News Release

Call to re-examine '14-day rule' limiting in vitro human-embryo research

Technological advances present opportunity to revisit current standard

Peer-Reviewed Publication

Case Western Reserve University

Bioethicists from Case Western Reserve University School of Medicine and The Hastings Center, working with a research administrator at The Rockefeller University, are proposing a reexamination of an internationally recognized rule limiting in vitro research on human embryos to 14 days post-fertilization. Under the rule, such research is permitted before the cut-off date at 14 days and prohibited thereafter.

In a Comment piece published in the May 4, 2016 online edition of Nature, the authors say that what is known as the "14-day rule" has essentially been theoretical until now because scientists have been technologically incapable of moving past the 14-day threshold. But they also note that the rule has produced great benefit by demarcating a clear time period - "a legal and regulatory line in the sand" ? within which research could take place. Moreover, "[t]he alternatives at each extreme -- banning embryo research altogether or imposing no restrictions on embryo use -- would not have made for good public policy in a pluralistic society," the team writes.

The call for reappraisal comes as two research groups report sustaining human embryos in vitro up to 14 days. This is the first time anyone has reported culturing human embryos in vitro beyond nine days, and rarely have they been reported as being sustained for more than seven. Along with earlier stem cell work carried out at The Rockefeller University, the new achievements could provide scientists with unprecedented capacity to study early human development, say the authors. At the same time, the advances "are on a collision course with the rule that limits embryo research to the first two weeks."

"We understand that this issue raises profound moral questions and that people have different stances regarding this type of research," said the lead author Insoo Hyun, PhD, associate professor of bioethics and philosophy at Case Western Reserve University School of Medicine and director of the CWRU Stem Cell Ethics Center. "But it is important to remind ourselves that the 14-day rule was never promoted as a fixed moral truth. Rather, it was designed to achieve a balance between allowing research and acknowledging opposing convictions on the part of many people. Therefore, as circumstances change, reconsideration of the existing limitations is legitimate."

At least twelve countries, including the United Kingdom, Canada, and Australia, have laws that restrict in vitro research on human embryos to the first 14 days of development. (Switzerland restricts human-embryo cultures to seven days.) In at least five others, including the United States, China, and India, nationally commissioned scientific guidelines stipulate the 14-day rule. Guidelines issued by the International Society for Stem Cell Research for the global research community also uphold the 14-day rule.

In preparing the 14-day rule, hundreds of medical and scientific associations submitted recommendations and dozens of public forums were held. "Any formal changes to the 14-day rule will require consensus-building involving scientists, policymakers and members of the general public," says co-author Amy Wilkerson, associate vice president for research support at The Rockefeller University. "The bioethical considerations are global so any reexamination of the rule should start at an international level. One goal should be to avoid a patchwork of guidelines and regulations that are impediments to collaborative international science."

Co-author Josephine Johnston, LLB, MBHL, director of research at The Hastings Center, notes that a reexamination of the rule need not lead to overturning it. "The 14-day rule was first developed more than 35 years ago, when both the science and the public discussion of embryo research were in different places than they are today. The passage of time alone suggests that a reexamination would be prudent," she says. "We should ask what the rule means for science and policy today, and consider whether it still fulfills its dual purpose of delineating a space for valuable scientific research while respecting the deeply held views of a diverse society. We do not know where such a reexamination may lead, but we believe it is important to openly consider both the scientific merits of research beyond 14 days and the ethical concerns that such research would raise."

In closing, the authors call on scientists to play an educational role in any debate about the 14-day rule. "Researchers of human developmental biology should engage with the public about what they are doing and why it matters. And they should consider designing their experiments in a way that, while furthering discovery, also addresses people's moral concerns," they write, "to prevent a public backlash and the implementation of reactive, more restrictive limits on research."


About Case Western Reserve University School of Medicine

Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation's top medical schools for research funding from the National Institutes of Health. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching. The School's innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century. Nine Nobel Laureates have been affiliated with the School of Medicine.

Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 25 among U.S. research-oriented medical schools as designated by U.S. News & World Report's "Guide to Graduate Education."

The School of Medicine's primary affiliate is University Hospitals Case Medical Center and is additionally affiliated with MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002.

About The Hastings Center

The Hastings Center, founded in 1969, is the longest-serving independent, nonpartisan bioethics research institute in the world. Its mission is to address fundamental ethical issues in health, health care, the life sciences, and the environment that affect individuals, communities, and societies.

About The Rockefeller University

The Rockefeller University is the world's leading biomedical research university and is dedicated to conducting innovative, high-quality research to improve the understanding of life for the benefit of humanity. Our 79 laboratories conduct research in neuroscience, immunology, biochemistry, genomics, and many other areas, and a community of 1,800 faculty, students, postdocs, technicians, clinicians, and administrative personnel work on our 14-acre Manhattan campus. Our unique approach to science has led to some of the world's most revolutionary and transformative contributions to biology and medicine. During Rockefeller's 115-year history, 24 of our scientists have won Nobel Prizes, 21 have won Albert Lasker Medical Research Awards, and 20 have garnered the National Medal of Science, the highest science award given by the United States.

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