November 1984 VI/3


Perhaps there are a few people living on the back of the moon who have not heard of Baby Fae, but most of us are familiar with her struggle for life as the first infant to receive a transplant of a baboon heart. Though she lived just short of three weeks with the transplant, the medical treatment she received spawned a host of ethical questions that live after her. We shall consider some of these questions in this essay.


When doing research which involves human subjects, most physicians and scientists in the United States follow regulations for ethical research published by agencies of the Federal Government. Indeed, if the research in question is funded by the Federal Government, following the Federal Regulations is mandatory. Evaluating human research protocols to ensure conformity with Federal Regulations is the responsibility of the Institutional Review Board (IRB). An IRB, required at every research institution, is mainly concerned with protecting the human subjects involved in research projects, but has some concern with the scientific validity of the project as well. At some schools, Saint Louis University, for example, all research projects involving human subjects must be approved by the IRB, not only those funded by the Federal Government.

The federal regulations for research involving children envision two types of research: that which "holds out prospects of direct benefit for the individual subject;" and that which "does not hold out the prospect of direct benefit for the individual subject." In this latter type of research there may be a benefit resulting from the study, such as new scientific knowledge, which would benefit other children but there is no direct benefit for the child or children involved in the research project. Concerning the first type of research which involves therapeutic treatment for the child or children in question, the regulations for ethical research are similar to those regulating research on adult human subjects. Hence consent must be received (in this case proxy consent because the child cannot give informed consent) and the risk of harm envisioned must be justified by the anticipated benefit.

But in regard to the research on children who do not benefit directly, the regulations are more involved. First of all, a distinction is made between "minimal risk of harm" to the subject and "more than minimal risk of harm." Minimal risk is equivalent to "physical and psychological harm that is normally encountered in the daily lives or in the routine medical or psychological examination of healthy children." Research which involves "more than minimal risk" may be approved by the IRB if there is "only a minor increase over minimal risk" and other requirements are met. If the IRB finds that the research involves a major increase over minimal risk, "the IRB can refer the project to the Department of Health and Human Services (DHHS) for study by a panel of experts, provided the IRB also "finds that the research presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health and welfare of children."

Some ethicists, myself included, believe the Federal Regulations for Research Involving Children are too lenient insofar as non-beneficial research is concerned. The main reason for this disagreement lies in the nature of proxy consent. A parent or guardian has the right of proxy consent only in order to benefit his or her child or ward. While an adult may freely subject himself or herself to risk research in which there is no personal benefit, it seems a parent or guardian does not have the same right over a child. Whatever the value of this opinion, I think it fair that the Baby Fae transplant should be evaluated in light of the more liberal ethical norms contained in the Federal Regulations.


In order to proceed with the ethical evaluation, let us ask the following questions:

(1) Should the physicians who performed the transplant on Baby Fae follow the Federal Guidelines for research on children? Legally speaking, they did not have to follow these guidelines because the research was funded by withholding a portion of the fees collected from private patients. (This method of funding research is an ethical issue in itself because cost shifting is involved.) But morally speaking, it seems the researchers at Loma Linda University do have an obligation to follow the federal regulations because they offer minimal ethical standards for our pluralistic society. To put it another way, if researchers do not follow the federal norms, which ethical norms will they follow?

(2) Did this research benefit Baby Fae directly or did it offer the kind of knowledge which would benefit other children? In spite of some early enthusiastic statements from same of the physicians doing the transplant, there seems to be no doubt that the transplant was not of direct benefit to Baby Fae. Otherwise, why would the IRB at Loma Linda University approve five baboon transplants in advance? Some might say, "Baby Fae benefitted because she would have died anyway and the transplant prolonged her life." But research may never be justified simply because the subject "will die anyway." Moreover, what benefit to prolong the life of an infant for three weeks and treat it as a thing rather than a person during that time? Others might say, "Maybe by some miracle she could have lived." But scientific research on humans is not based on miracles, it is based on certified knowledge and previous research on animals. To say that the research did not benefit Baby Fae directly does not imply it was per se unethical. But it does mean that the research should be subject to stringent standards.

(3) If the research did not benefit Baby Fae, did it involve more than minimal risk of harm? If so, was it a minor or a major increase? Clearly the surgery involved a major risk of harm. Not only was there the risk of immediate death, but there was the certainty of physical pain and suffering which resulted from the surgery and of deterioration of her vital organs from the drugs used to suppress her immunological defenses. In addition to the risk of physical harm, the risk of emotional harm must be considered as well. Baby Fae spent her last days as a research object, not in the arms of a loving mother. In sum it seems that the IRB at Loma Linda University did not have the right to approve the research on Baby Fae.


Because there was no hope of benefitting Baby Fae and because the risk of harm involved in the transplant procedure was a major increase over minimal harm, it seems the baboon heart research proposal should have been submitted to a national panel of experts selected by the Secretary of HHS. Research involving transplants from animals is not in itself unethical, but it should be carried on only after the protocol, its scientific justification, and an analysis of risk and benefit have been evaluated and approved by a group of competent peers.

Fr. Kevin O'Rourke, OP


1. Research Involving Children, Natl. Commission for Protection of Human Subjects of Biomedical and Behavioral Research, 0S77-0004, 1977; Federal Register, Vo1.48, n.46, 3/8/83, "Additional Protection for Children Involved as Subjects of Research," (All quotes from these documents.)

© Kevin O'Rourke, O.P.