FAQ's and Resources

SciShield Biological Registration Module (Bio Module).

Project renewal is every 3 years. 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 BU policies regarding the use of biohazardous materials.

Project closure indicates that all laboratory work has been completed to accurately reflect the status of work with biohazardous material.

“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 are subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and requiring 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

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 Coordinator for additional information.

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. For more information, please refer to the FAQs for Research on Genetically Modified Animals.

In certain cases, the purchase/transfer, breeding, and use of transgenic rodents are exempt from the NIH Guidelines; for more information, refer to Animal experiments covered under the NIH Guidelines Table.

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 if your research might require IBC approval or fall under the NIH Guidelines, please contact the IBC Coordinator for additional information.

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.