When the current guidelines regarding the ethical use of human embryos in research were developed, scientists couldn’t imagine the possibility of stem cell-derived embryo models (SEMs) that recapitulate different stages of embryonic development. But now that SEMs exist, new regulations and policies that permit their ethically appropriate research use need to be developed according to the paper, “Human Stem Cell-derived Embryo Models: Towards Ethically Appropriate Regulations and Policies,” published today in Cell Stem Cell.
“The similarity of the stem cell-derived embryos to natural embryos raise many ethical questions. It’s not obvious if they should be considered solely as lab models, or as akin to actual embryos in moral status and legal provisions,” said the paper’s co-author Dr. Jeremy Sugarman of the Johns Hopkins Berman Institute of Bioethics. “Ethical issues loom over rapid advances in embryo modeling and we need to take action now to ensure ethically appropriate scientific ingenuity and process.”
Sugarman outlined a number of broad areas with open questions pertaining to the use of SEMs in research, including:
Technical
How similar are SEMs to natural embryos? Can they develop a brain, or be implanted?
Ethical
Do SEMs have moral status? Is it ethically appropriate to derive SEMs? To use them for research?
Regulatory
Do existing laws, policies and legal definitions apply to SEMs? Are existing laws sufficient to regulate them? Do existing oversight bodies have authority over SEM research? Are new laws needed?
Sugarman points out that the 14-day rule that forms the cornerstone of many current embryo research policies and regulations, not permitting their use 14 days after fertilization, is complicated in regard to SEMs since no fertilization event exists from which the counting of days can begin.
“Existing legal definitions of ‘human embryos’ should be adapted to clarify which current provisions apply to SEMs and appropriate oversight must be established for this research,” said Dr. Sugarman.
“It is crucial that the scientific community continues to promote widespread discussion of experimental possibilities in order to inform the public about latest advances in this field, apprehend societal concerns, and propose specific guides for researchers. This kind of leadership is all the more needed as research progress dares human imagination, confounds ethical intuition and challenges the application of existing policies.”
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.
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 was the longstanding chair of the Ethics Working Group of the HIV Prevention Trials Network. He 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 co-leads the Ethics and Regulatory Core of the NIH Health Care Systems Research Collaboratory and is co-chair of the Johns Hopkins’ Institutional Stem Cell Research Oversight Committee.
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.