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Regulations & Policies

Facilities and Land

I. OBJECTIVE & PURPOSE

The University recognized the need for all faculty, staff, students, and visitors to work and meet in an environment free of undue risks to their health and well being. This policy provides for the oversight of all activities, conducted at or sponsored by the University, that use recombinant DNA and biohazardous materials, including, but not limited to, microorganisms, toxins, cultures of tissues, organs, and cells of human origin, and Select Agents including toxins as defined by federal law, by establishing the Institutional Biosafety Committee (the "IBC"). The IBC will ensure that the use of recombinant DNA and biohazardous materials is in compliance with all applicable federal, state and local laws, rules, regulations, and guidelines, including, but not limited to, the most current National Institutes of Health's Guidelines for Research Involving Recombinant DNA Molecules (the "NIH Guidelines").

II. STATEMENT OF POLICY

The IBC will oversee all University activities that use recominant DNA and biohazardous materials. The IBC, in conjunction with the University's Environmental Health and Safety Office, will establish and periodically review procedures and regulations, and will ensure adherence to these procedures and regulations to provide for the safe use of the recombinant DNA and biohazardous materials at the University and in activities sponsored by the University. The IBC will ensure compliance with Federal and State regulations and the most current practices and procedures for the safe use of recombinant DNA and biohazardous materials. The IBC will provide oversight for recombinant DNA activities as specified in the NIH Guidelines. All persons using recombinant DNA and/or biohazardous materials at the University, or in activities sponsored by the University, will be responsible for full compliance with the NIH Guidelines, all applicable governmental rules and regulations and the University's policies, procedures and guidelines.

III. STATEMENT OF PROCEDURES

Governance, membership, member training, meeting conduct and functions of the IBC will comply with the NIH Guidelines, any other applicable government rules and regulations, and the IBC's bylaws. Additionally, the Biosafety Officer (BSO), and employee of the University's Environmental Health and Safety Office, will be a full member of the IBC. The Chair and Committee Members wll be appointed by the Provost upon recommendation of the Assistant Vice President for Research. The IBC will operate administratively under the purview of the Assistant Vice President for Research.

All University users* of recombinant DNA and/or biohazardous materials must obtain the prior approval of the IBC for the use of these materials as outlined in the IBC bylaws and must successfully complete the University's Biosafety program annually. Any protocol utilizing humans or animals will require the independent review, and if necessary, the approval of the IRB or the IACUC, respectively. IBC approval must be obtained prior to final IRB or IACUC approval. All required approvals must be obtained prior to initiation of any work. Continued work with recombinant DNA and/or biohazardous agents will require strict adherence to rules and regulations specified in the IBC bylaws and the University's Biosafety Manual. The BSO in conjunction with the IBC has the authority to require modification and/or cessation of activities that are deemed unsafe. All University useres* contemplating the use of any Select Agent or Toxin must notify, and obtain the approval of, both the BSO and the IBC prior to ordering or bringing such materials onto campus.

*University user shall be defined as any student, staff or faculty of the University and anyone conducting activities involving any of the aforementioned substances either on property owned or operated by the University or in activities sponsored by the University.

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