Research Integrity and Assurance

Emerging Technologies

Emerging technologies

Recent advancements and developments in gene drives and CRISPR-Cas9 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 CRISPR or other genome editing technologies such as Transcription Activator-Like Effector Nucleases (TALENS) and Zinc Finger Nucleases (ZFN) 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:

  1. Does your research involve CRISPR or another gene editing technology? If yes, you will need to describe the technology (e.g., CRISPR/Cas9, ZNF, TALENS, Meganucleases) that is being proposed.
  1. For CRISPR systems, are the guide RNA (gRNA) and nuclease on the same plasmid, vector or delivery vehicle? If so, can this plasmid, vector or delivery vehicle transfect or infect a human cell and can the gRNA or CRISPR nuclease be expressed in human cells?
  1. For CRISPR research involving viral vectors, you must complete a Genome Target Scan (GT-Scan) for off target effects by your gRNA. This is necessary to determine if there is homology to human DNA and to assess the risk of potential exposure in the event of an unanticipated incident. (References: Bae et al., 2014; O’Brien and Bailey, 2014). An off-target database is available at http://www.rgenome.net/cas-offinder/.
     
  2. Will you use the genome editing technology in prokaryotes, eukaryotes or mammalian cells? If so, please specify which.
  1. How are you delivering the gene editing technology (e.g., nanoparticles, plasmid, lentivirus, adeno-associated virus, etc.)?
  1. Will the gene editing technology target embryos or germ line cells?
  1. Will you use the gene editing technology for human gene transfer research?
  1. 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 http://bit.ly/1TYNIAo.
Resources available to promote and facilitate biosafety in research activities at ASU:

Approaches to reduce CRISPR off-target effects for safer genome editing

This paper provides several techniques for pursuing more precise genome editing through CRISPR.

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.

iGEM Final Safety Form

The final checklist to assess risk of the experiments being performed for the iGEM Jamboree.

iGEM Safety Check-In Form

A short checklist to assess risks of synthetic biology experiments.

Regulating gene drives

Recommendations for regulatory oversight for gene drive experiments.

Safeguarding gene drive experiments in the laboratory

Containment recommendations for working with gene drive experiments in the laboratory.

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