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President's Council Takes on the Ethics of ART

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Many physicians working in the field of Assisted Reproductive Technologies (ART) braced for the release of the latest and fifth report by the President's Council on Bioethics, which takes an in-depth look at the practices and results of ART in the US. Now that the document has been finalized, we are instead pleasantly surprised.

A bevy of questions, recommendations and opinions emerge out of Reproduction and Responsibility: The Regulation of New Biotechnologies, leaving readers potentially baffled about what steps might be taken from its analysis. (See www.bioethics.gov) Yet the report stops short of recommending drastic or unreasonable changes, and instead calls for limitations to about a half-dozen of the most questionable practices (see below). In a reasoned and logical fashion, the report turns out to be a compendium of suggestions for federal monitoring, tracking and long-term research into the health implications of IVF babies and mothers.

The legislative limitations focus on those areas of research that are potentially driven by the promise of embryonic stem cell therapy, and/or cloning. Even in this politically charged area, the Council's recommendations mainly address the kind of obscure research that tinkers with, or attempts to defy the basic building blocks of procreation involving egg and sperm, such as:

- No transfer of human embryos into animals
- No hybrid human-animal embryos
- No human embryos into women without live-born child intent
- No conception other than by means of uniting egg and sperm
- No conception from gametes obtained from fetus or stem cells
- No conception by fusing the blastomeres from 2 or more embryos
- No human embryos for research beyond 10-14 day stage

Given that these suggested prohibitions in the draft report evoked little outcry, the scientific and medical community appear to be palliated by this report. The last item in particular suggests a maximum 10-14 day development stage for leftover embryos donated to research. By making sure that the embryos are donated for research early in their development, this notion gently disarms the politically prevailing view that no new embryos should be used by federal-funded research to develop new lines of embryonic stem cells.

It is well known that bioethics investigations around the world are driven out of concern that human cloning research is galloping ahead, outpacing the public's capacity to understand, let alone react to this brave new world. Media headlines announcing rat and cat cloning, and the creation of embryos from materials other than eggs and sperm seem to appear regularly in the news.

At the same time, public support for therapeutic research involving stem cells is spreading like wild-fire, prompting a majority of senators, as well as more than 200 members of Congress, including some with anti abortion views, to petition President Bush to lift the ban on new embryonic stem cell lines for federally-funded research. This should come as no surprise; 100 million Americans have various diseases that could eventually be benefited by the regenerative capacities of stem cells (i.e. therapeutic cloning), even though sound science to this effect remains elusive.

The Council's report also devotes considerable space describing the need for monitoring, testing and oversight. But again, it stops short of recommending strict new operational standards for ART practitioners, admitting that the current regulations work, notwithstanding the need for a little improvement.

Indeed, infertility practitioners are proud of the high standards they've established through peer-participating professional associations including the Association of Reproductive Medicine (ASRM) and the Society of Reproductive Technologies (SORT).

At the same time, the report's recommendation for a massive and ambitious long-term monitoring project of IVF patients' health is well founded. A 20-40 year federally funded study, following both mothers and their ART assisted children into later years, could reveal new insights into all infertility procedures and outcomes, especially if the research compliments what is already considered science.

The only caveat is additional costs of government monitoring, research and/or regulations have historically fallen back onto the consumer.

To conclude, the majority of ART physicians are in support of reining in the few rogue infertility researchers who have crossed an ethical line attempting to recreate and manipulate some of the core ingredients of procreation (i.e. reproductive cloning) with dangerous and unproven techniques. Reproduction and Responsibility is not expected to cause enormous ripples of change in the ART community. It does an excellent job of presenting the wide breadth of views on the topic, not squelching contrary opinions, but rather maintaining a healthy dialogue. We do not expect to see significant governmental controls emerge for the vast majority of couples who simply want our help in making a baby.
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About the Author

Dr. Herbert is a fertility expert and an innovator in the field.

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