Embryo research law needs tweaking to catch up with science

iBlastoid, with trophectoderm-like structure in blue and inner cell mass-like structure in yellow. © Monash Biomedicine Discovery Institute
  • Published in The Age, an opinion piece by Professor John Carroll explains that the new International Society of Stem Cell Research (ISSCR) guidelines on how research into early human life should proceed include statements that are in contradiction to Australian legislation, and that to bring Australian iBlastoid research into line with the new international recommendations will require discussion and possibly legislative change.
  • Read the in-depth story about the iBlastoid research, published in Nature in March 2021.

In March, Australian scientists made a globally significant announcement – they had generated a model of an early human embryo from skin cells, called iBlastoids. The discovery was important because it will allow researchers to investigate, without using human embryos, a time in human development that has been to date inaccessible, giving insights into the causes of infertility, developmental abnormalities and miscarriage.

In the last week of May, the international body representing stem-cell scientists released new guidelines on how research into early human life should proceed. The International Society of Stem Cell Research (ISSCR) guidelines incorporate recent advances like the iBlastoid models and provide a number of recommendations that potentially allow scientists to learn more about the earliest stages of human life. Importantly there are also clear statements on what should not be allowed, like genetic manipulation.

The most significant recommendation is the relaxing of the decades-old “14-day rule”, which in Australia and about a dozen other countries is a regulatory line-in-the-sand beyond which scientists cannot experiment on human embryos.

The 14-day rule dates back to the 1980s, a time when it was not possible to grow human embryos for longer than around six days post-fertilisation. While new technology now allows researchers to grow embryos in the lab beyond 14 days, the rule has meant that research designed to take them any further has not happened.

Why 14 days? It’s at day 14 that a human embryo ceases to be a ball of cells and develops the “primitive streak”, the very beginning of the neural cord that will ultimately give rise to the central nervous system. The deadline provided absolute clarity at a time when embryo research was a very new concept and had the dual benefit of engendering public trust while at the same time providing scope for research into early human development.

Now that scientists are able to culture human embryos for longer, there have long been calls to consider a revision, which these guidelines now address.

So, instead, what controls can be put in place to regulate human embryo research? The guidelines recommend that researchers wanting to grow human embryos beyond the two-week mark have their projects considered on a case-by-case basis, subject to several phases of review, to determine when the experiments must be stopped.

Of particular importance to Australian science is the ISSCR’s recommendation to address the creation of embryo-like or model structures from human stem cells, like the iBlastoids generated by Professor Jose Polo and his team at Monash University.

The new guidelines state that – given that these embryo models are not considered equivalent to human embryos under most legislation globally – they are not subject to the restrictions of the 14-day rule.

This statement brings the guidelines into direct contradiction with the current Australian 2002 legislation which defines an embryo not only as a product of an egg and a sperm, but also an embryo created by “any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears”.

iBlastoids can model several aspects of embryo biology, making them a great research tool, however they exhibit enough changes in their molecular and cellular makeup that scientists consider them different to human embryos. Regardless, the National Health and Medical Research Council has determined that, under Australian legislation, iBlastoids are subject to the same rules as research undertaken on real human embryos, including the need for a research licence and the 14-day rule.

Bringing Australian iBlastoid research into line with that of the new international recommendations will require discussion on the definition of a human embryo and possibly legislative change.

This is nothing to be frightened about. In 1979, when IVF was first developed, it would never have been predicted that more than 8 million babies, for parents who would unlikely have been unable to have a child, would result.

We have come a long way in being able to ethically and responsibly work with human embryos, and models of human embryos, so that we can unravel the causes of infertility, developmental abnormalities and miscarriage. The comprehensive and brave ISSCR guidelines are a timely reminder that, as is often the case, the law must change to keep up with science, and allow breakthroughs like IVF to happen.

Professor John Carroll - Director, Monash Biomedicine Discovery Institute / Dean, Biomedical Sciences at Monash University. This article appeared in The Age on 7 June 2021.


About the Monash Biomedicine Discovery Institute at Monash University

Committed to making the discoveries that will relieve the future burden of disease, the newly established Monash Biomedicine Discovery Institute at Monash University brings together more than 120 internationally-renowned research teams. Spanning six discovery programs across Cancer, Cardiovascular Disease, Development and Stem Cells, Infection and Immunity, Metabolism, Diabetes and Obesity, and Neuroscience, Monash BDI is one of the largest biomedical research institutes in Australia.  Our researchers are supported by world-class technology and infrastructure, and partner with industry, clinicians and researchers internationally to enhance lives through discovery.

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