Clear rules must be put in place to govern human embryo research so that regulators, researchers and funders can assess whether models produced from stem cells should be considered human embryos, two leading experts from the University of Manchester have argued.
In a joint article published online by Policy@Manchester, Dr Jonathan Lewis and Professor Søren Holm explain that studies with ‘human embryo models’ have the potential to improve understanding of some inherited diseases, early miscarriages and IVF outcomes .
But they warn: “In most countries, including the UK, human embryo models are not formally defined in law and therefore not covered by regulations governing in vitro embryo research. While creating opportunities to investigate aspects of embryo development that would generally be impermissible if actual human embryos were used, this regulatory climate has also attracted concern from stakeholders involved in human embryo model research.”
The authors refer to the HYBRIDA project – a three-year initiative funded by the European Commission – which revealed that researchers were concerned whether certain types of human embryo model research would be considered to create human embryos and therefore excluded from its funding programmes. EU. as well as potentially contrary to local laws and directives.
However, Lewis and Holm emphasize that defining a human embryo for the purposes of human embryo model research is “not an easy task.”
They continue: “There is a lack of consensus about what a human embryo is in terms of its defining properties and defining conditions. An alternative approach involves focusing on the typical functional capacities of a human embryo (eg, capacity to form a human being). This would involve testing a human embryo model to see if it had the relevant functional capabilities. The problem is that such tests would undoubtedly be considered unethical because they would require implantation in a womb.’
The academics believe that a “regulatory definition of the human embryo” is therefore required. They write: “This would not only ensure that sufficiently advanced human embryo models are, from a legal perspective, treated comparable to IVF embryos, cloned embryos and other human embryos intended for research, but would also allow researchers to develop and study human models embryos with a greater level of certainty about what legislators and funders require from these models.”
As a result, and as described in their final report for the HYBRIDA project, Lewis and Holm advocate two new measures.
“First, individual countries and the EU Commission should develop a regulatory definition of a human embryo to provide certainty to researchers about whether their models are captured by embryo research legislation or guidelines,” they argue. “This is an excellent opportunity for the UK to be a global pioneer in developing such a regulatory definition for the purposes of human embryo model research and enshrining it in relevant legislation.”
And secondly, “the UK and the EU must develop agreed standard clauses for cooperation agreements to ensure that the commitment not to create human embryos is recognized as valid in all countries participating in the cooperation.”
The authors conclude: “Failure to respond urgently to these calls for regulatory reform could not only lead to potential legal challenges to the research undertaken by those currently developing increasingly advanced and complex models of human embryos , but also to seriously impede the cross-border collaboration on which human embryo model research and claimed advances in health care are based.”
