Scientists seek to abolish ‘14-day rule,’ plan to do stem cell research on older embryos
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SKOKIE, Illinois, March 18, 2021 (LifeSiteNews) — An international body of scientists representing the stem cell research community plans to lift the current “ethical” ruling that embryos can only be grown for up to 14 days for the purposes of stem cell research, allowing human embryos to be cultured indefinitely.
The “14-day rule,” first published in 1979, has been in effect for over 40 years and has been incorporated into law in some countries, including the U.K. and Japan, but only exists as a guideline in the U.S. and China, among others.
The MIT Technology Review published a report on the International Society for Stem Cell Research’s (ISSCR) proposed extension to the hard limit. The ISSCR, which the Review noted has become the industry’s “de facto ethics regulator,” is considering the change in its current ruling “because of an onrush of new, boundary-busting research,” rather than being due to ethical considerations, the report said.
As an example, the Review details that a number of labs are now in the process of creating human-animal hybrids, or chimeras, from human cells and monkey embryos. At present, the two-week limit, after which point cultured embryos are destroyed, “stands in the way” of furthering this research.
The Review noted that throughout the “last 40 years, this voluntary guideline has served as an important stop sign for embryonic research. It has provided a clear signal to the public that scientists wouldn’t grow babies in labs. To researchers, it gave clarity about what research they could pursue.”
But now, the repeal of the rule “would come at a time when scientists are making remarkable progress in growing embryonic cells and watching them develop. Researchers, for example, can now create embryo-like structures starting even from stem cells, and some hope to follow these synthetic embryo models well past the old two-week line.”
The current 14-day limit delineates the point of cell differentiation, when distinct characteristics like a head and limbs begin to take on their unique form. This developmental marker first became a limit in embryonic research as in vitro fertilization (IVF) became possible, and popular, towards the end of the 1970s.
Speaking to LifeSiteNews, Dr. Michael J. New, associate scholar at the Charlotte Lozier Institute in Washington, D.C., raised concerns over the ISSCR’s proposal and questioned the trustworthiness of the people behind the push to gradually augment the research limit. He explained that “[as] technology has advanced, scientists want to push the envelope and allow for embryonic experimentation and research for even longer time periods.”
“In February, the Journal of Medical Ethics published an article by Sophia McCully proposing that the limits be extended to 28 days. However, this limit is arbitrary. As technology improves, scientific researchers will seek to conduct research on human embryos even later in their development,” he warned.
New cautioned to the unpredictability of scientific advancement. Pro-lifers, he said, should be concerned about the “distinct possibility in the future” of the development of artificial wombs.
“This would allow for experimentation on fetuses several months old. It could even allow for gruesome practices involving widespread harvesting of fetal organs. Historically, the scientific community has done a poor job setting ethical limits for its research practices. For instance, few in the scientific community have raised ethical concerns about using the body parts of aborted babies for research,” he said.
The Review also noted the growing possibility of “ectogenesis,” the growing of animals outside of the womb, including human children, since scientists are “motivated to grow embryos longer in order to study — and potentially manipulate — the development process.”
New explained that “[r]esearch on human embryos is an important bioethical issue that should concern pro-lifers.” He proposed that the “Dickey Wicker amendment, which limits the ability of the federal government to fund the creation of human embryos for research purposes, should be strengthened. Additionally, the United States should join Austria, Germany, Italy, Russia and Turkey by prohibiting research on human embryos.”
According to the MIT Technology Review, Josephine Johnston, a scholar with the Hastings Center, an ethics research institute, said that the creation of embryos outside the womb prompted the scientific community to establish ad hoc rules. “It was a political decision to show the public there is a framework for this research, that we aren’t growing babies in labs,” she said, despite the fact that babies are, in the earliest stages of their development, grown outside of the womb as part of the IVF process.
Initially, the two-week boundary posed no problem to IVF researchers and developers, who at the time were only able to foster embryos for a few days, which was sufficient for the IVF procedure and meant they had no methodological reason to object to the “ethical” limit. Alta Charo, a former professor at the University of Wisconsin and a member of ISSCR’s steering committee, observed that while there was no meeting of the research and the time limit, “you didn’t have to measure a loss in knowledge against other concerns, because we didn’t know how to culture things that long. That is what has changed. It’s easy to say no when it can’t be done.”
Now that scientists are able to grow embryos outside of the womb beyond that timeframe, objections to the limit are beginning to arise. Some scientists rallying for an extension in the rule couch their call for derestricting research by supporting an incremental relaxation of the rules, or having specific cases of research be given special permission to test beyond the normal limit.
Others justify abandoning the rule on account of the possibility of improving fertility or discovering the cause of birth defects. Johnson explained her belief that research beyond 14 days is not “driven by a concern for infertility or early miscarriage,” but rather it is “driven by an area that is still unexplored.”
“The embryo is a bit of a black box, and they would like to chart that territory,” she said.
Insoo Hyun, a bioethicist at Case Western Reserve University and co-author of the ISSCR’s research guidelines, confirmed Johnson’s speculation by suggesting that the time limit be extended to aid studies into genetic editing and its effects. “We would have to ensure they [embryos] develop normally, and to do that you have to study them beyond 14 days,” Hyun said, “You need to study that embryo as long as you can.”
According to the review, “startling technical advances” in embryonic research prompted the review in the 14-day guideline, which has been prepared since December, but researchers were afraid to publish it until this year for “[f]ears of a presidential tweet or government action to impede research” during Donald Trump’s tenure. Now, under President Joe Biden, those fears seem to have been allayed.