To be used for research activities including the generation of transgenic animals by breeding or the use of pre-generated genetically modified/engineered animals (GM animals). We cannot currently change the eProtocol application, and we are re-tasking sections of the application for our needs. Thus, in certain cases please ignore the question, and use the text boxes as needed.
Please ignore the red lettering on the eProtocol page that indicates that this section is only for rodents.
For the generation of GM animals not from breeding, please use the r/sNA section (2.) to describe the method(s) you will use (do not use 6.b).
For the generation of GM animals via breeding, please answer 6.a). Genotypes are not necessary to detail. Please consider the below requests for the use of those animals.
To account for only the use of existing GM animals in your application, please check “yes” for question 6.a) and include in the 6.a)i) text box - “EXISTING GE Animals - FOR USE ONLY”. In the text box for 6.a)ii) enter a general description of the phenotypes. The IBC admin may contact you for any clarifications. Please briefly describe, in the study objectives section 1.b), any experimental work with your GM animals from creation/receipt to disposal.
Regardless of the method of generation, it is likely you will use the GM animals after generation, which should be accounted for with the above procedure.
Please note that if GM animals are not administered any agents (r/sNA molecules, biological toxins, or infectious agents), then the Animal Housing Location in the Safety section 7a)ii of the application will not be activated. Instead, please add your animal housing location for breeding or use of GM animals to the list of Proposed Lab Work Locations in Safety section 7a)i.
eProtocol Guidance for GM Rodents
The use of GM rodents is generally considered a minimal risk activity and if this is the only IBC
related activity included in the application, it would be reviewed outside of the normal meeting
schedule. To account for the use of other purchased, provided, or already made genetically
engineered or genetically modified rodents for breeding purposes or for general use:
- Select the box for Genetic Modification of Animals in the Activities Include section.
- In the Study Objectives section 1b,
- Describe the work with the GM rodents. If cells or tissues are collected from the mice, please indicate so.
- If true, please write that the transgenic rodents do not contain 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).
- If you will breed GM/GE rodents and if it is also true, please state that all transgenic rodents resulting from breeding are not expected to contain more than one-half of an exogenous viral genome from a single family of viruses.
- Complete the Genetic Modification of Animals section 6.
- Responding “yes” to 6)a allows for the use of boxes 6a)i and 6a)ii to describe the GM rodents.
- To account for only the use of existing GM rodents in your application, check “yes” for question 6)a and include in the 6a)i text box- “EXISTING GM rodents FOR USE ONLY.”
- In the text box for 6a)ii enter a general description of the modified phenotypes and briefly describe the genetic modifications, making clear what genes are produced or impacted (knocked out), and describe any risks (if any) from these modifications. The IBC admin may contact you for any clarifications.
- Complete Safety section 7 and enter a lab location and animal housing location in Safety
- Note: the Animal Housing Location under Safety section 7a)ii only becomes active if other sections of the application indicate that administration of r/sNA, infectious agents, or biologically-derived toxins occurs with animals.
- In the Attachments section,
- Include a Biological Decontamination and Spill Clean-up Plan.
- Include a Biological Waste Disposal Plan.
- Include an SOP if experimental activities (other than breeding) are performed. Describe all handling or use of GM rodents, their containment, and PPE requirements. The level of detail included should provide enough information to assist the IBC in its risk assessment.
A job aid for submission of an IBC application to account for the use of genetically modified rodents is also available. Please send requests to email@example.com.