institutional undertakings. In accordance with the NIH Guidelines for Research Involving Recombinant DNA Molecules UK has established the IBC as the responsible unit for review and approval of recombinant DNA research. The Biological Safety Officer and the IBC must review all research involving infectious agents or recombinant DNA. All proposals, regardless of funding source, are subject to this review.
IBC review ensures that such research is conducted in full conformity with the provisions of the NIH Guidelines and guidelines from the Centers for Disease Control (Biosafety in Biomedical and Microbiological Laboratories, BMBL). The review includes an independent assessment of the required containment levels and the facilities, procedures, practices, training, and expertise of the personnel involved in recombinant DNA research. The IBC determines the proper hazard classification. Institutional policy requires IBC review and approval before the IRB may issue initial review approval.
No fewer than five members are selected so that they collectively have experience and expertise in recombinant DNA technology and the capability to assess research safety and potential risk to public health or the environment to serve on the IBC. At least two members are not affiliated with the institution apart from their membership on the IBC and represent the interests of the surrounding community with respect to health and the protection of the environment. The IBC must also have available as consultants persons knowledgeable in institutional commitments and policies, applicable laws, standards of professional conduct and practice, community practice, and the environment.
A1.1700 Institutional Biological Safety Officer
The Biological Safety Officer (BSO) works closely with the IBC and is responsible for developing, implementing, and directing a comprehensive biosafety program throughout all research laboratory and clinical areas that meets NIH, Centers for Disease Control, Occupational Health and Safety Administration, and sponsor requirements. The biological safety program covers research on recombinant DNA and human/plant/animal gene transfer; infectious agents and biologically derived toxins; and human tissues, fluids and cell/cell cultures. As the designated institutional official and administrator for the IBC, the BSO serves as an ex officio non-voting member of the Medical IRB, reviews and approves protocols involving the use of infectious agents and recombinant DNA, and makes recommendations to the IRB committees in their review of protocols that fall under the purview of the IBC. To maintain optimal compliance, the BSO develops and conducts educational programs for faculty, staff, and students to improve institutional biological safety; develops and maintains a database of microorganisms and recombinant DNA used in research experiments at the University; coordinates the acquisition, transfer, and use of “select agents” by UK researchers; performs all required inspections; audits laboratories and work practices and communicates findings to management; develops and maintains a biosafety cabinet certification program database; and investigates accidents and incidents involving biological agents and materials.
A1.1750 Radiation Safety Committee
The Kentucky Cabinet for Health and Family Services, Radiation Health and Toxic Agents Branch, authorizes UK to use radiation-producing devices and radioactive material in operations, education, research, and development activities. The Radiation Safety Committee (RSC), appointed by the President as a subcommittee of the Committee on Safety and Environmental