University Research Compliance

Biosafety Office

Responsibilities for Research Conduct

Faculty (Principal Investigator or PI)

The faculty member (PI) is the individual in charge of the specific research and instructional activity that is, or has the potential to be, of a biohazardous nature. As such, the PI is expected to set a proper example by his/her actions. The PI is expected to ensure that all persons involved with the project comply with all relevant external regulations and University procedures and policies. In addition to obtaining prior approval for the research, the investigator is responsible for seeking approval for any changes to the project once it has been approved. The PI is responsible for training, preparing safety and biosecurity documents, and ensuring that internal and external reporting requirements are met. These may include but are not limited to reports regarding inventory, disposition of biological agents and toxins, intra- and inter-institutional transport, purchases, and incidents. The investigator has a responsibility to ensure that the facility where the research or teaching is to be conducted is in compliance with all external regulations and University requirements.

Biological Safety Officer

The University's Biological Safety Officer works within a team environment to manage a comprehensive biological safety program that ensures compliance with applicable regulations, guidelines, policies, and directives. This includes protocol review, biosafety surveillance, biosafety training, and monitoring of federal regulations for compliance. The BSO corroborates that standard operating procedures (SOPs) regarding safety and security are followed to ensure minimal risk to the environment and to personnel working with biohazardous materials. The BSO provides guidance to the Institutional Biosafety Committee (IBC), and the Institutional Animal Care and Use Committee (IACUC) as needed. The BSO reports to the Assistant Vice President for Research Compliance.

Institutional Biosafety Committee (IBC)

The IBC reviews and grants approval for research and instructional activities involving recombinant or synthetic nucleic acid molecules, artificial gene transfer, microorganisms that are harmful to humans, animals, or plants, and biologically derived toxins. The IBC ensures that investigators comply with all external regulations, and university procedures, policies, and standards for working with biological agents. The IBC, in concert with the Biological Safety Officer, inspects research facilities and grants approval for these facilities to be used for research and instruction. The IBC has the authority to halt research in the event of non-compliance or an unresolved safety hazard. The IBC works closely with Environmental Health and Safety personnel, University Health Services, and members of the Institutional Animal Care and Use Committee, the Radiation Safety Committee, and the Institutional Review Board. IBC members are appointed for rotating three-year terms by the Vice President for Research. The Assistant Vice President for Research Compliance is a permanent voting member and serves as administrative officer of the committee. The IBC elects a chair who liaises with the Biosafety Officer and researchers. The IBC meets no less frequently than quarterly.

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Vice President for Research

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University Research Compliance

Biosafety Office

Responsibilities for Research Conduct