Governing Human Genome Editing

Gene editing is inexpensive, simple, and becoming more widely used in clinical applications, while “gene hacking” can be done by anyone who can buy equipment and chemicals. Two gene-edited babies are already over one year old, and gene editing is not just for treating somatic illness. Germline editing promises efficiency in eradicating many diseases, but ethical and legal questions persist about unknown, perhaps unknowable, transgenerational and global consequences. This issue interrogates roles of the public in considering what count as treatments or enhancements for individuals and entire species and explores what constitutes adequate oversight and governance, sustained safety and efficacy monitoring, and equity. 

Volume 21, Number 12: E1015-1110 Full Issue PDF
  • From the Editor
    Dec 2019

    Ethics, Values, and Responsibility in Human Genome Editing

    Sean C. McConnell, PhD and Alessandro Blasimme, PhD
    Genome editing is an inexpensive and efficient tool to introduce changes in DNA, but key ethical worries deserve attention.
    AMA J Ethics. 2019;21(12):E1017-1020. doi: 10.1001/amajethics.2019.1017.
  • Health Law
    Dec 2019

    What Is Prudent Governance of Human Genome Editing?

    Scott J. Schweikart, JD, MBE
    The Asilomar Conference of 1975 and the German Ethics Council offer guidance for a path towards prudent regulation in the face of unknown and significant risks.
    AMA J Ethics. 2019;21(12):E1042-1048. doi: 10.1001/amajethics.2019.1042.
  • Health Law
    Dec 2019

    Is Gene Editing Patentable?

    Lisa M. Gehrke, JD, MA
    Although advisory groups like the World Health Organization question whether certain forms of gene editing should be permitted, the US Patent Office routinely issues patents protecting this technology.
    AMA J Ethics. 2019;21(12):E1049-1055. doi: 10.1001/amajethics.2019.1049.
  • Policy Forum
    Dec 2019

    How Should Gene Editing Be Managed by Risk Managers?

    David Sine, D.Bioethics
    Little claims data exists upon which to make informed decisions about loss control or to draw upon when developing risk mitigation strategies.
    AMA J Ethics. 2019;21(12):E1059-1064. doi: 10.1001/amajethics.2019.1059.
  • Policy Forum
    Dec 2019

    Why Include the Public in Genome Editing Governance Deliberation?

    Alessandro Blasimme, PhD
    International debate about human genome editing governance has undergone a paradigm shift and suggests that inclusive public deliberation is still important.
    AMA J Ethics. 2019;21(12):E1065-1070. doi: 10.1001/amajethics.2019.1065.
  • Medicine and Society
    Dec 2019

    Prioritizing Women’s Health in Germline Editing Research

    Ruth M. Farrell, MD, MA, Marsha Michie, PhD, Christopher T. Scott, PhD, Rebecca Flyckt, MD, and Mary LaPlante, MD
    One reason for neglect of women’s health as patients and subjects has been restrictions on uterine transfer of modified human embryos, a boundary that has now been crossed.
    AMA J Ethics. 2019;21(12):E1071-1078. doi: 10.1001/amajethics.2019.1071.
  • Medicine and Society
    Dec 2019

    An Exclusive Interview With CRISPR

    Sean C. McConnell, PhD
    Clinically and ethically relevant questions are related to patient safety, therapeutic efficacy, equitable access, and global governance over humanity’s genetic legacy.
    AMA J Ethics. 2019;21(12):E1079-1088. doi: 10.1001/amajethics.2019.1079.
  • Medicine and Society
    Dec 2019

    What Should Clinicians Do to Engage the Public About Gene Editing?

    Tom Alsaigh, MD, Laura Nicholson, MD, PhD, and Eric Topol, MD
    Clinicians should have a working understanding of gene editing, controversy surrounding its use, and its far-reaching clinical and ethical implications.
    AMA J Ethics. 2019;21(12):E1089-1097. doi: 10.1001/amajethics.2019.1089.
  • Art of Medicine
    Dec 2019

    Sunset

    Antonio Yaghy, MD
    This image aims to promote reflection about patients’ feelings of sadness, despair, helplessness, and uncertainty upon being diagnosed.
    AMA J Ethics. 2019;21(12):E1103-1104. doi: 10.1001/amajethics.2019.1103.
  • Viewpoint
    Dec 2019

    Genome Editing, Ethics, and Politics

    Isabel Gabel, PhD and Jonathan Moreno, PhD
    Genome editing raises old questions, but CRISPR arose in a political landscape that vastly differs from the early aughts.
    AMA J Ethics. 2019;21(12):E1105-1110. doi: 10.1001/amajethics.2019.1105.