Opinion 2.169 - The Ethical Implications of Xenotransplantation
Xenotransplantation includes any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a non-human animal source or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live non-human animal cells, tissues, or organs. Although xenotransplantation offers a potential source of tissue, and organs for medical procedures, research in this area may uncover physical and psychological conditions that require medical attention. As such, physicians need to be involved in developing and implementing guidelines for continued research. Therefore, the following guidelines are offered for the medical and scientific communities:
(1) Physicians should encourage education and public discussion of xenotransplantation because of the potential unique risks such procedures pose to individual patients and the public.
(2) The medical and scientific communities should support oversight for the development of clinical trial protocols and of ongoing xenotransplantation research.
(3) Given the uncertain risk xenotransplantation poses to society, participants in early clinical trials may have to agree to (a) postoperative measures such as life-long surveillance, disclosure of sexual contacts, autopsy; and (b) a waiver of the traditional right to withdraw from a clinical trial until the risk of late xenozoonoses is reasonably known not to exist. These requirements may continue even if the transplanted tissue is rejected or removed. The informed consent process should include a discussion of the above issues as well as potential risks to third parties and psychological concerns associated with receiving an organ or tissue graft from an animal. Careful attention must be paid to both the content of the consent disclosure and the manner in which consent is obtained.
(4) It would be ethical to include children and incompetent adults in xenotransplantation research protocols only when the patients are terminally ill and alternative treatments are not available.
(5) Allocation protocols must be fair and in accordance with Opinion 2.03, "Allocation of Limited Medical Resources," which recommends that decisions regarding the allocation of medical resources among patients be based only on ethically appropriate criteria relating to medical need. These criteria include, but are not limited to, the likelihood of benefit, the urgency of need, the change in quality of life, the duration of benefit, and, in some cases, the amount of resources required for treatment.
(6) Sponsors of xenotransplantation research should assure that adequate funding exists for life-long surveillance and treatment of complications arising from xenotransplantation procedures on research subjects.
(7) At a minimum, all on-going research should adhere to the Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation, FDA guidelines relating to xenotransplantation, Opinion 2.07 "Clinical Research," and any additional precautionary measures believed to minimize potential risks to the public or to patients. It is inappropriate to participate in xenograft procedures outside federal guidelines.
(8) All xenotransplantation research should continue to promote high standards of care and humane treatment of all animals used in research (H-460.979, "Use of Animals in Research") and to apply these standards to the care and treatment of animals used as sources of transplantation material. (IV, VII)