Emerging technologies
Recent advancements and developments in gene drives, gene editing technologies, and their ease and low cost have highlighted the need to ensure that genome editing research is conducted in a safe manner.
ASU guidance for gene editing technologies
Researchers interested in using gene editing technologies such as CRISPR must submit their research disclosures to the ASU Institutional Biosafety Committee (IBC) for review.
When it comes to CRISPR, one of the main biosafety concerns is that the guide RNA will target a human gene (whether it is on purpose or as an off-target). Another concern is the potential for creating a gene drive (see #8 below for more information).
Risk Assessment
In order to perform a proper risk assessment, the IBC will ask the following questions regarding your research:
- Does your research involve CRISPR or another gene editing technology? If yes, you will need to describe the technology technology (e.g., CRISPR/Cas9, Base editing, Prime editing, PASTE (Programmable Addition via Site-specific Targeting Elements), that is being proposed.
- For gene-editing systems, can the plasmid, vector or delivery vehicle transfect or infect and/or be expressed in human cells?
- Will you use the genome editing technology in prokaryotes, eukaryotes or mammalian cells? If so, please specify which.
- How are you delivering the gene editing technology (e.g., nanoparticles, plasmid, lentivirus, adeno-associated virus, etc.)?
- Will the gene editing technology target embryos or germ line cells?
- Will you use the gene editing technology for human gene transfer research?
- Will the research involve the creation of a gene drive experiment (i.e., a system that greatly increases the probably that a trait will be passed on to offspring). (Reference: Akbar et al., 2015). For more information about gene drives, please visit https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4692367/.
Resources available to promote and facilitate biosafety in research activities at ASU:
Biosafety Considerations for Contained Research Involving Gene Drive Modified Organisms
Update to the NIH Guidelines from April 2024
Biosecurity Risk Assessment for the Use of Artificial Intelligence in Synthetic Biology
Genome-wide CRISPR off-target prediction and optimization using RNA-DNA interaction fingerprints
CRISPR-Cas9: Safeguarding gene drives
A general guidance document from the Wyss Institute.
Emerging Technology: Concerning RNA-guided gene drives for the alteration of wild populations
Guidance for genome editing of wild populations.
Human Genome Editing: Science, Ethics, and Governance
This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents seven (7) general principles for the governance of human genome editing.
Recommendations for regulatory oversight for gene drive experiments.