Biological models of human embryos that can develop heartbeats, spinal cords and other distinctive features will be governed by a code of practice in Britain to ensure researchers work responsibly.
Made from stem cells, they more or less mimic the biological processes that work in real embryos. By growing them in the lab, scientists hope to learn more about how human embryos develop and respond to their environment, questions that would be impossible to answer with real embryos donated for research.
Scientists have been working on stem cell-based embryo models, or SCBEMs, for years, but the technology only made global headlines last summer when researchers said they had created one with a heartbeat and traces of blood. Made without the need for eggs or sperm, the ball of cells has some features that would typically appear in the third or fourth week of pregnancy.
The technology, which proponents believe could shed new light on possible causes of infertility, is so new that SCBEMs are not directly covered by UK law or regulations. The situation makes the scientists continue the research in an uncomfortable gray area. The new guidelines, drawn up by experts at the University of Cambridge and the Progress Educational Trust, aim to clarify the situation by setting out rules and best practice.
Dr Peter Rugg-Gunn, a member of the code of practice working group, said the guidance had “taken stem cell-based embryo models out of the gray zone and onto more stable footing”. It should also reassure the public that research is conducted carefully and under proper scrutiny, added Rugg-Gunn, who is a group leader at the Babraham Institute.
The code reminds researchers that there can be “a range of emotional reactions” to SCBEMs with heartbeats, spinal cords and other recognizable features, and urges them to be “aware of and sensitive to these concerns, regardless of whether they are considered ethical .or legally relevant”.
Under existing UK law, scientists can grow actual human embryos donated for research in the laboratory for up to 14 days, although many argue that the limit should be extended to allow the study of later stages of embryonic development.
The new guidelines establish an oversight committee that will decide on a case-by-case basis how long specific embryo models can be cultured. The code does not rule out experiments that make them grow for more than 14 days, but Roger Sturmey, professor of reproductive medicine at Hull York Medical School and chair of the code of practice working group, said any such experiments “would have to be very well justified become”.
The code prohibits any human SCBEMs from being transferred into the womb of a human or animal, or allowed to develop into a viable organism in the laboratory.
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Sandy Starr, the deputy director of the Progress Educational Trust, said he expected researchers, funders, research institutes, publishers and regulators to recognize the guidelines. Scientists who worked outside the code would “find it difficult to publish, find funding and face scorn from their peers”, he added.
