The purpose of this policy is to describe the Institutional Biosafety Committee’s (IBC) review and approval procedures required for all research activities that involve whole genetically engineered vertebrate animals. This includes any vertebrate animal in which the genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived there from, into the germ-line. This also includes the breeding of genetically engineered animals.
All Principal Investigators and research staff must comply with this policy as required by the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. All animal work must be approved by the Institutional Animal Care and Use Committee (IACUC) prior to initiation. If the research involves genetically engineered vertebrate animals, including generation of the mutants or subsequent breeding, this IBC policy also applies.
The physical and biological containment levels for experiments involving genetically engineered animals must conform to Guidelines unless directed by the IBC. The containment levels required for research involving recombinant or synthetic nucleic acid molecules associated with or in animals are based on classification of experiments in Section III, Experiments Covered by the Guidelines. For the purpose of animal research, four containment levels are established in Appendix G in the Guidelines for physical containment of smaller animals: BL1, BL2, BL3 and BL4.
“This section covers experiments involving whole animals in which the animal’s genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the germ-line (transgenic animals) and experiments involving viable recombinant or synthetic nucleic acid molecule-modified microorganisms tested on whole animals. For the latter, other than viruses which are only vertically transmitted, the experiments may not be conducted at BL1-N containment. A minimum containment of BL2 or BL2-N is required.”
“This section covers experiments involving the generation of rodents in which the animal’s genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the germ-line (transgenic rodents). Only experiments that require BL1 containment are covered under this section; experiments that require BL2, BL3, or BL4 containment are covered under Section III-D-4, ‘Experiments Involving Whole Animals.’”
Please note: Designations such as “whole transgenic animals” and “whole animals” include genetically engineered rodents for this section unless covered in Section III-E-3 “Experiments Involving Transgenic Rodents (BL1) as shown above.
“Special care should be used in the evaluation of containment conditions for some experiments with transgenic animals. For example, such experiments might lead to the creation of novel mechanisms or increased transmission of a recombinant pathogen or production of undesirable traits in the host animal. In such cases, serious consideration should be given to increasing the containment conditions.”
Before initiating any research project that is expected to generate (breed) genetically engineered vertebrate animals (see purchase and transfer exemption stated in Section III), the Principal Investigator (PI) must:
The information below will be gathered from the IACUC protocol for reporting to the IBCs to address, as appropriate.