Code of Medical Ethics: Organ Transplantation Guidelines

2.15 Financial Incentives for Organ Donation.

The voluntary donation of organs in appropriate circumstances is to be encouraged. However, it is not ethical to participate in a procedure to enable a living donor to receive payment, other than for the reimbursement of expenses necessarily incurred in connection with removal, for any of the donor's non‑renewable organs.

Procedures involving financial incentives for cadaveric organ donors should have adequate safeguards to ensure that the health of donors and recipients is in no way jeopardized, and that the quality of the organ supply is not degraded. Incentives should be limited to future contracts offered to prospective donors. By entering into a future contract, an adult would agree while still competent to donate his or her organs after death. In return, the donor's family or estate would receive some financial remuneration after the organs have been retrieved and judged medically suitable for transplantation. Several other conditions would apply:

(1) Only the potential donor, and not the donor's family or other third party, may be given the option of accepting financial incentives for cadaveric organ donation. In addition, the potential donor must be a competent adult when the decision to donate is made, and the donor must not have committed suicide.

(2) Any incentive should be of moderate value and should be the lowest amount that can reasonably be expected to encourage organ donation. By designating a state agency to administer the incentive, full control over the level of incentive can be maintained.

(3) Payment should occur only after the organs have been retrieved and judged medically suitable for transplantation. Suitability should continue to be determined in accordance with the procedures of the Organ Procurement and Transplantation Network.

(4) Incentives should play no part in the allocation of donated organs among potential transplant recipients. The distribution of organs for transplantation should continue to be governed only by ethically appropriate criteria relating to medical need. (1, 111, V)

Issued June 1984.

Updated June 1994 based on the report "Financial Incentives for Organ Procurement: Ethical Aspects of Future Contracts for Cadaveric Donors," issued December 1993.

Journal 1994 Examines the current system governing the transfer of transplantable organs. Proposes that a futures market in bodily organs would alleviate the shortage of available organs. Argues that existing organ transplantation laws must be amended to allow a futures market to operate. Quotes Opinion 2.15. Crespi, Overcoming the Legal Obstacles to the Creation of a Futures Market in Bodily Organs, 55 Ohio St. L J. 1, 74 (1994).

Code of Medical Ethics: Current Opinions with Annotations p.30

2.155 Mandated Choice and Presumed Consent for Cadaveric Organ Donation.

A system of mandated choice for organ donation, in which individuals are required to express their preferences regarding organ donation when renewing their drivers' licenses or performing some other state-mandated task, is an ethically appropriate strategy for encouraging donation and should be pursued. To be effective, information on the importance of organ donation and the success of organ transplantation should be provided when the donation decision is made.

A system of presumed consent for organ donation, in which individuals are assumed to consent to be organ donors after death unless they indicate their refusal to consent, raises serious ethical concerns. For presumed consent to be ethically acceptable, effective mechanisms for documenting and honoring refusals to donate must be in place. In addition, when there is no documented refusal by the individual decedent, the family of the decedent would have to be contacted to verify that they do not know of any objections to donation by the decedent while living. (I, III, V) -

Issued June 1994 based on the report "Strategies for Cadaveric Organ Procurement: Mandated Choice and Presumed Consent," issued December 1993.

2.157 Organ Procurement Following Cardiac Death. Given the increasing need for donor organs, protocols for procurement following cardiac death have been developed. In some instances, patients or their surrogate decision makers request withdrawal of life support and choose to serve as organ donors. In these cases, the organs can be preserved best by discontinuation of life support in the operating room so that organs can be removed two minutes following cardiac death. In other scenarios, patients who suffer unexpected cardiac death may be cannulated and perfused with cold preserving fluid (in situ preservation) to maintain oroans. Both of these methods may be ethically permissible, with attention to certain safeguards.

1. When securing consent for life support withdrawal and organ retrieval, the health care team must be certain that consent is voluntary. This is particularly true where surrogate decisions about life-sustaining treatment may be influenced by the prospect of organ donation. If there is any reason to suspect undue influence, a full ethics consultation should be required.

2. In all instances, it is critical that there be no conflict of interest in the health care team. Those health care professionals providing care at the end of life must be separated from providers participating in the transplant team.

3. Further pilot programs should assess the success and acceptability of organ removal following withdrawal of life-sustaining treatment.

4. In cases of in situ preservation of cadaveric organs, the prior consent of the decedent or the consent of the decedent's surrogate decisionmaker makes perfusion ethically permissible. Perfusion without either prior specific consent to perfusion or general consent to organ donation violates requirements for informed consent for medical procedures and should not be permitted.

5. The recipients of such procured organs should be informed of the source of the organs as well as any potential defects in the quality of the organs, so that they may decide with their physicians whether to accept the organs or wait for more suitable ones.

6. Clear clinical criteria should be developed to ensure that only appropriate candidates, whose organs are reasonably likely to be suitable for transplantation, are considered eligible to donate organs under these protocols.

Issued June 1996 based on the reports "Ethical Issues in the Procurement of Organs Following Cardiac Death: The Pittsburgh Protocol" and "Ethical Issues in Organ Procurement Following Cardiac Death: In Situ Preservation of Cadaveric Organs," issued December 1994.

2.16 Organ Transplantation Guidelines.

The following statement is offered for guidance of physicians as they seek to maintain the highest level of ethical conduct in the transplanting of human organs.

(1) In all professional relationships between a physician and a patient, the physician's primary concern must be the health of the patient. The physician owes the patient primary allegiance. This concern and allegiance must be preserved in all medical procedures, including those which involve the transplantation of an organ from one person to another where both donor and recipient are patients. Care must, therefore, be taken to protect the rights of both the donor and the recipient, and no physician may assume a responsibility in organ transplantation unless the rights of both donor and recipient are equally protected. A prospective organ transplant offers no justification for a relaxation of the usual standard of medical care for the potential donor.

(2) When a vital, single organ is to be transplanted, the death of the donor shall have been determined by at least one physician other than the recipient's physician. Death shall be determined by the clinical judgment of the physician, who should rely on currently accepted and available scientific tests.

(3) Full discussion of the proposed procedure with the donor and the recipient or their responsible relatives or representatives is mandatory. The physician should ensure that consent to the procedure is fully informed and voluntary, in accordance with the Council's guidelines on informed consent. The physician's interest in advancing scientific knowledge must always be secondary to his or her concern for the patient.

(4) Transplant procedures of body organs should be undertaken (a) only by physicians who possess special medical knowledge and technical competence developed through special training, study, and laboratory experience and practice, and (b) in medical institutions with facilities adequate to protect the health and well-being of the parties to the procedure.

(5) Recipients of organs for transplantation should be determined in accordance with the Council's guidelines on the allocation of limited medical resources.

(6) Organs should be considered a national, rather than a local or regional, resource. Geographical priorities in the allocation of organs should be prohibited except when transportation of organs would threaten their suitability for transplantation.

(7) Patients should not be placed on the waiting lists of multiple local transplant centers, but rather on a single waiting list for each type of organ. (I, III, V) issued prior to April 1977.

Updated June 1994 based on the report "Ethical Considerations in the Allocation of Organs and Other Scarce Medical Resources Among Patients," issued June 1993. In addition, the 1986 Report of the U.S. Task Force on Organ Transplantation is an excellent resource for physicians involved in organ transplantation.

Journal 1987 Discusses the issue of the right of the individual to consent to organ removal and then examines the doctrine of informed consent as it is applied in the context of live organ donation. Evaluates the extent to which removal of non-regenerative organs disrupts the basis for application of the traditional informed consent model. Additional attention is devoted to special concerns regarding consent in cases of children and incompetent patients, with consideration of the role of judicial review in these types of cases. Quotes Opinion 2.15 (1986) [now Opinion 2.16]. Adams, Live Organ Donors and Informed Consent: A Difficult Minuet, 8 J. Legal Med. 555, 560-61 (1987).

2.161 Medical Applications of Fetal Tissue Transplantation. The principal ethical concern in the use of human fetal tissue for transplantation is the degree to which the decision to have an abortion might be influenced by the decision to donate the fetal tissue. In the application of fetal tissue transplantation the following safeguards should apply: (1) the Council on Ethical and Judicial Affairs' guidelines on clinical investigation and organ transplantation are followed, as they pertain to the recipient of the fetal tissue transplant (see Opinion 2.07, Clinical Investigation, and Opinion 2.16, Organ Transplantation Guidelines); (2) a final decision regarding abortion is made before initiating a discussion Of the transplantation use of fetal tissue; (3) decisions regarding the technique used to induce abortion, as well as the timing of the abortion in relation to the Gestational age of the fetus, are based on concern for the safety of the pregnant woman; (4) fetal tissue is not provided in exchange for financial remuneration above that which is necessary to cover reasonable expenses; (5) the recipient of the tissue is not designated by the donor; (6) health care personnel involved in the termination of a particular pregnancy do not participate in or receive any benefit from the transplantation of tissue from the abortus of the same pregnancy; and (7) informed consent on behalf of both the donor and the recipient is obtained in accordance with applicable law. (1, IV, V)

Issued March 1992 based on the report "Medical Applications of Fetal Tissue Transplantation," issued June 1989 (JAMA. 1990; 263: 565-570).

Updated June 1996.

Journal 1990 Presents an update on current medical research regarding Parkinson's disease. Discusses the relevance

of fetal tissue transplantation to this research. Concludes that continued neurological research is necessary. References

Opinion 2.16 1. Joynt, Neurology, 263 2660 (1990).

2.162 Anencephalic Neonates as Organ Donors. Anencephaly is a congenital absence of major portion of the brain, skull, and scalp. Anencephalic neonates are thought to be unique from other brain-damaged beings because of a lack of past consciousness with no potential for future consciousness.

Physicians may provide anencephalic neonates with ventilator assistance and other medical therapies that are necessary to sustain organ perfusion and viability until such time as a determination of death can be made in accordance with accepted medical standards, relevant law, and regional organ procurement organization policy. Retrieval and transplantation of the organs of anencephalic infants are ethically permissible only after such determination of death is made, and only in accordance with the Council's guidelines for transplantation.

Updated June 1996 based on the report "Anencephalic Infants as Organ Donors-Reconsideration."

Journal 1994 Criticizes both the White House's proposed National Bioethics Advisory Commission and certain purely private ethical advisory bodies. Proposes that an appropriately organized new federal advisory body could provide essential guidance in developing public bioethical policies, particularly if the meaningful input of ethics scholars at universities, ethics centers, and other private organizations and public commissions were sought. Cites Opinion 2.162. Capron, Ethics.- Puiblic and Private, 24 Hastings Center Rep. 26, 27 (November/ December I994).

2.165 Fetal Umbilical Cord Blood. Human umbilical cord blood has been identified as a viable source of hematopoietic stem cells that can be used as an alternative to bone marrow for transplantation. It is obtained by clamping the umbilical cord immediately after delivery.

The use of umbilical cord blood raises two main ethical problems. First, the exact timing of the clamping has a significant impact on the neonate. Studies indicate that early clamping may cause an abrupt surge in arterial pressure, resulting in intraventricular hemorrhage (particularly in premature infants). Second, there is a risk that the infant donor will develop a need for his or her own cord blood later in life. If that child was a donor and this later need arises, he or she might be without blood, when he or she could have had his or her own blood stored.

To avoid health risks, normal clamping protocol should be followed and not altered in such a way that might endanger the infant. Additionally, parents of the infant must be fully informed of the risks of the donation and written consent should be obtained from them.

The second concern, that the child may need the blood later in life, is more complex. The possibility that an infant donor would be in need of his or her own umbilical cord blood is highly speculative. There are a number of reasons why the infant may not need the blood later. The diseases that are treated by bone marrow transplantation are not common, and there may be other treatment alternatives available, particularly in the future when the illness would occur. Additionally, the demand for fetal umbilical cord blood will increase as it becomes medically certain that the blood may be used in persons unrelated to the donor. This situation will reduce the need to store a particular infant's blood since umbilical cord blood from other donors would be available. If the blood is sufficient for use in unrelated individuals, then the donor may obtain the cord blood from another donor later in life, making the need to store his or her own blood unnecessary. These original donors, however, should be given priority in receipt of such blood if they need a donation later in life.

For all of these reasons, it would generally not be unethical to use the cord blood. However, if the child-donor is known to be at risk for an illness that is treated by bone marrow donation, the child should not be used as a donor, and his or her blood should be stored for future use. (I, V)

Issued June 1994.

Updated June 1996.

2.166 The Use of Minors as Organ and Tissue Donors. Minors need not be prohibited from acting as sources of organs, but their participation should be limited. Different procedures pose different degrees of risk and do not all require the same restrictions. In general, minors should not be permitted to serve as a source when there is a very serious risk of complications (e.g., partial liver or lung donation which involve a substantial risk of serious immediate or long-term morbidity). if the safeguards in the remainder of this opinion are followed, minors may be permitted to serve as a source when the risks are low (e.g., blood or skin donation, in which the donated tissue can regenerate and spinal or general anesthesia is not required), moderate (e.g., bone marrow donation, in which the donated tissue can regenerate but brief general or spinal anesthesia is required) or serious (e.g., kidney donation, which involve more extensive anesthesia and major invasive surgery).

If a child is capable of making his or her own medical treatment decisions, he or she should be considered capable of deciding whether to be an organ or tissue donor. However, physicians should not perform organ retrievals of serious risk without first obtaining court authorization. Courts should confirm that the mature minor is acting voluntarily and without coercion.

If a child is not capable of making his or her own medical decisions, all transplantations should have parental approval, and those which pose a serious risk should receive court authorization. In the court authorization process, the evaluation of a child psychiatrist or psychologist must be sought and a guardian ad litem should be assigned to the potential minor donor in order to fully represent the minor's interests. When deciding on behalf of immature children, parents and courts should ensure that transplantation presents a "clear benefit" to the minor source, which entails meeting the following requirements:

(1) Ideally the minor should be the only possible source. All other available sources of organs, both donor pools and competent adult family members, must be medically inappropriate or significantly inferior. An unwilling potential donor does not qualify him/her as medically inappropriate.

(2) For transplantations of moderate or serious risk, the transplantation must be necessary with some degree of medical certainty to provide a substantial benefit; that is, it both prevents an extremely poor quality of life and ensures a good quality of life for the recipient. A transplant should not be allowed if it merely increases the comfort of the recipient. If a transplant is not presently considered to provide a substantial benefit but is expected to do so within a period of time, the transplant need not be delayed until it meets this criterion, especially if the delay would significantly decrease the benefits derived from the transplant by the recipient.

(3) The organ or tissue transplant must have a reasonable probability of success in order for transplantation to be allowed. What constitutes a reasonable chance of success should be based on medical judgments about the physical condition of the recipient and the likelihood that the transplant will not be rejected or futile, or produce benefits which are very transient. Children should not be used for transplants that are considered experimental or non-standard.

(4) Generally, minors should be allowed to serve as a source only to close family members.

(5) Psychological or emotional benefits to the potential source may be considered, though evidence of future benefit to the minor source should be clear and convincing. Possible benefits to a child include continued emotional bonds between the minor and the recipient, increased self-esteem, and prevention of adverse reaction to death of a sibling. Whether a child will capture these benefits depends upon the child's specific circumstances. A minor's assent or dissent to a procedure is an important piece of evidence that demonstrates whether the transplant will offer psychological benefits to the source. Dissent from incompetent minors should be powerful evidence that the donation will not provide a clear benefit, but may not present an absolute bar. Every effort should be made to identify and address the child's concerns in this case.

(6) It is essential to ensure that the potential source does not have any underlying conditions that create an undue individual risk. (1, V)

Issued June 1994 based on the report "The Use of Minors as Organ and Tissue Donors," issued December 1993.