February 1986 VII/6


Research is the lifeblood of medical progress. Ensuring ethical research programs, however, is not always easy. For example, after the heart of a baboon was implanted in an infant with hypoplastic leftheart syndrome, the procedure was criticized because scientific as well as ethical norms were not observed. (l) Specifically, the researchers "were far too optimistic about the therapeutic benefits." Moreover, the artificial heart program has been questioned on ethical grounds because benefits are described in less than accurate language. (2) One heart recipient, for example, described by the hospital as being in satisfactory condition, has had three strokes, has lost his power of speech and memory, and is far from the quality of function predicted by the medical team. The disconcerting aspect of both these cases is that they were approved by Institutional Review Boards (IRBs) as being ethically acceptable. While a full ethical analysis of the aforementioned cases is not the purpose of this essay, it might be helpful to consider some basic ethical concepts which, if emphasized and underlined, might guide IRBs more surely.


Research programs in the United States receive their ethical direction from the norms published by the Department of Health and Human Service (DHHS) which norms are applied by IRBs which function at every research institution.(3) The ethical norms of DHHS seem to be inadequate for two reasons:

1. The norms of DHHS do not distinguish between informed consent and proxy consent; thus they allow decisions to be made for incompetent persons which do not respect their rights.

2. The norms of DHHS apply only to children the distinction between therapeutic research (that which will benefit a patient personally) and non-therapeutic research (that which will benefit society by providing new knowledge but will not benefit the subject of the research protocol.

Let us say a word about these distinctions. In order to respect the worth and integrity of an individual, informed consent is required before a person can be a subject of a research program. Informed consent means that the subject has knowledge concerning the research, understands how it will affect him or her, and freely consents to be in the program. Clearly, the only people capable of giving informed consent are those who are conscious and competent. If one is in coma, a minor, senile or retarded, one cannot give informed consent. If there is a question of admitting a person who is a minor, in coma, senile or retarded into a research program, then the guardian of that person must be consulted. But the guardian does not give informed consent for the minor. Rather the parent or guardian gives proxy consent. When we give proxy consent for another, we act as benefactor for that person. We are allowed to give permission for· only those procedures that would benefit the patient. In the same way that informed consent protects the worth and integrity of a competent person, so tile principle of "only benefitting" a minor or ward protects the worth and integrity of a competent person, so the principle of "only benefitting" a minor or ward protects the worth and integrity of a noncompetent person.

The limits of proxy consent become even more evident when we emphasize the distinction between therapeutic, and non-therapeutic research. Competent persons who offer informed consent are able to engage in research projects which do not offer therapeutic benefit, but which will improve human knowledge. Thus competent persons can take a risk with their own well-being, risking injury, anxiety or impairment in order to benefit other human beings. But we are not able to offer another person to the risk of pain, injury or impairment unless the possible pain, injury or impairment is associated with therapy needed for the person in our care. If we equate informed consent and proxy consent, then we give to the person granting proxy consent the right to "use" other people for nontherapeutic research.


The lack of clarity in regard to the nature and limits of consent and research, may incline IRBs to approve protocols merely by asking the question: Does the person giving consent know the risks and benefits? But the questions, "Is this proxy consent?" or "Is this nontherapeutic research?" are often overlooked. Thus a minor may be subject to harm or pain, or a competent person may not have the benefits and risks explained accurately.

The Nuremberg Declaration, a statement made to counteract the research atrocities perpetuated upon helpless victims in World War II "who were going to die anyway," is very careful to limit the subjects of research projects, it states:

"The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be able to exercise free power of choice.... and should have sufficient knowledge and comprehension.... to enable him to make an understanding and enlightened decision."

Some may reply to our considerations that children and other persons equal to minors should "wish to benefit others" and therefore should be included in nontherapeutic research. This is beside the point. To determine what others should wish is not the right given to proxies. Rather, they are given only the right to determine what would be of benefit to their wards. Some may wish to extend the term "benefit" to include social values. Thus some would claim that the impaired, retarded and children do "benefit" from nontherapeutic research because they contribute to the common good. By using words metaphorically we can justify anything. "Benefit" in the context of research implies that the research protocol will be therapeutic for the person who is a subject.

Finally, if we limit the research upon infants, retarded, and impaired people even when competent, will it not slow down medical progress? For example, if we wait until there is a possibility of true benefit for an infant with a hypoplastic heart syndrome before allowing infants into the research program, will we not slow down research upon xenotransplants and if we insist upon a more accurate description of benefits from the artificial heart, would we not impede medical progress? Yes, insisting upon more rigorous ethical norms may slow down research, but there is a much more important value at stake here than knowledge of xenotransplants or artificial hearts. The value we are concerned with is how we will care for the young, the weak, the impaired in our society. As the Helsinki Statement, another attempt of the international scientific community to establish ethical norms for research, declared: "in research on man the interest of science or society should never take precedence over consideration of the well-being of the subject." In sum, the Federal norms seem inadequate to the task of ensuring ethical research projects.

Kevin O'Rourke, OP


1. Caplan, "Ethical Issues Raised by Research Involving Xenografts," JAMA, Dec. 20, 1985,Vo1.254, n.23.

2. "Jarvik Heart Ban Almost Urged," St. Louis Post Dispatch, Feb.21,1986.

3. Federal Register, Mar. 8, 1983.

© Kevin O'Rourke, O.P.