Jeffrey Kahn, Andreas C. Dracopoulos Director of the Berman Institute and Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, has been appointed to an international commission convened by the U.S. National Academy of Medicine, the U.S. National Academy of Sciences, and the Royal Society of the U.K., with the participation of science and medical academies around the world, to develop a framework for scientists, clinicians, and regulatory authorities to consider when assessing potential clinical applications of human germline genome editing. The framework will identify a number of scientific, medical, and ethical requirements that should be considered, and could inform the development of a potential pathway from research to clinical use – if society concludes that heritable human genome editing applications are acceptable.
The commission is the latest action from the international science community to address issues around human genome editing. It follows the Second International Summit on Human Genome Editing in Hong Kong – convened last November by the U.S. National Academies, the Royal Society, and the Academy of Sciences of Hong Kong. The topic became a focus of global attention when a scientist from China revealed at the summit that as a result of his research, twins had been born whose embryonic genomes had been edited. The scientist was widely condemned by the global scientific community for violating long-standing scientific principles and ethical norms.
The commission will:
identify the scientific issues – as well as societal and ethical issues, where inextricably linked – that must be evaluated for any possible clinical application of germline genome editing;
identify protocols and preclinical validation for evaluating the potential for off-target effects, mosaicism, and any potential long-term side effects that may result;
discuss ways to assess the balance between potential benefits and harms of germline editing applications to a child and to subsequent generations;
design appropriate protocols for obtaining patient consent and ethical approval from review committees, and for satisfying requirements of regulatory authorities;
assess possible mechanisms for long-term monitoring of children born with edited genomes; and
outline research and clinical characteristics that would form part of an oversight structure, including defining criteria for heritable genome editing, monitoring any clinical use, and bringing forward concerns about human experiments.
The commission will hold public meetings and an international workshop, and will also issue a call for public input to inform their work. The commission’s final report is expected to be issued in the spring of 2020.
Professor Rothenberg is a leading national expert on legal issues in health care. Over the last two decades she has focused her research primarily on the ethical, legal and social implications of genetic testing and research, including the legislative approaches to genetic information in the health insurance and employment context, the impact of genetic research on racial and ethnic populations and women’s health care, and the use of genetic information in the courtroom. Professor Rothenberg is co-editor of the book Women and Prenatal Testing: Facing the Challenges of Genetic Technology and co-author of five articles on genetics and public policy that have been published in the journal Science, the most recent of which is “Judging Genes: When Should Judges Admit or Compel Genetic Tests?” Her other numerous publications cover diverse research interests including the role of gender in health care, AIDS, research ethics, the right to forego treatment, emergency care, and new reproductive technologies. She has testified before federal and state legislatures on a wide range of issues, including the U.S. House of Representatives’ Genetic Information Nondiscrimination Act.
Professor Rothenberg has served on the Maryland Stem Cell Research Commission since its inception in 2006 (Chair from 2008-2010) and Co-Chaired the 2009 World Stem Cell Summit. She is a past president of the American Society of Law, Medicine and Ethics and former co-editor-in-chief of the Journal of Law, Medicine & Ethics. During sabbaticals and IPA leaves from the law school, she has worked at the NIH in the Office of Research on Women’s Health, the National Institute for Child Health & Human Development (NICHD) and NHGRI. She has served on the NICHD Institutional Review Board and has been a member of the NIH Recombinant DNA Advisory Committee, the National Action Plan for Breast Cancer, and numerous NIH panels on prenatal care, the recruitment and retention of women in clinical studies, and the ethical, legal and social implications of genetics.
She received both a B.A., magna cum laude and Phi Beta Kappa, from Princeton University and an M.P.A. from Princeton’s Woodrow Wilson School of Public and International Affairs. She earned a J.D. from the University of Virginia School of Law where she was a member of the Order of the Coif.
Dr. Sugarman is the author of over 350 articles, reviews and book chapters. He has also edited or co-edited four books (Beyond Consent: Seeking Justice in Research; Ethics of Research with Human Subjects: Selected Policies and Resources; Ethics in Primary Care; and Methods in Medical Ethics). Dr. Sugarman is on the editorial boards of several academic journals.
Dr. Sugarman consults and speaks internationally on a range of issues related to bioethics. He was senior policy and research analyst for the White House Advisory Committee on Human Radiation Experiments, consultant to the National Bioethics Advisory Commission, and Senior Advisor to the Presidential Commission for the Study of Bioethical Issues. He also served on the Maryland Stem Cell Research Commission.
He was the founding director of the Trent Center for Bioethics, Humanities and History of Medicine at Duke University where he was also a professor of medicine and philosophy. He was appointed as an Academic Icon at the University of Malaya and is a faculty affiliate of the Kennedy Institute of Ethics at Georgetown University.
Dr. Sugarman is currently a member of the Scientific and Research Advisory Board for the Canadian Blood Service and the Ethics and Public Policy Committees of the International Society for Stem Cell Research. He is co-chair of the Johns Hopkins’ Institutional Stem Cell Research Oversight Committee. In addition, he is chair of the Ethics Working Group of the HIV Prevention Trials Network and co-leads the Ethics and Regulatory Core of the NIH Health Care Systems Research Collaboratory.
Dr. Sugarman has been elected as a member of the American Society of Clinical Investigation, Association of American Physicians, and the National Academy of Medicine (formerly the Institute of Medicine). He is a fellow of the American Association for the Advancement of Science, the American College of Physicians and the Hastings Center. He also received a Doctor of Science, honoris causa, from New York Medical College.