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Regulating fertility

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by Jeffrey P. Kahn, Ph.D., M.P.H.
Director, Center for Bioethics
University of Minnesota

The debate over embryonic stem cell research is focusing attention on the policies and practices in reproductive medicine.

Clinics that perform assisted reproductive technologies create embryos to help couples who can't have children naturally, and in the process end up with thousands of embryos left frozen and unused. Such embryos have become the center of discussion about future sources of stem cells, now that the Bush administration has established policies for limited federal funding of stem cell research.

Why has reproductive medicine avoided scrutiny until now, and what are the implications of efforts to bring it under tighter control?

Unregulated history

The development of assisted reproductive technologies (ARTs) began with efforts to create "test tube babies" with in vitro fertilization in the 1970s. But rather than commit public funding to advance such research, the federal government banned the use of federal funds for research on human embryos, largely as a byproduct of the debate over abortion. Without federal funding, research on human embryos was outside of federal regulation and oversight, and continues to take place in private settings with private investment, beyond governmental rules and public scrutiny.

In addition to the absence of federal oversight, scrutiny from health insurance companies was also absent, since the vast majority of insurers don't cover assisted reproductive technologies. Whatever we might think about health insurers, they perform the valuable function of determining the appropriate use of new and expensive technologies, by refusing to pay for services that don't meet certain standards. Since assisted reproduction isn't usually covered, there is very limited third-party oversight. ARTs have slipped through the cracks in the oversight system that covers nearly every other area of clinical research and medical care.

Why treat ARTs differently?

There is no good reason why assisted reproduction ought to be treated differently than other area of medicine, except for its unique history.

Without insurance to pay for it, assisted reproduction became market-driven. New technology introduced by one clinic is quickly offered by others as a matter of survival. But unlike other areas of medicine, in which new therapies are developed after controlled research in humans, ARTs often are introduced directly from the lab as clinical services for patients. Data are collected as patients are treated with untested new approaches, creating the only area of medicine where patients come for treatment but in reality pay for the privilege of being research subjects.

The irony is hard to ignore: The research protection policies applied elsewhere in medical research were driven by efforts to prevent exploitation of the vulnerable -- yet patients confronting infertility are often the most vulnerable.

There are a few straightforward ways to bring assisted reproduction into the fold. First, research in assisted reproduction should receive the same sort of approval and oversight as federally funded research. Second, rules must be implemented to help decide what should be done with the hundred thousand or more frozen embryos sitting in clinic freezers. Couples should decide what should happen to embryos that they no longer need. There can easily be limits for how long embryos will remain stored -- the United Kingdom has established a five-year limit.

Such policies are long overdue. Bringing assisted reproductive technologies into the open will better serve patients and improve research oversight. In the process, it will go a long way toward convincing the public that this is a technology we can manage.

Visit the
"Ethics Matters" Archive
where you'll find other columns from Jeffrey Kahn
on a wide range of bioethics topics.


"Ethics Matters" is a biweekly feature from the
Center for Bioethics and CNN Interactive.






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