Human Genome Editing: Science, Ethics, and Governance: New NASEM Report

Human Genome Editing: Science, Ethics, and Governance, a new report of the National Academy of Sciences and National Academy of Medicine is now available as a free PDF download.

The report sets forth criteria for policymakers and stakeholders, that must be met before permitting clinical trials of heritable : editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

Genome editing is a powerful tool for making precise alterations to an organism’s genetic material. In humans, the technologies could offer a cure for genetic diseases such as Huntington’s disease and sickle cell anemia among many others.

Recognizing both the promise and concerns related to human genome editing, the National Academy of Sciences and the National Academy of Medicine convened the Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations to carry out the study that is documented in this report. While genome editing has potential applications in agriculture and non-human animals, this committee’s task was focused on human applications.

One of the charges to the committee was to identify principles that many countries might be able to use to govern human genome editing. The principles identified by the committee are:

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 non-maleficence.

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 (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.

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) high quality 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 de-stigmatizing 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.

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