Request for Renewal of Ethics Approval

Find below relevant information to renewal of the REB approval for any project involving human subjects. A renewal is usually performed annually.

REB Project Identification Number:

Title of Research Project:

Principal Investigator:

Is the project being carried out as described in the original project?  Yes  No

If no, please explain the differences.

Have any research subjects suffered any serious or unexpected harms?  Yes  No

If yes, please describe.

Has there been any significant change in the information on which the REB provided ethics approval, e.g., new knowledge from the literature, from the present project or from other sources?  Yes  No

If yes, please describe the new information, and indicate how it differs from that in the previous or original ethics approval, and its impact on the ethics of the research underway.

Have there been any internal or external audits of the research, preliminary (stopping rule) analyses, reports of data and safety monitoring boards etc?  Yes  No

If yes, please describe

Have any amendments been made to the application since its original approval  Yes  No

If yes, please explain them

If yes, were these amendments approved by the REB  Yes  No

If yes, when? If no, why not?

Are you now requesting any amendment(s) to the application?  Yes  No

If yes, please describe and justify the proposed amendment(s).

When do you expect the project to be completed?

If the project or consent information have changed since the original application was approved, or are requested at this time, please provide the current or proposed versions and indicate where the changes were made.

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Principal Investigator

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Date