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. Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance SUMMARY 9 PREPUBLICATION COPY—SUBJECT TO FURTHER EDITORIAL REVISION 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. RECOMMENDATIONS In light of the considerations detailed above, the committee made a series of recommendations targeted to basic research and to clinical applications, both somatic and germline. A summary of the key messages in these recommendations is found in Box S-2. Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance 10 HUMAN GENOME EDITING PREPUBLICATION COPY—SUBJECT TO FURTHER EDITORIAL REVISION BOX S-2 Oversight and Use of Human Gene Editing: Summary of Recommendations Global Principles for Research and Clinical Use Consider and apply the global principles in governance of human genome editing (2.1) Promoting well-being Transparency Due care Responsible science Respect for persons Fairness Transnational cooperation Basic Laboratory Research Use existing regulatory processes to oversee human genome editing laboratory research (3.1) Somatic Genome Editing Use existing regulatory processes for human gene therapy to oversee somatic human genome editing research and uses (4.1) Limit clinical trials or therapies to treatment and prevention of disease or disability at this time (4.2) Evaluate safety and efficacy in the context of risks and benefits of intended use (4.3) Require broad public input prior to extending uses (4.4) Germline (Heritable) Genome Editing Permit clinical research trials only for compelling purposes of treating or preventing serious disease or disabilities, and only if there is a stringent oversight system able to limit uses to specified criteria (5.1) Enhancement Do not proceed at this time with human genome editing for purposes other than treatment or prevention of disease and disability (6.1) Encourage public discussion and policy debate with respect to somatic human genome editing for uses other than treatment or prevention of disease and disability (6.2) Public Engagement Public input should precede any clinical trials for an extension of human genome editing beyond disease treatment and prevention (7.1)