Accountability: Being answerable for one’s actions or the ability to give an honest account of events and take responsibility for their consequences.
Adaptive management: An iterative decision-making process in which uncertainties are progressively resolved through monitoring of the system in question.
Allele: A variant form of a gene at a particular locus on a chromosome. Different alleles produce variation in inherited characteristics.
Asilomar: The 1975 Asilomar Conference on Recombinant DNA, convened to discuss the potential biohazards of recombinant DNA research, guidelines on safe laboratory practices, and the potential roles of regulation. The conference concluded that containment be made an essential aspect of experimental design, and that the effectiveness of containment practices matches the estimated risk of the particular experiment as closely as possible.
Attribute: A measurable characteristic of the ecological entity.
Bayesian networks: Graphically depicted web of nodes that link cause and effect relationships using conditional probability to describe the interactions and to generate the probability outcome or outcomes.1
Biosafety: Policies and practices intended to prevent harm to the health or safety of human beings, other living organisms, or the environment, especially those pertaining to safe handling and containment of infectious agents.
Biosecurity: An integrated system of best scientific practices, environmental controls, and policy and regulation that identifies and manages risks of intentional misuse of technologies, particularly biological agents and processes, in ways that threaten public health or national security.
Biotechnology: A number of methods that endow new characteristics in an organism.
Capacity building: The provision and promotion of education and practical training, particularly within low-resource and unskilled communities, often with respect to essential services.
Cartagena Protocol on Biosafety to the Convention on Biological Diversity: An international agreement that addresses the safe handling, transport, and use of living modified organisms resulting from modern biotechnology, with the aim of protecting biological diversity and human health. One hundred and seventy countries are signatories to the agreement, which took effect on 11 September 2003.
Community: A group of people who live near enough to a potential field trial or release site that they have tangible and immediate interest in the gene drive project.
1Marcot, B.G., J.D. Steventon, G.D. Sutherland, and R.K. McCann. 2006. Guidelines for development and updating Bayesian belief networks applied to ecological modeling and conservation. Can. J. Forest Res. 36(12):3063-3074.
Compliance: The act of following or obeying a rule or order, particularly with respect to governmental regulation.
Confinement: The use of ecological conditions or biological methods to prevent unintended or uncontrolled persistence of an organism in the environment.
Conservation: The protection and preservation of the natural environment or particular species, including the maintenance of habitats and genetic diversity.
Containment: The use of human-made or natural physical restrictions to prevent unintended or uncontrolled release of an organism into the environment.
CRISPR (Clustered regularly-interspaced short palindromic repeats): A naturally occurring mechanisms of immunity to viruses found in bacteria that involves identification and degradation of foreign DNA.
CRISPR/Cas9: A gene editing platform in which an endonuclease and a guide RNA are used to introduce double strand breaks at a specified location within the genome.
Dual use potential: The potential for the findings from research intended for human benefit to be misused for intentionally harmful purposes.
Dual use research of concern (DURC): Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to pose a significant threat to public health and safety, agricultural crops and other plants, animals, the environment, military equipment and supplies, or national security.2
Ecological entity: A species, population, habitat, or ecosystem characteristic or function.
Ecological risk assessment: The study and use of probabilistic decision-making tools to evaluate the likely benefits and harms of a proposed activity on the wellbeing of humans and environment, often under conditions of uncertainty.
Ecosystem: A dynamic biological system consisting of all of the organisms in a specific environment and the non-living features of the environment with which they interact.
Ecosystem services: The functions and products of ecosystems that contribute to human wellbeing.
Effect: A potential beneficial or harmful outcome.
Endemic: A situation in which disease is present continuously at some level in an area.
Endpoint: Societal, human health, or environmental value that is to be managed or protected.
Engagement: Seeking and facilitating the sharing and exchange of knowledge, perspectives, and preferences between or among groups who often have differences in expertise, power, and values.
Environmental assessment: A determination of whether a US federal government decision to allow a specific action has the potential to cause significant environmental effects.
Environmental impact statement: A detailed document from proposed major US federal agency actions that are expected to significantly affect the quality of the human environment.
Epigenome: The physical factors affecting the expression of genes without affecting the actual DNA sequences of the genome.
Epistemic uncertainty: A lack of knowledge about determinate facts.
Field trial: An experiment designed to test a promising new product or process in a context similar to that in which the product or process is intended to be used.
Fitness: A description of the ability to survive and reproduce, equal to the long-term average contribution to the gene pool by individuals having a particular genotype or phenotype.
Fixation: 100% frequency of a gene.
Gene: a segment of DNA that serves as a basic unit of heredity.
Gene drive: A system of biased inheritance in which the ability of a genetic element to pass from a parent to its offspring through sexual reproduction is enhanced. Thus, the result of a gene drive is the preferential increast of a specific genotype that determines a specific phenotype from one generation to the next, and potentially throughout a population.
Gene editing: A technique that allows researchers to alter the DNA of organisms to insert, delete, or modify a gene or gene sequences to silence, enhance, or otherwise change an organism’s specific genetic characteristics.
Gene flow: The transfer of genetic information from one population into another population (also called gene migration).
Genetic engineering: Introduction of DNA, RNA, or proteins manipulated by humans to effect a change in an organism’s genome or epigenome.
Genetically modified: An organism whose genotype has been altered, including alteration by genetic engineering and nongenetic engineering methods.
Genome: The complete sequence of DNA in an organism.
Genome editing: Specific modification of an organisms’ DNA to create mutations or introduce new alleles or new genes.
Genotype: An individual’s genetic identity.
Germ line: A cellular lineage in sexually reproducing organisms that produces the gametes (eggs and sperm) which transmit genetic material to the next generation.
Gonotaxis: Biased movement toward the germline.
Governance: The process of exercising oversight through traditions (standards of practice) or regulations by which individuals and communities are held accountable. Governance often involves such policy tools as professional standards of practice and codes of conduct; formal guidelines, agreements, and treaties; and legislation or other governmental regulation.
Homology-directed repair: A naturally occurring mechanism for repair of a DNA sequence in a cell that has a double strand break. This repair mechanism inserts a copy of the DNA sequence from a homologous chromosome or artificially added DNA with homologous sequence into the DNA that has the break as a template for the repair.
Horizontal gene transfer: Movement of genes between populations of otherwise distinct species. Hybrid: The offspring of two plants or animals of different species or varieties.
Indigenous species: Species that occur naturally in a given geographic area or have evolved there without human intervention. Also called native species.
Institutional Animal Care and Use Committee: A multidisciplinary committee responsible for providing ethical review and oversight of research involving animal subjects, with the goals of protecting animal welfare and ensuring the quality of the science (also called an animal welfare committee).
Institutional Review Board (IRB) for the Protection of Human Subjects: A multidisciplinary committee responsible for providing ethical review and oversight of research involving human participants with the goal of protecting their welfare (also called an ethics committee, an ethics review committee or a research ethics committee).
Invasive species: A non-indigenous (or non-native) species that disrupts and often replaces one or more indigenous species.
Keystone Species: Any species whose effect on its ecosystem is disproportional to its relative abundance.
Linguistic uncertainty: Ambiguities in the terminology used to describe concepts.
Meiotic drive: Any process which causes one male or female germ cell to be over- or underrepresented during meiosis, and hence in the next generation.
Migration: The movement, often seasonal, of populations, groups, or of individuals across geographic space.
Mitigation: Actions, policies, and programs that serve to prevent, minimize, or compensate for disruption of the natural environment.
Monte Carlo method: A statistical analysis that relies on repeated sampling of probability distributions of model inputs to estimate the final probability distribution for each of the model outputs (also called Monte Carlo experiments or Monte Carlo simulations).3
3Burmaster, D.E., and P.D. Anderson. 1994. Principles of good practice for the use of Monte Carlo techniques in human health and ecological risk assessments. Risk Anal. 14(4):477-481.
Mutagenic chain reaction: A gene drive mechanisms to using CRISPR/Cas9.
Nature: The totality of the material universe, including the forces and processes that exist or occur independent of human action.
Non-target effect: A direct, unintended, short- or long-term consequence for one or more organisms other than the organism intended to be affected by an action or intervention. Concern about non-target effects typically centers around unforeseen harms to other species or environments, but non-target effects can also be neutral or beneficial.
Off-target effect: A direct, unintended, short- or long-term consequence of an intervention on an organism other than the intended effect on that organism.
Overreplication: Increased copies of a genetic element within and organism.
Pathogen: A biological agent, such as a virus, bacterium, or parasite, that causes disease.
Phased testing pathway: A step-wise approach to guide the preparation for and conduct of research in the laboratory through environmental release.
Phenotype: The observable traits of an organism (i.e., how an organisms appears outwardly and physiologically).
Population: All of the individuals of a given species within a defined ecological area.
Population biology: The study of populations, including their natural history, size, migration, evolution, and extinction.
Population replacement: The use of genetic methods to change specific traits in an entire population.
Population suppression: Intentional reduction of the number or distribution of a population through physical, chemical, or biological means, particularly with pest species (also called population reduction).
Publics: Groups who lack the direct connection to a project that stakeholders and communities have but nonetheless have interests, concerns, hopes, fears, and values that can contribute to democratic decision making.
Recombinant DNA (rDNA): Any novel DNA sequence created using genetic engineering.
Refractoriness: A condition in which an organism is intrinsically unable to support the development of a pathogen to an infective stage or to a point of sufficient abundance such that the organism cannot transmit disease.4
Responsible conduct of research: Commitment by researchers and their institutions to practices that sustain the integrity of science, particularly in the core areas of: conflict of interest; research with humans and animals and safe laboratory practices; mentor–trainee responsibilities and rela-
4World Health Organization. “Guidance framework for testing of genetically modified mosquitoes.” TDR news item. Available: www.who.int/tdr/news/2012/guidance_framework/en/index.
tionships; peer review; data acquisition, management, sharing and ownership; collaborative research; responsible authorship and publication; research misconduct and responding to allegations of misconduct; the scientist as a member of society; environmental and societal impacts of research; and other contemporary ethical issues in research.
Reversal drive: The currently theoretical process by which the effects of a gene drive are reversed, using either the process that triggered the original gene drive or another process as yet undeveloped.
Risk: The probability of an effect on a specific endpoint or set of endpoints due to a specific set of a stressor or stressors. An effect can be beneficial or harmful.
Risk assessment: The process by which all available evidence on the probability of effects is collected, evaluated, and interpreted to estimate the probability of the sum total of effects.
Risk communication: The process through which concerns about and tolerance of risk are articulated by stakeholders and the results of risk assessment and risk management are communicated to decision makers and the public.
Risk management: The process of identifying and implementing measures expected to reduce risk to a tolerable level.
RNA interference (RNAi): A natural mechanisms found in nearly all organisms in which the levels of transcripts are reduced or suppressed.
Scientific community: A dynamic international, multidisciplinary network of scientists and scientific institutions including, for example, investigators, science educators, universities, research institutes, funding organizations, regulatory bodies, and publishers, united by their common commitment to the advancement of scientific knowledge through the use of critical, reproducible methods.
Selfish genetic elements: Stretches of DNA that are certain to pass down from a parent organism to nearly all of its offspring.
Split gene drive: A research approach in which gene drive components (for example, Cas9, gRNA, and the donor template) are supplied separately to the organism.
Stakeholder: A person with a professional or personal interests sufficient to justify engagement, but may not have geographic proximity to a potential release site for a gene drive technology.
Standard operating procedures (SOPs): Written, step-wise instructions or descriptions of essential, routine practices, intended to ensure consistent and safe performance.
Sterile insect technique (SIT): A method of pest control using area-wide inundative releases of sterile insects to reduce reproduction in a field population of the same species.5 Sterilization is typically carried out chemically or through exposure to radiation.
Stressor: Any agent or actor with the potential to alter a component of the ecosystem.
Synthetic biology: The ability to develop novel traits or organisms using synthetic genes or by bringing together genes from multiple organisms. Also defined as the ability to generate novel traits or organisms using computational designed DNA or reagents that are not directly found in nature.
Target Product Profile: A strategic development process tool that uses set of criteria to predefine ideal attributes of a candidate product and subsequent modifications to acceptance thresholds.
Trait: A genetically determined characteristic or condition.
Transcription Activator-Like Effector Nucleases (TALENs): A class of engineered restriction enzymes generated by the fusion of a transcription activator-like effector DNA-binding domain to a DNA-cleavage domain that can be used as a genome editing tool.
Transgene: Any gene transferred into an organism by genetic engineering.
Transgenic organism: An organism into which one or more genetic sequences from another species or synthetic sequences have been introduced into its genome by genetic engineering.
Transposable element: Small DNA segments that can move from one part of the genome to another by excising themselves and randomly inserting elsewhere in the genome. Also called transposons or jumping genes.
Underdominance (also called heterozygous disadvantage): A condition in which the phenotypic expression of the heterozygote is less than that of either homozygote.
Values: Deeply held, complicated, sometimes evolving beliefts about what kinds of things—in humans’ lives and the world at large—should be fortered, protected, or avoided.
Vector: An organism that spreads disease to other species by transmitting one or more pathogens rather than causing infection itself.
Wild-type: The collection of genotypes or alleles found in a natural population.
Wolbachia: A symbionts bacteria found in the cells of many invertebrates, including insects and nematodes that affect the reproductive biology of its hosts.
Zinc finger nucleases: A class of engineered restriction enzymes generated by the fusion of a zinc finger DNA-binding domain to a DNA-cleavage domain that can be used as a genome editing tool.