The Institutional Biosafety Program (IBP) at Rush protects investigators, other institutional personnel, and the community at large from potential biological or bio-mimetic hazards of biomedical research. Regardless of funding source, all recombinant DNA (rDNA) research and other related activities (see below) are to be conducted in compliance with the NIH Guidelines on Recombinant DNA Research (rev. 2002) under the supervision of the Institutional Biosafety Committee (IBC). The Biological Safety Officer (BSO) is an executive official and voting member of the IBC, and assists in preparation of the mandatory IBC Application Form for IBC approval of such research. The BSO also oversees other potentially biohazardous research activities outside the jurisdiction of the IBC. The BSO will periodically assess compliance of IBC-approved programs with the Guidelines using the on-site Biosafety Inventory and other means.
Research Activities that Require IBC Application. Any use of rDNA technology requires an IBC Application Form. Although some rDNA experiments are exempt from formal committee approval, the IBC makes the exemption determination. Other activities that require formal IBC application are the creation of new transgenic rodent strains (even with the aid of an external commercial service), the deliberate infection of experimental animals, and the use of recombinant toxins of biological origin. Acquisition and use of existing transgenic rodent strains requires written notification, but not formal approval, of the IBC. All IBC approvals undergo Continuing Review annually from the date of original approval, or whenever protocols or personnel are changed.
MPTP Special Procedures. Use of the bio-mimetic chemical MPTP requires the filing of an MPTP Investigator's Handbook with the IBC. All individuals working with this chemical also must file the Rush MPTP Workers Informed Consent with the IBC, and receive specialized safety evaluation and training from medical and Occupational Safety personnel.
Select Agents. Select agents are specific microorganisms and toxins identified as unusually hazardous by the U.S. Department of Health and Human Services and/or the U.S. Department of Agriculture. Quantities of select agents in excess of individually specified ceiling amounts may be lawfully possessed only under stringent Federal regulations administered by each institution. Investigators studying or planning to study toxins or microorganisms should immediately check them against the Select Agents List and contact the BSO if the agent(s) are listed.
Nanoparticles. Various particulate materials under study as drug delivery systems may have particle sizes small enough to evade filtration by HEPA biological safety cabinets and other standard containment methods. Investigators planning to study such materials should contact the BSO.
Federal Permits. Rare or endangered live species (foreign or domestic) or tissue samples derived from them may be lawfully obtained and studied only with a permit from the U.S. Fish and Wildlife Service. Similarly, certain microorganisms afflicting animals that are not Select Agents nevertheless require a USDA permit and lab inspection. Contact the BSO for assistance in application for such permits.
Training. The Institutional Biosafety Program provides web-based training modules for investigators and their research personnel. The training is designed to ensure compliance with regulations and guidelines, and to improve technical expertise in biosafety issues. Individual consultation with the BSO about any issues not addressed by this training is encouraged.
Resources. A number of useful Biosafety Resources are maintained at this link.