

School board or community agency specify site(s)

Community within the GTA specify site(s)

International specify site(s)

Other specify site(s)

4. OTHER RESEARCH ETHICS BOARD APPROVAL(S)

a) Does the research involve another institution or site?Yes No

b) Has any other REB renewed the ethics approval for this project? Yes No

If Yes, please provide a copy of the approval letter with this application.

5. FUNDING STATUS

a)

Funded *
Yes No / Agency: / Fund #: 4(6 digits)
Agency: / Fund # :4(6 digits)
Funding Period: / Year 1 Year 2 Year 3 Year 4Other
Applied for funding Yes No / Agency: / Submission date:
Agency: / Submission date:

*b) If funded, are funds administered through UofT Research Services? Yes No

c) If “No,” what site/institution administers the funds?

6. PROJECT INFORMATION

a) Have there been any changes to the study protocol, consent process or documents since the most recent approval? Yes No

If Yes, please submit an Amendment Form with your application. Revised procedures may not be used until approved.Please note that this does not refer to already approved amendments.

b) Have there been any changes in research personnel who interact with participants and/or have access to personal data? Yes No

If Yes, please list former/new personnel and position:

c) What is the current status of the study?

Research participants are currently being recruited/participating.

Provide start and end dates (estimated):

Research participants will be recruited/participate

Provide start and end dates (estimated):

Research participant involvement has been completed

On hold – please elaborate:

Final Analysis in progress

This study involves secondary data analysis only

NB: If Annual Renewal 4 of 4: If recruitment or data collection continues beyond 5 years from your original ethics approval, you will be required to submit a new application for review by the appropriate REB. Please refer to your 5-digit ethics protocol number in the title of your new ethics submission.

d)How many research participants have completed the study?

e)How many are currently participating?

f)How many have withdrawn?

Provide reasons for withdrawal:

g)How many participantsare yet to be recruited?

h)Please describe any issues or concerns that you have encountered with recruitment or data management?

i)Since receiving original ethics approval, have any ethical concerns (minor or major) arisen?

Yes No

If Yes, please describe concerns in detail, use additional page(s) if necessary.

j)Have there been any adverse or unanticipated events?

Yes No

If Yes, please submit an Adverse/Unanticipated Event Report Form as soon as possible.

7. STUDY SUMMARY, PROGRESS AND RESULTS

a. Provide a brief summary of study progress,or any interim findings over the past 12 months (100-200 words):

b. Since the last REB review, have there been any changes in your assessment of the risk and potential benefit of the study based on your findings?
Yes No
If Yes, please describe:

c. In order to fulfill privacy requirements, researchers must de-link identifying information, encrypt personally identifiable information, and only allow personnel access to data on a need-to-know basis. Please confirm and elaborate if any of these are not possible or have not happened.

8. SIGNATURES

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

U of T Office of Research Ethics accepts e-mailed or scanned submissions as long as it is sent from a faculty researcher's/supervisor's institutional e-mail account. Please send the completed documents via e-mail to .

Signature of Investigator: ______Date:

AND (if applicable):

Signature of Faculty Supervisor/Sponsor: ______Date:

Instructions:

A suspension of approval may occur if we do not receive the annual renewal form at least 14 days before date of expiry. Suspension of approvalwill have implications for administration of funds and compliance with University policy. Pleaseemail your Annual Renewal form to .
**Please note that under no circumstances can we provide an extension to the approval cycle of one year minus a day**

NOTE: We cannot process the form until all the signatures are in place. Please submit your protocol and supporting documents as a single attachment (if possible). Signatures should be included as an inserted image into the document, or the hard copy can be signed, then scanned and e-mailed to us.
If neither method is possible, the ORE will accept confirmation of Investigator or Supervisor representation, provided that an institutional email is used.

UT Office of Research Ethics – Annual Renewal Form 1

12 Queen’s Park Crescent West – McMurrich Building, 2nd floor, M5S 1S8, Toronto

Version Date: Aug 2012