Biosafety Program

Biologically active materials are capable of causing injury and disease if not handled properly.  Currently, work with Risk Group 2 or higher biohazards can only be conducted under a license issued by the Public Health Agency of Canada (link), required by the Human Pathogens and Toxins Act.  Additionally, Lakehead University has the responsibility under the Ontario Occupational Health and Safety Act (OHSA) to take every reasonable precaution to protect employees from workplace hazards.  Although students and volunteers are not employees, Lakehead University requires that students and volunteers adhere to all health and safety policies and procedures, see policy

The Tri-Councils (NSERC, SSHRC, CIHR) require adherence to the standards in Health Canada’s document “Canadian Biosafety Standards, 3rd Edition” (CBS).  In order to meet this obligations, the Lakehead University Biosafety Committee (Terms of Reference) reviews and grants approval for any work with biohazardous materials used in all Lakehead University facilities.  As required by the Tri-Council Granting Agencies, research funds for projects involving biohazardous materials will not be released to the Researcher until an approved biosafety protocol is in place.  Approvals are granted after a risk-based review of the proposed work to ensure that biohazardous materials are handled as safely as possible and within the requirements of the CBS.

To access funds for preliminary work prior to approvals being granted, researchers must contact the Biosafety Officer for guidance.  Recently the Federal Government of Canada has expanded legislation to regulate the use of human and animal pathogens.  See the Public Health Agency and Canadian Food Inspection Agency websites for information.

For all work involving biohazardous materials applications must be made to the Biosafety Committee using the Romeo System.

For multi-user facilities or teaching facilities, a Facility application must be filed.  Only applications submitted through Romeo will be accepted.  The Biosafety Committee will grant a permit based on the information provided with this application for a maximum period of five (5) years. The permit will list all manipulations approved for the lab. 

 For research labs, individual Project applications are required. A Biosafety Project application must include all aspects of the research project involving biohazards.  Only applications submitted through Romeo will be accepted.  In accordance with Tri-council requirements, this application is required for each grant awarded that involves work with biohazards.  It is therefore imperative that all manipulations to be used in the research project are declared in the application.  The Biosafety Committee will grant research approvals for the shortest of the following: term of the grant, or if unfunded for a maximum of five (5) years.  One Biological Risk Assessment form should be submitted for all work in each risk group, regardless of the number of projects approved.

 Continuing Work After the Expiry of a Permit

Prior to the end of the Project, should work be continuing, a new project/facility application must be submitted to the Biosafety Officer.  This must include updated supporting documentation.  

Other Considerations 

  1. Personnel:
 All personnel must be trained prior to beginning work in the lab. See Training for details.
  2. Facilities: 
Labs must meet the physical requirements for the biosafety level applied for before a permit will be granted. This will be confirmed by an inspection conducted by the Biosafety Officer.
  3. Biosafety Approval is Conditional on:
    • proper maintenance of lab facilities, verified by inspection every six (6) months.
    • adherence to the CBS and Lakehead University policy, including Laboratory Safety Operating Procedures.
    • prompt resolution to any non-compliance items
    • all personnel have updated training
    • biohazardous materials are obtained through approved channels only (i.e. purchase order) and Biosafety Officer is aware of the acquisition.
  4. Changes to Project/Lab/Biohazards in useChanges can be made at any time, but must be approved by the Biosafety Officer using the Renewal/Amendment Event tab in Romeo.

Facility/Teaching Application

  1.  Complete the Application Form found on Romeo.  Log in through Myinfo.
  2.  Complete the Biological Risk Assessment Form (include all manipulations anticipated).  For each manipulation checked, you must provide a reference to the relevant section of the Lab Specific Biosafety Manual or relevant SOPs.
  3.  Include a copy of the Lab Specific Biosafety Manual or the relevant SOPs
  4.  Update "Biosafety Personnel List" spreadsheet shared with the BSO.  If you do not have this spreadsheet available contact labsafety@lakeheadu.ca.

Research Project Application

  1. Complete the Application Form found on Romeo.  Log in through Myinfo.
  2. Complete the Biological Risk Assessment Form (include all manipulations anticipated) For each manipulation checked, you must provide a reference to the relevant section of the Lab Specific Biosafety Manual or relevant SOPs.
  3. Include a copy of the Lab Specific Biosafety Manual and all required laboratory specific SOPs (Templates are available here).
  4. Update "Biosafety Personnel List" spreadsheet shared with the BSO.  If you do not have this spreadsheet available contact labsafety@lakeheadu.ca.
  5. Complete an Application for each research grant involving work with biohazardous materials (Note instructions Section 4 of application form)

 

In order to have your Project or Facility/Teaching application reviewed at the next Biosafety Committee Meeting, please submit your application by the submission due date.

 

Biosafety Application Submission Dates for Committee Review:
February 1, 2022
March 15, 2022
June 15, 2022
August 15, 2022
October 15, 2022
November 15, 2022

 

Renewals

All biosafety permits must be renewed annually and must be completed via Romeo.  Renewals are due as follows:

Permit Type

Date Due

Research

February 28

Teaching

June 30

Facility

September 28

 

Resources:

Use the following step-by-step tutorials to assist with applying or renewing a project application.

How to Apply for a Biosafety Project

How to Renew/Amend a Biosafety Project