Artificial insemination in vitro-fertilization in a laboratory

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.

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  1. Nowadays, in specific fields, much of the evidence from which scientific discourse is based has tended to be replaced by statements, considered axiomatic, called “principles” or “rights”, but arising from consensus, not from anthropological reality, and that is precisely what has happened in the case of the human embryo.
    If scientific logic is followed, the absolutely certain probability is that we do not cease to belong to our species at any stage of development, although now under functionalist philosophies, only want to recognize the rights, especially to life, of humans who can reason, interrelate, socialize or suffer, functions that by their stage of development does not correspond to early embryos and therefore, they are measured according to unreal postulates from the laws of the same embryology of development.
    Currently, although most of the books on the biology of human development point out that the human being begins at conception and this is taught in any University, for many it is not clear what or who an embryo is.
    The criterion of the Warnock report, which arose from the need to endorse assisted reproduction, continues to be not only valid, but as the article by Sony and Baylis points out, it is now expanded. Although the Warnock report itself pointed out at the time, that in no way was the 14-day limit based on scientific fact, but on consensus, at the time of germline emergence.
    The Committee openly stated that this time limit was a totally arbitrary compromise adopted “in order to mitigate public anxiety” and to allow scientists as much time as possible for embryonic research.
    Yet the Committee admits that embryonic life begins with fertilization: “Once fertilization occurs, the subsequent developmental process continues from one to the next in a systematic order leading to a cleavage, to the morula, to the blastocyst, to the development of the embryonic disc, and thus to identifiable features within the embryonic disc such as the primitive line, neural fold, and neural tube.”
    We now know, from the development of embryology, the unique characteristics of the zygote, its axes, poles, asymmetry, and we also recognize the current inability to know the exact mechanism of monozygotic twinning, which does not coincide only with the appearance of the germ line as the basis of individuality.
    Currently, there is a desire to achieve this social balance on an “ethics of minimums”, but renouncing goods to agree on the “lesser evil” is also irrational, since evil, (greater or lesser), is the absence of good, and precisely “in good” is what Bioethics aims to achieve.
    I consider that from the point of view of ethics, it is more honest to recognize, for those who are in favor of embryonic manipulation, that, indeed, the human being is so from conception, since it never changes in its genome development and that as a human being, as the Universal Declaration on Bioethics and Human Rights points out, is synonymous with person, since this is how it is handled in this Declaration. And, that if it is decided to attempt against the life of that human being, it is done in the awareness that it is a human being and deserves respect, but even so, for interests considered superior to human life, it is decided to attempt against it.
    This reflection would be realistic and sincere, although dangerous for Universal Human Rights, the fight against discrimination and realistic Bioethics.

    María de la Luz Casas M PhD
    Panamerican University, Mexico
    CIBUP
    mcasas@up.edu.mx

  2. Thank you for your comment. I am sympathetic to several of your claims. There is a fundamental point on which we disagree. I do not believe that “human being” and “person” are synonymous terms. The first is about biology and is used to reference a member of the species Homo Sapiens. The second is about ethics and is used to make claims about the right to life. From my perspective, it is possible to have non-human persons just as it is possible that some humans may not count as persons — these are matters for debate and discussion.

    A human embryo can become a human fetus, which in turn can become a live born human. Different individuals will grant this developing being the status of person (protectable life) at different developmental stages

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