<b>July 5, 2003</b> – Scientists in the field of human fertility are coming under pressure to rein in maverick researchers whose experiments push ethical boundaries and caused public revulsion this week. Critics say the lack of agreed standards is damaging the reputation of more mainstream researchers. While some countries have stringent guidelines backed up by enforceable legislation, others have none at all. In those cases, given the will and the cash, anything goes. Eggs and sperm, donated in good faith, can be used in whatever research the scientists desire. Paul Serhal, director of the assisted conception unit at University College London, said fertility research was facing a critical question: "How do we prevent people doing monstrous things?"
The ethical crisis was thrown into vivid relief this week at a European fertility conference in Madrid when an Israeli-Dutch team reported they had matured eggs from an aborted foetus in the hope of finding a new source of eggs for couples needing treatment. Alarmed headlines such as the Sun's Your Mother Was Aborted Baby were followed, the next day, with the news that a private fertility clinic in America had created bizarre hybrid human embryos called chimeras by merging male cells with female embryos.
Approval
Neither experiment would have been allowed in the UK, says the human fertility and embryology authority (HFEA). But the hybrid embryos had received ethical approval in the US and the foetal eggs research was approved in Israel. Both studies were presented in Madrid at the European Society of Human Reproduction and Embryology's annual meeting.
Most scientists are in no doubt that the studies, in particular the work on chimeric embryos, have delivered a blow to the public's confidence in fertility research. "Studies of this nature are going to backfire on mainstream scientists who are doing genuine scientific work," said Dr Serhal. "They will tarnish our image."
Only the HFEA can issue licences for research on embryos in the UK. Certain areas are banned, such as placing a human embryo in an animal. The authority would not have approved the chimera work. "We think it's illegal," said Alison Cook of the HFEA. "The [HFEA] Act says that we are not allowed to alter the genetic material of any embryonic cell. We believe the spirit of the law would not allow you to put in an extra cell."
The prospect of a child being born from an egg from an aborted foetus would also be unacceptable to the authority because of the difficulty for the child coming to terms with its origins. All IVF clinics must consider above all the interests of the children they may help create. But the framework in the UK is not mirrored elsewhere. "The country you most need to regulate is the one that's least likely to accept regulation: the United States," said fertility expert Robert Winston at Hammersmith hospital, west London. "The problem is that they do not in general want central regulation, so you have different rules in different states."
Federal law washes its hands of embryo research by a refusal to fund any of it, so the work is left to private clinics and research institutes governed by the patchwork of state laws. A few states ban embryo research because of the passions evoked over abortion and the right to life. Elsewhere there is little restraint.
Norbert Gleicher, whose team created the chimera foetuses, is the founder and head of the Centre for Human Reproduction, which has clinics in Chicago and New York. He appeared to have no trouble getting ethical approval for the work, which was intended to investigate a technique for curing genetic diseases.
Scientists are divided on how best to tackle the maverick element of fertility re searchers or whether they even need to be tackled. "The only way to rein them in is to have a body like the HFEA in different countries," said Dr Serhal. "When you know there is someone breathing down your neck, you're going to think twice, if not more, before doing something stupid."
But there is no guarantee a global HFEA would be the answer. In the UK, some private clinics flout the fertility guidelines but do not seem to be penalised. "They aren't even being threatened with having their licences taken away," said Allan Templeton of the Royal College of Obstetricians and Gynaecologists.
Prof Winston argues there's little need to rein in the fringe scientists. "I don't think these people are going to do any real damage, except to the reputation of science." He feels that rather than seeking stringent legislation the answer, if one is needed, lies in the hands of bodies such as the European Society of Human Reproduction and Embryology, which should prevent mavericks from attending their conferences and presenting their work.
Lab notes: Global guidelines
Britain
Liberal, compared with Europe elsewhere, permitting stem cell research, studies on donated embryos up to 14 days' gestation and production of embryos just for research. The human fertilisation and embryology authority states research has to be "necessary or desirable".
France
All experiments in France on human embryos forbidden since 1994 without clearance from the national consultative committee on ethics for life sciences and health. The 39-member committee has a conservative take on ethics of research on aborted embryos. Members so far not asked to rule on use of embryos' eggs.
United States
Federal law prohibits federal funds backing embryo research, but each state decides its own approach. Some states maintain a total ban on research.
Italy
Home to controversial advocate of artificial insemination, Severino Antinori. But cloning, selling or importing gametes and human embryos, is banned: in the pipeline, a law giving jail terms of up to 20 years for contravention, stamping out efforts to "to obtain a human being from one starting cell genetically identical to another human being, alive or dead".
Israel
Legal and ethical framework appears not to be restrictive. Cloning for human reproduction banned in 1998, but cloning allowed for "therapeutic purposes". Talmudic law says neither egg, sperm nor early-stage embryo have value: embryos are "not human" until 40 days old.
