Center for the Study of Ethics in the Professions at IIT

A Statement by the Board on Medicine, National Academy of Sciences

February 28, 1968

Progress in medicine depends largely on the cautious extension to man of a body of carefully integrated knowledge derived from programs of basic and developmental research in the laboratory. Extension to man is itself an investigative process that must meet the same meticulous scientific standards that obtain in the laboratory and the extension can appropriately be started only when the total body of knowledge has reached a certain point. It is clear that this point has been reached in the case of cardiac transplantation.

Careful, detailed laboratory investigations in a number of centers have demonstrated the feasibility of a surgical technique for cardiac transplantation. With the skillful use of immunosuppressive agents, investigators have succeeded in maintaining the life of laboratory animals subjected to cardiac transplants for periods up to a year or more. Moreover, considerable relevant knowledge has been acquired from carefully controlled clinical investigations involving the transplantation of a kidney in a human being.

But, in contrast to the transplant of a paired organ of man such as the kidney, cardiac transplantation raises new, complex issues that must be faced promptly. In the case of a kidney transplant, the donation of the organ is not crucial to the donor; in the event of failure, the recipient may be kept alive for extended periods until another attempt is made. In the case of cardiac transplantation, the life of the donor cannot be maintained. Further, the recipient's life cannot be salvaged if the transplanted heart does not function. Highly important is the fact that the length of time that the recipient can survive is as yet conjectural, even if the immediate result is favorable as indicated by prompt resumption of function by the transplanted heart. Thus the procedure cannot as yet be regarded as an accepted form of therapy, even an heroic one. It must be clearly viewed for what it is, a scientific exploration of the unknown, only the very first step of which is the actual surgical feat of transplanting the organ. In this connection, it is clear that there are considerably more institutions whose staffs include men with the surgical expertise appropriate for the first step of the investigation-the actual transplantation -than have available the full capability to conduct the total study in terms of all relevant scientific observations.

Because of these special circumstances it is the considered view of the Board on Medicine of the National Academy of Sciences that for the present, cardiac transplantation should only be carried out in those institutions in which all of the fo1lowing criteria can be met:

1. The surgical team should have had extensive laboratory experience in cardiac transplantation, and should have demonstrated not only technical competence but a thorough understanding of the biological processes that threaten functional survival of the transplant, i.e., rejection and its control. Investigators skilled in immunology, including tissue typing and the management of immunosuppressive pro- should be readily available as collaborators in the transplantation effort.
effort.
2. As in any other scientific investigation, the overall plan of study should be carefully recorded in advance and arrangements made to continue the systematic observations throughout the whole lifetime of the recipient. The conduct of such studies should be within an organized framework of information exchange and analyses. This would permit prompt access by other investigators to the full positive and negative results . Thus the continued care of each recipient would be assured the continuing benefit of the most up-to-date information. Such an organized communication network would also permit the findings to be integrated with the work of others and assist in the planning of further investigative efforts. In this way, it would be possible to ensure that progress will be deliberate, and that the experience from each individual case will make its full contribution to the planning of the next.

3. As the procedure is a scientific investigation and not as yet an accepted form of therapy, the primary justification for this activity in respect to both the donor and recipient is that from the study will come new knowledge of benefit to others in our society. The ethical issues involved in the selection of donor and recipient are a part of the whole complex question of the ethics of human experimentation. This extremely sensitive and complicated subject is now under intensive study by a number of well-qualified groups in this country and abroad. Pending the further development of ethical guidelines, it behooves each institution in which a cardiac transplantation is to be conducted to assure itself that it has protected the interests of all parties involved to the fullest possible extent.

Rigid safeguards should be developed with respect to the. selection of prospective donors and the selection of prospective recipients. An independent group of expert, mature physicians-none of whom is directly engaged in the transplantation effort-should examine the prospective donor. They should agree and record their unanimous opinion as to the donor's acceptability on the basis of the evidence of crucial and irreversible bodily damage and imminent death. Similarly the prospective recipient should be examined by an independent group of competent physicians and clinical scientists including a cardiologist and an expert in immunology. In this instance the consulting group should also record their opinion as to the acceptability of the recipient for transplantation on the basis of all the evidence including the presence of far-advanced, irreversible cardiac damage and the likelihood of benefit from the procedure.

Enumeration of the above criteria is based on the conviction that in order to obtain the scientific information necessary for the next phase in this form of organ transplantation, only a relatively small number of careful investigations involving cardiac transplantation need be done at this time. Therefore, the Board strongly urges that institutions, even though well-equipped from the standpoint of surgical expertise and facilities but without specific capabilities to conduct the whole range of scientific observations involved in the total study, resist the temptation to approve the performance of the surgical procedure until there has been an opportunity for the total situation to be clarified by intensive and closely integrated study.