Panel at AAAS Discusses Quest for Global Guidelines on Stem Cell Research

It may be difficult, if not impossible, for nations to agree on internationally consistent laws for the conduct of research on human embryonic stem cells, experts said at March 1 panel discussion at the American Association for the Advancement of Science (AAAS).

Given the disparity in current laws and the fact that many nations have no laws at all governing stem cell research, they said it is essential for scientists and policy makers to agree on ethical guidelines that researchers can adhere to across national borders.

The panel discussed results of a recent three-day meeting in the United Kingdom, attended by 60 scientists, ethicists and legal experts from 14 nations, that produced a consensus statement on some guiding principles for stem cell research around the globe.

The path-breaking statement acknowledged the moral disagreements about some elements of stem cell research and noted that societies have the authority to regulate science. But it urged policy-makers to “refrain from interfering with the freedom of citizens unless good and sufficient justification can be produced for doing so.”

The consensus statement asked governments to be measured in their regulation of science, with flexible laws that can accommodate rapid scientific advances. The statement also asked for clear and explicit laws so that scientists will know what is and is not permitted.

The statement was released Feb. 24 at the conclusion of the meeting at the Wellcome Trust Hinxton Conference Centre in Cambridgeshire, United Kingdom. The attendees established the Hinxton Group, an interdisciplinary consortium. Its mission is to foster international collaboration and dialogue on ethical and legal issues emerging from stem cell science.

Three of the Hinxton attendees discussed the statement and the next steps during the AAAS session, which was co-sponsored by AAAS, the British Embassy and The Phoebe R. Berman Bioethics Institute at The Johns Hopkins University.

At the AAAS panel discussion, Anne McLaren, a developmental biologist at the Gurdon Institute of Cambridge University, outlined some of the disparities in existing laws regarding stem cell research. Many nations allow scientists to derive human embryonic stem cell lines from spare embryos that would otherwise be discarded at fertility clinics, she said. But there are notable exceptions. In Europe, Ireland, Norway, Austria, Italy and Germany prohibit such use of spare embryos, she said. In the United States, researchers who use federal funds are barred from using spare embryos to create new stem cell lines beyond those already in existence on Aug. 9, 2001.

McLaren said that many nations prohibit the technique called somatic cell nuclear transfer or SCNT to create human embryonic stem cell lines. In that procedure, the DNA from the nucleus of a somatic cell, such as a skin cell, is injected into an egg whose nucleus has been removed. The egg is then coaxed to grow to an early-stage embryo that can be harvested for stem cells. The United Kingdom, Sweden, Belgium, China and South Korea permit use of SCNT methods to create stem cells, McLaren said. Such methods also can be used by researchers in the United States who do not accept federal funds. Israel allows SCNT, McLaren said, but prohibits women from donating eggs, effectively barring the procedure.

Alignment of Ethics, Science, and State: The Full Program For access to audio presentations from this event, click here.

Ruth Faden, executive director of The Phoebe R. Berman Bioethics Institute at The Johns Hopkins University, said stem cell scientists will have to cope with conflicting legal regimes from country to country for the foreseeable future. “Scientists have a moral obligation as well as a legal obligation to obey the law,” she said, but lawmakers also have a responsibility to craft laws that are clear in their intent. Ambiguity can create “a chilling effect,” she said, when scientists are unsure whether the procedures they are considering are legal or not.

One concern is the issue of extra-territorial jurisdiction. Under German law, for example, a German scientist who undertakes a procedure that is illegal in Germany could be prosecuted for doing the procedure in another nation where the procedure is legal. Faden said nations should be circumspect about extending their extra-territorial jurisdiction in laws regulating stem cell research. The Hinxton Group statement also recommends that research institutions “should neither discriminate against nor restrict the freedom of their investigators who want to travel to do work that is undertaken with scientific and ethical integrity.”

Peter Donovan, a professor of biological chemistry, developmental and cell biology at the University of California, Irvine, said scientists recognize that the work they do affects society. “A lot of the work we do is funded by the public, and we are accountable to the public for the money we spend,” Donovan said. Scientists are often the first to understand the ethical implications of their work, he said, and have an obligation to explain them to the public and to lawmakers.

While the Hinxton meeting was planned long before the revelations of fraud in the work of South Korean stem cell scientist Hwang Woo Suk, Faden said the recommendations in the consensus statement could help improve confidence in the integrity of stem cell research. The statement urged journal editors to encourage authors to include explicit descriptions of their roles in research projects and to require submission of data verifying the authenticity of embryonic stem cell lines.

“We recognize that journals can’t be the policemen,” Donovan said, “but they can be awfully helpful to the field.” Still, he said, even if all the Hinxton recommendations had been followed by the editors of Science, where Hwang’s fraudulent papers were published, “I’m not sure that they would have caught what happened.”

McLaren said the peer review system used by science journals can detect bad science and bad fraud but is “not set up to detect good fraud” that is clever enough to escape the notice of reviewers.

Despite the notoriety of the Hwang case, there was little discussion of the issue at the Hinxton meeting, Donovan said. Instead, the conferees tended to concentrate on broader ethical issues, including new challenges on the horizon that may not be adequately addressed by existing ethics codes and institutional review boards. Faden mentioned the possibility that gametes — sperms and eggs — could be derived outside the body from embryonic stem cells, raising disturbing new possibilities for reproductive medicine. In theory, individuals could reproduce through the fusion of their own gametes, a type of asexual reproduction in which a child would be produced without the union of sperm and egg from a man and woman.

Scientists say stem cell research holds more immediate promise in helping them understand some of the underlying mechanisms at work in certain degenerative diseases. Eventually, the research could lead to customized therapies for persons who suffer from Alzheimer’s disease, diabetes, Parkinson’s disease and other ailments.

If stem cell research does lead to clinical applications, McLaren predicted that the diversity of national laws and regulations could produce the same situation as was seen with the advent of in vitro fertilization (IVF) clinics for test-tube babies. Patients who could afford it soon undertook “reproductive tourism,” traveling to nations where IVF and techniques such as pre-implantation genetic diagnosis are allowed. McLaren said that when stem cell therapy becomes “clinically feasible and available, the same sort of thing will happen.”

The Hinxton statement said it is imperative for scientists to “actively and honestly engage with the public about the promises and limitations” of embryonic stem cell research. That point was echoed by Alan I. Leshner, the chief executive officer of AAAS, who served as moderator of the panel discussion. He urged the participants to find ways to systematically engage the public in a discussion of the issues raised by stem cell research.

Earl Lane

2 March 2006