research and care, while others are of particular importance in the context of an emerging technology, but all are foundational for the governance of human genome editing. In this context, the committee focused on principles that are aimed at protecting and promoting the health and well-being of individuals; approaching novel technologies with careful attention to constantly evolving information; respecting individual rights; guarding against unwanted societal effects; and equitably distributing information, burdens, and benefits. Differences in social and legal culture inevitably will lead to different domestic policies governing specific applications of genome editing. Nonetheless, some principles can be shared across national borders. Thus, while the overarching principles presented here are aimed primarily at the U.S. government, they and the responsibilities that underlie them are universal in nature. The principles are listed in Box 2-1 and elaborated below. BOX 2-1 Overarching Principles for Research on and Clinical Applications of Human Gene Editing Genome editing holds great promise for deepening understanding of biology and for preventing, ameliorating, or eliminating many human diseases and conditions. Along with this promise comes the need for responsible and ethically appropriate approaches to research and clinical use. The following general principles are essential foundations for those approaches: 1. Promoting well-being 2. Transparency 3. Due care 4. Responsible science 5. Respect for persons 6. Fairness 7. Transnational cooperation Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance 24 HUMAN GENOME EDITING PREPUBLICATION COPY—SUBJECT TO FURTHER EDITORIAL REVISION 1. Promoting well-being: The principle of promoting well-being supports providing benefit and preventing harm to those affected, often referred to in the bioethics literature as the principles of beneficence and nonmaleficence. Responsibilities that flow from adherence to this principle include (1) pursuing applications of human genome editing that promote the health and well-being of individuals, such as treating or preventing disease, while minimizing risk to individuals in early applications with a high degree of uncertainty; and (2) ensuring a reasonable balance of risk and benefit for any application of human genome editing. 2. Transparency: The principle of transparency requires openness and sharing of information in ways that are accessible and understandable to stakeholders. Responsibilities that flow from adherence to this principle include (1) a commitment to disclosure of information to the fullest extent possible and in a timely manner, and (2) meaningful public input into the policy-making process related to human genome editing, as well as other novel and disruptive technologies. 3. Due care: The principle of due care for patients enrolled in research studies or receiving clinical care requires proceeding carefully and deliberately, and only when supported by sufficient and robust evidence. Responsibilities that flow from adherence to this principle include proceeding cautiously and incrementally, under appropriate supervision and in ways that allow for frequent reassessment in light of future advances and cultural opinions. 4. Responsible science: The principle of responsible science underpins adherence to the highest standards of research, from bench to bedside, in accordance with international and professional norms. Responsibilities that flow from adherence to this principle include a commitment to (1) highquality experimental design and analysis, (2) appropriate review and evaluation of protocols and resulting data, (3) transparency, and (4) correction of false or misleading data or analysis. 5. Respect for persons: The principle of respect for persons requires recognition of the personal dignity of all individuals, acknowledgment of the centrality of personal choice, and respect for individual decisions. All people have equal moral value, regardless of their genetic qualities. Responsibilities that flow from adherence to this principle include (1) a commitment to the equal value of all individuals, (2) respect for and promotion of individual decision making, (3) a commitment to preventing recurrence of the abusive forms of eugenics practiced in the past, and (4) a commitment to destigmatizing disability. 6. Fairness: The principle of fairness requires that like cases be treated alike, and that risks and benefits be equitably distributed (distributive justice). Responsibilities that flow from adherence to this principle include (1) equitable distribution of the burdens and benefits of research and (2) broad and equitable access to the benefits of resulting clinical applications of human genome editing. 7. Transnational cooperation: The principle of transnational cooperation supports a commitment to collaborative approaches to research and governance while respecting different cultural contexts. Responsibilities that flow from adherence to this principle include (1) respect for differing national policies, (2) coordination of regulatory standards and procedures whenever possible, and (3) transnational collaboration and data sharing among different scientific communities and responsible regulatory authorities. Copyright © National Academy of