Ethicists call for new safeguards for stem cell donors

With last week's announcement of a new, more efficient way to create human embryonic stem cell lines, it has become even more crucial to develop a unique set of protections for the women who donate their eggs to make the research possible, according to two biomedical ethicists at the School of Medicine.

In a paper in the May 20 issue of Science, ethicists Mildred Cho, PhD, associate professor of pediatrics, and David Magnus, PhD, associate professor of pediatrics and director of the Stanford Center for Biomedical Ethics, pointed out that these women fall between the cracks of the normal protections for people involved in medical research. They advocated creating a new category of research subjects for these women to ensure that they are fully informed of the risks of egg donation.

"We're worried that the lens through which these women are viewed could downplay some concerns," Magnus said.

Magnus and Cho's paper was published in the same issue of the journal in which a paper from South Korea revealed that scientists had successfully used a new technique to create new human embryonic stem cell lines. That development, Magnus and Cho said, makes it imperative to address the ethical issues surrounding how eggs for this type of research are collected.

To be sure, this isn't the first time people have thought about the women who go through considerable personal risk to donate their eggs. In recent months, there have been rules issued by the California Institute for Regenerative Medicine, created after Californians voted last fall for Proposition 71 to fund embryonic stem cell research, and recommendations issued by the National Academies of Science. Both sets of guidelines require that women receive no compensation for providing eggs so as to avoid their being financially coerced into donating. Both organizations also recommend that women sign consent forms indicating that they understand the risks of the procedure.

But Magnus and Cho's article takes the protections even further, starting with an analysis of how egg donors for this research are in a situation that does not fit neatly into the existing medical ethical rules.

Viewed from one angle, for instance, the women are similar to other tissue donors. This is how the women in the South Korean study were treated. However, unlike blood or sperm donors these women undergo considerable risk — donating eggs is at best uncomfortable and at worst deadly.

When Cho reviewed the consent forms for the South Korean study she found they were lacking details about exactly how risky the egg collection can be. "They were never told about the risk of infertility or death," she said.

Another alternative is to treat the women as research subjects, who also go through considerable risk to benefit other people.

Yet egg donors don't quite fit this mold either, the authors noted. Research subjects get some benefit from their participation whereas egg donors never get anything in return for their risk—embryonic stem cell research has yet to medically benefit a single person.

What's more, when researchers use tissues that are anonymous, it is not considered to be research on human subjects. That means that institutional review boards, which oversee research involving human subjects, do not have to review the consent forms signed by egg donors for stem cell work.

Magnus and Cho proposed creating a new category for egg donors called "research donors." Along with the new title, the women would be covered by a set of protections designed specifically for their unusual situation. In order for the egg collection to be ethical, the donors need to understand fully both the risks of donating eggs and the reality that their donation may not ever cure a disease or benefit another person, Magnus and Cho explained.

Achieving this second objective requires a terminology change. As long as some aspects of stem cell research are referred to as "therapeutic cloning," there is an assumption that some form of therapy will result. This is a goal, but so far it isn't a reality, Magnus and Cho contended. Until such therapies exist, researchers should simply refer to the work as "stem cell research" so that donors don't assume their risk will necessarily have a benefit, Magnus and Cho said.

If the women risk death and receive no benefit, what's the incentive for donation? Magnus and Cho argued that such donors should be advocates of research without any expectation of a reward. Only in this situation would the egg donation be ethical.

Magnus and Cho recommended several steps to put such protections in place. Institutional review boards need a set of guidelines to help them judge the consent process, and journals that publish stem cell research should verify that all work they publish conforms to those guidelines. Additionally, those journals should move away from using the word "therapy" to describe the research.

By adopting these changes, Magnus and Cho hope that women donating much-needed eggs will make those donations with a clear understanding of the risks and benefits of their decision.