Biological Use Authorization

The Institutional Biosafety Committee (IBC) is a committee of the University Research Council and is managed through the Division of Research Affairs. The IBC reviews research and teaching activities involving recombinant DNA and biohazardous materials as noted below.  A Biological Use Authorization (BUA) application must be approved by the IBC prior to receiving or beginning research or teaching activities on campus conducted by SDSU or Foundation employee(s), or in collaboration with SDSU or Foundation employee(s) involving:

  1. Recombinant DNA molecules and recombinant DNA-containing organisms or cell cultures which are subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules.
  2. Pathogenic microorganisms or agents potentially infectious to humans, animals and/or plants.
  3. Human or non-human primate blood, blood products, body fluids, or other potentially infectious materials such as brain, CNS tissues, lymphoid tissues, gut, and bone marrow, and cell cultures.
  4. Carcinogens, mutagens, teratogens, and toxins which, when administered in vivo to animals or in vitro to cells or tissue cultures, might induce an adverse biological outcome to animals and plants.
  5. CDC select agents or APHIS livestock and plant pathogens or toxins.
  6. Animals for which a reasonable potential for transmission of zoonotic agents exists, e.g., wild-trapped animals, farm animals and non-human primates; exotic animals and plants, e.g., non-indigenous animal, plant or insect pathogen, or pests.
  7. Use of animals and/or plants in conjunction with recombinant DNA, infectious agents, human or non-human primate organs, tissues or cell cultures, toxic materials, select agents, or zoonotic animal materials.
  8. Large scale production of cultures larger than 10 liter at any one time regardless of Risk Group or Recombinant DNA Material.
  9. Transfer of recombinant DNA or RNA derived from recombinant DNA into one or more human research participants.

A BUA Application provides the Institutional Biosafety Committee a detailed description of work with biohazardous materials, in order to evaluate and control biological hazards. A separate BUA application is required for research activities and teaching activities.  A single BUA application may be submitted to cover multiple related projects.  The IBC reviews each application during a convened meeting and approves or denies a BUA application based on adherence to the NIH Guidelines for Research Involving Recombinant DNA, CDC/NIH Biosafety in Microbiological and Biomedical Laboratories and SDSU IBC Policies.  When the application is approved, the IBC sends an authorization letter to the Principal Investigator indicating a BUA Number, NIH Guidelines designation number (if applicable), and Laboratory Biosafety/Animal Biosafety Level facility containment and work practice (i.e. BSL/ABSL1, BSL/ABSL2, BSL/ABSL3).  San Diego State University Research Foundation requires a Biological Use Authorization from IBC prior to awarding a funded grant.  The BUA application is protocol specific.