Institutional Review Committee

Unanticipated or adverse event report

APPLICANT INSTRUCTIONS

·  This form must be submitted to the IRC if an unanticipated or adverse event occurs during your research project. Follow the instructions carefully to ensure you include all necessary information as incomplete forms will not be accepted.

·  In the case of an unanticipated or adverse event, all procedures related to the research project must be halted until IRC grants approval to resume.

·  Such events must be reported to the IRC within 14 days and a separate form completed for each discrete event.

·  Depending upon the nature of the reported event, the IRC may grant approval to resume research, request alteration to the research protocol and/or informed consent procedure, suspend or terminate the research project. You will be advised of the decision in writing.

·  Submission must be electronic, to , and you will receive a confirmation email

1.  PROJECT DETAILS

1.1.  Project title

1.2.  Principal researcher OR responsible supervisor

1.3.  Student researcher (if applicable)

1.4.  IRC application number (from IRC approval letter)

1.5.  Period (dates) of approval (from IRC approval letter)

2.  EVENT DETAILS

1. 

2. 

2.1.  Date

2.2.  Description (describe the event in detail, including the circumstances which lead to its occurrence, and provide justification for any actions taken by the researchers)

2.3.  Outcome (describe the outcome or resolution of the event, the perceived impact on any participants involved and any ongoing management)

2.4.  Recurrence risk (identify the likelihood that such an event will or will not reoccur, providing justification)

3.  DECLARATION

The information contained herein is, to the best of my/our knowledge and belief, accurate and complete.

I/we agree that the research process will remain halted until written approval to resume is granted by the IRC. If approval is granted, the project will be undertaken in strict accordance with the approved protocol and relevant laws, regulations and guidelines.

Principal researcher/responsible supervisor:

Name
Contact details
(both phone and email)
Signature
Date

Student Researcher (if applicable):

Name
Contact details (include both phone and email)
Signature
Date

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