Rules Would Guide Research Efforts

By Rick Weiss Washington Post Staff Writer Concerned that the world’s patchwork of laws and ethics rules governing human embryonic stem cell research is sowing confusion and stymieing international collaborations, scientists, ethicists and others have mounted a major effort to devise a set of universal principles that would guide the research everywhere. The principles, one version of which was released by an international working group last week, would not supersede national or state laws. But they could codify basic rules of acceptable behavior in the many jurisdictions that lack stem cell laws — including most U.S. states and the United States as a whole, where Congress has deadlocked over the issue for years. Among the emerging principles are that restrictions on the research should be rare, well-justified and flexible enough to accommodate changes in the quickly evolving field, and that scientists should be free to do work abroad that is banned in their own country. The hope is that the principles will gain widespread acceptance over time, much as did early declarations of human rights. But the reach for consensus on stem cell research may be even more ambitious — and difficult — than that. Embryonic stem cell research involves the creation and destruction of the earliest forms of human life — an act that raises no alarms in some cultures, such as in Japan, but ignites intense controversy in the United States and other nations. The field’s need for human embryos also creates a potentially lucrative market in human eggs that, depending on one’s perspective, could be an opportunity for potential donors or put them at risk of exploitation. Opinions have also differed as to whether it is proper for scientists facing restrictions at home to conduct the banned research in countries where it is allowed — a practice some call “research tourism.” Still, proponents say, even a nominally successful effort to define generally acceptable practices could greatly help the fledgling science by facilitating the kind of international collaboration that has paid off in less-contentious fields. “It’s very difficult in labs today to have all the expertise yourself,” said Peter J. Donovan, a biology professor at the University of California at Irvine, who worked on last week’s consensus statement. That statement came from the Hinxton Group: 60 scientists, doctors, philosophers, lawyers, scientific journal editors, federal regulators and others from 14 countries who met in Hinxton, England, to consider “ethically acceptable norms” of stem cell research. A separate working group of the International Society for Stem Cell Research is expected to release its recommendations in July, building on advice issued last year by the National Academy of Sciences. The Hinxton Group agreed on 15 principles and strategies. While recognizing that each society has the authority to regulate science, for example, the group called on legislators to be “circumspect” and refrain from interfering with the pursuit of scientific knowledge “unless good and sufficient justification can be produced.” The group encouraged lawmakers to be “clear and explicit” when they do pass restrictions. That has been a major sticking point in Massachusetts, where stem cell researchers and lawyers have spent months and a large number of billable hours trying to understand what is legal there. The Hinxton Group agreed that scientists should not be subject to prosecution for going abroad to conduct research banned at home. That matters to Israeli scientists who travel abroad to solicit eggs from women because human egg donation is illegal at home. But it would not protect German scientists who create human embryonic stem cell colonies in foreign labs to avoid Germany’s ban because the German constitution explicitly proclaims “extraterritorial reach” over its citizens. Consensus among the Hinxton participants was achieved in part by sidestepping some of the more difficult issues, such as the moral status of embryos — a hot-button topic obliquely acknowledged in a recommendation that “any risk of harm should be commensurate with expected overall benefit.” On the issue of protecting human life, it deals only with “born, identifiable human persons,” such as egg donors and patients who might participate in stem cell clinical trials, said Ruth R. Faden, executive director of the Phoebe R. Berman Bioethics Institute at Johns Hopkins University and a member of the group. With Donovan and others, Faden described the group’s deliberations yesterday at a Washington seminar sponsored by the American Association for the Advancement of Science and the British Embassy. The Hinxton effort began long before recent revelations that researchers at Seoul National University had lied about their accomplishments, and little time was devoted to discussing that problem — viewed by many as having little to do with stem cell research specifically. But several of its recommendations focus on the responsibility of scientific journal editors to ensure that stem cell studies are conducted with adequate scientific and ethical rigor — a reflection of concerns raised in the aftermath of the Korean debacle. The group’s consensus statement (at ) calls upon journals to require explicit descriptions of each author’s contribution, especially when collaborators come from countries with different rules. It also recommends that journal editors demand signed statements from authors that they adhered to relevant laws and regulations, and a statement describing any conflicts of interest.