tion of human subjects in research. These hearings were in part fueled by controversy about reports of fetal research being done in Sweden.
The National Research Act (Public Law 93-348) established a National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. This law further prohibited research on a fetus from an elective abortion until the commission had reported back to Congress. Just after passage of this law, a panel that had been convened in 1971 by the (then) Department of Health, Education, and Welfare (DHEW) issued its report. This report recommended that research resulting in no harm to the fetus be permitted, so long as that research might benefit other fetuses. The panel further recommended, as a protection to pregnant women, that no research be requested or initiated until after the abortion had been initiated. Despite the panel's report, the National Research Act took precedence and all such research was banned pending the National Commission report.
After the National Commission issued its report (Report and Recommendations: Research on the Fetus), fetal research following abortion was permitted under subsequent DHEW regulations for therapeutic reasons, but otherwise held to the standard of "minimal risk." Minimal risk means that no more potential harm is tolerated than would be encountered in daily life. In the case of a fetus, almost all interventions exceed minimal risk, and the regulations did not distinguish between fetuses that were carried to term and those intended for abortion. The DHEW regulations, however, contained the possibility of waiver of the minimal risk standard on a project-by-project basis by a complicated procedure to be decided ultimately by an Ethics Advisory Board.
The first Ethics Advisory Board (EAB) was convened in 1978. The sole waiver issued by this body was to test the efficacy of using fetal blood samples for prenatal diagnosis of sickle cell anemia. The charter for the EAB expired in 1980, and despite publication of a draft charter in 1988, it has not been reactivated.
The Health Research Extension Act was passed, reauthorizing the National Institutes of Health. This legislation contained two important additions. First, a three-year moratorium was imposed on issuing waivers for fetal research, so that