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The purpose of this blog is to stimulate thought and discussion about important issues in healthcare. Opinions expressed are those of the author and do not necessarily express the views of CMDA. We encourage you to join the conversation on our website and share your experience, insight and expertise. CMDA has a rigorous and representative process in formulating official positions, which are largely limited to bioethical areas.

Crossing the Bright Red Line: Editing Human Beings

August 2, 2017

by D. Joy Riley MD, MA (Ethics)

This blog originally appeared on the Tennessee Center for Bioethics and Culture blog. It is being republished with permission. For more information, visit


“Sooner than we expected.” A friend—a scientist steeped in the bioethics realm—wrote to me of her surprise at the announcement of the first embryonic humans edited in the United States. Steve Connor, writing in the MIT Technology Reviewreported the work on July 26. Doubtless, the publication of the work in a scientific journal will follow.

The article, “First human embryos edited in U.S.” by Steve Connor, describes the process thusly: “A person familiar with the research says ‘many tens’ of human IVF embryos were created for the experiment using the donated sperm of men carrying inherited disease mutations.” It is not clear which mutation(s) was/were present in the sperm. The gene editing took place at fertilization, and the embryos were allowed to develop for “a few days.”

The work was done by Shoukhrat Mitalipov and his team at the Oregon Health and Science University. Mitalipov has previously been in the news for his cloning work (here and here) and his application to the FDA to allow him to produce embryos through “mitochondrial replacement,” otherwise known as “three-parent embryos.” There has been some discussion and disagreement about whether or not the three-parent embryos, which dealt only with the DNA in mitochondria, constituted germline engineering, whereby genetic changes are passed along to future generations. That is because mitochondria are only passed from mother to child. If only male embryos were produced as “three-parent embryos,” then that genetic change would not be passed along to succeeding generations.

There is no question about the gene-editing of nuclear DNA, however. This work by Mitalipov’s lab is germline engineering and crosses a line that heretofore has been a bright red line. In fact, as recently as 2008, of the 192 countries in the world, 44 had laws explicitly banning germline modification, and NO nation had any explicit law permitting it (see the testimony of Richard Hays; countries are listed in the graphic to the right).

Should we be surprised?

  1. The U.S. does not have laws explicitly banning germline modification/engineering. Indeed, Connor notes in the MIT Technology Review article about Mitalipov: “His team’s move into embryo editing coincides with a report by the U.S. National Academy of Sciences in February that was widely seen as providing a green light for lab research on germline modification. The report also offered qualified support for the use of CRISPR for making gene-edited babies, but only if it were deployed for the elimination of serious diseases.
  1. Although Shoukhrat Mitalipov holds a position in the department of obstetrics and gynecology at the Oregon Health & Science University, he is not a physician. Instead, he holds a PhD in developmental and stem cell biology, and a master’s degree in biology of reproduction from Russian universities. He was a postdoctoral fellow in the department of animal, dairy and veterinary sciences at Utah State University. Presumably, he has taken no oath forswearing harm to humans.  Even if he had forsworn causing harm to humans, many people, including some physicians, do not regard microscopic embryonic humans as “fully human.”
  2. At least in the United States, the stage has been set, gradually, step by step, for such research to take place. (See “CRISPR—Who’s In Charge, Parts I-III” here for recent developments.)
D. Joy Riley MD, MA (Ethics)

D. Joy Riley MD, MA (Ethics)

Dr. Riley is executive director of The Tennessee Center for Bioethics & Culture and serves on the ethics committee of a Nashville-area hospital. Board certified in internal medicine, her writing and lecture topics include medical ethics, organ transplantation ethics, stem cell research, genetics, end-of-life issues and assisted reproductive technologies. With Scott B. Rae, she co-authored Outside the Womb: Moral Guidance for Assisted Reproduction, and with C. Ben Mitchell, Christian Bioethics.