For the first time in five years, the International Society for Stem Cell Research (ISSCR) has updated its guidelines for stem cell research. One major change is the relaxation of the “14-day rule”, which outlaws growing human embryos in a lab for longer than two weeks.
The ISSCR’s new guidelines do not impose a limit; instead, any project involving the growth of human embryos will be subject to individual approval through a scientific and ethical review process, which will involve assessing public support and ensuring a minimal number of embryos is used.
While some may see this change as controversial, researchers seem to welcome the more nuanced approach to a rapidly developing field.
Professor Megan Munsie from the University of Melbourne, who was a member of the ISSCR 2021 Guidelines Taskforce, says that the new guidelines are necessary in the face of major developments in stem cell and human embryo research since 2016.
“The new guidelines provide a series of detailed and practical recommendations in response to recent scientific and clinical developments,” says Munsie, who is also Convenor of Stem Cells Australia.
“Specifically, they address the ethical and policy issues raised by the use of human embryos in research; creation of human embryo models using stem cells; use of chimeric animals and embryos in research; clinical translation of stem cell-based therapies; and applications of technologies such as mitochondrial donation and genome editing.”
The guidelines will be used as a reference point for not only researchers and doctors, but also policymakers, industry, funding agencies and the public.
However, some of the recommendations are at odds with current national regulations.
For example, the guidelines recommend the relaxation of the 14-day rule, which is law in at least 12 countries, including Australia, New Zealand, the US, and the UK.
The rule is based on the notion that by day 15, the embryo reaches a point of biological individuation. This is also around the time the earliest development of the nervous system begins, which raises the question of whether the embryo can feel pain.
But as researchers have previously pointed out, the answer is not so clear-cut.
“We know that as the embryo starts to develop, there is a greater risk of pain, but the current 14-day limit is an arbitrary compromise between gaining utilitarian benefit of scientific research, and alleviating public concern,” legal scholar Dr Patrick Foong, from Western Sydney University, told Cosmos earlier in the year.
The 14-day rule was therefore a tool to allow scientific research, instead of the alternatives of banning embryo research or removing the restriction altogether.
Now, the new guidelines have removed the specific number of days, but still recommend a rigorous review process. This will provide a foundation on which to drive further national discussions as stem cell research advances.
“The fact that these guidelines have been developed by the research community itself indicates a deep sense of responsibility and integrity and an active desire to ensure that the science is in step with the community,” notes Professor Melissa Little, Chief Scientist at the Murdoch Children’s Research Institute, Melbourne, and incoming President of the ISSCR.
“As we find that we can generate almost any human tissue from a stem cell, we are also beginning to model the earliest stages of human life. Indeed, researchers here in Australia have shown that this is possible and may hold the key to understanding early challenges to life.
“While these are only models, it remains important to have oversight and a framework around appropriate behaviour.”
Professor Rachel Ankeny, an expert in bioethics and science policy at the University of Adelaide, points out that although Australia is well-placed to have such oversight, we will have to step up.
“Australia does not currently have mechanisms for engaging the public or gauging support for such proposals in an efficient or accurate manner, including considerations of social justice, research prioritisation, or appropriate use of resources,” she says.
“If the ISSCR guidelines are to be followed, we will need more systematic engagement of diverse publics about their values in relation to stem cell research, and particular types of studies of embryos beyond 14 days.
“Australia could become a world leader not only in this scientific field but in responsible, transparent, and publicly engaged stem cell research and its applications, if such processes could be put in place.”