Human and Vertebrate Animal Tissue

Studies involving fresh tissue, blood or body fluids obtained from humans and/or vertebrate may contain microorganisms and have the potential of causing disease. Therefore, a proper risk assessment is required.

Rules

The rules for potentially hazardous biological agents apply to projects involving human and vertebrate animal tissue. In addition, there are the following rules:

1. If tissues are obtained from an animal that was sacrificed for a purpose other than the student's project, it may be considered a tissue study. If the animal was euthanized solely for the student's project, the study must be considered a vertebrate animal project and adhere to the vertebrate animal rules for studies conducted at a regulated research institution.
   
   
2. Biosafety level 1 studies involve the collection and examination of fresh tissue and/or body fluids, (not including blood or blood products, see rule 4) from a noninfectious source with little likelihood of microorganisms present. Biosafety level 1 studies can be conducted in a BSL-1 laboratory and must be supervised by a Qualified Scientist or trained Designated Supervisor.
   
   
3. Biosafety level 2 studies involve the collection and examination of fresh tissues or body fluids that may contain microorganisms belonging to BSL-1 or 2. These studies must be conducted in a regulated research institution under the supervision of a Qualified Scientist.
   
   
4. All studies involving human or wild animal blood or blood products should be considered a Biosafety level 2 study and must be conducted in a BSL-2 laboratory under the supervision of a Qualified Scientist. All blood must be handled in accordance with standards and guidelines set forth in the Occupational Safety and Health Act, 29CFR, Subpart Z. Any tissue or instruments with the potential of containing bloodborne pathogens (eg. blood, blood products, tissues which would release blood when compressed, blood contaminated instruments) must be properly disposed of after experimentation.
   
   
5. Human breast milk of unknown origin, unless certified free of HIV and Hepatitis C, should be considered BSL-2. Domestic animal milk may be considered BSL-1.
   
   
6. Any study involving the collection and examination of body fluids which may contain biological agents belonging to BSL-3 or 4 is prohibited for high school students.
   
   
7. Studies of human body fluids, where the sample can be identified with a specific person, must have IRB review and informed consent. Students using their own body fluids are exempt from this requirement.
   
   
8. The following types of tissue do not need to be treated as potentially hazardous biological agents:
   1. Plant tissue
   2. Established cell and tissue cultures (e.g., those obtained from the American Type Culture Collection). The source and catalog number of the cultures should be identified in the Research Plan Attachment.
   3. Meat or meat by-products obtained from food stores, restaurants, or packing houses
   4. Hair
   5. Teeth that have been sterilized to kill any blood borne pathogen that may be present. Chemical disinfection or autoclaving at 121 degrees Celsius for 20 minutes is a recommended procedure.
   6. Fossilized tissue or archeological specimens