WASHINGTON - The announcement of sheep clone Dolly spawned a nationwide examination of the ethical consequences of biological research.
Now being used as routine research tools are the human equivalent of cells that have allowed scientists to create transgenic mice, and public interest is likely to mount in the ethical boundaries appropriate for scientific research.
With an eye to the ethical dilemmas raised by such experiments, the University of Wisconsin at Madison and the Geron Corp., of Menlo Park, Calif., took care to address every issue that creating human embryonic stem cells presented. (See related story, p. 1.)
Norman Fost, professor of pediatrics and director of the medical ethics program at the university, said the university consulted ethics professionals to ensure that embryo research followed guidelines established by panels from this country and abroad. In addition, couples who donated the embryos participated in an extensive informed-consent process.
Patents Offer Protection Against Unethical Use
Because the technology and the cell lines are under patent protection, all uses of the technology will require a license that will not be granted if the user intends to use the cells for cloning human beings or germ line manipulations of human beings.
"The cells will allow people to study the mysteries of differentiation," said Fost. "The potential home run for this technology is the ability to create cells that produce dopamine or insulin and reimplant them in people in a way in which they won't reject them."
The cells may allow more researchers to explore human development, too. "This is a remarkable achievement," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "It really could take the heat off of embryo research, and let valuable biomedical research move forward without the limitations imposed by conducting embryo research."
Congress prevents the federal funding of embryo research in its appropriations to the National Institutes of Health. It is unclear, however, whether that ban would apply to cell lines derived from embryos. Nevertheless, because the cells can't simply be implanted into a woman's uterus and become a human life, the technology does an end run around many ethical questions associated with human embryo research.
However, those cells could be genetically manipulated and placed into another blastocyst as a first step to introducing new genes into human beings. While neither the researchers involved in the project nor Geron Corp. have any intention of conducting such experiments, the possibility remains that they could be carried out by others.
Wisconsin Project Not Subject To Federal Oversight
Erik Parens, a researcher associated with the Hastings Center, in Garrison, N.Y., noted that the experiments conducted by the Wisconsin researchers had no federal oversight.
"It really points to a strange situation in this country where there is hardly any oversight of research with very wide-ranging social implications," Parens said. "I think we are very bad at looking at how new technologies are likely to be used in the future."
Had the research involved genetic manipulation of the cells, it would likely have come under the purview of the Recombinant Advisory Committee, Parens noted. As it is, no federal body reviewed the experiment for its ethical implications.
Parens does not advocate a complete ban on ethically difficult research, but supports full and frank public discussions of the research and their potential future uses. Feldbaum agrees.
"You are just kidding yourself and doing a disservice to the real scientific possibilities if you don't expect or encourage a broader scientific debate about the future applications of this technology," Feldbaum said. "BIO has participated in that discussion in the past and will be pleased to participate in the future."
While acknowledging that no ethics body is currently charged with handling the issues associated with research involving human embryonic stem cells, Feldbaum noted it was a topic that could potentially be addressed by the National Bioethics Advisory Commission. n