Two leading experts from the University of Manchester argue that clear rules should be created for research on human embryos in order that regulators, researchers and funders can assess whether models derived from stem cells must be considered human embryos.
In a joint article published online by Policy@Manchester, Dr Jonathan Lewis and Professor Søren Holm explain that studies using “human embryo models” have the potential to enhance understanding of some genetic diseases, early miscarriages and IVF outcomes.
Nonetheless, they warn: “In most countries, including the UK, human embryo models should not formally defined in law and subsequently should not covered by embryo research regulations. While this regulatory climate creates opportunities to explore elements of embryo development that might not generally be permitted using real human embryos, it has also raised concerns amongst stakeholders involved in human embryo model research.”
The authors point to the HYBRIDA project – a three-year initiative funded by the European Commission – which revealed that researchers were concerned about whether certain forms of research on human embryo models may very well be regarded as the creation of human embryos and thus excluded from EU funding programs, and will also potentially violate local laws and guidelines.
Nonetheless, Lewis and Holm emphasize that defining the human embryo for the needs of research on human embryo models is “not a simple task.”
They proceed: “There is no such thing as a consensus on what a human embryo is when it comes to its defining characteristics and determining conditions. An alternate approach is to deal with the standard functional capabilities of a human embryo (e.g., the flexibility to form a human). This could mean testing a human embryo model to find out whether it possesses the relevant functional capabilities. The issue is that such testing would undoubtedly be considered unethical because it might require implantation right into a uterus.”
The scientists imagine that “a regulatory definition of the human embryo” is subsequently needed. They write: “This could not only be certain that sufficiently advanced human embryo models are treated from a legal perspective in a fashion comparable to IVF embryos, cloned embryos and other human embryos intended for research purposes, however it would also allow researchers to develop and investigate human embryo models with a greater degree of certainty about what legislators and funders require of those models.”
Subsequently, as outlined of their final report on the HYBRIDA project, Lewis and Holm advocate two recent measures.
“First, individual countries and the EU Commission should develop a regulatory definition of the human embryo to offer researchers certainty about whether their models are covered by embryo research laws or policies,” they argue. “This provides a wonderful opportunity for the UK to be a worldwide pioneer in developing such a regulatory definition for the needs of human embryo model research and enshrining it within the relevant laws.”
And secondly: “The UK and the EU must develop common standard clauses for cooperation agreements to be certain that the commitment to not create human embryos is recognised as valid in all countries involved within the cooperation.”
The authors conclude: “Failure to reply urgently to those calls for regulatory reform couldn’t only result in potential legal challenges to the research of those currently developing increasingly advanced and complicated human embryo models, but could also seriously hamper the cross-border collaboration on which human embryo model research and the supposed health advances related to it depend.”
