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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
Biohazardous materials are those materials of biological origin that could potentially cause harm to humans, domestic or wild animals, plants, or the environment. Examples include recombinant DNA; transgenic animals or plants, human, animal or plant pathogens; biological toxins; human blood and certain human body fluids; and human or monkey cell cultures. 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 personnel or the community.

Categories of Biohazardous Agents:

  1. Categories of Biohazardous Agents

    1. Any agents listed as Biological Select Agents Toxins  (42 CFR 73) pathogenic/non-pathogenic and/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 blood, body fluids, tissues and/or cell lines
    4. Non-Human Primate blood, body fluids, tissues and/or cell lines
    5. Infected clinical specimens/ biologically contaminated specimens
    6. Tissues from genetically modified animals
    7. Any potentially infectious animals or animal tissues
    8. Cultured animal cells and the potentially infectious agents these cells may contain
    9. Microbial agents pathogenic to humans, plants and/or animals
    •  Bacterial pathogens e.g.,
      • Rickettsiae
      • Chlamydiae
    • Bacteria with drug resistant plasmids
    • Viruses
      • Oncogenic
      • Animal/plant
      • Viral vectors
    1.  Fungi
    •  Fungal pathogens
    1. Parasites
    2. Allergens
    3. Toxins or Venoms
    4. Nanoparticles
    5. Chemicals that elicit a biological effect

    In addition to work with biohazardous agents, the Brown University IBC also requires registration of production of the following:

    • Genetically engineered animals by use of recombinant or synthetic nucleic acid technologies
    • Generation of genetically engineered rodents through breeding two different transgenic lines 

Biological Research Authorization Forms and Resources

- Policy on Biological Research Authorizations
- Brown BRA Guidance 2018
- Brown IBC BRA Form 2018
- Brown IBC BRA Amendment Form 2018
- Non-Research Exposure Control Plan (ECP) Template
- Research-Exposure Control Plan 2018
- Training Form Template for Exposure Control Plan
- 2019 IBC Calendar