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Policy of the Bio Safety Committee

Terms of Reference

Mandate

Nipissing University’s BioSafety Committee is authorized by the Board of Governors of Nipissing University to provide policy direction and make recommendations to the Vice President, Academic and Research, for all matters pertaining to the use of biohazardous materials in research and in teaching. The BioSafety Committee reviews BioSafety permit applications for teaching, research and testing, issues permits, and monitors activities involving the use of biohazardous materials to confirm compliance with internal and external standards including: Public Health Agency of Canada (PHAC), Canadian Food Inspection Agency (CFIA), National Institute of Health (NIH), Occupational Health and Safety Act and Regulations (OHSA), Nipissing University’s Policies and the BioSafety Committee’s Policies and Procedures.

Administrative

  1. The BioSafety Committee shall meet at least every semester (Spring, Summer, Fall, Winter) with meetings called by the Chair at times convenient for all representatives;

  2. The first spring meeting shall be designated as the annual meeting, no later than mid-May.

  3. In accordance with internal and external regulations the BioSafety Committee:
    a. Issues and reviews BioSafety permits for the use of all biohazardous materials to be used by research and academic personnel and to develop and recommend policies and procedures to be followed by all users (principal investigators, post doctoral fellows, laboratory technologists, student researchers, maintenance staff, etc.) to meet or exceed the requirements of the internal and external standards;
    b. Advises on policy and protocols relating to the BioSafety Program to promote safe and environmentally appropriate practices,
    c. Reviews on an annual basis (or sooner) and recommends any amendment to policies governing facilities involving biohazardous material;
    d. Recommends measures to ensure compliance with the policies governing facilities involving biohazardous materials;
    e. Advises the Vice President Academic and Research of any perceived need for additional resources to establish, maintain, or improve the BioSafety Program.

  4. Face-to-face meetings are essential for adequate discussion of research protocols and for collective education of the BioSafety Committee members. Deadline dates to submit applications should be posted on the BioSafety web-site as well as a schedule of BioSafety Committee meetings, if determined ahead of time. Regular attendance by BioSafety Committee members is important, and frequent unexplained absences should be construed as notice of resignation.

  5. The BioSafety Committee shall operate by consensus. A quorum will consist of 50% of the members, always including a research faculty member.

  6. The Chair of the BioSafety Committee shall be elected from among the members.  The Chair will work closely with the BioSafety Officer to address reporting, permit issuance and other issues and concerns that may arise.

  7. Minutes of all BioSafety Committee meetings shall be prepared and maintained by a recording secretary provided by the office of the Vice President Academic and Research.
    a.       To assist internal and external audits or research monitoring, and to facilitate reconsideration or appeals, the minutes shall clearly document the BioSafety Committee decisions and any dissents, and the reasons for them.  Failure to do so may expose researchers and institutions to legal liability. 

  8. The proceedings and deliberations of the BioSafety Committee are strictly confidential. Confidentiality shall apply to BioSafety Committee files including application forms, attachments and their content, names of applicants and correspondence with applicants.

  9. The BioSafety Committee, through the BioSafety Officer, will submit by the 1st of October an annual report to the Vice-President Academic and Research who will in turn present the report to the Board of Governors.  The report shall include the numbers of proposals reviewed and permits issued; BioSafety issues and concerns that have been addressed in the past year and, if necessary, recommendations concerning changes to the BioSafety Policies and Procedures.

  10. Nipissing University must ensure that the BioSafety Committee and the BioSafety Officer have the appropriate financial and administrative independence to fulfill their primary duties including support for the administrative processes and educational activities by the BioSafety Committee including:

  • Distribution of protocols and procedures to BioSafety Committee members
    Producing and distributing minutes and reports

  • Keeping files and records

  • Operational costs of the BioSafety Committee meetings, including travel/parking costs for the community member or any external experts required

  • Supporting attendance to the CABS (Canadian Association of Bio Safety) annual meeting for the BioSafety Officer (or other delegated member)

  • Supporting attendance to the OUBSO (Ontario University Bio Safety Officer) annual meetings

  • Workshop attendance for the BioSafety Officer in areas requiring increasing expertise

  • Supporting educational activities including BioSafety related training opportunities for staff and technologists.

Compliance and Conformance

  1. To monitor physical facilities involved in the use of hazardous agents described in the PHAC guidelines and to recommend policies regarding the regular testing and maintenance of all university biohazard containment equipment;

  2. To monitor the certification and recertification of containment level 2 laboratories;

  3. To monitor the movement of biohazardous materials within the University and for compliance with the Transportation of Dangerous Goods (TDG) Regulations when shipping or receiving biohazardous materials;

  4. To ensure that all users, especially the principal investigator, are fully aware of the guidelines and of the nature of containment required for research;

  5. To monitor compliance of users with respect to levels of containment and established policies and procedures;

  6. To review reports of incidents involving biohazardous materials and ensure appropriate action is taken to prevent reoccurrence.

  7. To investigate and ensure remediation of containment failure;

  8. Ensure appropriate access control of containment level laboratories and secure storage of potentially biohazardous materials;

  9. To review summary results of external (e.g. PHAC site audits) and internal inspections and recommend appropriate action. By unanimous committee vote, recommend to the VPAR to revoke a permit and recommend suspension of funding per NSERC MOU Schedule 13, section 2.1(f) (g) (h) or rescind a suspended permit;

  10. The committee, through its Chair and/or BioSafety Officer, shall notify the Vice President, Academic and Research on any issues when appropriate.

Procedures for Review of Protocols

  1. The Request for Biohazard Approval form is appropriately filled out, including attachments, and submitted electronically to the BioSafety Officer with one signed copy before the deadline.

  2. Upon receipt of the form, it is assigned an identification number by the BioSafety Officer.

  3. Pro-tem approval is signed by the BioSafety Officer and the original is to be included in the permit application.

  4. The form is reviewed by the BioSafety Committee at the next scheduled meeting or sooner if required.
    a. If all criteria are met – biohazard approval is given and permit is issued.

  5. If some criteria are not met – letter is sent to the Principal Investigator indicating areas to be resolved, including training for research personnel.
    a. If all criteria are met – biohazard approval is given and permit is issued.

  6. All permits must be reviewed annually taking into consideration any change in policies, standards and guidelines.

  7. All persons engaged in overseeing activities using biohazardous agents must submit an annual record of disposal to the BioSafety Officer for any biohazard agent that was utilized in those activities. This includes both research and teaching activities.

Lab Containment and Security

Training. Assessment and Review

  1. The BioSafety Officer will develop and deliver BioSafety training programs with input from the BioSafety Committee.

  2. To provide advice, education, and training programs where applicable to facilitate compliance relevant to BioSafety;

  3. In consultation with the BioSafety Officer, review, recommend and act as an expert resource for BioSafety education and training programs for University employees and researchers, and monitoring training activity.

  4. Review research and teaching proposals involving the procurement, use, storage, transfer, and disposal of biohazardous materials to assess risk, containment requirements, proposed procedures, training and expertise of personnel.

Reporting

  1. Report to the appropriate external regulatory bodies, substantial problems and/or violations of guidelines, and significant accidents or illnesses;

  2. Provide to the appropriate regulatory body any and all reports required by those bodies through the BioSafety Officer;

  3. Provide an annual report of its activities in the previous year and compliance status to Vice President Academic and Research;
    a. All such reports will normally be prepared by the BioSafety Officer and approved by the BioSafety Committee.

  4. Provide a copy of all permits and/or suspension of permits to the Office of Research.

Membership

  1. All members are appointed for a 3 year renewable term.  Appointees will be recommended by their Departmental Chairs and appointed by the Vice-President Academic and Research.  When deemed necessary for specific expertise, ad hoc consultants will be brought in;

  2. The committee membership shall consist of:
    a. BioSafety Officer (non-voting);
    b. Manager of Environmental Health and Safety (non-voting);
    c. At least one faculty member from each department who uses biohazardous materials for research or teaching purposes AND;
    d. At least one Faculty member from any of the Science Departments (i.e. Biology, Chemistry, Psychology, Geography, Physical Education, Math or Computer Science) who does not  actively use biohazardous materials for research or teaching purposes (voting);
    e. At least one member of the Laboratory Technical Support staff (voting);
    f. At least one Laboratory Teaching Faculty member (voting);
    g. Nurse practitioner from the Faculty of Nursing (or physician from outside the University);
    h. Secretary to be provided by the Vice President Academic and Research (non-voting);
    i. If transgenic vertebrate animal research activities are undertaken, a veterinarian is required on the committee (voting).

Approved by Board of Governors
February 2, 2012 Board meeting
Resolution: 2012-02-05

If a BioSafety Committee member’s permit application or permit renewal application is being discussed, that member will recuse him/herself from any decision making process regarding that application.

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