Federal ethics council releases report on ART

Revision of embryo use regulations recommended

The current lack of oversight for assisted reproductive technology (ART) and human embryo research is compromising the future of children created using ART as well as hindering the progress of research into new and innovative treatments for diseases and conditions, a new report from the President’s Council on Bioethics indicates.

The April 1 report, "Reproduction and Responsibility: The Regulation of New Biotechnologies," urges the federal government to 1) fund more studies of the impact of ART on the families and children already affected by it; 2) encourage oversight mechanisms to monitor the progress of research involving human gametes (sperm and eggs), embryos, and reproductive processes; and 3) update current federal legislation to ban certain extreme procedures before they are performed.

"The intersection of assisted reproductive technologies and genomic knowledge is an increasingly busy intersection and one that raises a daunting array of opportunities and dilemmas for patients suffering with infertility and for doctors and researchers," the council’s chair Leon R. Kass, MD, PhD, said in a statement announcing the release of the report. "It raises the prospect, but also certain kinds of risks, of new life for children born with these procedures. And it has certain social implications important for regulators and policy-makers and indeed for the American public as a whole."

Need for guidance

Because there is no "uniform, comprehensive and enforceable system of data collection, monitoring, or oversight" of ART technologies and private human embryo research, there is little information to guide the development of laws and policies, council members stated.

The result is that existing federal regulations are out of date and unworkable and, at the same time, private research and activities continue unguided and unmonitored by society.

A good example is the current controversy over stem cell research, says Michael Sandel, D.Phil., professor of government at Harvard University in Cambridge, MA, and a council member.

"A great merit of the [recommendations] in the report is that they point to a possible solution to the vexed issues of cloning and stem cell research that could overcome the current impasse in the United States Senate," Sandel noted in the council’s open session to discuss the report’s findings.

Despite widespread opposition to reproductive cloning, a federal ban has been impossible due to disagreements about such a law’s impact on biomedical research. Yet biomedical research has been impeded by fears that research into therapeutic cloning could lead to a slippery slope of unfettered experimentation with human embryos.

"Recent scientific developments illustrate the need to adjust federal funding policy," Sandel continued. "Only 17 [stem] cell lines are currently available on the National Institute of Health’s registry for federally funded research."

In March, Harvard biologist Douglas Melton, PhD, announced the creation of 17 new embryonic stem cell lines that he intends to make available, free of charge, to scientists for noncommercial research purposes, Sandel said. The cell lines were derived using private funds from blastocysts left over from in vitro fertilization clinics, and meet all of the same ethical requirements as the existing lines eligible for federally supported research.

Under current federal policy, research on these cell lines is ineligible for federal funding simply because they were derived after 9 p.m. on Aug. 9, 2001. "Now, the Aug. 9 cutoff may have been a reasonable compromise 2½ years ago when it was thought that some 60 or 70 cell lines would be available," Sandel says. "But in the light of what we know now, that cutoff looks less and less sustainable."

The United States needs to be able to move forward in this area with well-considered, thoughtful policies that take into account the values and opinions of the society as a whole, instead of interim stopgap measures, he says. The council’s report represents an important first step.

"The proposed regulations taken together also point toward a possible compromise on federal funding of stem cell research," Sandel says. "They do so by addressing at least one of the main worries people have about stem cell research, which is the slippery slope worry. This is the worry that without clear limits, embryo research could lead down a slippery slope of exploitation and abuse."

The fear is that if our society allows stem cell research today, tomorrow some people might try to transfer embryos into a woman’s uterus, or an animal’s uterus or to grow organs for transplant, creating the nightmare prospect of embryo farms, fetuses exploited for spare parts, and the commercialization of human life, he explains.

"The regulations contained in this report address that slippery slope argument. They do so by assuring that such research is done responsibly, within carefully prescribed limits," Sandel says. "No embryos used for research could be used or preserved beyond a 10- or 14-day limit, or transferred into a woman’s uterus or into an animal’s body to grow organs for harvest, nor could embryos be bought and sold. By assuring that stem cell research is conducted within these limits, these regulations address the slippery slope objection, the worry about exploitation and abuse."

Diagnosing the situation

Although the report examined a range of potential regulatory and policy approaches, it made only a few specific recommendations, the council noted.

Its review of the field determined that data were lacking in a number of crucial areas and the council was not prepared to recommend sweeping institutional reforms or innovations without sufficient evidence, the executive summary indicated.

"This report is fundamentally a diagnostic document," the summary stated. "Even most of the recommendations with which it concludes aim largely at improving the nation’s capacity for future diagnosis of the state of this field."

Nevertheless, the council still contended that immediate action was needed in some areas to "alleviate some clear and significant present problems, especially including the lack of information on certain key practices and their consequences."

The recommendations fall into three major categories: studies and data collection, oversight and self-regulation by professional societies, and targeted legislative measures. Key recommendations include:

  • A federally funded longitudinal study of the impact of assisted reproductive technologies on the health and development of children born with their aid
  • Federally funded studies on the impact of ART on the health and well-being of women
  • Undertake federally funded comprehensive studies on the uses of reproductive genetic technologies, and on their effects on children born with their aid
  • Prohibition of the transfer, for any purpose, of any human embryo into the body of any member of a nonhuman species
  • Prohibition of the production of a hybrid human-animal embryo by fertilization of human egg by animal sperm or of animal egg by human sperm
  • Prohibition of attempts to conceive a child by any means other than the union of egg and sperm
  • Prohibition of attempts to conceive a child by using gametes obtained from a human fetus or derived from human embryonic stem cells
  • Prohibition of attempts to conceive a child by fusing blastomeres from two or more embryos
  • Prohibition of the use of human embryos in research beyond a designated state in their development (between 10 and 14 days after fertilization)
  • Prohibition against the buying and selling of human embryos
  • Prohibition on the issuing of patents on claims directed to or encompassing human embryos or fetuses at any stage of development

Reaction from professional societies

Representatives from professional societies of specialists in infertility and reproductive medicine expressed support for the report, with some reservations about recommendations that the societies improve their strategies to monitor and compel compliance with ethical standards.

Eric Surrey, MD, president-elect of the Society of Assisted Reproductive Technology (SART) says, "SART has always been proud of the role we have played in self-regulation. We began collecting ART outcomes data several years before the federal government got involved and have a long history of setting guidelines for our members. While we have always approached this in an educational rather than punitive manner, we look forward to examining the suggestions from the council to see if the process can be improved to benefit our patients and their physicians."

An earlier draft of the council’s report released last year drew fire from some patient groups and fertility experts for appearing to advocate involuntary government monitoring of reproductive choices and proposals to ban already common practices such as selling human gametes. The final draft dropped those recommendations and altered some language that critics contended seemed to equate human embryos with children.

"This report is the result of a comprehensive well-researched review and evaluation of current reproductive technology with much thoughtful consideration by members of the council," says Marian Damewood, MD, president of the American Society of Reproductive Medicine. "We may not have consensus on every conclusion presented; however, the council was very willing to listen to our comments and concerns. We are looking forward to continue to work with the council and have invited Dr. Kass to meet with our board of directors in a few weeks."

The council’s report is available in electronic form on the web site of the President’s Council on Bioethics (www.bioethics.gov).

Sources

  • Marian Damewood, MD, and Eric Surrey, MD, American Society of Reproductive Medicine and The Society for Assisted Reproductive Technology, 1209 Montgomery Highway, Birmingham, AL 35216-2809.
  • Leon R. Kass, MD, PhD, and Michael Sandel, D. Phil., President’s Council on Bioethics, 1801 Pennsylvania Ave., N.W., Suite 700, Washington, DC 20006.