In the debate about medical experiments on human beings, 1984 was a landmark year. Public controversy on the issue literally spanned the continuum of human life from conception to natural death.
- In England, a government commission concluded a two-year study by suggesting that experimentation should be allowed on newly fertilized human embryos. The study was prompted by a 1982 announcement by in vitro fertilization pioneer Robert Edwards that he had observed some newly conceived embryos for two weeks before allowing them to expire in a Petri dish. At the urging of the Catholic bishops of Great Britain and many others, Parliament began consideration of a bill to prohibit such experiments.
- A legislative debate gathered momentum in the United States over federal standards on fetal experimentation which allow unethical experiments in certain circumstances. Tighter standards were approved by Congress after long debate, then invalidated when President Reagan vetoed the bill which included these standards as amendments.
- Experimental medical treatment for humans already born became a topic for nationwide discussion with the first clinical use of new organ transplant techniques. In the celebrated cases of "Baby Fae" Barney Clark and William Schroeder, Americans contemplated the use of animal and mechanical organs in human beings and discussed the fine line between exotic treatment for an individual and medical research to benefit future generations.
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."1
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.2
Another argument, applied to both the intended victim of an abortion and the child born dying from an abortion, could be bluntly expressed as: "They are going to die anyway, so why not make use of them to advance medical progress?"
Louisell, in his 1975 dissent, gave this answer: "The argument that the fetus-to-be-aborted `will die anyway' proves too much. All of us `will die anyway: A woman's decision to have an abortion, however protected . . . does not change the nature or quality of fetal life. We do not subject the aged dying to unconsented experimentation, nor should we the youthful dying."5 In Louisell's view it was one thing to say one cannot legally prevent others from having abortions, and quite another to use this as a pretext for destructive actions of one's own. The above-mentioned experiment involving sickle-cell anemia, for example, did directly cause some miscarriages, and the knowledge that the experiment could harm the fetus may even have prevented some women from changing their minds about having an abortion later.
One might add that the same issue was raised at the Nuremberg trials concerning Nazi physicians ultimately convicted of crimes against humanity. According to Dr. Andrew Ivy, a medical consultant at the trials, these physicians said of their victims that "since they would die in the concentration camp one might as well obtain some good for humanity out of them."6
Despite the absence of any cogent argument for their existence, these features of the 1975 regulations have survived into the present. In 1984, Congress approved new statutory standards that would repeal the "waiver clause" and specify that the child involved in abortion must not be subjected to an experiment that would not be carried out on children intended for live birth. But these standards were approved as amendments to a much larger bill authorizing several new programs at the National Institutes of Health, and the entire bill was vetoed by the President for fiscal reasons. Consideration of this bill has resumed in the present Congress.
Principles of Human Experimentation
Two key distinctions run through this debate on fetal research that can be applied to research at any stage of human life. These are the distinctions between "therapeutic" and "non-therapeutic" research, and between "consenting" and "unconsenting" subjects. Both distinctions are based on respect for the inviolability of each individual human being. "Non-therapeutic" research is more difficult to justify than "therapeutic" interventions because in the former case one runs the risk of using the individual merely as a means to some larger social good. This risk turns into reality when the subject has not given informed consent or is incapable of giving such consent. Since the human subject has an inherent right to life and bodily integrity, a researcher has no right to risk harm to this person for the benefit of mankind—unless that person freely volunteers to undergo such risk to serve others.
Catholic morality recognizes that this kind of service, like the willingness to become an organ donor, can be a genuine expression of Christian charity. It also recognizes certain moral limits. As Pope Pius XII observed in 1952, one has a responsibility to maintain one's own life and health, and no one should consent to non-therapeutic research that would "entail, either immediately or subsequently, acts of destruction, or of mutilations and wounds, or grave dangers."7 Because life ultimately belongs to its Creator, we are called to careful and responsible stewardship over our own lives.
The most difficult problems in this area, however, involve subjects, such as children, who are incapable of informed consent. It is generally agreed that parents or guardians can give informed consent on behalf of their child for beneficial medical treatment, even when the treatment may be experimental. But can parents consent to research that imposes risk on their child for the benefit of others?
Until quite recently, that question would have been answered almost unanimously in the negative. Western codes of medical ethics, especially those formulated in the wake of the Nuremberg trials, insist on the inviolability of the unconsenting human subject. In 1964, for example, Dr. Ross G. Mitchell spoke for many when he said that "an experiment is permissible provided that the risk does not exceed the ordinary risks of daily living .... Experiments carrying a greater risk may, of course, be permissible if an ill child is expected to benefit directly. I believe it is dangerous to suggest that an experiment which might otherwise be unjustifiable is justified because it is for the common good"8
This approach has been endorsed by ethicists representing all three strands of the Judeo-Christian moral tradition. Perhaps the point has been expressed most forcefully by Methodist theologian Paul Ramsey of Princeton University. Ramsey approaches the issue in terms of the special covenant between a child and a parent committed to the child's welfare: "Faithfulness to a child," he points out, "includes the requirement that we do not inflict pain or risk in addition to those of ordinary daily living. But fidelity to a human child also includes never treating him as a means only, but also as an end."9
Speaking from a Roman Catholic perspective, Father Richard McCormick of the Kennedy Institute of Bio Ethics agrees: "Where children are concerned, proxy consent is legitimate when the experimentation involves no discernible risks, discomforts, or inconvenience—in human judgment."10 In 1975 Father McCormick urged the Commission for the Protection of Human Subjects (without success) to apply this principle to the unborn child.
Rabbi Seymour Siegel, Professor of Theology and Ethics at Jewish Theological Seminary in New York, reached a similar conclusion in his 1975 testimony before the Commission: "Experiments for the `good of medicine' or for the sake of the `progress of knowledge' are not automatically legitimated, if they cause harm to people now, because someone in the future might benefit. What comes in the future is what the Talmudic literature calls `the secrets of the Almighty. This does not mean that we have no responsibility toward the future. However, we have a greater responsibility to those who are now in our care."11 Rabbi Siegel urged the Commission to recall the results when Nazi physicians ignored the sanctity of individual lives to serve what they saw as a greater good for mankind.
American law has reinforced this ethical consensus by decreeing that parents do not have the right to expose their children to significant risk to advance medical knowledge. In 1968, Justice Warren Burger (then serving on the D.C. Court of Appeals) reflected this legal tradition when he said that "no adult has the legal power to consent to experiments on an infant unless the treatment is for the benefit of the infant."12
It is clear that this tradition is not being consistently applied to the unborn child and premature infant, at least when abortion is involved. But the ethical principles recounted here also raise questions about other forms of experimentation.
Experiments on the Embryo
With new advances in recombinant DNA research, pressure has grown in the scientific community to allow genetic experiments on embryos fertilized in vitro. Three considerations make this debate slightly different from the debate about experimentation on the child in the womb.
First, the embryo is completely separate from the mother. Thus there is no possible conflict between the child's life and any alleged "right of privacy" of the mother. But it also seems to invite some researchers to treat the newly conceived embryo as just another lab specimen—one that can be frozen for later use or even discarded if imperfect. The American Fertility Society, for example, sees such embryos simply as the property of parents, to be disposed of as they wish. The depersonalized manner in which these embryos are conceived seems to encourage some scientists to dehumanize the product of the process.
Second, this debate primarily concerns embryos less than two weeks old, who some ethicists see as not deserving full protection because of speculations about the absence of human "individuation" at this stage. In August 1984, two Catholic theologians responded to this argument in Congressional testimony on embryo experimentation. Father Donald McCarthy of the Pope John XXIII Medical-Moral Research and Education Center cited Dr. Robert Edwards, himself a leading proponent of experimentation, as saying that the embryo is "a microscopic human being—one in its very earliest stages of development." Father McCarthy urged full protection of the human embryo from fertilization because it is clearly a distinct member of the human species whose development "culminates in an adult human being by a continuous dynamic growth if only nourishment and a favorable environment are provided." Father Richard McCormick's testimony admitted philosophical uncertainty about the "personhood" of the very early embryo, but concluded that "the certain personhood of the embryo or its achieved individuality" need not be proved to establish a strong presumption against non-therapeutic experimentation. A rule against such experiments, he argued, should be based on "the respect we owe to that which is en route to becoming personal life" and on "the risk of erosion of respect for human life that might occur without it."13
Finally, this form of experimentation poses risks of an entirely new order to the subject. In most human research one deals with risk of pain or injury. With genetic modification of the early embryo we confront the risk of depriving children of membership in the human species. This may have been a factor in Pope John Paul II's unusually forceful words in a speech to the Pontifical Academy of Sciences in October 1982: "I condemn, in the most explicit and formal way, experimental manipulations of the human embryo, since the human being, from conception to death, cannot be exploited for any purpose whatsoever."14
The transplants performed on "Baby Fae," Barney Clark and William Schroeder pose a less fundamental problem insofar as their treatment was designed to benefit these patients as individuals. While some people's sensitivities were offended by the thought of transplanting a baboon heart into a human child, or replacing the human heart with a mechanical pump, Catholic theologians do not see this as a moral problem in and of itself. The ethical question is: Were these treatments so experimental that they could be foreseen as offering no reasonable hope of benefit to the particular patient involved?
This question has been raised most frequently regarding the "Baby Fae" case. Some critics of this ultimately unsuccessful experiment believe either that the child's parents were essentially consenting to an experiment they knew had no real chance of saving their child, or that their consent was not genuine because they had been given false hope regarding the treatment's effectiveness. Kenneth Vaux, a Protestant ethicist at the University of Illinois, has written that the physicians involved probably knew that the therapy was futile but pursued it because of their intense desire to test the new "baboon heart" transplant on a human. On this basis Vaux concludes the treatment was unethical. "Christian ethics," he argues, "strongly contends that we must not harm or sacrifice ourselves, and certainly not those lives entrusted to our care, for abstract goals such as future benefit."15 Yet ethicist Father Robert Friday of the Catholic University of America saw the transplant as a last resort that had a plausible chance of extending the child's life, and thus as justifiable. But Father Friday also expressed concern that in a society "where abortion is taken as a matter of course" and the rights of handicapped newborns have been questioned, newborns might be seen by some as "not as human as the rest of us" and used for non-therapeutic research.16
Regarding Barney Clark and William Schroeder, the first human recipients of the artificial heart, there is less disagreement because it seems clear they exposed themselves to the risk of an experimental procedure after giving informed consent and considering the risks and benefits of other proposed therapies. A third recipient of the artificial heart, Thomas Creighton, actually prompted the observation that the law is sometimes stricter than morality. The version of the artificial heart used briefly to sustain Mr. Creighton had not been approved for use in humans by the FDA. Creighton's physician argued afterwards that this treatment gave his patient "a reasonable chance of survival" when nothing else might have offered that chance, and that he had a moral responsibility to take advantage of this opportunity.17
These and other applications of the basic moral principles regarding human experimentation will continue to exercise the ingenuity and discernment of all of us, not only of professional ethicists. But there is no reason to think the principles themselves are any less useful or relevant today than they were in times when medical science seemed less complex. Nor is there reason to think that morality is an obstacle to scientific progress. Pope John Paul II has not hesitated to praise "freedom of research" as "one of man's noblest "attributes," while reminding scientists that medical experiments "must all be subject to moral principles and values, which respect and realize in its fullness the dignity of man."18 The Church is convinced there is no contradiction between science and morality, that true human progress is never advanced by forgetting the inviolable dignity of the human individual.
Richard Doerflinger is Assistant Director of the NCCB Office for Pro-Life Activities.
Diamond, Eugene F. M.D. "Redefining The Issues in Fetal Experimentation;" in AUL Studies in Law and Medicine, No. 2.
Hurley, Most Rev. Mark J. The Church and Science. Boston: Daughters of St. Paul, 1982, $6.00 (cloth), $5.00 (paper).
McCarthy, Donald G. and Albert S. Moraczewski, O.P. (eds.). An Ethical Evaluation of Fetal Experimentation: An Interdisciplinary Study. Braintree, MA: Pope John Center, 1976, $8.95.
McCormick, Richard A., S.J. How Brave a New World: Dilemmas in Bioethics. New York: Doubleday, 1981, $15.95.
Moraczewski, Albert S., O.P. (ed.) Genetic Medicine and Engineering: Ethical and Social Dimension. Braintree, MA: Pope John Center, 1983. Available from the Catholic Health Association, St. Louis, $17.50 Ramsey, Paul. The Patient as Person. New Haven: Yale University Press, 1970, $10.95.
Reiser, Stanley Joel, Arthur J. Dyck and William J. Curran (eds.). Ethics in Medicine: Historical Perspectives and Contemporary Concerns. Cambridge: MIT Press, 1977, $27.50.
Varga, Andrew C. The Main Issues in Bioethics (rev. ed.) New York: Paulist Press, 1984, $10.95.
- NCCB Committee for Pro-Life Activities
- Pope John XXIII Medical-Moral Research and Education Center
- Catholic Health Association
- "Dissenting Statement of Commissioner David W. Louisell," reprinted in Eugene F. Diamond, M.D., Redefining the Issues in Fetal Experimentation. Americans United for Life: Studies in Law and Medicine, No. 2 (p. 11).
- The regulations governing fetal experimentation are contained in the Code of Federal Regulations at 45 C.FR. 46.201 to 46.211.
- Diamond, op. cit., (pp. 3 4.)
- See Reiser, Dyck, and Curran (eds.), Ethics in Medicine: Historical Perspectives and Contemporary Concerns. MIT Press: Cambridge, 1977 (pp. 449 50).
- Diamond, op. cit. (p. 10).
- Reiser et al., op. cit. (p. 270).
- Pope Pius XII, Allocution to the First International Congress of Histopathology, September 13, 1952.
- Ross G. Mitchell, "The Child and Experimental Medicine," British Medical Journal 4, No. I, March 21, 1964 (p. 724).
- Paul Ramsey, The Patient as Person. Yale University Press: New Haven, 1970 (p. 35).
- Reprinted in Richard A. McCormick, S.J., "Public Policy and Fetal Research," in How Brave a New World? Doubleday: New York, 1981(p. 84).
- Seymour Siegel, "A Bias for Life," in Hastings Center Report. June 1975 (p. 23).
- Warren E. Burger, "Reflections on Law and Experimental Medicine;" U.C.L.A.. Law Review 15, No. 2, February 1968 (p. 438).
- See Origins (N.C. Documentary Service), Auest 23, 1984 (pp. 173 76).
- Pope John Paul II, Address of October 23, 1982, to participants in a Week of Study on Biological Experimentation sponsored by the Pontifical Academy of Sciences; L'Osservatore Romano (Eng. ed.), November, 8, 1982.
- Kenneth Vaux, "Baby Fae and Human Wholeness;" in Christian Century): December 5, 1984.
- Marianne Comfort, "Moral Theologian Justifies 'Baby Fae' Transplant," Arlington Catholic Herald, November 8, 1984 (p. 6).
- "Artificial Heart was Ethical, Says C.U. Professor," Arlington Catholic Herald, March 14, (1985 (p. 22).
- Pope John Paul II, Address to representatives of Spanish universities, November, 3, 1982, in Origins, November 18, 1982 (p. 370); Address of October 23, 1982 (see note 14).