Capital Report: A Word to the Wise

Abstract

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: provisions of section 204(d) of part 46 of title 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, 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. …