Egg donor payments raise issues for IRBs
Egg donor payments raise issues for IRBs
Board should consider amounts, understanding of risks
It could be months before IRBs in New York state may see any protocols calling for compensation of women who donate eggs for stem cell research.
But Robert Klitzman, MD, of the Empire State Stem Cell Board's (ESSCB) ethics committee, says it's not too early for IRBs to start thinking about the issue, which he says may eventually face IRBs in other states as well.
While IRBs are used to looking at compensation for participation in research studies, the egg donor situation raises some issues they don't normally deal with.
Women who donate eggs for in vitro fertilization typically are paid much more than the average research subject — guidelines published by the American Society for Reproductive Medicine generally allow payments of up to $5,000 — up to $10,000 with specific justification.
The ESSCB's decision calls for payments to research donors not to exceed those limits.
Arthur Caplan, PhD, director of the Center for Bioethics at the University of Pennsylvania in Philadelphia, says it may be more than IRBs are willing to approve for research subjects.
"That sort of thing could start to tip the pay scale in other studies, and make a real headache for the IRB," Caplan says. "Even if the state were to create a pot of money, it doesn't mean that IRBs are always going to be comfortable with it."
He suggests that institutions may try to outsource reviews of this kind to private IRBs to get around IRB hang-ups about the size of the compensation.
Klitzman, associate professor of clinical psychiatry at Columbia University in New York City, says the ESSCB decision doesn't mandate any payments at all, it just makes them possible. He says IRBs are free to decline to allow such payments, but he does urge them to look at the arguments put forward in defense of the compensation.
Proponents say the payments are ethical in part because of the invasive nature of hormonal induction and the risks that exist. They say that it is inherently unfair to pay women less for research donor eggs than for eggs produced for IVF.
"There's been a consensus among clinicians that it does not cause undue inducement," Klitzman says.
Caplan says offering such large amounts might be particularly problematic for IRBs if it involved poor women — women in developing countries, for example, or impoverished women in the United States.
Klitzman and Caplan say there are other issues IRBs must consider when reviewing a proposal to pay women for donor eggs:
-Assessing risk vs. benefit. Klitzman notes that the risks of serious consequences from hormonal induction — chiefly a condition called ovarian hyper-stimulation syndrome — currently are thought to be relatively small. But as more research is done about the procedure, and more women are followed longer, that risk profile may change. He says IRBs who handle research in this area should stay up-to-date about the potential risks.
He and Caplan both say the risks of the procedure need to be explained very clearly in the informed consent, so that potential donors understand them. Klitzman says the ESSCB plans to post informed consent templates online with suggested language.
-Recruitment materials. IRBs also need to keep a careful eye on the advertising done to attract potential donors. Klitzman notes that he's done studies looking at recruitment Web sites for other types of research, and has found examples where the benefits of studies are overemphasized, relative to the risks.
"They can't leave that in the hands of the researcher," Caplan says. "They have to look at those materials and make sure they're not underplaying the risk."
-Frequency of donations. While this issue is not directly addressed in the ESSCB's resolution, Klitzman says IRBs will have to make a decision about how many times a woman can donate eggs for research.
-Psychological counseling. Klitzman says his board is mandating that researchers who recruit women for egg donation make psychological counseling available to women if they need it. They did mandate screening for every woman.
"IRBs should be sensitive to the fact that (egg donation) can raise psychological issues for women," he says.
Klitzman says that if IRBs have questions about the decision and about specific issues raised by it, they should contact the New York State Stem Cell Science staff.
"As a member of the board, I personally would be very interested to know what kinds of questions and challenges IRBs come across," he says. "If IRBs find they have trouble with certain aspects, that would be helpful to know. We'd be delighted to hear from IRBs and work with them."
Ann Willey, director of the Office of Laboratory Policy and Planning for the New York State Department of Health, is serving as a contact for IRBs on this issue. She can be reached at (518) 486-2523.
For more information about the stem cell program, access the New York State Stem Cell Science Web site at www.stemcell.ny.gov.
It could be months before IRBs in New York state may see any protocols calling for compensation of women who donate eggs for stem cell research.Subscribe Now for Access
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