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Policy Title: Biosafety

Boise State University Policy #5080
Effective Date: January 1992
Rev: July 1995
November 1999
January 2014

Purpose:
To establish authority and responsibilities of the University, Institutional Biosafety Committee, and Principal Investigators conducting funded and unfunded research and academic activities involving biohazardous material.

Additional Authority:
Centers for Disease Control and Prevention – Biosafety in Microbiological and Biomedical Laboratories – 5th edition and subsequent revisions.
Idaho Division of Building Safety – Bloodborne Pathogens, 330
National Institutes of Health – NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) – 59 FR 34472 and subsequent amendments.
Occupation Safety and Health Administration – Bloodborne Pathogens,
29 CFR 1910.1030

Scope:
Applies to funded and unfunded research and academic activities involving biohazardous material.

Responsible Party:
Vice-President for Research and Economic Development, 426-5732
Office of Research Compliance, 426-5401

Definitions:
Biohazardous Material – An infectious agent or biological material presenting a risk to the health of humans, animals, or other forms of life such as: certain types of DNA, recombinant DNA and synthetic nucleic acid molecules; bloodborne pathogens; infectious organisms and viruses; select agents; and biological toxins.

Recombinant DNA – Molecules constructed outside a living cell by joining natural or synthetic DNA/RNA segments to DNA/RNA molecules that can replicate in a living cell.


Policy

  • I. Policy Statement
    • The possession and utilization of hazardous materials is essential to Boise State University’s research enterprise. Therefore, Boise State is committed to following the guidance of and fulfilling the obligations set forth by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and other applicable agencies regarding the safe handling of biohazardous material.
  • II. Authority and Responsibilities
    • A. The Vice President for Research and Economic Development (VPRED) has delegated certain responsibilities to the Institutional Biosafety Committee (IBC) to ensure compliance with the University’s regulatory obligations and to the Office of Research Compliance (ORC) for support and oversight of the IBC. The VPRED appoints IBC members to ensure appropriate composition and representation in accordance with federal guidelines and committee effectiveness.
    • B. The Institutional Biosafety Committee (IBC)
      • 1. Generally, the IBC is responsible for the review and approval of funded and unfunded research and academic activities involving biohazardous material to assist the university and Principal Investigators (PIs) in adhering to these regulatory requirements and guidelines.
      • 2. Specifically, the IBC has the following authority and responsibilities:
        • a) Review activities involving biohazardous material and determine appropriate level of review based upon the material, activity, and associated risk as outlined in the IBC Program Guide;
        • b) Approve, not approve, or require modification of activities involving biohazardous material to ensure compliance with regulatory obligations and University policies and programs;
        • c) Report approval status in accordance with agency requirements; and
        • d) Report non-compliance to the VPRED (through the ORC) and appropriate agencies as required.
        • e) Suspend or terminate activity approval based upon non-compliance with regulatory obligations and University policies and programs;
    • C. The ORC provides administrative support and oversight of the IBC, which includes maintaining official records and developing program guidance, forms, and procedures.
    • D. The PI has the responsibility to:
      • 1. Sufficiently complete and submit applicable forms to the IBC for activities requiring review;
      • 2. Abstain from performing activities requiring IBC approval where approval is not granted;
      • 3. Ensure activities under their direction adhere to the scope and procedures approved by the IBC; and
      • 4. Communicate risks associated with the activity to individuals with potential exposure to any associated hazards.