The UK’s first guidelines for research with stem cell-grown embryo models state that all studies involving these models should be overseen by a dedicated committee.
Scientists have been uncertain about the appropriate boundaries of their work due to long-standing ethical and legal issues. These are intended to be resolved by the code of practice by a working group headed by researchers from the University of Cambridge.
Although stem cell-based embryo models are exempt from UK laws prohibiting the use of embryos in research, they are comparable to real embryos in that they are used to investigate early developmental processes.
There has never really been a chance for scientists, ethicists, and lawyers to get together and reach a moral consensus on using these embryo models.
Sarah Edwards, Bioethicist, University College London
Traditionally, human embryos donated by patients undergoing in vitro fertilization have been used by scientists researching the early stages of human development. However, these embryos can be difficult to get, and they can only be researched for a maximum of 14 days following fertilization according to UK law.
An alternative has surfaced recently: biological constructs resembling embryos made from human stem cells. These models may be produced in enormous quantities from a single cell line in the laboratory because they are biological models rather than real human embryos, they can also be utilized to investigate developmental processes beyond the 14-day mark.
Still, there are significant ethical concerns with stem cell-based embryo models. For example, it is unknown if they could eventually grow into viable organisms. Guidelines for working with embryos were issued by the International Society for Stem Cell Research (ISSCR) in 2021. One of the recommendations was for nations to set up specialized oversight for work on specific types of embryo models. Until now, no such framework has existed in the UK.
After more than two years of collaboration with researchers, attorneys, sociologists, bioethicists, organizations like ISSCR, and the general public, a new code of practice was developed.
We wanted to include as many voices as possible, it is so important that the working group reflects the perspectives of people all across the U.K.”
Roger Sturmey, Developmental Biologist, University of Hull
Sturmey chaired the working group that put the document together.
The creation of an oversight committee to examine each research project involving stem cell-based embryo models is one of the group's main proposals. The group, which was composed of scientists, lawmakers, sociologists, and bioethicists, would weigh the moral, social, and ethical ramifications of the research before determining whether to approve it.
Consistent with the ISSCR's 2021 guidelines, the paper does not set a definitive time limit for how long researchers can develop embryo models in the lab. The authors state that because different embryo models represent different embryonic stages and develop at different rates, it is unrealistic to have a single set time restriction.
According to Sturmey, researchers must instead provide a case-by-case justification for the duration of their experiments.
The code stipulates that neither the development of an embryo model into a living organism nor its transfer into the womb of a human or an animal should be permitted. The report does not suggest various degrees of monitoring for less complete, “nonintegrated” models and “integrated” models that incorporate cells found beyond the embryo, such as early placental cells, in contrast to the ISSCR standards.
The guidelines also call on scientists to increase public trust by disclosing study findings and being open about it.
It is the moral duty of scientists to communicate their research to the public as, fundamentally, the research should suit the public’s interests. One could argue that the groups who are sprinting fastest ahead in research have the biggest responsibility of all.”
Kathy Niakan, Chair- Interdisciplinary Group, Cambridge Reproduction, University of Cambridge
Not engaged in the report, Paola Bonfanti, a stem-cell biologist at the Francis Crick Institute, stated, “Controversy around using stem cells and embryoids in research still exists, just because we can model embryos does not mean we can rebuild humans in a dish. It is paramount that scientists communicate this effectively to the public.”
To join the oversight committee, the group is currently searching for interdisciplinary expertise around the United Kingdom.
As research with embryo models advances so quickly, the team promises that the rules will be periodically evaluated and modified.
Although they are voluntary, Sturmey said the guidelines “should be adhered to by all research groups, as it shows they are working in a moral and responsible way.”
Researchers Develop Innovative Human Macrophage Model for Disease Study