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A word to the wise.

Legislation with sweeping impact often can seem quite obscure and innocuous. Consider this example. Title I, Subtitle A, Part III, Section 121, Paragraph (c) of the National Institutes of Health Revitalization Act of 1993 contains the following sentence: "The provisions of section 204(d) of part 46 of title 45 of the Code of Federal Regulations (45 CFR 46.204(d)) shall not have any legal effect." On its face, this sentence would not seem to merit much attention, and in fact, as the bill sailed through Congress this past year, it didn't get much. But little more than a year ago, this sentence would probably have prompted a presidential veto, because for the first time in more than a decade, it allows the federal government to fund research on in vitro fertilization (IVF). What a difference a year makes.

The history of "45 CFR 46.204 (d)," as it is fondly known to its intimates, tells a fascinating story of science policy problem solving. The expunged section of the Code of Federal Regulations concerns the protection of human subjects. It prohibits funding of IVF research without approval from an Ethics Advisory Board. The requirement was established in the mid-1970s, when the possibility of test-tube babies thrilled the public but troubled ethicists, philosophers, and theologians.

By itself, 45 CFR 46.204(d) would not have limited the government's ability to fund research on in vitro fertilization. The Carter administration created the Ethics Advisory Board but then let its charter expire. Before it went out of existence, the board had completed a report on the ethics of IVF and embryo research. The board had determined that IVF was an ethical procedure and that research intended solely to improve the success rate of the process was also ethically acceptable. But the Reagan and Bush administrations failed to renew the board's charter, and without a board, government couldn't fund IVF research, so there was a de facto moratorium.

Both the research community and research administrators at the National Institutes of Health chafed under this restriction. For researchers, it meant that private funds had to be used for IVF research. That didn't stop medical centers from offering in vitro fertilization to infertile couples, and over the decade of the 1980s the number of IVF centers around the country grew from a handful to several hundred. There have now been 23,000 babies born by IVF in this country, but the success rate of the procedure is still depressingly low and the cost alarmingly high.

For research administrators, it's been frustrating not to be able to support a promising medical technology. Quietly, persistently, officials from NIH, particularly from the National Institutes of Child Health and Human Development, lobbied to end the moratorium. Their strategy was to convince their superiors in the Department of Health to reinstitute the Ethics Advisory Board.

In 1988 the plan nearly worked. The assistant secretary of health told Congress there would be a new board, but plans for a new charter stalled, and when the Bush administration came into office, plans for a board were put back on the shelf.

With the election of Bill Clinton, NIH officials saw a new opportunity. Clinton was not philosophically oppsed to IVF research, but he too had shown little enthusiasm for reconstituting an Ethics Advisory Board. So with lobbying support from the American Fertility Society, and the willing cooperation of Senator Edward Kennedy (D-mass.) and Representative Henry Waxman (D-Calif.), they hit on the strategy of simply eliminating the requirement that the Ethics Advisory Board approve IVF research projects. Language doing that was slipped into the NIH Revitalization Act of 1993, and President Clinton signed the act last summer. The most strident opposition to the act came because it explicitly removed the ban on federal funding for transplantation research using fetal tissue from induced abortions, so Title 1, Subtitle A, Part III, Section 121, Paragraph (c) attracted very little attention.

Duane Alexander, director of the National Institute of Child Health and Human Development, decided shortly after the act passed that it would be prudent to revisit the guidelines laid down for IVF research by the Ethics Board in 1979, since new research was bound to raise new issues. So he sought and received permission to create an ad hoc advisory panel to address the subject of IVF and embryo research. Alexander was in the process of recruiting members for that panel when news of an experiment with cloning human embryos captured the national spotlight last October. The news media sketched the potential ethical nightmares of cloning research, so Alexander was pleased to point out that such research would not be funded until his new advisory panel has its say.

The panel is supposed to give a new set of guidelines to the director of NIH next June. After that, the government should start supporting a much broader portfolio of research in the new world reproductive technology. Quite an achievement for one small sentence.
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Title Annotation:on the approval of in vitro fertilization research
Author:Palca, Joseph
Publication:The Hastings Center Report
Date:Mar 1, 1994
Previous Article:Parental control and teenage rights.
Next Article:The question of human cloning.

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