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Policy on Genetically Engineered Animals

Introduction

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.

Scope

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.

IBC Review Requirements

  • EXEMPT
    The purchase or transfer of commercially available genetically engineered rodents is exempt from IBC review under the NIH Guidelines under Section III-D-4-c and Appendix C-VII. However, if the animals are contained at BL2 or higher they are not exempt.

  • NOT EXEMPT

    1. Any production of genetically engineered animals by use of recombinant or synthetic nucleic acid technologies requires Institutional Biosafety Committee Approval before Initiation (Guidelines Section III-D-4). Methods for this production include, but are not limited to: DNA microinjection, retrovirus-mediated gene transfer, and embryonic stem cell mediated gene transfer. The IBC shall refer to Appendix G and Q of the Guidelines to determine appropriate containment.

    2. Any generation only (defined as breeding) of genetically engineered rodents requires Institutional Biosafety Committee Notice Simultaneous with Initiation (Guidelines Section III–E-3).

Physical and Biological Containment Levels for Experiments Involving Genetically Engineered Animals

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.

NIH Guidelines, Section III-D-4: Experiments Involving Whole Transgenic Animals (BL2- BL3 containment)

“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.”

NIH Guidelines, Section III-E-3: Experiments Involving Transgenic Rodents (BL1)

“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.”

Procedure for IBC Approval of Research with GE Animals in Section III-D-4

  1. Obtain IACUC approval for use of the animals.
  2. Submit a registration form to the IBC for review at a full Committee meeting. (In rare instances, the project may need to be referred to the NIH Office of Biotechnology Affairs (OBA) for NIH review, e.g., use of a modified animal that may compromise agriculture, if released).

Procedure for IBC Review of Research with GE Animals in Section III-E-3

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:

  1. Obtain IACUC approval for use of the animals. As part of the IACUC approval, the details of the research and/or breeding planned with genetically engineered animals is required.

  2. After IACUC approval, the protocol is listed on the relevant Subsequent Actions Report for appropriate IBC review. (In rare instances, the project may need to be referred to the NIH Office of Biotechnology Affairs (OBA) for NIH review, e.g., use of a modified animal that may compromise agriculture, if released.)

  3. Before genetically engineered animals (not commercially available) can be shipped to or from the Tufts University and scientists at other institutions or companies, the investigator must clearly describe the animals, and include but not be limited to, gene constructs, plasmids and genetic changes in the animals. International shipments may require special review due to export requirements.

  4. The PI is responsible for reporting the inadvertent release of genetically engineered animals, improper disposal, or other incidents in the laboratory or vivaria to the IBC Manager, who shall report them to the IBC, the Attending Veterinarian and to the NIH, if deemed necessary. Reporting will also be made to the pertinent local agencies, as required.

IBC/IACUC Research with Genetically Engineered Animals

The information below will be gathered from the IACUC protocol for reporting to the IBCs to address, as appropriate.

  1. Animal species used
  2. Transgene name [or family] and function (if more than one, please list each separately)
  3. Transgene source
  4. Vector(s) used
  5. Method of animal transformation
  6. Physical location of the area(s) where the live animals are taken
  7. Does the gene encode a toxin or other hazardous agent

 

 

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