Appendix B
Agenda and Summary of Workshop on Medical and Ethical Issues in Maintaining the Viability of Organs for Transplantation

National Academy of Sciences

Institute of Medicine

Washington, D.C.

Wednesday, July 30, 1997, Room 2004

Agenda

Welcome and Introduction

John T. Potts, Jr., Principal Investigator

Federal Government and Political Considerations

Judith Braslow, Director, Division of Transplantation, Health Resources and Services Administration

UNOS, Procurement, Allocation, and Data Collection

Lawrence Hunsicker, President, United Network for Organ Sharing

Organ Procurement Issues in the Context of the Non-Heart-Beating Donor

Phyllis Weber, Executive Director, California Transplant Donor Network

Laurie Garretson, Executive Director, New Mexico Donor Program

Scientific Issues and Medical Perspectives

Harold Helderman, President, American Society of Transplant Physicians

Paul Terasaki, Professor of Medicine and Surgery, University of California at Los Angeles

Transplant Coordination

Mark Reiner, Past President, North American Transplant Coordinators Organization



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--> Appendix B Agenda and Summary of Workshop on Medical and Ethical Issues in Maintaining the Viability of Organs for Transplantation National Academy of Sciences Institute of Medicine Washington, D.C. Wednesday, July 30, 1997, Room 2004 Agenda Welcome and Introduction John T. Potts, Jr., Principal Investigator Federal Government and Political Considerations Judith Braslow, Director, Division of Transplantation, Health Resources and Services Administration UNOS, Procurement, Allocation, and Data Collection Lawrence Hunsicker, President, United Network for Organ Sharing Organ Procurement Issues in the Context of the Non-Heart-Beating Donor Phyllis Weber, Executive Director, California Transplant Donor Network Laurie Garretson, Executive Director, New Mexico Donor Program Scientific Issues and Medical Perspectives Harold Helderman, President, American Society of Transplant Physicians Paul Terasaki, Professor of Medicine and Surgery, University of California at Los Angeles Transplant Coordination Mark Reiner, Past President, North American Transplant Coordinators Organization

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--> NHBD Supply, Results, Projections, and Other Data Howard Nathan, Executive Director, Delaware Valley Transplant Program Consumers: Concerns of Donors and Recipients Maggie Coolican, Volunteer Chair, National Donor Family Council John Newmann, Past President, American Association of Kidney Patients Lisa Kory, Executive Director, Transplant Recipients International Organization Ron Green, heart recipient Scientific Issues and Surgical Perspectives Anthony D'Alessandro, University of Wisconsin Medical School Ethical Concerns Robert M. Arnold, Associate Professor of Medicine, University of Pittsburgh James Childress, Professor of Religious Studies, University of Virginia Hospital Workshop Summary On July 30, 1997, the Institute of Medicine (IOM) conducted a workshop on non-heart-beating donor (NHBD) transplantation. This workshop, "The Medical and Ethical Issues in Maintaining the Viability of Organs for Transplantation" was held at the IOM and was open to the public. The principal investigator, Dr. John T. Potts, Jr., and the senior special experts were also in attendance. Dr. Potts outlined the two assumptions that formed the basis of the day's discussion. First, all possible avenues to address the inadequate donor supply should be explored and, if feasible, implemented. Second, patients that will become donors should be well cared for in an ethical manner. Federal Government and Political Considerations Judith Braslow of the Division of Transplantation at the Department of Health and Human Services (DHHS) highlighted the value that a group such as the senior special experts—who are not part of a transplant program but experts in their own fields of medicine, law, and ethics—can bring to a discussion of the prescribed subject matter. Many organ procurement organizations (OPOs) are examining the potential of non-heart-beating donation programs to address the organ shortage problem. However, the ethical and medical issues involved in enhanced NHBD procurement are not clear. For this reason, the Division of Transplantation and DHHS suggested that an outside and objective party such as the IOM address these

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--> issues and assist the OPOs and transplant programs in initiating and enhancing their NHBD programs. The important questions to be considered are the following: What is the state of the art of procurement and the use of NHBD organs? What are the ethical and medical implications of non-heart-beating donation? What are the timing and criteria used to make decisions about termination of life support, declaration of death, and organ preservation and recovery efforts? What are the rights of NHBDs? The Division of Transplantation (DOT) is in the Health Resources and Services Administration of the DHHS. Its principal responsibilities are oversight of the Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry contracts, which are both awarded to the United Network for Organ Sharing (UNOS). DOT is also responsible for efforts to increase organ donation. Towards this goal, DOT functions as a resource for the transplant community (OPOs, transplant centers, patients) and for policymakers. DOT also serves as a focal point for discussion of transplant issues. Efforts by DOT and other parts of the transplant community have resulted in increases in organ donation. From 1994 through 1996, donation increased 6.2%. However, during that same time frame, the waiting list increased by 34%. With the everincreasing demand for organs, the transplant community has begun to use "expanded" donors, including older donors and NHBDs. Currently, NHBDs account for only 1% of the cadaver donors in a year, but it is hoped that this number can be increased. Within the DHHS there are efforts to increase organ donation through the conditions of participation of the OPOs and through managed care organizations. The Division of Transplantation has been working with several health maintenance organizations (HMOs) to inform the public about organ donation. Additionally, among the OPOs there are efforts to work both collectively and individually to improve donation. There are many contentious issues, both medical and ethical, in the field of transplantation. Some do not apply specifically to NHBDs, for example, the allocation of organs and tissues to those on the waiting list. Others, such as the potential effect of managed care on organ transplantation, involve NHBDs more directly. Maintaining potential donors on life support can be expensive. Hospitals may be encouraged to obtain permission for removal of life support without awaiting a determination of brain death. Without an NHBD program, these potential donors are lost. Dr. Braslow presented data to support her main points. These data are included earlier in the body of this report.

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--> UNOS: Procurement, Allocation, and Data Collection Dr. Lawrence Hunsicker, president of UNOS, spoke about issues that affect the supply of and demand for organs. The United Network for Organ Sharing (UNOS) has a number of responsibilities: Establish membership criteria for OPOs and transplant centers. Develop policy for wait listing criteria and organ allocation. Maintain the Scientific Registry, the data source of transplantation. Increase organ donation. With regard to organ donation, UNOS has focused on efforts to affect the "pre-donation environment." Part of that environment is the awareness of the general public about organ donation and the need for organs, and part is professional acceptance and promotion of organ donation, including understanding the needs and the role of hospital personnel in organ procurement through donor identification and maintenance. Making the general public more aware and supportive of organ donation and making families, at the appropriate time, more likely to give consent are issues that require more study, as well as better implementation in practice. The number of cadaver organ donors is rising slightly over time, as are the number of organs procured per donor. However, these numbers do not approach the number of people currently on the waiting list or the number added yearly to the list. The number on the waiting list will expand until the number removed (through death and transplantation, or for other reasons) equals the number added. Under certain assumptions, this equilibrium might be expected at about 50,000. However, such equilibrium is not an acceptable goal since the death toll on the waiting list would be extremely high. Nor is any equilibrium likely since the character of the waiting list will change with changes in organ availability and waiting times. It can be surmised that with 50,000 people on the waiting list, the median waiting time for transplantation (the time elapsing before one-half of the people are transplanted) would be so long that many patients would never be listed. Organ Procurement Issues in the Context of the NHBD Phyllis Weber of the California Transplant Donor Network and Laurie Garretson of the New Mexico Donor Program discussed the day-to-day realities of procuring organs from NHBDs and the issues that OPOs face in initiating NHBD programs. One of the obstacles can be the lack of enthusiasm of their related hospitals for an NHBD program, although some hospitals would like to have such a program. Still another complication is the level of detail a hospital will tolerate in protocols from the OPOs. Some hospitals want to develop internally

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--> many or all aspects of their practice. OPOs must take these factors into consideration. There is consistency among OPOs in some provisions of NHBD practice, but there are essentially no standards in some areas, such as where in the hospital removal from life support and cannulation procedures take place, what medications are given to donors and when they are administered, and when cannulation is performed. These areas of inconsistency put public trust at risk, but any standards developed should allow flexibility provided this does not compromise public support for NHBD programs. Protocols should be locally adopted with consultation of numerous committees including ethics and the clergy. Organizations, at this point, are often hesitant to begin programs for fear of being accused of causing or speeding the death of donors. The crucial thing that both OPO and hospital staff need to understand is that the role of the family, and the role of staff in assisting the family, do not end with consent. The benefit to members of the family in being able to donate and provide something positive from their tragedy can be helpful in their grieving process. Because NHBD organ recovery is often more complicated, which has led to greater caution about this complexity on the part of OPO staff, it is likely that NHBD families are better informed about the procurement process than families of brain-dead donors. NHBD procedures require detailed explanations, but Ms. Weber reported that families are often ahead of the health care profession in accepting donation and the issues and complexities that are involved. OPOs involve the families in many of the decisions and share information to prevent distrust. Also, they rely on the attending physician to pronounce death and perhaps could expand this role to avoid ethical conflicts and blurring of the line between the organ donor and the dying patient. However, there has not been an attempt to come together to establish one policy, and the OPOs and their programs could benefit from some feedback on standards or guidelines for many of these issues. Both Ms. Weber and Ms. Garretson responded positively to a question about the value of recommendations for some consistent NHBD protocol provisions. Scientific Issues and Medical Perspectives As was mentioned by Judith Braslow of DOT, the organ shortage has brought about the use of donors accepted under expanded criteria. There have been numerous studies of the effect of these donor organs on outcomes. One of the concerns expressed by OPOs and others was the potential for reduced viability of NHBD organs. Dr. Harold Helderman, president of the American Society of Transplant Physicians (ASTP), presented workshop attendees with the results of numerous studies of the comparability of organs, particularly kidneys from NHBDs to organs from heart-beating cadaver donors. Because of the use

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--> of expanded criteria for donors, both heart-beating donor and NHBD kidneys currently tend to come from older donors, although NHBDs tend to be the older. The use of NHBDs is widespread (25 of 66 OPOs in 1994) but infrequent, accounting for only 1% of cadaver donors. These organs also tend to be from older donors and always have longer warm ischemic times than those from brain-dead donors. However, many of the data show that in the case of controlled NHBDs, this does not seem to affect graft and recipient survival rates negatively compared to heart-beating donors. Uncontrolled NHBDs are associated with a considerably higher rate of delayed graft function, but ultimately, survival of these grafts is not substantially worse than heart-beating donor graft survival. A goal of the ASTP is the analysis and dissemination of scientific data on transplantation to inform policymaking. The ASTP put together a position statement on NHBD, with its suggestions, reservations, and goals for NHBD programs. This statement has five parts: The ASTP supports and applauds all clinically and scientifically sound means of expanding the donor pool, within ethical and legal considerations. The ASTP continues to subscribe wholly to the ''dead donor rule" and feels that NHBDs meet those criteria. The ASTP subscribes to the altruistic view of donation and to preservation of the autonomy of the donor family and wishes of the patient, if known. The ASTP is opposed to the utilization of NHBDs without established protocols and procedures for retrieval that have been approved by the necessary bodies. Uncontrolled NHBDs do not meet the principles of the ASTP, particularly in the area of consent, and therefore, the ASTP does not support the widespread use of this organ source. If institutions choose to pursue this donor group, they should do so under the protocols and approval of their institutional review boards. Accompanying Dr. Helderman was Dr. Paul Terasaki of the University of California at Los Angeles. Dr. Terasaki and his colleagues have been developing a formula for meeting the growing national demand for organs. They have developed a projection of the numbers of donors from different categories that would be needed and achievable to meet the growing shortage. They suggest that in the next 10 years, if demand continues to grow at the same rate it has for the past 10 years, there will be close to 70,000 people on the waiting list for a kidney transplant. This model proposes an accelerated effort over the next four years to increase donors from all sources, including living donors, expanded donors, and NHBDs. Dr. Terasaki's data show that the risk of using older donors would be mitigated by matching them to older recipients. For the NHBD

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--> part of the effort, the model calls for 700 more NHBDs per year, nationally. After the initial four years at this level of accelerated, aggressive recruitment of donors, the model would allow for the tapering off of living donors and extended donors, with the new levels of NHBDs and heart-beating donors eventually entirely meeting the needs of patients with organ failure. This model works on the assumption that the waiting list maintains the same rate of growth, although it is expected that as organs became more readily available, the number of waiting list members would likewise increase. However, Dr. Terasaki noted that the model's time frame could be extended or slightly upgraded to meet this potential change in the rate of growth of the waiting list. Another important contribution to this model would be passage of legislation that allows the cannulation and perfusion of donors prior to the consent of families, since kidneys from victims of trauma (emergency room deaths) have better survival rates than kidneys from NHBDs that die non-trauma-related deaths. Whatever the issues, the NHBD will play an essential role in future efforts to meet the demand for organs, according to Dr. Terasaki. Transplant Coordination Mark Reiner, past president of the North American Transplant Coordinators Organization (NATCO), spoke about some of the issues and concerns that have arisen in transplant coordinator work with NHBDs. Although NATCO believes that there is misinformation about NHBDs generated by the media, this has created a good opportunity for discussion. There are too many inconsistencies in the procedures for NHBDs and a need for some consensus, he believes. The rights of the potential donor and rights of donor families to make end-of-life decisions should be no different than for any dying patient. There should be a good flow of information, and communication with the family should be supportive as well. Ideally, NATCO believes that explaining the donation process and obtaining consent for donation should be done by the transplant coordinator, accompanied by the attending physician or other hospital staff who have rapport with the family. Other issues and concerns requiring national attention include timing and types of medications administered to NHBDs. Further study of the efficacy and effect of these drugs will be essential to decide these issues. Also, the determination of death can be a very difficult issue and is rife with conflicts of interest. The criteria to ascertain brain death are fairly well established, but prior to the reexamination of the NHBD as a source of organs, the determination of cardiac death did not require great precision. Therefore, few if any scientific studies are available, and only anecdotal information and experience remain to inform this debate. A concern was expressed that since it is less costly to end life support early, an NHBD program would encourage a decrease in the pronouncement of

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--> brain death and the procurement of the full range of organs in good condition from heart-beating donors. Managed care and other cost-containment considerations could influence this trend. The potential for a diminished supply of hearts and other extrarenal organs should be considered in the development of protocols. NATCO supports increased use of NHBDs, but because of the issues that still must be resolved it urges careful preparation of hospital staff. NHBD Supply, Results, Projections, and Other Information Dr. Howard Nathan discussed his work in attempting to define the number of potential NHBDs in the United States and his efforts with the Coalition for Donation. The number of cadaver donors has increased over the past 4 years by about 12–13%. However, the number is currently at a plateau of about 1% growth per year. Dr. Nathan and his colleagues have done several reviews of medical records in different states to determine what the number of potential donors, including NHBDs, would be if all potential donors were referred to OPOs. They predict no more than 14,000 brain-dead donors and about 25,000–26,000 NHBDs, which shows the overwhelming potential of NHBDs to increase the donor pool. Even with the usual 50% consent rate, the potential is for approximately 14,000 NHBDs nationally in a given year. These projections point up the need for some consensus on increasing the number of NHBDs. However, there are difficulties in creating and implementing nationwide policy and protocols related to the extreme diversity among OPOs. Most OPOs are separate entities from transplant programs, but 9 of the 63 OPOs are still attached to transplant programs and are actually in the hospitals. There are 15 OPOs that cover populations of more than 5 million people. The rest cover considerably fewer people. The number of hospitals that an OPO is connected with ranges from 8 to 182, and the OPOs serve from 1 to 18 transplant centers each. According to DHHS regulations, OPOs must maintain a certain level of donor recruitment to continue to participate in Medicare and the OPTN. This level is based on the statistic of donors per million population (dmp). Many feel that this number does not account for enough of the local characteristics—cultural, social, and ethnic—of the OPOs' service areas. However, it is currently used to identify OPOs with particularly successful donor programs. These programs have been studied to determine if some of their practices could be applied nationwide for better national procurement. Such studies have not been focused on NHBDs. An increase in NHBDs is not the only source of increasing donations in general. Dr. Nathan spoke of some local efforts in the state legislatures to boost donation. One example is the Pennsylvania law that requires hospitals to report

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--> all deaths to their OPOs at or near the time of death. This means that donors are being referred even when they may not meet brain death criteria, which had been the previous practice of OPO referrals. This routine referral law includes a fine for hospitals failing to report deaths to the OPO and has resulted in a significant increase in donors, many of them NHBDs. Illinois passed the "live and learn" legislation in 1993 that dedicated $2 million annually to public education on donor issues. Advertisements and donor card registry drives boost donor sign-up and donation. Other efforts, such as voluntary routine referral, have been successful in other areas throughout the country. These types of efforts could expand donation and solve some of the concerns about the loss of potential NHBDs who are not referred. This can happen only if OPOs have active NHBD programs. The focus of UNOS's efforts to increase public awareness of donor need is the Coalition on Donation. Dr. Nathan is the president of this organization, which was started only a few years ago. The Coalition on Donation is discussed briefly in the body of this report. Consumer Concerns of Donors and Recipients Ms. Maggie Coolican, from the National Donors Family Council and the mother of a young donor, spoke about the discoveries that have come from the interaction of donor families. Donor families frequently express common concerns and convictions about organ donation. The way a family is treated during the dying process of a loved one and the request for organ donation has a tremendous impact on the consent rate, as well as on its feelings about the donation afterwards. Most families express a positive feeling and benefit from the ability to give a gift during their time of tragedy, but some also feel that there is a lack of information and consideration from medical and OPO staff. Trust and belief in the medical community are essential to the continuance of an altruistic model of organ donation. Families need to be offered the opportunity to be involved in considering options and understanding what is going to happen during the procurement process. Because families, once they have decided to donate organs, often want to have as many usable organs as possible, interventions such as catheterization and medication, when there are assurances that they will not be unduly harmful to the potential donor, are usually acceptable to the family. However, Ms. Coolican again stressed the importance of involving and informing the family about such matters. There is evidence of many inconsistencies throughout the health care system in the practices of organ procurement and donation requests. These variations can have an effect on the trust of donor families in the care they and their loved ones received. This is an important consideration because donor families can be a strong voice in promoting organ donation. It is important that any national

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--> consensus for NHBDs be developed with collaborative efforts that involve input from the public as well as experts. Issues that should be included are consent for medication and other invasive procedures; education of the family and health professionals about the process and the reasons for particular interventions; consistency in supporting the rights of families; and making the experience of non-heart-beating donation as similar as possible to the dying process with non-donors. Lisa Kory of the Transplant Recipients International Organization and John Newmann of the American Association of Kidney Patients spoke about the importance of public education in maintaining public trust. Public education efforts should, in general, focus on the crucial need for organs, so that when the time of decision comes, there is a base of understanding as well as a predisposition to consent. Professional education about the care of potential donors and the legal and ethical issues involved is crucial as well. Some standardization in the form of medical practice guidelines about donor care and the declaration of death could prove essential for avoiding conflicts of interest and improving public trust. The final speaker for the donor and recipient panel was Ron Green, recipient of a heart transplant, who spoke in part for Ms. Kory. He voiced the concerns of the patient waiting for a transplant. These patients want to be assured that the organs they received are obtained under the highest ethical standards. This assurance is also important to prevent public mistrust from decreasing the consent rate and the donor pool. Standardization of OPO protocols, particularly for NHBDs, where mistrust is high following critical media reports, should be adopted in the near future. The public needs to understand that the donor's physician, and not a member of the organ recovery team, makes the decisions about critical care, and ultimately determines death. It should be generally understood that the decision to withdraw life support is made completely by the families and is separate from the potential donation. All of these issues, if standardized and well explained, will help increase public trust in non-heart-beating organ donation and organ donation in general. Scientific Issues and Surgical Perspectives The University of Wisconsin, where Dr. Anthony D'Alessandro is part of the organ transplant program, has a unique perspective on the NHBD issue, since it has been engaged in NHBD procurement continually since 1974. The university has averaged approximately 10% NHBDs annually since 1988. Dr. D'Alessandro briefly outlined the procedure for NHBD organ retrieval. After the decision to terminate life support, and the second decision to donate organs, the patient is moved to the operating room (OR) for the withdrawal of life support or may remain in the intensive care unit depending on the wishes of

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--> the family to be in attendance. Cannulas are placed in the femoral arteries for the purpose of perfusion of cooling and preserving solution following the declaration of death. Prior to the removal of support, heparin (10,000-30,000 U) and phentolamine (10-20 mg) are administered. The reason for using phentolamine is to prevent vasospasm during the dying process. The program has not noted any more than minimal and transient reactions with either of these drugs, and its reading of the literature indicates no reason for expecting an adverse affect in most donors. Both drugs are utilized in other settings in higher doses than used in organ procurement. In fact, phentolamine has many positive cardiac effects. Dr. D'Alessandro believes that these drugs do not harm the patient or hasten their death. Dr. D'Alessandro's noted that short intervals of warm ischemia do not have much impact on the long-term function of the graft. This is true in kidneys, and Dr. D'Alessandro expressed a growing comfort with moderate ischemia for livers as well. For kidneys, the initial rate of dialysis for recipients is higher in NHBD transplants than in heart-beating transplants, but the follow-up shows little or no long-term impact. In a 10-year follow-up, graft survival was 42% in NHBDs and 50% in heart-beating donors which is not a statistically significant difference. Many are skeptical about the viability of organs other than kidneys exposed to even short periods of warm ischemia. Based on his experience, Dr. D'Alessandro encouraged exploration of the potential of extrarenal organs from NHBDs. The University of Wisconsin has had success with the transplantation of livers and pancreases and has done one lung transplant from a NHBD. Dr. D'Alessandro also encourages the development of broad guidelines for NHBDs, but warns against strict national protocols that can stifle innovation. The guidelines should be beneficial to transplant centers and OPOs exploring a NHBD program, but not so burdensome as to prevent the development of these programs. Ethical Concerns Dr. Robert Arnold, chair of the committee that developed the Pittsburgh protocol for NHBDs in 1992, discussed three topics with major ethical ramifications in the development of any standards or guidelines for non-heart-beating donation. Because of their important ethical implications, these provisions and any others about which there are concerns should be developed and discussed with public trust as a leading objective. Dr. Arnold stressed that this meant not just gaining public trust, but really deserving it by thoroughly examining all of the areas of possible conflict of interest or appearance of impropriety. NHBDs are currently only a small percentage of cadaver donors, but due to ongoing changes in medical practice, this percentage could increase quickly. For example, the withdrawal of life support is often happening within the first 24 to 48 hours after the critical event and before the patient can meet brain death criteria.

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--> These patients, however, are potential NHBDs, which makes a national consensus even more critical. Determination of Death The issue that makes procedures for the determination of death so critical in organ donation is that this determination has to be moved as close as possible in time to the cessation of cardiac function. In doing this, transplant personnel risk taking organs from patients who are not yet dead. In the Pittsburgh protocol, the standard is 2 minutes without cardiac function, and this defines the cessation as "irreversible." There are few, if any, empirical data that indicate when autore-suscitation of cardiac function is no longer possible. Dr. Arnold noted that the 2-minute definition assumes that even if the cessation could be reversed, it can be defined as irreversible because a decision has been made not to resuscitate. It is important to remember that these patients have decided, or their families have decided, that they will forgo life-sustaining treatment. Interventions to Promote Organ Viability Although the priority goal is to optimize the care of the dying patient, interventions are undertaken in the dying patient in most OPO protocols to promote the viability of organs. These include the use of femoral catheters, administration of medications, arterial monitoring to reliably determine death, and even the fact that death usually takes place in the OR so that procurement can begin immediately. Are there ethical barriers to these interventions if they are not for the benefit of, or might even be harmful to, the dying patient? Conflicts of Interest NHBD protocols and procedures have quite a bit of variation, which offers the advantage of promoting innovation but also has disadvantages. Some of the NHBD concerns truly require national standards, such as the interval of asystole that indicates irreversible loss of cardiac function. Many local hospitals do not have the medical and ethical expertise to develop and review a NHBD policy. This is worrisome because with adverse public reporting, local policies can have national impact. Consensus on the national level, involving experts in all fields of medicine applicable to this process, and public input would be particularly helpful for areas in which hospitals are most likely to face accusations of conflict of interest. Dr. James Childress followed with some final points on applicable ethical principles for the NHBD situation. First, he drew a line between the donor patient and the donation. In most cases, the patient who is dying does not consent

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--> to organ donation. Usually the family is the donor, and the dead patient is the donation. Another consideration is the difference between the patient and the donor. Too often these terms are intermixed, and a patient often is referred to as a donor even before consent has been obtained. Dr. Childress suggested, at minimum, use of the terms donor and potential donor to distinguish between the two. Regarding many of the issues, but particularly the concerns of treating the patient versus treating the organs, Dr. Childress encouraged the IOM to see this not as finding a balance, but as aiming for a goal within certain limitations. The goal in this case is organ procurement that can be realized within ethically acceptable limits. This reflects better the direction of the discussion of the pressing need for organs and suits better the accepted assumption that increasing organ donation is a worthy and ethical objective. There are two ethical approaches that Dr. Childress suggested for consideration and application. First, there are other situations in medicine that might compare to organ procurement and NHBDs in terms of what can be done to a dead body and what is meant by patient benefit. These accepted values and norms might inform discussion and public understanding of non-heart-beating donation in ways that could apply to the development of standards. Another means of looking at these issues and their ethical impact is the principle of double effect. Dr. Childress gave an example to explain this concept. In any case of care at the end of life there are accepted procedures for relieving pain and suffering, even at the risk of hastening death. The legitimate goal is relieving pain by doing what is necessary. The risk of hastening death is acceptable under the principle of double effect because it is not intended and is counterbalanced by the good effect of relieving pain. Dr. Arnold noted that this principle could be extended to viewing the preservation of donor organs as the family's good objective and accepting certain measures that further this objective even if they may pose the unintended risk of hastening death. Could this be publicly or medically accepted? What interventions would cross the line of acceptability? What cannot be done even with family consent? These questions may be answerable only with public input and both medical and ethical expertise in a process of consensus policy development. Dr. Childress did not propose accepting all his suggestions but rather including them as part of the discussion of the important issues. Conclusion At the end of the workshop, Dr. Potts, the principal investigator, thanked the participants and observed that their contributions had provided a most helpful and thought-provoking foundation for the analysis, findings, and recommendations of this report.

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