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Human Experimentation

Human Experimentation

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Felicific Forest

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Fetal Experimentation


Congress first addressed this subject in 1974 when reports came to its attention of unethical experiments involving infants born alive during late term abortions. The researchers claimed that since these children were dying from a procedure that was perfectly legal, and in any case could survive outside the womb for only a short time, they did not deserve full protection as human subjects. Congress disagreed and imposed a moratorium on all federal support for fetal experimentation. The moratorium was lifted only after a new National Commission for the Protection of Human Subjects drafted regulations to establish permanent federal safeguards for this area of research.

But this interdisciplinary team of experts in law, medicine and ethics never reached a consensus on whether the unborn child deserves full protection as a fellow human being. Some members thought such protection was inappropriate in light of the U.S. Supreme Court's abortion decisions. Only one Commission member, legal scholar David Louisell, took a clear stand in defense of equal protection for all human subjects before and after birth. Is it the mere youth of the fetus; he asked his colleagues, that is thought to foreclose the full protection of established human experimentation norms? Such reasoning would imply that a child is less deserving of protection than an adult. But reason, our tradition, and the U.N. Declaration of Human Rights all speak to the contrary, emphasizing the need of special protection for the young.

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On the key issues, Louisell's was the sole dissent from the compromise produced by the Commission. Its final proposal, promulgated as federal regulations in 1975 and still in force without substantial change, departed from what Louisell called "established human experimentation norms" on three points:



There was little disagreement that "therapeutic" research, designed primarily to meet the health needs of a particular child, was permissible. But a problem arose in the Commission's treatment of non-therapeutic research; designed not to benefit the research subject but to gain knowledge that may benefit others. Such experiments would be allowed, with the informed consent of the parents, if the experiments were of "minimal risk" –defined as the degree of risk the subject would experience in daily life or during routine physical or psychological examinations. These protections seemed meaningless when applied to the unborn child intended for abortion, since the parents have already committed themselves to destroying their child and the risks of "daily life" will soon include a violent death. The final regulations did not specifically address this ambiguity, but it was clear that many researchers saw the child-to-be-aborted as a prime subject for experiments that would be too dangerous for others.

A similar loophole involved regulations governing research on premature infants—a class of subjects which the regulations referred to as "fetuses ex utero." Again parental consent was required, and again seemed meaningless if the child struggling for survival had left the womb as the result of an abortion. Moreover, such infants were to be divided into three different categories. If viable (i.e., capable of sustained survival outside the womb), they would automatically fall under a separate set of fairly strict regulations governing experiments on children. If their viability was uncertain, they were not to be subjected to any interventions except those intended to bring them to viability. But if they fell under the category of "non-viable fetuses ex utero they could be subjected to any form of non-therapeutic experimentation so long as nothing was done either to hasten death or to prolong the child's dying. Here there were no restrictions on the amount of injury or pain a researcher might inflict. Some Commissioners argued that a fetus probably could not feel pain before viability in any case—an opinion which now seems almost willfully ignorant.

Finally, the regulations contained a clause allowing the Secretary of Health, Education and Welfare to waive the "minimal risk" standard when an experiment was considered too important to leave undone. The only standard remaining in such a case was that "the risks to the fetus involved are . . . outweighed by the sum of the benefit to the fetus and the importance of the knowledge to be gained." In any such experiment, of course, the "benefit to the fetus" would be zero; because there would be no need for a waiver clause if the experiment was intended to benefit the subject. What this clause made possible was a straightforward utilitarian calculus in which the pain, injury or death of an unborn child or premature infant would be justified by projected benefits to society. Here also, the child involved in an abortion seemed to be the intended target, since this is the only circumstance in which a parent is likely to agree to such an experiment. This clause has been used at least once, to test a prenatal diagnostic technique of uncertain risk on unborn children intended for elective abortion. The test was for sickle-cell anemia, a disease which presently has no cure. Its chief use for the foreseeable future will be to facilitate abortion decisions.

Brother Edwin
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The moral highground

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