CMRC Guidelines for the Use of Transgenic Animals

The term “transgenic animal” refers to an animal in which there has been a deliberate modification of the genome, in contrast to spontaneous mutation. National Institutes of Health (NIH) have established strict guidelines on the proper use and disposal of transgenic animals, plants, and other forms of recombinant DNA (rDNA) in research. The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) outlines institutional and investigator responsibilities and can be found at:

Compliance with NIH Guidelines
All NIH-funded projects involving rDNA must comply with NIH Guidelines. As per the NIH Guidelines, all non-NIH funded projects involving rDNA conducted at or sponsored by an institution that receives NIH funding must comply with NIH Guidelines. Failure to follow NIH Guidelines can result in the suspension, limitation, or termination of NIH funds for all rDNA research at the institution. As a NIH-funded institution, Children’s Memorial Hospital (CMH) has developed both a policy and a protocol, outlined in this fact sheet, through which investigators may obtain institutional authorization to work with transgenic animals. As an investigator working with transgenic animals, it is your responsibility to meet these requirements.

Policy on Transgenic Animal Research
It is the policy of Children’s Memorial Hospital that all research conducted at CMH including Children’s Memorial Research Center (CMRC) and other CMH affiliates involving transgenic animals must receive approval from the Institutional Animal Care and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC) prior to the start of any work. Although some projects will qualify as exempt from the NIH Guidelines, all projects that involve transgenic animals must be registered. Research projects will be assessed by the Committee on an individual basis.

Protocol for Institutional Approval
You must register your research project with the IBC. To receive registration forms or further information, contact the Office of Sponsored Program’s Senior Administrative Assistant (to be named) at 755-6302 . As a registered rDNA user you will be required to submit an Annual Status Report and update registration information whenever there are changes in facilities, personnel, and experimental protocols associated with the project.

Disposal of Transgenic Animals
When a transgenic animal is euthanized or dies, the entire carcass shall be disposed of to avoid its use as food for human beings or animals unless food use is specifically authorized by an appropriate federal agency. Typically, incineration is employed for transgenic animal disposal. Specific recommendations may be made for a project by the Institutional Biosafety Committee.

FAQ about Transgenic Animals
For transgenic animals, particularly mice where transgenic means “expressing a gene” and not a knock-out, if the investigator has the animal made for them or purchases these animals, are these studies exempt?
The language of the NIH Guidelines specifically mentions only the purchase and transfer of transgenics being exempt (assuming BSL1). The use of the animal is not exempt from the NIH Guidelines. The use is an area where the Institutional Biosafety Committee at a minimum has to be consulted and the experiments with the animal have to be done at BSL1 or above as appropriate.

Once knock-out mice are made is their use exempt from the NIH Guidelines? What BSL should be used?
For knock-outs the germ line is altered and the way they are made requires recombinant techniques. The NIH Guidelines do not distinguish between the generation of a knock-out and its use. Therefore under section III-D-4, BSL1 (or higher if appropriate) is required. It is within the purview of the Institutional Biosafety Committee to increase the containment level for any type of research that is defined in the NIH guidelines.

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