Two Stanford medical bioethicists say women who donate eggs for stem-cell research are not being adequately informed of potential health risks, including infertility and death.
In a paper published in the May 20 issue of Science, ethicists Mildred Cho, PhD, associate professor of pediatrics and David Magnus, PhD, director of the Stanford Center for Biomedical Ethics, wrote that women donating eggs for stem-cell research fall between the cracks of normal protections for people involved in medical research. As a result, they are neither adequately informed about the risks of the procedure, nor told the risk they take may not ever benefit anyone or cure a disease.
Treated similarly to tissue donors, this group of women faces risks unlike blood or sperm donors, and a different protocol should be in order, they said.
Cho looked at the consent forms for women used in South Korean stem-cell research published in the same issue of Science, and found the forms lacked crucial information about the risks of egg collection. "They were never told about the risk of infertility or death," she said.
There is a 1 to 5 percent risk of hospitalization from complications of egg follicle stimulation and extraction, including acute respiratory distress syndrome and kidney failure and a .2 percent risk of ovarian torsion a dangerous twisting of the ovaries, according to Magnus.
The chief culprit of the infertility and complications is a condition caused by the hormones given to egg donors. These hormones stimulate the ovaries to produce multiple eggs for extraction. Some ovaries respond "exuberantly," creating a condition called ovarian hyperstimulation syndrome.
The ovaries enlarge and leak fluid, which can collect in the lungs. Blood clots and kidney impairment can occur in moderate cases. Stroke, kidney failure, heart attack and even death can result in severe cases, although these consequences are rare with adequate treatment, according to the Society of Assisted Reproductive Technologies.
Magnus and Cho want to create a new category called "research donors" for the egg donors. Institutional review boards routinely review research involving human subjects. But when researchers use tissues donated anonymously, as egg donors do, it isn't considered research on human subjects; the review boards haven't been obligated to review the consent forms, they said.
Three weeks ago, however, the National Research Council guidelines for the National Institutes of Medicine addressed the loophole, and will now mandate that egg and sperm donors get a full review, including informed consent. Those protections may be in place in the United States, but women in countries without such safeguards are still left at risk, Cho said. Journals publishing stem-cell research should therefore also verify that research they publish conforms to those guidelines.
In order for egg collection to be ethical, the current terminology some researchers use, "therapeutic cloning," should be changed. "Therapeutic cloning" is a misnomer that may mislead donors because although that is a goal, there are currently no stem-cell therapies, the two bioethicists said. Until such therapies exist, Magnus and Cho suggest researchers refer to their work as "stem-cell research" so that donors don't assume their donation and its attendant risks have a benefit.