personal privacy of the couple if names and other details came to light. Altering national statutes to accommodate reasonable clinical investigations, in any event, seems an awkward route to sensible public policy.
LESSONS FROM OVERSIGHT OF FETAL RESEARCH, RECOMBINANT DNA RESEARCH, AND HUMAN GENE THERAPY The legislative and bureaucratic history of fetal research is all well and good, but what has it meant to research? Has it led to a real moratorium? The various legislative bans on federal funding were never expected to block all scientific research on in vitro fertilization. If the intention were to ban all human cloning, then this moratorium on federal funding is not the appropriate model. Private sector activity was anticipated and understood by lawmakers to be going on. In many respects, the situation now is much as OTA reported it a decade ago. The federal moratorium has shifted in vitro fertilization and related research to private centers that do not receive federal funds for research on human subjects, and so can conduct work outside 45 CFR 46. Thus most of the work takes place outside the research mainstream. With the possible exception of some research undertaken by Mark Hughes that overlapped with activities funded by the National Center for Human Genome Research last year, however, the federal moratorium appears to have held. (The Hughes case may or may constitute an infraction. Federal funding for Dr. Hughes was cut off when this came to light, but the nature, extent, or even existence of work that was federally funded and fell afoul of federal guidelines has not been publicly disclosed. A congressional inquiry has been initiated). For most of the past 23 years, a ban has remained in place for federally funded in vitro fertilization and fetal research of more than minimal risk. This ban has been punctuated by two periods when proposals were considered for federal funding— 1978–1980, when the EAB existed to review proposals (including some fetoscopy studies that were approved), and 1994-1995, when NIH assembled a panel to consider what criteria should guide funding for fetal research. The boundaries of the moratorium have shifted slightly with the shift from NIH authorization statute to executive branch back to NIH authorization to ban removal to new bans imposed by annual appropriations. Fetal research has proven irresolvable within Congress, and has provoked repeated fights. With a shift to the appropriations committees, such fights can now be expected to take place every year, meaning more or less continually. The various moratoria on fetal research were initially imposed by Congress, and subsequent moratoria were either due to actions of Congress or decisions not to act by Secretaries of Health and Human Services (in several cases over the years, usually to spare the President from precipitating controversies that policy change would entail). The various bans were imposed because of ethical concerns, not biohazard danger to patients, or lack of informed consent. The dangers were not palpable to the investigators whose freedom of inquiry was constrained. The risks were to unborn fetuses, and for early embryonic research in particular, the moral standing of the “research subject” was a matter of moral belief, often grounded in theology. H-19