title: Criteria for identifying and evaluating candidate sites for open-field trials of genetically engineered mosquitoes.
abstract: Recent laboratory successes in the development of genetically engineered mosquitoes for controlling pathogen transmission have fostered the need for standardized procedures for advancing the technical achievements to practical tools. It is incumbent in many cases for the same scientists doing the in-laboratory discovery research to also take on the initial challenges of developing the pathway that will move the technologies to the field. One of these challenges is having a set of criteria for selecting collaborators and sites for efficacy and safety field trials that combine rigorous science with good ethical and legal practices. Specific site-selection criteria were developed in four categories-Scientific, Regulatory, Community Engagement, and Resources-in anticipation of open-field releases of a transgenic mosquito strain designed to suppress populations of the dengue vector mosquito, Aedes aegypti. The criteria are derived from previous published material, discussions, and personal experiences with the expectation of providing guidance to laboratory scientists for addressing the conceptual and operational considerations for identifying partner researchers and countries with whom to collaborate. These criteria are not intended to be prescriptive nor can they be applied to every circumstance where genetic approaches are proposed for deployment. However, we encourage those involved in the discovery phase of research to consider each criterion during project planning activities, and where appropriate, incorporate them into a "go/no-go" decision-making process for further development and testing of the technologies.
authors.affiliation: 1 Department of Microbiology & Molecular Genetics, University of California , Irvine, California.
authors.forename: David M
authors.initials: DM
authors.lastname: Brown
authors.forename: Luke S
authors.initials: LS
authors.lastname: Alphey
authors.forename: Andrew
authors.initials: A
authors.lastname: McKemey
authors.forename: Camilla
authors.initials: C
authors.lastname: Beech
authors.forename: Anthony A
authors.initials: AA
authors.lastname: James
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D009033:Culicidae / Q000235:genetics*; D005260:Female; D005818:Genetic Engineering; D007303:Insect Vectors / Q000235:genetics*; D008297:Male; D009032:Mosquito Control / Q000379:methods*; D012941:Social Responsibility