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The purpose of the University's Biological Safety Program is to assist all Principal Investigators and research staff in implementing all applicable regulations, standards and guidelines when handling infectious or potentially infectious biological agents in the research and clinical laboratory and other facilities. To safely handle biological agents in the laboratory, the proper Biological Risk Assessment process must be developed with every agent present in the laboratory or facility by analyzing the agent’s specific risk factors.

The proper risk assessment for a biological agent will minimize or eliminate the potential exposure to the agent by managing the risk thru the classification of agents into Biological Safety levels as follows:

  • Biosafety Level 1 (BSL1)
  • Biosafety Level 2 (BSL2)
  • Biosafety Level 3 (BSL3) and
  • Biosafety Level 4 (BSL4)



The biosafety level as a risk management concept includes a. the biological agent itself, b. the respective practices, and c. the appropriate laboratory (facilities). It is the responsibility of the Principal Investigator to assign the biosafety level to the agent(s) he/she uses in the laboratory, to implement the necessary practices and to design the laboratory according to the requirements of the specific biosafety level.

For more detailed and in depth information on the proper risk assessment process with biological agents and the classification in Biosafety levels, please, check the following online reference:

CDC/NIH - Bopsafety in Microbiological and Biomedical Laboratories (BMBL), 4th Edition

RESEARCH WITH ANIMALS

When working in research with animals, the risk assessment process must have in consideration the animal behavior and physiology as a key risk factor. This additional factor convey the need to classify research with animals and infectious agents into a Animal Biosafety levels as follows:

  • Animal Biosafety Level 1 (ABSL1)
  • Animal Biosafety Level 2 (ABSL2)
  • Animal Biosafety Level 3 (ABSL3) and
  • Animal Biosafety Level 4 (ABSL4)
  • More information on the use of animals for research purposes with infectious or potentially infectious agents can be obtained from the above online reference.

    The requirements to obtain privileges for the use of animals for research purposes are under the responsibility of the Institutional Animal Care and Use Committee (IACUC). For more detail information login at the IACUC web site at: IACUC or by calling at (305) 243-2311.

    RECOMBINANT DNA RESEARCH



    If you are working or intend to work in recombinant DNA research, you must comply with the National Institute of Health Guidelines for Research Involving Recombinant DNA, also known as the NIH Guidelines: NIH Guidelines

    Compliance with the NIH Guidelines requires the Principal Investigators to make the appropriate biological risk assessment of his/her rDNA construct and to assign the appropriate Risk group as per the NIH guidelines as follows:

    • Risk Group 1 (RG1)
    • Risk Group 2 (RG2)
    • Risk Group 3 (RG3) and
    • Risk Group 4 (RG4)
    • Once the risk group has been assigned, the Principal Investigator must also establish the appropriate Biosafety level for his/her rDNA construct as per the CDC/NIH (see above online reference).

      To get approval to do rDNA research at the University of Miami, you must contact the Institutional Biosafety Committee (IBC) by login in at: http://www.miami.edu/rdna or by calling at (305) 243-9291.

      For more information on the biological safety program at the University of Miami or on any issue dealing with biological agents, please contact .(JavaScript must be enabled to view this email address) at (305) 243-3269.