In 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research considered many aspects of fetal research. The Commission received some detailed ethical, legal, and scientific analyses, invited public testimony, and recommended guidelines for biomedical research involving the human fetus.'One of the authors of the present article (KJR) chaired the Commission. Many of its recommendations became federal regulations on fetal research issued in 1975.These regulations expliatly govern only research "conducted by the Department of Health and Human Services (DHHS) or funded in whole or in part by a Department grant, contract, cooperative agreement or fellowship."' However, as Baron pointed out in his legal review, they effectively cover all federally funded institutions, regardless of the source of the funds the institution may be using for fetal research.' To qualify for federal funds, these institutions must obtain DHHS' approval of an assurance that includes "a statement of principles governing the institution in discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of source of funding."' These institutional statements follow the requirements of the federal regulations governing fetal research. If an institution that receives DHHS funds werc alleged to have committed violations in privately funded fetal research, the issues would doubtless be examined within the scope of the federal regulations.These regulations have been in effect for more than a decade. Very little if any federally supported nontherapeutic research has taken place, although the replations permit it within careful limits. However, during this period medical advances and attitude shifts have occurred that suggest that the regillations should be submitted to the kind of re-appraisal that any system of ethical guidance periodically requires. C'ltrasonography, early prenatal diagnosis, and in vitro fertilization (IVF) have all been developed since the regulations w r e promulgated. Research-ers are using or seeking to use such technology in fetal diagnosis and treatment, in transplantation of fetal tissues and organs, and in studies of the pre-implantation human embryo. Recent discoveries about the fetus and the pregnant woman also indicate the need for re-evaluation of rhe concepts of "minimal risk" and "no discernible risk" rhat played an important part in the Commission's original recommendations.The first half of this paper reviews the ethical concerns that led to the regulations, describes their main features, and briefly summarizes the activities of the Ethics Advisory Board created in 1977. Since this board was allowed to lapse in 1980, fetal research has been proceeding largely without either federal funds or federal oversight, to the potential detriment of fetuses and pregnant women. The impact of this situation is examined in several key areas of fetal research.The second half of the paper discuss...
