Guidance Framework For Testing Genetically Modified Mosquitoes

Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges, including the reduction of poverty and the burden of vector-borne diseases, such as malaria and dengue, which disproportionately impact low and middle income countries. However, due to their intrinsic qualities of rapid spread and irreversibility, gene drive systems raise many questions with respect to their safety relative to public and environmental health. Because gene drive systems are designed to alter the environments we share in ways that will be hard to anticipate and impossible to completely roll back, questions about the ethics surrounding use of this research are complex and will require very careful exploration. Gene Drives on the Horizon outlines the state of knowledge relative to the science, ethics, public engagement, and risk assessment as they pertain to research directions of gene drive systems and governance of the research process. This report offers principles for responsible practices of gene drive research and related applications for use by investigators, their institutions, the research funders, and regulators.

The framework aims to provide global perspectives on principles, tools and mechanisms to support Member States and relevant stakeholders to mitigate and prevent biorisks and govern dual-use research. The framework adopts the One health approach and focuses on the role that responsible life sciences research can play in preventing and mitigating risks caused by accidents, inadvertent or deliberate misuse with the intention to cause harm to humans, nonhuman animals, plants and agriculture, and the environment. The framework is primarily intended for those who have responsibilities in the governance of biorisks, such as policy makers and regulators in charge of developing national policies to harness the potential benefits of the life sciences while constraining their risks. The framework is also directed towards scientists and research institutions, educators, trainers, project management staff, funding bodies, publishers, editors, the private sector and all relevant stakeholders that are part of the research life cycle. The governance of biorisks is an issue that should engage all countries, although countries will have different contexts, needs and starting points. Mitigating these risks will require individual and collective actions among different stakeholders and disciplines. Mitigating biorisks and governing dual-use research is a shared responsibility.

This book comprehensively covers the latest development in developing and deploying the genetically modified vectors, particularly Anopheles and Aedes mosquitoes responsible for transmitting malaria parasites and dengue viruses, the most deadly and/or debilitating among all the vector-borne diseases. It is considered timely and commensurate to bring about a book dealing with the various ecological, biological and social as well as regulatory aspects for the deployment of genetically modified vectors in special context with the biosafety of humans, his associates, and the environment. Written by an array of specialists and experts in various subjects of genetically modified organisms, this book centrally addresses the (i) basic principles of the genetic manipulation of vectors and they are potential impact on human and the environment, (ii) ecological, biological, ethical, legal and social implications of the use of genetically modified vectors, (iii) identification of potential hazards; assessment and management of risks for human and environment; risk/benefit analysis, (iv) principles and practices for the assessment and management of biosecurity and biosafety in laboratories (and in the field), (v) guiding principles for creation and management of institutional or national biosafety review boards and ethics review committees, and (vi) development and application of a biosafety regulatory framework and its related legal principles at national levels for securing the development and use of vector control methods based on genetic modification strategies. This publication will be useful to researchers, scientists, and professionals engaged in academic and research institutions, government or non-government, as well as students in universities and medical colleges.

Malaria is one of most serious infectious diseases today and has afflicted humankind for thousands of years. A significant number of people still die from this mosquito-borne disease, despite the use of various malaria prevention and control methods over hundreds of years and more than a century of coordinated global control efforts using modern tools, together with research into and development of new strategies for prevention, diagnosis, and disease treatment. Genetic approaches that focus on the vector mosquitoes to prevent malaria parasite transmission have been considered for many decades. Genetic control strategies received a significant boost with the successful development of gene drive systems, genetic methods for rapidly spreading beneficial genes and phenotypes through mosquito populations. This book reviews some concepts of gene drive systems and describes pioneering applications to control mosquito populations and prevent parasite transmission.

Technology for modifying the genotypes and phenotypes of insects and other arthropods has steadily progressed with the development of more precise and powerful methods, most prominently transgenic modification. For many insect pests, there is now almost unlimited ability to modify phenotypes to benefit human health and agriculture. Precise DNA modifications and gene drive have the power to make wild-type populations less harmful in ways that could never have been performed with previous transgenic approaches. This transition from primarily laboratory science to greater application for field use has also necessitated greater development of modeling, ethical considerations and regulatory oversight. The 2nd Edition of Transgenic Insects contains chapters contributed by experts in the field that cover technologies and applications that are now possible. This edition includes increased attention to associated challenges of risk assessment, regulation, and public engagement. This book will be very valuable to students and researchers in entomology, molecular biology, genetics, public health and agriculture, and will also appeal to practitioners who are implementing the technology, and to regulators, stakeholders and ethicists.