Clear rules governing human embryo research must be established to enable regulators, researchers and funders to assess whether stem cell-generated models should be considered as 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 hereditary diseases, early miscarriages and IVF outcomes. But they warn: “In most countries, including the UK, human embryo models are not formally defined in legislation, and are therefore not captured by regulations governing in vitro embryo research.

While creating opportunities to explore aspects of embryo development that would generally be impermissible were real human embryos to be used, this regulatory climate has also attracted concern from stakeholders involved in human embryo model research.” The authors reference the HYBRIDA project - a three-year initiative funded by the European Commission - which revealed that researchers were concerned about whether certain types of human embryo model research would be deemed to be creating human embryos and thereby excluded from EU funding programmes, as well as potentially running counter to local laws and guidelines. However, Lewis and Holm stress that defining the human embryo for the purposes of human embryo model research “is no easy task.

” They continue:.