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Research Using Recombiant-DNA, Biohazards and Bloodborne Pathogens

Institutional Biosafety Committee
The Institutional Biosafety Committee (IBC) has at least five university members and at least two nonaffiliated members having experience or expertise in recombinant-DNA technology and the capability to assess the safety of activities using biological materials. The University must also establish and implement policies that provide for the safe conduct of recombinant-DNA research.

To this end, a Biosafety Manual has been developed providing the necessary policies and procedures. This Manual applies to University research and teaching, all University employees and students, and all those using University facilities. All research and teaching conducted by ODU employees or students, involving any of the agents/materials listed below, must be approved by the ODU Institutional Biosafety Committee (IBC) prior to initiation:

  1. Microorganisms (including those considered low risk to healthy humans and that are contained at Biosafety Level 1 (BSL-1)). There shall be no research requiring Biosafety Level 3 or 4 containment and no storage of these materials will be allowed on the University campus.
  2. Pathogens and potential pathogens of humans, animals, or plants. "Animals" refers to both invertebrates and vertebrates.
  3. Human Derived Materials including blood, blood components, fluids, unfixed organs, tissues and cell lines (primary and established).
  4. Non-Human Primate Derived Materials (including established cell lines).
  5. Recombinant DNA (and RNA) activities including exempt and non-exempt activities, and the creation or use of transgenic plants and animals.
  6. Select Agents and toxins as defined by CDC (42 CFR 73) or USDA (9 CFR 121), including strains and amounts exempted from the select agent regulations.

Biological Materials (BSL1, BSL2, Animal Biosafety, Blood, Bloodborne Pathogens, NIH exempt rDNA and Select Agents)
All principal investigators who conduct research with biological materials designated as BSL1, BSL2, Animal Biosafety, Blood, Bloodborne Pathogens, NIH exempt rDNA or Select Agents must formally document with the Biological Safety Officer that their protocols and facilities do not jeopardize the health and well-being of themselves, other University employees, or the general public. Researchers shall submit an Application for the Use of Biological Materials for IBC approval and complete the required training before initiating a project or class using these materials. Researchers may wish to review Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH) 5th ed. 2009.


Bloodborne pathogens include the use of human blood, body fluids capable of carrying blood borne pathogens, or unfixed human tissues or organs. See ODU Bloodborne Pathogens Exposure Control Plan. Additional training is required annually by OSHA to work with these materials.

Applications for working with biological materials may be approved for up to 5 years but must be renewed annually using the Annual Review/Renewal Form. After 5 five years, if work on the originally approved application is still continuing, the PI will be asked to submit a new application to the IBC for approval. Changes to IBC approved applications must be approved prior to implementation using the IBC Amendment Form. Applicable training must be documented on the IBC Training Record for all individuals listed on an IBC application. For detailed instructions on how to complete the online training requirements, click here.

Recombinant DNA
Genetic engineering is the artificial manipulation, modification, and recombination of DNA or other nucleic-acid molecules in order to modify an organism or population of organisms. The term initially meant any of a wide range of techniques for modifying or manipulating organisms through heredity and reproduction. Now the term denotes the narrower field of recombinant-DNA technology, or gene cloning, in which DNA molecules from two or more sources are combined, either within cells or in test tubes, and then inserted into host organisms in which they are able to reproduce.

Through recombinant-DNA techniques, bacteria have been created that are capable of synthesizing human insulin, human interferon, human growth hormone, a hepatitis-B vaccine, and other medically useful substances. Recombinant-DNA techniques, combined with the development of a technique for producing antibodies in great quantity, have made an impact on medical diagnosis and cancer research. Also, plants have been genetically adjusted to perform nitrogen fixation and to produce their own pesticides. Bacteria capable of biodegrading oil have been produced for use in oil-spill cleanups.

Genetic engineering also introduces the fear of adverse genetic manipulations and their consequences (e.g. antibiotic-resistant bacteria or new strains of disease). Therefore, the IBC must insure that the University complies with the National Institutes of Health (NIH) "Guidelines for Research Involving Recombinant DNA Molecules" (October 2011) which are applicable to all NIH supported recombinant-DNA research in the United States. The National Science Foundation (NSF) has incorporated the NIH Guidelines in its regulations.

The IBC reviews and approves all recombinant-DNA research not in the exempt category. Researchers shall submit an Application for the Use of Recombinant-DNA in Research Form. Applicable training must be documented on the IBC Training Record for all individuals listed on an IBC application. The application may be approved for up to five years but must be renewed annually using the Annual Review/Renewal Form and amended using the IBC Amendment Form. After 5 five years, if work on the originally approved application is still continuing, the PI will be asked to submit a new application to the IBC for approval. Researchers whose research is exempt under the NIH Guidelines should complete the Application for the Use of Biological Materials.

Biosafety Level 2
All principal investigators who conduct research with agents designated Biosafety Level 2 must formally document with the Biological Safety Officer that their protocols and facilities do not jeopardize the health and well-being of themselves, other University employees, or the general public. Researchers shall submit a Biosafety Level 2 Form. Researchers may wish to review Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH) 4th ed. 1999.

Etiological Agents
Classification of Human Etiological Agents on the Basis of Hazard


Blood, Bloodborne Pathogens
The use of any specimen of human origin is also regulated. This includes the use of human blood, body fluids capable of carrying blood borne pathogens, or unfixed human tissues or organs. See ODU Bloodborne Pathogens Exposure Control Plan.