Bioethics Forum Essay
Human Embryo Research Beyond 14 Days? International Perspectives
Five years ago, independent research teams in the United States and the United Kingdom succeeded in cultivating human embryos in the laboratory for 12-to-13 days – longer than ever before. They could have continued their research but didn’t. They stopped because of the broad international consensus that such research should not be permitted beyond 14 days (often referred to as the 14-day rule). And, in the U.K. stopping would have been further incentivized by the legal prohibition on such research.
This technical achievement sparked an ethical debate that had been simmering for some time. Following on this research scientists were at pains to highlight the many potential benefits of human embryo research beyond 14 days including increased understanding of human development, the causes of recurring miscarriage, and congenital anomalies.
In late May these scientists, and no doubt others waiting in the wings, got their wish. The International Society for Stem Cell Research (ISSCR) updated its 2016 guidelines, eliminating the previous prohibition on human embryo research beyond 14 days. The task force responsible for the 2021 update included a 10-member steering committee and 35 working group members, including some of the researchers involved in the 2016 breakthrough research.
Laws and Guidelines
The 14-day rule has served as an international standard since 1990 when it was included in the Human Fertilisation and Embryology Act in the U.K. This limit has since been introduced in legislation, guidelines, or codes of ethics in many other countries. A recent survey of 22 top research-intensive countries found that 17 of 22 countries permitted human embryo research and that a majority of these (12 of 17 countries) included the 14-day limit.
In South Africa, the 14-day limit is legally established in the National Health Act 2003, which permits research on embryos with the appropriate permissions and only until the embryo reaches the 14-day threshold. In Canada, the Assisted Human Reproduction Act of 2004 stipulates that no person shall knowingly “maintain an embryo outside the body of a female person after the 14th day of its development following fertilization or creation, excluding any time during which its development has been suspended.”
In the U.S. there is no legally mandated time limit on human embryo research. This is surprising insofar as the U.S. was the first country to propose the 14-day limit back in 1979. There are, however, limits on human embryo research. The Further Consolidated Appropriations Act of 2000 includes a provision (widely known as the Dickey-Wicker Amendment) that prohibits federal funding for human embryo research. Research that is funded by state or local government or by private institutions is not constrained by this. This research is governed by national and international stem cell research guidelines – the 2010 guidelines issued by the U.S. National Academies of Science, Engineering and Medicine and the 2016 guidelines issued by the issued by the International Society for Stem Cell Research. Until recently both include the 14-day rule.
ISSCR Guidelines from 2016 to 2021
The 2016 guidelines included three broad categories of research: permissible after typical research review and approval (category 1), permissible only after specialized research review and approval (category 2), and prohibited (category 3). In the revised 2021 guidelines, these categories are significantly modified. Human embryo research “beyond 14 days or formation of the primitive streak, whichever appears first” is removed from Category 3 (prohibited research activities).
Research up-to 14 days is now explicitly included in Category 2 research (“permissible only after review and approval through a specialized scientific and ethics review process”). As for research that exceeds the 14-day limit, this appears in no research category. Instead, the 2021 guidelines “call for national academies of science, academic societies, funders, and regulators to lead public conversations touching on the scientific significance as well as the societal and ethical issues raised by allowing such research.” In other words, not much guidance here and considerable irony. The revised 2021 guidelines promote public engagement, and yet the decision to discard the 14-rule – an international standard – was made without public input.
This juxtaposition brings to mind the words of Daniel Brison, a professor of clinical embryology at Manchester University: “As scientists it is essential that we are seen not to be changing this rule simply because we now have the technical ability to work beyond 14 days, but instead because we can demonstrate that the public support the aims of the research,” he said. “Without this clear public backing, we risk being accused of changing the rules out of expediency.”
Expediency: “The quality of being convenient and practical despite possibly being improper or immoral.”
Sheetal Soni (@Sheetal_Soni) is a lecturer at the University of KwaZulu-Natal. Françoise Baylis (@FrancoiseBaylis) is University Research Professor at Dalhousie University, a member of the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, and author of Altered Inheritance.