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Requirements for Research Grants and Contracts Dealing with NIH Regulated and/or Biohazardous Materials

by schmidy last modified May 28, 2013 10:47 AM

The following are required for biohazardous use registration and authorization as applicable:

  1. Institutional Biosafety Committee (IBC) registration and approval
    1. Materials covered by IBC registration include:
      1. Use of human-derived or non-human primate materials (i.e. blood, body fluids, tissues or cell lines)
      2. Biological and/or biohazardous agents (i.e. biologically-derived toxins, etc.)
      3. Recombinant or Synthetic Nucleic Acid Molecules
      4. Human gene therapy
      5. Production of transgenic animals at UofL
      6. Use of CDC or USDA Select Agents
  2. IBC Application Registration Form

  3. Completion of a satisfactory laboratory inspection including, but not limited to:
    1. University of Louisville standardized laboratory biohazard signage must be posted and current. The biohazard signage request form can be found below.
    2. A Biosafety Laboratory Checklist (Word)  is available for your reference prior to the inspection. Items included on the checklist are areas we may survey while in your lab.
    3. Biological Safety Cabinets (BSCs) must be certified annually. A list of NSF-certified vendors and the BSC certification policy can be found below.
  4. Biohazard Signage Request Form (Word)

    Vendor List for Biological Safety Cabinet Certification (PDF)

    Biological Safety Cabinet Policy (PDF)

  5. Completion of Special Animal Safety Protocols (SASPs) when biological agents and/or rDNA are used in conjunction with animals.


    SASP Templates

  6. Completion of Standard Operating Procedures (SOPs) for laboratory use of biologically-derived toxins or biohazardous agents. Examples include Pertussis Toxin (PTX), Complete Freund's Adjuvant (CFA), etc.


    Example SOP Template (Word)

  7. Completion of the following may also be needed:
    1. Bloodborne Pathogens (BBP) training if dealing with potentially infections blood or body fluids (annual).
    2. Exposure Control Plan (Word)
    3. Hepatitis B Vaccine (PDF)
    4. International Air Transport Association (IATA) training if shipping or receiving biohazardous materials (contact DEHS for more information) (every 3 years).
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