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.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• COMMITTEE ON GENE DRIVE RESEARCH IN NON-HUMAN ORGANISMS: RECOMMENDATIONS FOR RESPONSIBLE CONDUCT
• BOARD ON LIFE SCIENCES
• Preface
• Acknowledgment of Reviewers
• Summary
  • STATE OF THE SCIENCE OF GENE DRIVES
  • ECOLOGICAL AND ENVIRONMENTAL CONSIDERATIONS
  • CHARTING HUMAN VALUES
  • PHASED TESTING AND SCIENTIFIC APPROACHES TO REDUCE GENE DRIVES' POTENTIAL HARMS
  • ASSESSING RISKS OF GENE-DRIVE MODIFIED ORGANISMS
  • PUBLIC ENGAGEMENT
  • GOVERNANCE OF GENE DRIVES
  • GENE DRIVES ON THE HORIZON
  • REFERENCES
• 1. Introduction
  • PURPOSE OF THE STUDY
  • WHAT ARE GENE DRIVES? AND, HOW COULD THEY BE USED?
  • CASE STUDIES
  • KEY DEFINITIONS AND CONCEPTS
  • CONCLUSIONS
  • REFERENCES
• 2. The State of Knowledge of the Molecular Biology, Population Genetics, and Ecology of Gene-Drive Modified Organisms
  • SELFISH GENETIC ELEMENTS AND THEIR DRIVE MECHANISMS
  • CRISPR/CAS9-BASED GENE DRIVES
  • POPULATION ECOLOGY AND ECOSYSTEM CONSIDERATIONS
  • CONCLUSIONS
  • REFERENCES
• 3. Case Studies to Examine Questions About Gene-Drive Modified Organisms
  • BASIC CRITERIA FOR THE DEVELOPMENT OF GENE-DRIVE MODIFIED ORGANISMS
  • CASE STUDY 1: USING AEDES AEGYPTI AND AEDES ALBOPICTUS MOSQUITOES TO MANAGE DENGUE
  • CASE STUDY 2: USING ANOPHELES GAMBIAE MOSQUITOES TO COMBAT HUMAN MALARIA
  • CASE STUDY 3: USING CULEX QUINQUEFASCIATUS MOSQUITOES TO COMBAT AVIAN MALARIA IN HAWAII
  • CASE STUDY 4: CONTROLLING POPULATIONS OF NON-INDIGENOUS MUS MUSCULUS MICE TO PROTECT BIODIVERSITY ON ISLANDS
  • CASE STUDY 5: CONTROLLING NON-INDIGENOUS CENTAUREA MACULOSA KNAPWEEDS TO PROTECT BIODIVERSITY IN RANGELANDS AND FORESTS
  • CASE STUDY 6: CONTROLLING PALMER AMARANTH TO INCREASE AGRICULTURE PRODUCTIVITY
  • CASE STUDY 7: DEVELOPING A VERTEBRATE MODEL FOR GENE DRIVE RESEARCH USING ZEBRAFISH
  • REFERENCES
• 4. Charting Human Values
  • CENTRAL VALUE CONSIDERATIONS IN DEBATES ABOUT GENETIC ENGINEERING
  • POTENTIAL HUMAN BENEFITS OF GENE DRIVES
  • POTENTIAL HUMAN HARMS OF GENE DRIVES
  • VALUES RELEVANT TO POTENTIAL ENVIRONMENTAL EFFECTS
  • CONCERNS ABOUT JUSTICE
  • CONCLUSIONS
  • REFERENCES
• 5. Phased Testing and Scientific Approaches to Reducing Potential Harms of Gene Drives
  • THE PHASED TESTING PATHWAY
  • CONTAINMENT, CONFINEMENT, AND MITIGATION STRATEGIES
  • LEARNING FROM FIELD RESEARCH AND BIOCONTROL EFFORTS WITH OTHER TYPES OF MODIFIED ORGANISMS
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
• 6. Assessing Risks of Gene-Drive Modified Organisms
  • WHAT IS RISK?
  • ASSESSING ENVIRONMENTAL IMPACTS VERSUS ASSESSING RISKS
  • KEY CONSIDERATIONS FOR ECOLOGICAL RISK ASSESSMENTS OF GENE-DRIVE MODIFIED ORGANISMS
  • A CONCEPTUAL CAUSE-EFFECT MODEL
  • ILLUSTRATING A CONCEPTUAL CAUSE-EFFECT MODEL USING TWO CASE STUDIES
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
• 7. Engaging Communities, Stakeholders, and Publics
  • COMMUNITIES, STAKEHOLDERS, AND PUBLICS
  • MOTIVATIONS FOR ENGAGEMENT
  • CHALLENGES OF ENGAGEMENT
  • FRAMEWORKS TO GUIDE ENGAGEMENT
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
• 8. Governing Gene Drive Research and Applications
  • WHAT IS GOVERNANCE?
  • KEY CONSIDERATIONS FOR GOVERNING GENE DRIVES
  • RELEVANT GOVERNANCE FRAMEWORKS FOR GENE DRIVE RESEARCH AND APPLICATIONS IN THE UNITED STATES
  • BIOSECURITY CONSIDERATIONS
  • GOVERNANCE OF GENE DRIVES IN GLOBAL CONTEXTS
  • CONCLUSIONS AND RECOMMENDATIONS
  • REFERENCES
• 9. Gene Drives on the Horizon: Overarching Considerations
• Glossary
• Acronyms
• APPENDIXES
  • Appendix A. Agenda for the Workshop on the Science, Ethics, and Governance Considerations for Gene Drive Research
  • Appendix B. List of Gene Drive Webinars
  • Appendix C. Mosquito Control Strategies
  • Appendix D. Rodent Control Strategies
  • Appendix E. A Brief History of Ecological Risk Assessment
  • Appendix F. Biographical Sketches of Committee Members

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2016. Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values. Washington, DC: The National Academies Press. doi: 10.17226/23405.