The business of research.

The report of the Human Embryo Research Panel issued in September. 1994 comes in the aftermath of legislation - the National Institutes of Health (NIH) Revitalization Act of 1993 - that put an end to an eighteen - year de facto moratorium on embryo research in the United States. We are troubled by a number of aspects of the report, especially by (1) the fact that the proposed guidelines apply only to government-sponsored research and leave the for-profit sector unregulated, (2) the misleading impression that all embryo research falling under the guidelines is directed at improving health and not driven by its scientific or commercial potential, and (3) the panel's failure to address germ-line genetic engineering, although the research being regulated clearly points in that direction. Regulating Human Embryo Research The right of legitimate governments to allocate public funds for scientific research has been established in practice and law. With the explosion of publicly funded science after World War II and the experience of unethical human experiments in most industrialized countries, governments were also faced with regulating certain spheres of scientific activity involving hazardous materials, human subjects, animal research, and more recently genetic engineering. The recommendations of the panel would add a new set of guidelines that regulate research with human embryos or ova derived from women or fetuses. One of the key limitations of this form of regulation is its scope, since any regulations issued by NIH will only apply to federally funded research. NIH has no statutory authority to regulate the emerging IVF industry. So an obvious question is, If regulations are established for federally sponsored research, what will happen to privately funded research? The panel's report states that research on preimplantation embryos is already being carried out in many privately financed laboratories throughout the United States. Is there any reason to believe that federal guidelines will be adopted by private companies? If they are adopted on a voluntary basis, how will compliance be monitored? An analogy might be drawn with the NIH guidelines for recombinant DNA research. Men those guidelines were first issued in 1976 biotechnology companies were new and few in number, but despite this they were able to lobby against various congressional bills, which were subsequently defeated. But scores of companies, seeking to gain public confidence in genetic engineering, pledged to abide by the NIH guidelines and with very few reported exceptions, voluntary compliance seemed to work. This is not a good model for embryo research, however, because the circumstances are different. In the 1970s the biotechnology industry was just getting started and the threat of federal legislation provided a strong incentive for industry compliance with the NIH guidelines. Also, the biotechnology industry was largely made up of molecular geneticists who had appointments at universities and brought the culture of the research universities to the start-up companies. Commercial success was still years away, tempering the profit incentive for circumventing the guidelines. The fact that selected municipalities passed their own standards, which were stricter than the NIH guidelines, also served to keep the industry in check. Furthermore, CEOs were aware that they might be more strictly regulated if many private sector violations were disclosed. Another difference from the present situation is that, at least initially, the NIH guidelines were addressed exclusively to laboratory hazards and did not proscribe experiments on ethical grounds. In contrast to the conditions surrounding the issuance of the recombinant DNA guidelines, the IVF industry will have been growing for more than a decade before the projected embryo research guidelines are put in place. According to the panel's report, much of the IVF research has been directed by clinicians who lack experience in basic research and developmental biology. …