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Biological Research Authorization

Brown University’s Institutional Biosafety Committee (IBC) is responsible for regulating the use of biohazardous agents to ensure compliance with appropriate regulations and guidelines and to safeguard the health and safety of Brown University personnel and the community. The Committee serves as the official regulatory body of the faculty and staff in all matters relating to the use of biohazardous agents in basic research. The Committee also serves as the Institutional Biosafety Committee as defined in the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (Federal Register, Wednesday, November, 2013).

Biohazardous Agents
A biohazardous agent is one that is biological in nature, capable of self-replication and has the capacity to produce deleterious effects upon other biological organisms, particularly humans. The IBC, in its scope and function, defines a biohazard as: Biological agents or substances present in or arising from the work environment which present or may present a hazard to the health or well-being of the worker or the community. Biological agents or substances which could be biohazardous include, but are not limited to, infectious or parasitic agents; non-infectious microorganisms such as some fungi; yeasts and algae; plants and plant products, and animals and animal products which cause occupational disease.

Categories of Biohazardous Agents:

  1. Any use of agents listed as select agents or biological toxins  (42 CFR 73) whether or not  pathogenic or exempt from the federal regulations
  2. Any synthetic or recombinant nucleic acid work including that exempt from NIH guidelines
    1. Recombinant or synthetic nucleic acid work with transgenic animals including Drosophila melanogaster, C. elegans, etc.
    2. Recombinant or synthetic nucleic acid work with plants
  3. Human or Non-Human Primate blood, body fluids, tissues and/or cell lines
  4. Infected clinical specimens/ biologically contaminated specimens
  5. Tissues from genetically modified animals
  6. Any potentially infectious animals or animal tissues
  7. Cultured animal cells and the potentially infectious agents these cells may contain
  8. Microbial agents pathogenic to humans, plants and/or animals
    1.  Bacterial pathogens e.g.,
      1. Rickettsiae
      2. Chlamidiae
    2. Bacteria with drug resistant plasmids
    3. Viruses 
      1. Oncogenic
      2. Animal/plant
      3. Viral vectors
  9.  Fungi
    1.  Fungal pathogens
  10. Parasites
  11. Allergens
  12. Toxins or Venoms
  13. Nanoparticals that have biological significance

Biological Research Authorization Forms and Resources

- Policy on Biological Research Authorizations
- Application/Renewal for Biological Research Authorization
- Ammendment for Biological Research Authorization
- Non-Research Exposure Control Plan (ECP) Template
- Training Form Template for Exposure Control Plan