The debate about stem cell research has focused for years on the moral status of the human embryo, largely overlooking the welfare of women who will provide eggs to produce those embryos. But that situation is changing. The recent revelations about ethical breaches in obtaining eggs for research in Korea have brought attention to the implications for women's health and the potential commodification of their eggs.

The current controversy surrounds Hwang Woo-suk, the South Korean researcher who achieved celebrity status after creating the world's first cloned human embryos in 2004. Last month, Hwang announced the establishment of the World Stem Cell Foundation with great fanfare, accompanied by high international interest. Last week, however, Hwang resigned from his position as head of the foundation after admitting that his lab had received eggs both from women who had been paid and from two junior researchers on his team.

Under widely accepted international guidelines, scientists do not conduct research on human subjects who are in a dependent relationship with them, in order to avoid exploitation. While Hwang did not break any laws in using eggs from junior researchers on his team, he clearly violated international standards. In addition, Hwang subsequently denied the source of the eggs when asked about this by journalists and other researchers.

The procurement of eggs for Hwang's cloning research has been further clouded by the admission that a key member of his team, Roh Sung-il, paid women the equivalent of $1,400 out of his own pocket for their eggs. Korean television broadcast interviews with three of the women who provided eggs. All three said they had been in dire financial situations, and two stated they had not been informed about the potential risks posed by the egg retrieval process[1]. Roh's admission came one week after he conceded to knowingly using illegally traded eggs to perform artificial insemination for infertile couples. Ten women and four egg brokers were arrested in that controversy for violating a new South Korean law that prohibits commercial trade in eggs or sperm and carries a fine of several years in prison.

Just before the flurry of exposures in mid-November, cloning researcher Gerald Schatten of the University of Pittsburgh abruptly withdrew from a twenty-month partnership with Hwang. Schatten said he had received new information that led him to realize that Hwang had improperly obtained eggs for research.

The charges of ethical and legal violations bring attention to the significant risks of the drugs and procedures used for egg extraction, and to the prospect of creating a market for human eggs that may induce young and low-income women to subject themselves to those risks in return for payment. Many observers saw the World Stem Cell Foundation as an effort to make an end run around the laws that South Korea and some other countries--though not the United States--have put in place to regulate stem cell research.

The World Stem Cell Foundation had been set to begin recruiting women to provide fresh eggs for its work through the San Francisco-based Pacific Fertility Center. After learning of the ethical breaches, PFC backed out of the deal. "With Dr. Schatten's withdrawal, it is impossible for us to establish the ethics of the whole thing," said PFC medical director Philip Chenette.

The current situation in South Korea is emblematic of unresolved issues surrounding egg extraction wherever it is practiced. Some women's health advocates and public-interest groups have been raising concerns about the potential for exploitation of young or low-income women if researchers offer payments for eggs. Last April, a committee set up by the National Academies of Sciences agreed, and recommended that payments be limited to reimbursement for direct expenses like transportation and childcare.

Although egg extraction is widespread in the assisted reproduction field, it is not regulated in the United States because fertility clinics operate as private commercial ventures. For much the same reason, the risks this procedure poses for women have not been well studied or widely discussed--though it is well-known that serious adverse reactions can occur and that the drugs used for egg extraction have caused at least two deaths.

Egg extraction for research will take place in an environment of overheated expectations for medical breakthroughs, growing commercial and political pressures for early stem cell results and little oversight. Recognizing these dangers, California State Senators Deborah Ortiz (D-Sacramento) and George Runner (R-Lancaster) authored a bill that offered some protections for egg providers. It was passed by overwhelming majorities in both of the state's legislative chambers but was vetoed in October by Governor Arnold Schwarzenegger.

Until recently, all embryonic stem cells were produced from embryos created but not used during in vitro fertilization procedures. The World Stem Cell Foundation was set to focus instead on stem cells derived from embryos produced by research cloning or somatic cell nuclear transfer (SCNT). A number of countries with active stem cell research programs, including Canada, have decided not to pursue SCNT for now because of concerns about the well-being of women and the commodification of human eggs.

Many stem cell researchers have promoted SCNT, which involves merging adult cells with eggs whose nuclei have been removed, as a way to produce individually tailored therapies--a "personal biological repair kit," as Ronald Reagan Jr. described it in a speech at the 2004 Democratic National Convention. But this approach to stem cell treatments would likely be very costly--a bill that Medicaid, and for that matter most health insurers, would not readily pick up. It would also require a vast number of women's eggs.

More modest scenarios envision SCNT as a way to produce stem cell models of specific genetic disorders for investigation and drug testing. Researchers have not publicly estimated how many eggs they would need for these purposes.

In order to provide eggs, women typically undergo hormonal treatments that first "shut down" and then "hyperstimulate" their ovaries. Surgical extraction of multiple eggs follows. This is a time-consuming and invasive process associated with potentially serious and occasionally life-threatening health problems. Estimates of the number of women taking fertility drugs who develop severe forms of a condition known as Ovarian Hyperstimulation Syndrome (OHSS) range from 1 percent to 10 percent; the wide variation is another sign that more study of OHSS is urgently needed. In rare cases, OHSS can be fatal.

In the UK, reports of two OHSS deaths have surfaced in the past six months. Twenty-nine-year-old Jackie Rushton died in June after undergoing hormonal treatment for in vitro fertilization. Her mother, Angela Hickey, told BBC News online, "Jackie was given a booklet that mentioned OHSS, but she thought it was so rare that she did not take much notice of it. Some people do not have any problems, and a percentage are very successful and have babies. But I would not want this to happen to anyone else."

If stem cell research of the sort that requires large numbers of women's eggs begins in the United States, will the absence of any regulation regarding egg provision put women's health in danger? Will women who provide the eggs be adequately informed about the risks to which they're agreeing? Will they receive medical care if they experience any adverse reactions? This is a particularly pressing question when OHSS develops, since it can often be reversed with prompt medical treatment.

And who would cover the costs? Will some egg donors suffering side effects delay seeking medical care, especially those who are uninsured or whose medical insurance doesn't cover experimental procedures? Unfortunately, this vital question has yet to be addressed by stem cell researchers, policy makers or media reports.

Women whose eggs are used for research are the first guinea pigs of scientists using human cloning techniques for stem cell research. The recent developments in South Korea illustrate dramatically that international ethics standards are insufficient for preventing misconduct, coercion and commercialization. In the United States, no regulation of stem cell research exists, allowing great potential for women to be exploited for their eggs. The focus in the United States on the moral status of embryos has simplified the complex issues of stem cell research and left women's health out of the debate. We need to look beyond the politics of embryos and focus attention on the well-being of women, conducting this important research with integrity.

Emily Galpern, MPH, is Project Director on Reproductive Health and Human Rights for the Center for Genetics and Society.

Marcy Darnovsky, PhD, is Associate Executive Director of the Center for Genetics and Society.