Fetal research and fetal-tissue research: policy debate but no resolution.
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This article reviews some of the significant contributions of fetal research and fetal tissue research over the past 20 years. The benefits of fetal research include the development of vaccines, advances in prenatal diagnosis, detection of malformations, assessment of safe and effective medications, and the development of in utero surgical therapies. Fetal tissue research benefits vaccine development, assessment of risk factors and toxicity levels in drug production, development of cell lines, and provides a source of fetal cells for ongoing transplantation trials. Together, fetal research and fetal tissue research offer tremendous potential for the treatment of the fetus, neonate, and adult.
Since 1973, fetal research has repeatedly been used as a weapon in the war against abortion, miring important research in seemingly endless controversy. Government funding of fetal research has been suspended several times: A 1974 moratorium was lifted in 1975 after regulations concerning such research were promulgated; in 1985, a moratorium was placed on some federally funded fetal research; and in 1988, the assistant secretary for health halted all federally funded research on fetal tissue transplantation while an outside advisory panel examined related ethical, legal and scientific issues. The panel deemed such research acceptable, while also recommending that safeguards be established to separate abortion from transplantation research and to prevent profiteering from or encouragement of abortion. Although the report was forwarded to the assistant secretary in January, the moratorium has not yet been lifted by the new administration.
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The transition from innovation to standard of care for fetal surgery should be guided by ethical considerations. We provide an ethical framework that identifies criteria for the investigation of fetal surgery. This framework addresses the initiation and assessment of clinical trials to determine whether they establish a standard of care, describes an appropriate informed consent process, considers whether selection criteria should include the abortion preferences of the pregnant woman, and considers whether physicians have an obligation to offer referral to such investigation. This ethical framework, in a clinically comprehensive fashion, takes account of the physician's obligations to the fetal patient, the pregnant woman, and future fetal and pregnant patients. We apply this framework to clinical investigations of fetal surgery for spina bifida.
It may be that the current system of formal definitions, ethical theories, and voluntary professional guidelines to protect patients from unwittingly becoming subjects of research is inadequate to meet the challenge of surgical innovation. Important questions, such as when surgical innovation becomes research involving human subjects or how to distinguish between variations on an existing technique and true innovations, are key. These questions also apply to MFS as an innovative surgical therapy. Now that MFS has been recognized as experimental and formal clinical trials will be conducted, it is important to ensure adequate protection of the pregnant women and fetuses involved as human research subjects. This issue is even more pertinent in light of the new regulations regarding fetuses as research subjects. Those responsible for reviewing study protocols will have to be especially careful when examining the new version of DHHS regulations as they apply to future studies in the field of MFS.
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