Crucial to develop set of protections for women who donate eggs to stem cell research

Now that stem cell researchers have devised an efficient way of creating new human embryonic stem cell lines, biomedical ethicists at the Stanford University School of Medicine say it's crucial to develop a unique set of protections for the women who donate their eggs to make the research possible.

In a paper published 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, point out that these women fall between the cracks of the normal protections for people involved in medical research. They advocate creating a new category of research subjects for these women to ensure that they are adequately 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. Their paper is published in the same issue of the journal in which stem cell researchers in South Korea and the United States announced that they've created new human embryonic stem cell lines, making it imperative to address the ethical issues surrounding how eggs for this type of research are collected.

Magnus and Cho note that this isn't the first time people have thought about the women who go through considerable personal risk to donate their eggs. The California Institute for Regenerative Medicine, created after Californians voted last fall to fund embryonic stem cell research, and a recent set of recommendations issued by the National Academies of Science both require that women receive no compensation so they aren't coerced into donation. What's more, both organizations require that women sign consent forms indicating that they understand the risks of the procedure.

However, Magnus and Cho argue that women who donate eggs for stem cell research have a unique set of needs and should be treated accordingly.

Viewed from one angle, 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 looked over 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 in order to benefit other people.

But egg donors don't quite fit this mold either, the authors note. Research subjects get some benefit from their participation whereas egg donors never get anything in return for their risk - stem cell research has yet to medically benefit a single person. What's more, when researchers use tissues that are anonymous it isn't considered to be research on human subjects. Because of that, institutional review boards - the entities responsible for approving research involving human subjects - aren't obligated to review the consent forms signed by egg donors for stem cell research.

Magnus and Cho want to create a new category they call "research donors" for the egg donors. Along with the new title, the women should have a set of protections designed specifically for their unusual situation. In order for the egg collection to be ethical, the researchers say that women need to fully understand both the risks of donating eggs and the reality that their donation may not ever cure a disease or benefit another person.

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 argue. Until such therapies exist, they suggest that researchers simply refer to the work as "stem cell research" so that donors don't assume their risk will necessarily have a benefit.

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

In order for all egg donors to receive these protections, Magnus and Cho suggest several solutions. 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. What's more, 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.

http://med-www.stanford.edu