In the January 2018 issue of Pathogens and Global Health Adelman et al. seek to establish standard operating procedures (SOPs) for gene drive research in arthropods and ask fundamental questions as to why these procedures are necessary. At a time when the field is rapidly advancing, systematically defining a standard of research is crucial.
The paper lays out the four containment recommendations made by Akbari et al. (2015) to prevent the release of gene drive organisms, which are: molecular confinement, ecological confinement, reproductive confinement and barrier confinement. It’s suggested that at least two of these standards are met for approval of gene drive research in arthropods. Many institutions are limited in their abilities to meet these recommendations, such as those in tropical regions wanting to work on local disease vectors, which violates the ecological confinement recommendation. These ethical issues should be addressed when establishing SOPs.
Gene drive research at NIH-funded institutions must be approved by an Institutional Biosafety Committee that consults the Biosafety in Microbiological and Biomedical Laboratories and NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules texts. Additionally, reviewing entities may consult the Arthropod Containment Guidelines (ACG) when approving research in arthropods. These documents should be revised to address research with gene drive organisms and should be open to amendments to facilitate progress. Additionally, entities without NIH funding would benefit from an external review process relying on NIH standards and the ACG for guidance.
Adelman et al. approach SOP development categorically, addressing key areas of arthropod containment, including:
Access: Define what access to the insectary means. Only trained personnel should have unsupervised access to locked facilities.
Entry/Exit: The Insectary should be contained within double doors and a vestibule sign-in will slow passage and prevent arthropod escape.
Facility Integrity: Annual facility checks of containment failure hotspots are expanded to weekly. Protocols for unscheduled integrity checks in the event of emergency are clearly defined.
Waste Disposal: SOPs specify exactly how gene drive organisms and associated waste should be killed and disposed of, respectively, before leaving the insectary.
Escape Management: Record and report any escaped or “free-flying” insects. SOPs lay out what to do in the unlikely event of an escape.
Experimental Manipulation: Screening and sorting of organisms need concise protocols with visual aids. Common, repetitive tasks are points of accidental release and need clear SOPs.
Along with these key areas, the paper emphasizes the importance of SOP brevity to maintain compliance. The idea is that long, complicated protocols may be ignored. The authors also suggest that while documentation such as sign-in sheets help ensure accountability, some amount of anonymity will facilitate honest issue reports.
Zach N. Adelman, David Pledger & Kevin M. Myles (2018): Developing
standard operating procedures for gene drive research in disease vector mosquitoes, Pathogens and Global Health, DOI: 10.1080/20477724.2018.1424514