The purpose of this guideline is to identify the types of experiments that involve transgenic rodents that require approval by the Institutional Biosafety Committee (IBC) and to describe the Animal Biosafety Level (ABSL) containment level to be used, as stipulated in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).
Covered Parties
This guideline applies to all individuals engaged in research at or under auspices of Boston University.
Procedures
The Institutional Animal Care and Use Committee (IACUC) must review all proposed uses of live vertebrate animals in research, teaching and testing, including regular reviews of all ongoing projects. Transgenic rodent experiments must be reviewed and approved by the IACUC prior to initiation in accordance with the Animal Welfare Act, Public Health Service policy, and BU policies.
The following chart describes the minimum Animal Biosafety Level (ABSL) containment level required based on the type of experiment, and when IBC approval is needed. The IBC reserves the right to recommend a different containment level if deemed necessary through IBC review of an application.
Purchase or Transfer of Transgenic Rodents
Category of Experiment
Minimum ABSL
NIH Guidelines
Needs IBC?
Purchase or transfer of transgenic rodents*
1
Exempt (Appendix C-VII)
No
Purchase or transfer of transgenic rodents
2
Require IBC Approval (III-D-4)
Yes
*The purchase or transfer of transgenic rodents requiring BL1 containment is exempt under Appendix C-VI. Subsequent use of these animals is also exempt providing the experimental protocol does not involve the use of recombinant DNA.
Breeding of Transgenic Rodents
Category of Experiment
Minimum ABSL
NIH Guidelines
Needs IBC?
Breeding rodents from one strain (propagation/colony maintenance)
1
Exempt
No
Breeding rodents from one strain (propagation/colony maintenance)
2 or higher
III-D-4-b
Yes
Breeding rodents from two strains (generating a new strain) providing neither parental rodent contains the following genetic modifications:
(i) incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or
(ii) incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR);
and (iii) the rodent that results from the breeding is not expected to contain more than one-half of an exogenous viral genome from a single family of viruses.
1
Exempt (Appendix C-VII)
No
Breeding rodents from two strains (generating new strain) if the parental rodent contains the following genetic modifications:
(i) incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or
(ii) incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR); or
(iii) the rodent that results from the breeding contains more than one-half of an exogenous viral genome from a single family of viruses.
1
IBC notice simultaneous with initiation
(III-E-3)
Yes
Breeding rodents from two strains (generating new strain)
2 or higher
III-D-4
Yes
Creation of Transgenic Rodents
Category of Experiments
Minimum ABSL
NIH Guidelines
Needs IBC?
Generation of transgenic or knock-out rodents in which the animal’s genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefore, into the germ-line
1
III-E-3
IBC notice simultaneous with initiation
Yes
Generation of transgenic or knock-out rodents in which the animal’s genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefore, into the germ-line
2 or higher
III-D-4 Require IBC Approval
Yes
Experiments with Transgenic Rodents
Category of Experiment
Minimum ABSL
NIH Guidelines
Needs IBCInstitutional Biosafety Committee
The IBC is an instituti...?
Experiments with transgenic rodents without rDNA involved*
1
Exempt
(Appendix C-VI)
No
Experiments with transgenic rodents with rDNA involved**
1 or higher
III-D-4-a
Yes
Rodent study involving viable recombinant or synthetic nucleic acid molecule-modified microorganism tested on rodents
Refer to viral vector table
Require IBC Approval
Yes
Rodent study involving viable human materials, such as human cells, etc. tested on rodents
2 or higher
N.A.
Yes
*The purchase or transfer of transgenic rodents requiring BL1 containment is exempt under Appendix C-VI. Subsequent use of these animals is also exempt providing the experimental protocol does not involve the use of recombinant DNA.
** If the protocol does involve the use of recombinant DNA then the research is covered under III-D-4-a. All experiments involving the use of transgenic rodents requiring BL2 or higher containment are subject to the NIH Guidelines. See above for applicable sections.
Definitions
Transgenic rodents: Rodents (typically mice or rats) 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.