How to Apply for Biosafety Permits, Renewals, and Amendments
The Research Safety Committee reviews all research projects involving infectious or biological agents to ensure compliance with the Canadian Biosafety Standards, 3rd Edition and the Agreement on the Administration of Agency Grants and Awards by Research Institutions between the University of Windsor and Tri-Council and/or other granting agencies. Valid biosafety certificates are required before proceeding with this type of research. Additionally, principal investigators must have a valid biological safety certificate for the acquisition and purchase of biohazardous materials, including cell lines and BSL-1/2 materials.
To apply for a biosafety certificate, follow the below steps:
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Ensure that all workers working with biological materials have the appropriate training.
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Complete the Application for Biological Safety Certificate through the ERSO Portal.
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Refer to the ERSO Guide for Researchers for guidance about completing your application through ERSO or watch the How-to Video included at the bottom of this page.
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If you have any biosafety related questions for your application, please consult with the Biosafety Officer by contacting ccc@uwindsor.ca.
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If you experience any technical issues with ERSO, please contact the Office of Research and Innovation Services (ORIS) at erso@uwindsor.ca.
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When your application has been submitted through ERSO, it will move to the "Applications: Under Review" folder. Once it has moved to this folder, you may view your submission, but edits cannot be made to the application. The Biosafety Officer will conduct an initial file audit of the application to identify any potential issues. Once satisfied, the Biosafety Officer will forward the application to the Research Safety Committee for vetting.
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The Research Safety Committee will review the application and may approve, conditionally approve, or defer the application.
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If you receive a deferral decision, address outstanding conditions, and consult with the committee and the Biosafety Officer.
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If you receive a conditional approval, address the minor changes, and resubmit application to the committee for final approval.
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Once approved, you will receive an email notifying you of the decision, with a copy sent to the Biosafety Officer and Environmental Health and Safety Manager. You can view your approved application in ERSO under the "Applications: Post Review" folder.
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A copy of the biosafety permit will be sent to the Principal Investigator to print and display in their facility and the University of Windsor Certification Management System (ERSO) will be updated to reflect the new permit.
NOTE: Principal investigators must adhere to the conditions specified in their application, and the Research Safety Committee may visit a laboratory to confirm that approved protocols are being followed. Ensure that you have a Biological Inventory List Sheet available, as this will be checked during regular biosafety inspections.
Any changes to materials, personnel, and facilities require an amendment to the biosafety permit. To submit a biosafety amendment, follow the below steps:
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Complete the Renewal/Amendment to Biological Safety Certification through the ERSO Portal.
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Click on the “Applications: Post Review” folder.
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Click the “Events” button on the application you wish to amend.
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Under the “Create New Event” heading, select the "Renewal/Amendment to Biological Safety Certification" form.
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Fill in the required information and outline the changes being made to your permit.
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Click the “Submit” button. Indicate any further comments, if required, in the pop-up comment box, and then click submit.
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Refer to the How-to Video at the bottom of this page for further guidance.
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When your amendment has been submitted through ERSO, you can view it under the “Applications: Post Review” folder. Click the “Events” button on the application in which you submitted the amendment. You will see your submitted amendment under the “Events: Under Review” folder. The Biosafety Officer will conduct an initial file audit of the amendment to identify any potential issues. Once satisfied, the Biosafety Officer will forward the amendment to the Research Safety Committee for vetting.
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If there are reviewer comments, you will see them under the header "Events: Requiring Attention" on the ERSO homepage, and it will be highlighted in red.
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Click on "Events: Requiring Attention", and then click "Events" under the corresponding file.
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Select the "Latest Workflow" button under the "Events Requiring Attention" folder. You will then be able to view the comments under the "Logs" tab.
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Make the requested edits in the application and click "Re-Submit." Indicate any further comments, if required, in the pop-up comment box, and then click submit.
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The Research Safety Committee will review the application and may approve, conditionally approve, or defer the application.
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If you receive a deferral decision, address outstanding conditions, and consult with the committee and the Biosafety Officer.
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If you receive a conditional approval, address the minor changes, and resubmit application to the committee for final approval.
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Once approved, you will receive an email notifying you of the decision, with a copy sent to the Biosafety Officer and Environmental Health and Safety Manager. You can view your approved amendment in ERSO under the “Applications: Post Review” folder. Click the “Events” button on the application in which you submitted the amendment. You will then see your approved amendment under the “Events: Post Review” folder.
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A copy of the amended biosafety permit will be sent to the Principal Investigator to print and display in their facility and the University of Windsor Certification Management System (ERSO) will be updated to reflect the new permit.
If you have any biosafety related questions for your application, please consult with the Biosafety Officer by contacting ccc@uwindsor.ca.
If you experience any technical issues with ERSO, please contact the Office of Research and Innovation Services (ORIS) at erso@uwindsor.ca.
Biosafety certificates are valid for one to three years, depending on the risk classification of the project (see pages 7-10 of the Biosafety Manual for more information). If a certificate is set to expire, a renewal application is required and should be submitted to the Research Safety Committee at least two months before the expiration date for review and approval.
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Complete the Renewal/Amendment to Biological Safety Certification through the ERSO Portal.
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Click on the “Applications: Post Review” folder.
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Click the “Events” button on the application you wish to renew.
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Under the “Create New Event” heading, select the "Renewal/Amendment to Biological Safety Certification" form.
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Fill in the required information and outline any changes being made to your permit. If there are no changes to your biosafety permit, you may click the "Renewal Only: No Changes" box in the amendment/renewal form and complete the remainder of the application as required. Please note that if there has been a change in the authorized personnel, this constitutes as a change to the permit.
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Click the “Submit” button. Indicate any further comments, if required, in the pop-up comment box, and then click submit.
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Refer to the How-to Video at the bottom of this page for further guidance.
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When your renewal has been submitted through ERSO, you can view it under the “Applications: Post Review” folder. Click the “Events” button on the application in which you submitted the renewal. You will see your submitted renewal under the “Events: Under Review” folder. The Biosafety Officer will conduct an initial file audit of the renewal to identify any potential issues. Once satisfied, the Biosafety Officer will forward the renewal to the Research Safety Committee for vetting.
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If there are reviewer comments, you will see them under the header "Events: Requiring Attention" on the ERSO homepage, and it will be highlighted in red.
-
Click on "Events: Requiring Attention", and then click "Events" under the corresponding file.
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Select the "Latest Workflow" button under the "Events Requiring Attention" folder. You will then be able to view the comments under the "Logs" tab.
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Make the requested edits in the application, and click "Re-Submit." Indicate any further comments, if required, in the pop-up comment box, and then click submit.
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The Research Safety Committee will review the application and may approve, conditionally approve, or defer the application.
-
If you receive a deferral decision, address outstanding conditions, and consult with the committee and the Biosafety Officer.
-
If you receive a conditional approval, address the minor changes, and resubmit application to the committee for final approval.
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Once approved, you will receive an email notifying you of the decision, with a copy sent to the Biosafety Officer and Environmental Health and Safety Manager. You can view the approved renewal in ERSO under the “Applications: Post Review” folder. Click the “Events” button on the application in which you submitted the renewal, and you will see your approved renewal under the “Events: Post Review” folder.
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A copy of the renewed biosafety permit will be sent to the Principal Investigator to print and display in their facility and the University of Windsor Certification Management System (ERSO) will be updated to reflect the new permit.
If you have any biosafety related questions for your application, please consult with the Biosafety Officer by contacting ccc@uwindsor.ca.
If you experience any technical issues with ERSO, please contact the Office of Research and Innovation Services (ORIS) at erso@uwindsor.ca.
Important Information about Biological Safety Permits
Researchers should continue to follow the safety measures outlined in the Biological Safety Manual (.pdf file) in addition to their approved safety protocol.
If the Research Safety Committee finds that a principal investigator is not following their approved protocol, the committee reserves the right to suspend/revoke a previously approved certificate, which would suspend all research activities and access to research funds until further notice. It is the responsibility of the researcher to ensure that all the information included in their permit application is accurate. If a principal investigator wishes to cancel their permit, please notify the Research Safety Committee and Chemical Control Centre immediately by emailing rsc@uwindsor.ca and ccc@uwindsor.ca.
Human Somatic Cell Line
If the research to be conducted will use any human somatic cell line, the project will require a full Research Ethics Board (REB) Tissues and Fluids application unless the project meets all of the following 4 terms in either scenario:
Terms for exemption of the re-use of de-identified human somatic cell lines are:
a) the researcher will comply with known consent terms;
b) the researcher does not know or have access to the identity of the participant;
c) the researcher will not take any steps to identify the participant; and
d) the research is unlikely to reveal the identity of the participant.
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Terms for exemption of the re-use of publicly identified human somatic cell lines are:
a) the cell line is already available and identified in the public domain;
b) it is impossible or impracticable to seek participant consent;
c) the researcher will comply with known consent terms; and
d) the research is unlikely to harm the participant.
In most cases, research with purchased commercial cell lines will meet these terms. However, it is important to fill out the Cell Lines Exemption Form and submit it to ethics@uwindsor.ca. If you are unsure if your research requires an REB Tissues and Fluids application or the Cell Lines Exemption Form, please contact ethics@uwindsor.ca for preliminary discussion.
Please consult the following links for more information:
https://www.pre.ethics.gc.ca/eng/consultations_2021_cell_exemptions-exemptions_cellulaires.html
https://ethics.gc.ca/eng/tcps2-eptc2_2022_chapter12-chapitre12.html
If the research uses human stem cells (not somatic cells), the research project will require a Tissues and Fluids application. Additionally, review from CIHR’s Stem Cell Oversight Committee (SCOC) would be required, if the research is involving human pluripotent and human totipotent stem cells that: have been derived from an embryonic source; and/or will be transferred into humans or non-human animals. To confirm if this applies to the research project, please contact ethics@uwindsor.ca to discuss.
There may be instances where the REB may require additional application materials over and above the Tissues and Fluids application depending on the context of the research project. The REB will notify the researcher as needed with support in these cases.