Resources and FAQs
The resources below are provided for your reference and convenience. For more specific questions or assistance regarding the IBC at CSU, please contact us.
NIH Guidelines FAQs
- Experiments that are Exempt from the NIH Guidelines
- Genetically Modified Animals and the Use of rDNA in Animals
- Animal Experiments Covered Under the NIH Guidelines
- Reporting of Incidents Involving rDNA to the NIH
- Biosafety Considerations for Research with Lentiviral Vectors
For additional resources from NIH/OSP visit the NIH’s Frequently Asked Questions
CSU IBC FAQs
- Login with your CSU eID and password.
- Click “Add My Name to RICRO Database”
- Fill out the brief personal information page, including a brief statement describing your experience working biohazardous materials, infectious agents and/or recombinant DNA, and the type of training received.
- Once completed, click “Submit”
Project renewal reduces the administrative burden of filling out a new application for continuation of previously approved projects. This process confirms that active work is being conducted for the project, that the information on the form is accurate, and ensures compliance with federal regulations and CSU policies regarding the use of biohazardous materials.
The Renewing status indicates that you have started the process for annual renewal but have not yet submitted the request and you are able to make changes before submission. It is important to note that changes to the project that are not solely administrative (i.e. adding a room number) may require additional information and an Amendment for IBC review. For instructions on how to submit your project for review, please view the IBC Renewing Guide or contact the IBC Coordinator for assistance.
Project closure indicates that all laboratory work has been completed to accurately reflect the status of work with biohazardous material. Agent closure indicates that the agent is no longer being stored or used by the PI’s laboratory group. This process is necessary to ensure that projects are confirmed as complete by the PI.
“Genome editing” (also called gene editing) is a term used to describe a relatively new set of technologies that enable one to make precise changes in the DNA of a plant, animal or other living organism. These technologies allow scientists to cut the DNA at a specific location in the genome and then add, remove, or substitute one or more specific nucleotides. Several approaches to genome editing have been developed, for example, clustered regulatory interspersed short palindromic repeat associated nucleases (CRISPR), zinc-finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and oligonucleotide-directed mutagenesis (ODM). However the CRISPR-Cas9 system has recently generated a lot of excitement because it is faster, cheaper, more accurate, and more efficient than other existing genome editing methods.
Genome editing is a faster and easier method of making changes to the genome of a plant, animal, or other living organism than methods used previously to make such changes. It also allows for the intentional addition, substitution, or deletion of specific nucleotides in an organism’s genome. Genetic engineering, also called genetic modification or genetic manipulation, is the direct manipulation of an organism’s genes using recombinant DNA (rDNA) technologies. This involves the transfer of new DNA (rDNA construct) from one organism’s genome and combining it with the DNA of another organism. The process can be used for inserting genes, as well as to remove (or “knock out”) genes. The resultant organism is often referred to as “recombinant” or “transgenic” (This is an organism whose genetic makeup has been altered by the addition of genetic material from an unrelated organism.).
Yes, CRISPR-Cas9, ZFNs, and TALENs typically involve some type of gene insertion and
therefore are subject to the NIH Guidelines for Research Involving Recombinant or Synthetic
Nucleic Acid Molecules (NIH Guidelines) and thus require IBC approval. Additionally, if the gene
editing system is being expressed from a plasmid or any other type of recombinant vector then
the research would be covered under the NIH Guidelines.
The section of the NIH Guidelines that applies depends upon how the gene editing
technology is used, specifically the delivery system, the intended host, and the gene(s) altered.
Examples, of which section certain types of work fall under, include:
- Editing a pathogen’s genome = Section III-D-1
- Delivery via viral vector into cells = III-D-3 or III-E-1
- Generating a transgenic animal = III-D-4 or III-E-3
A: As with traditional rDNA methods, there are some experiments with CRISPR that are exempt
from the NIH Guidelines. Section III-F and Appendix C of the NIH Guidelines describes experiments that may be exempt, as well as exceptions to the exemptions. If you are uncertain as to whether or not your work is exempt, please contact the IBC at RICRO_IBC@mail.colostate.edu.
Yes, IBC approval is required for the purchase, transfer, breeding, use, and/or
experimentation with transgenic animals, and typically falls under section III-D-4 of the NIH
Guidelines. This applies to all transgenic animals, regardless of the technology used to create
them, and includes (but not limited to) transgenic arthropods and zebrafish. In certain cases, the
purchase/transfer, breeding, and use of transgenic rodents are exempt from the NIH Guidelines;
for more information see Animal experiments covered under the NIH Guidelines.
The answer depends on the technique employed in the study. If traditional recombinant
methods are used to knock out the gene, then the work and the subsequent product would be
covered under the NIH Guidelines. If new genome editing techniques (such as CRISPR-Cas9) are
used, then the work to generate the knock out would be covered by the NIH Guidelines, but the
subsequent product may not be. If you are uncertain as to whether or not your work falls under
the NIH Guidelines, please contact the IBC at RICRO_IBC@mail.colostate.edu.
If the veterinary clinical study involves administering recombinant or synthetic nucleic acid molecules to animals, then the work would be covered under the NIH Guidelines and IBC approval would be required. Likewise, if the study involves administering gene edited or genetically engineered cells or organisms to animals, then the work would be covered under the NIH Guidelines and IBC approval required. In addition, an environmental assessment is often required. These studies must also be filed with the FDA-CVM or USDA prior to initiating such research in client owned animals.