Federal law requires the establishment of a Institutional Biosafety Committee (IBC) at institutions where recombinant biological materials are used in research. At UCSF, the IBC is appointed by the Vice Chancellor for Research and consists of a Chair, Vice Chair, and members selected to represent the UCSF faculty, staff, and public interests, and to provide expertise in a wide variety of biological disciplines. At least two community members with no UCSF affiliation other than membership on the IBC are required, and are responsible for representing the surrounding community’s interests regarding health and environmental protection. Ex Officio members include the Director of OEH&S, the Biological Safety Officer (BSO), the Director of the Animal Care Facility, and the Public Health Officer, or their designated representative. The IBC membership represents collective expertise and research experience in recombinant DNA, infectious agents, toxins, and biological safety, which are applied to the evaluation of appropriate safety measures needed for experiments that may pose potential risks to health or the environment.
The IBC is also specifically authorized by the Chancellor to limit or suspend any research that is not in compliance with UCSF biosafety policies and procedures. The IBC advises and works with OEH&S in administering the various aspects of the campus Biological Safety Program.
The IBC is responsible for: ensuring that research conducted at UCSF is in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (“Guidelines”), and the Biosafety in Microbiological and Biomedical Laboratories, 5th edition (“BMBL”); with drafting campus biosafety policies and procedures; and with reviewing individual research proposals for biosafety concerns. The IBC meets monthly to review proposals from faculty at all UCSF campuses (Parnassus, Mission Bay, SFGH, Mount Zion), from affiliated Institutes (Gladstone, Gallo, Howard Hughes Medical Institute, and others) and from faculty members who work off-campus. Veterans Administration-funded projects are specifically excluded from the IBC's charge. The IBC does not oversee biosafety policies for the hospitals, clinics or clinical laboratories, but does provide consultation when requested. Biosafety policies for hospitals and clinics are the responsibility of the respective Hospital Epidemiology and Infection Control Committees.
Principal Investigators (PIs) who wish to perform research using biological materials must submit a Biological Use Authorization (BUA) application to the IBC for approval prior to beginning work. The Committee generally reviews applications that involve work at Biosafety Level 2 or 3 and the BSO and Assistant Biosafety Officers (collectively “BSOs”) review Biosafety Level 1 research applications. BSL 1 applications are usually considered exempt from committee review unless a BSO has specific concerns that warrant full Committee involvement, or if the work involves certain types of recombinant genetic work. IBC review includes an independent assessment of the containment levels required by the NIH Guidelines for the proposed research, an assessment of the laboratory facilities, procedures and practices, and a review of the training and expertise of personnel.
While the IBC cannot alter the Risk Group of an organism, it is within the IBC’s authority to raise or lower containment for the work involving the organism based upon a full risk assessment of the work being done. Recommendations for the biosafety level (BSL) of laboratory operation are often modified according to the number of infectious particles encountered in the project and the usual route of infection. As an example, purified Mycobacterium tuberculosis is classified as RG 3 because of the serious consequences of becoming infected.