Stanford bioethicists want stronger protections for women donating eggs for stem

[Guest guest]

Stanford bioethicists want stronger protections for women donating

eggs for stem cell research

20 May 2005 Medical News Today

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

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.

Stanford University Medical Center integrates research, medical

education and patient care at its three institutions - Stanford

University School of Medicine, Stanford Hospital & Clinics and Lucile

Packard Children's Hospital at Stanford. For more information, please

visit the Web site of the medical center's Office of Communication &

Public Affairs at http://mednews.stanford.edu.

Stanford University Medical Center

http://med-www.stanford.edu/MedCenter/MedSchool