that are impossible to answer well without a great deal of data accumulated in a very deliberate and consistent way.

MINIMIZING POTENTIAL RISKS

Nearly all of the speakers cautioned against relying on probabilities because the most important strategy in collecting oocytes for stem cell research is to be cautious in relying on probabilities, because the most important strategy to minimize the potential risks to oocyte donors is to make decisions based on common sense on a case-by-case basis. Of course, physicians try not to subject any of their patients to unnecessary risks, but because research donors represent a special situation—women who are undergoing a procedure not for their own benefit but for the benefit of others—the workshop participants said that even greater care should be taken to make sure that these donors do not pay for their altruism with their own health.

“We absolutely want to minimize risk for our reproductive donors,” said Dr. Marcelle Cedars. “For example,” she said, “there might be risks in terms of a difficult position of an ovary or getting every last follicle that I might take for a patient that I wouldn’t take for a reproductive donor. And perhaps we should go even one step beyond that in terms of our donors for research.”

There was some discussion as to just how far to go to minimize potential risks, particularly with regard to the issue of excluding particular donors with certain risk factors. “I notice that we’ve all agreed we should be conservative,” said Kurt Barnhart, director of the Center for Clinical Research on Women’s Health at the University of Pennsylvania, “but we’ve all danced around the issue by not offering specifics on what should be excluded and what shouldn’t.” The issue, he said, is finding a balance—to minimize potential risk but “not exclude everybody who might want to participate. We need to be cautious, of course, to minimize potential risk, but we don’t want to eliminate something without evidence for eliminating it.”

Zev Rosenwaks had a somewhat different take. “The big difference between research donors and IVF patients,” he said, “is that whenever possible, if you identify any irregularity, whether it be infectious, anatomic, or otherwise, a research donor should be excluded. We have to be careful to think about statistics, but at the end of the day common sense in terms of potential complications should rule.”



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