• A "Golden Rule" position, adopted in the United States, based on the concept of equal protection of wanted and unwanted fetuses, with research limited to "minimal risks" and exceptions permitted only after review by an Ethics Advisory Board (EAB) and a waiver of restrictions by the Secretary of Health and Human Services.

Up to 1980, the role of the U.S. government in relation to research ethics was primarily that of patron of public discourse. During the 1980s, in a political climate influenced by antiabortion sentiment, the government dismantled most of the public process for debate and resolution, including the EAB. Federal support of fetal tissue transplant research was placed under an "indefinite moratorium" (lifted by President Clinton in 1993). As a consequence, there has been essentially no federally funded embryo or in vitro fertilization research.

Every major question related to fetal research in the United States (and many aspects of research with other vulnerable populations such as children, prisoners, and the mentally ill or impaired) needs reexamination and new policy parameters. A critical question for the future of research is whether selectively greater investigative risks are justified in instances of elective abortion, especially in the first trimester of pregnancy. Up to the present time, National Institutes of Health researchers have not been permitted to investigate the causes of cancer in human embryos obtained after in vitro fertilization (IVF). Yet, experiments with living children involving more than minimal risk, without prospect of direct benefit to the subjects but with the possibility of deriving greater knowledge about their disorders, have been allowed. The ability to transfer genes into fetal cells for therapeutic trials calls for new studies of the natural history of genetic diseases, including genetic causes of cancer. An Ethics Advisory Board to the Secretary of Health and Human Services should be restored to serve as an ongoing resource in an overall reevaluation of research ethics, beginning with fetal research.

FEDERAL AND STATE REGULATIONS OF FETAL RESEARCH: A CURRENT PERSPECTIVE2

LORI B. ANDREWS

American Bar Foundation, Chicago, Illinois

In 1971, medical investigators in Massachusetts undertook an experiment to learn how pregnant women metabolize certain antibiotics and whether the antibiotics cross the placenta. The research involved women planning to abort, who had consented to administration of the drugs. Specific consent had not been requested, however, for subsequent analyses of the aborted fetuses to determine

2  

See also Lori B. Andrews, "Regulation of Experimentation on the Unborn," Journal of Legal Medicine 14:25–56, 1993.



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