For four decades, scientists world-over have self-imposed a moratorium on doing laboratory research on human embryos 14 days post-fertilization. It’s known as the 14-day rule. This research is done outside the womb in petri dishes or test tubes or by examining early cells under the microscope.
Until recently, research beyond 14 days was only a theoretical issue, as scientists didn’t have the tools to keep experimental embryos alive longer. But that’s changed. Technology is now available to prolong the viability of the embryo in the laboratory. Consequently, a fierce debate has emerged over whether to expand the permissible research window to 28 days.
A growing number of proponents claim the additional two weeks would yield major scientific benefits. Studying human embryos at this stage of development could furnish crucial information, such as why miscarriages happen and why birth defects and genetically-derived malignancies occur. It could further a better understanding of how primitive tissues and early organs develop, including the nervous system (which does not appear until after the second or third week after fertilization). Human embryos are also important for stem cell research, as researchers develop cell-based therapies to treat human diseases.
“[I]t is now safe and timely to make a policy change and extend the rule without fear of any ‘moral and regulatory slippery slope,” wrote Sophia McCully, an influential bioethicist and member of the British Pharmacological Society, in the Journal of Medical Ethics in 2021.
But not everyone agrees. Philosopher Anna Smajdor, a University of Oslo bioethicist, challenges the push to extend the 14-day rule. The arguments she and other critics make are social and philosophical, not biological or research-need oriented ones. No one is hurt by the current standard, she says, therefore there is no reason to change it.
Either position — keeping the 14-day cut-off or extending it — raises fundamental science and ethical questions about experimenting on embryos: On what basis should we decide and who should make the decision?
Differing laws around the world
With doctors, scientists, and ethicists promoting different analytical frameworks, agendas, and perspectives, science is at a stalemate. The key problem is that there is no agreed upon objective method to guide countries in evaluating whether to revise the current standard. (The same problem vexes us on similar issues arising out of new technologies, such as whether to allow human genetic engineering or human cloning for reproductive purposes).
Last year, the British-based International Society for Stem Cell Research (ISSCR), which is widely considered the official voice of the stem cell community, announced it no longer endorsed the prevailing international 14-day standard.
Previously revised in 2016, the ISSCR standard has long provided a rubric for what science the biomedical community agrees is worthy, and which projects are off-limits. It recommended that “national academies of science, academic societies, funders and regulators” around the world engage the public in conversations about the scientific and issues and whether the two-week limit should be extended depending on the research objectives.
The guidelines traditionally have carried unusual weight globally. In the United States, no federal statute regulates research on embryos (as is also the case for the IVF industry, which is mostly unregulated). However, in a non-binding opinion in 1979, the Ethics Advisory Board of the Department of Health, Education, and Welfare supported a voluntary 14-day rule.
Similarly, Canada, China, India, Japan, and Spain permit experimentation until 14 days, although their positions are cemented by law. Other countries take more extreme positions, for and against.
On one end of the policy spectrum, Austria, Germany, Italy, Russia and Turkey forbid research on human embryos. The Oviedo (Bioethics) Convention of the Council of Europe with 35 signatory countries, 29 of which have ratified it, opposes embryo research altogether. The Netherlands, while not a signatory, currently agrees, although it is in the process of reviewing their law, the Dutch Embryos Act.
On the other end of the policy spectrum, Brazil and France set no time constraints. This may be a harbinger of research tourism, as scientists might seek out countries with relaxed legal constraints.
The debate is fiercest in the United Kingdom, where ISSCR is based. Embryo research (along with IVF procedures and practice) is governed by the Human Fertility Act (HFA), first enacted in 1990. The 14-day standard was reviewed in a comprehensive 2017 report by the Nuffield Council on Bioethics. Now, some British scientists and ethicists are calling to amend and relax the HFA. John Applebay is a lecturer in medical ethics at Lancaster University:
We now know more about the science of embryo development compared to over 30 years ago when the Act came into force. It now makes ethical and scientific sense to extend the permissible window for embryo research to 28 days (i.e., the ’28-day rule’). Maintaining the status quo of the 14-day rule is therefore by no means a morally neutral option.
Should policymakers seek out guidance from philosophers, ethicists, lawyers, scientists or the public?
In the UK and some European countries, the government leans on philosophers and lawyers to draft policies—what Sheila Jasanoff, Harvard University professor of law and society, has called “official bioethics”. (Something similar happens in the US with regard to health insurance determinations, although the issues are more mundane and revolve around politics and economics rather than bioethics).
But the method upon which even scholars base their recommendations is anything but structured, uniform, reliable, or even widely accepted in the philosophical community, argued the late Mary Warnock, a British philosopher of morality, education and the mind.
Warnock is best known for chairing a 1984 commission whose report formed the basis of the British Human Fertilisation and Embryology Act (1990 as amended). She spent decades exploring “where do you draw the line,” arguing that the public is “entitled to know, and even to control” professional practices.
But know what? And what tools would the public use to evaluate, let alone “control” researchers?
In a sense, the 14-day rule that she and her commission endorsed — which also underlies the recent HFA ruling on the issue — was based on something akin to ‘gut bioethics’. Warnock herself admitted she couldn’t reconcile the different perspectives of the committee members when she first unveiled her recommendation, and called for the public to sound in:
[M]any of the philosophers … could not shake off the belief that morality was a set of subjective and often incompatible views and premises. [Some said] “Look at the benefits” and [others] … at the other extreme, [some] said “I don’t care what the benefits are: I feel it to be wrong…”
Jasanoff has agreed with Warnock. She, too, wants ‘society’ (the lay populace) to take control over the inquiry. But if scientists and ethicists are having such differences, one wonders how the public will grapple with the issue.
Barbara Pfeffer Billauer, JD MA (Occ. Health) Ph.D. is Professor of Law and Bioethics in the International Program in Bioethics of the University of Porto and Research Professor of Scientific Statecraft at the Institute of World Politics in Washington DC.
Editor’s note/correction: Title updated 9-27-22 at 10:14amET
