Research Compliance

Research Using Recombinant-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 Biosafety Level 2 activities. 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.

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" (51 FR 16958, May 28, 2002) 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. The application may be approved for one year and may be renewed for up to five years using the Recombinant DNA Research Protocol/ Renewal 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 Principal Investigator's Statement of Exemption Form.
 
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.