Attitudes Regarding Organ Donation From Non–Heart-Beating Donors Sean P. Keenan, Barry Hoffmaster, Frank Rutledge, Jeannette Eberhard, Liddy M. Chen, and William J. Sibbald Purpose: To determine the attitudes toward organ donation from non–heart-beating cadaver donors in a sample of the general public and health care workers. Materials and Methods: A moderator-administered questionnaire was completed by members of the general public, recruited randomly from a professional consumer research group’s database, and health care workers recruited from the same database, family practice clinics, and local hospitals. Two primary scenarios were tested: (1) patient in coma, not going to survive intensive care unit (ICU), and (2) patient lapsing in and out of consciousness, lifetime institutional care. Results: Sixty members of the general public and 68 health care workers completed the questionnaire. The majority of both groups were aware life support could be withdrawn in Scenario 1, however, significantly fewer were aware life support could also be withdrawn in Scenario 2 (83% general public vs 34% general public, P .001 and 94% health care workers vs 78% health care workers, P .012). Uncertainty in prognosis was cited as the primary concern. The issue
of organ donation was directly linked with withdrawal of life support. The majority of both groups believed that organ donation would be permissible if further life support were deemed to be not in the patient’s best interest because of poor short-term prognosis (94% health care workers and 98% general public for Scenario 1 and 87% health care workers and 81% general public for Scenario 2).The greatest difficulty arose in defining futility of care. Expected quality of life, patient’s and family’s values, opinions, and religious beliefs were felt to be most important in determining decisions regarding futility and withdrawal of life support. Physician beliefs and values were felt to influence decisions more than they should. Conclusions: Both the general public and health care workers support the use of non–heart-beating cadaver donors once a decision has been made to withdraw life support. However, both groups raised concerns regarding how the decision to withdraw life support is made. Copyright 2002, Elsevier Science (USA). All rights reserved.
HE SUCCESS OF solid-organ transplantation has led to transplantation becoming the treatment of choice for many cases of end-stage heart, lung, liver, and renal failure.1 This success has resulted in an increased demand that has overwhelmed the present day supply.1-8 Attempts to resolve this dilemma include expanding recruitment of potential donors from traditional sources and exploring alternative sources of transplantable organs. The most common source of organs for donation remains the brain-dead organ donor with an intact circulation.2 Despite evidence that the general public supports organ transplantation, actual donation rates remain disappointingly low.6-8 Even with a marked increase in recruitment of actual donors and use of living related and unrelated donors,9,10 organ demand likely will continue to far outstrip supply.1,2 This realization has prompted consideration of alternative sources of donor organs. One potential source is the non–heart-beating cadaver donor.1,2,11-25 Transplantation from this source may be either uncontrolled, involving patients pronounced dead on arrival at the hospital or dying in the hospital despite resuscitation efforts, or controlled, involving non–brain-dead patients undergoing withdrawal of
life support. Controlled donations are now used in some centers in the United States and Europe,12-24 but despite increased interest in the use of non–heart-beating cadaver donors, relatively few centers have adopted programs using this resource. As a result, the number of donors from this category made up less than 1% of the total number of
T
Journal of Critical Care, Vol 17, No 1 (March), 2002: pp 29-38
From the Department of Medicine, Royal Columbian Hospital, New Westminster, British Columbia; Centre for Health Evaluation and Outcome Sciences, St. Paul’s Hospital and University of British Columbia, Vancouver, British Columbia; Richard Ivey Critical Care Trauma Center, Victoria Campus, London Health Sciences Centre, London, Ontario; Department of Philosophy, University of Western Ontario, London, Ontario; Insights, Inc., London, Ontario; and the Department of Medicine, Sunnybrook Hospital, Toronto, Ontario. Supported by the Richard Ivey Critical Care Trauma Center, London Health Sciences Centre, University of Western Ontario, London, Ontario; and Novartis, Canada. S.P.K. was supported by a Canadian Lung Association/Medical Research Council of Canada Fellowship. Address reprint requests to Sean P. Keenan, MD, Intensivist and Respirologist, Royal Columbian Hospital, Suite 103, 250 Keary St, New Westminster, British Columbia, Canada V3L 5E7. Copyright 2002, Elsevier Science (USA). All rights reserved. 0883-9441/02/1701-0004$35.00/0 doi:10.1053/jcrc.2002.33036 29
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cadaver donors in 1993 in the United States2 and have not increased appreciably since that time. Unresolved ethical issues are major stumbling blocks to widespread adoption of a non–heartbeating cadaver donor program.1,3,11,25-28 Two principal moral questions are: (1) How confident can we be that a decision to withdraw life support in a specific case is in the patient’s best interests (ie, is further care truly futile or against the patient’s wishes?), and (2) How certain can we be that the cessation of circulation and respiration is irreversible at the time resuscitation is begun to preserve organs (ie, is the patient truly dead?). Although health care workers and ethicists continue to debate these matters, insight into societal acceptability of non–heart-beating cadaver donor programs may be gained from informed public opinion. Although specialists in particular fields may be in the best position to educate society about the relevant issues, these same specialists may be too close to the issues to have unbiased opinions. The objective of this study was to determine the understanding and attitudes of members of the general public and health care workers in 1 Canadian health care region toward organ donation in general, and organ donation from non–heart-beating cadaver donors in particular. METHODS The study was conducted in 2 phases and was approved by the Review Board for Health Sciences Research Involving Human Research of the University of Western Ontario.
Phase 1: Questionnaire Development The issues to be addressed with members of the general public and health care workers were identified and defined in 2 ways. First, a systematic review of the literature on organ donation, futility of care, and withdrawal of life support was conducted. Second, former patients who survived their intensive care unit (ICU) stay and family members of patients who died in the ICU were interviewed. Our search strategy for the literature review included the use of personal files and a computerized search of the electronic database, Medline, from 1966 to 1996 using the key words non-heart-beating cadaver donor, asystolic cadaver donor, withdrawing, withholding, futile care, and terminal care. The references of all relevant articles were reviewed for additional pertinent studies or reviews. A focus group was then conducted, consisting of health care workers involved in withdrawal of life support, an ethicist, and members of a professional consumer research group to identify themes to develop a discussion guide. By using this discussion guide, 3 former patients and their spouses were interviewed as couples; both parents of a patient who did not survive were interviewed together; and a daughter of a patient who did not survive was
interviewed on her own. From these interviews, information was gathered about the attitudes and expectations of these patients and their families toward the withdrawal of life support and organ donation. Those interviewed made suggestions about how to conduct these processes and what factors should, and actually do, influence decisions about withdrawing life support. By using the information collected from the interviews and literature search, a multidisciplinary team of 2 survey specialists, 2 ICU physicians, an ICU social worker, and an ethicist refined the issues and developed a questionnaire. The questionnaire was piloted for clarity of language and content validity.
Phase 2: Questionnaire Administration Sampling Methodology Members of the general public were randomly selected from a database of over 3,000 people who had previously participated in at least 1 focus group for a professional consumer research company in London, Ontario, or who had agreed to participate in focus groups in the future. To ensure they were representative of the general public, participants were matched for age, sex, and income in accordance with the 1991 census in London, Ontario. Health care professionals were recruited from the same database and, in addition, volunteers not listed in the database were solicited through contacts at local family practice clinics and hospitals.
Questionnaire The questionnaire was completed by the following 5 groups: (1) general public ages 18 to 39; (2) general public ages 40 and above; (3) nonphysician health care workers with recent or current experience in intensive care, coronary care, emergency medicine, or operating theater; (4) nonphysician health care workers from settings other than those specified in (3); and (5) physicians, including those with and without intensive care or emergency medicine experience. In a 1-hour session, a trained moderator administered the questionnaire. Each respondent completed the questionnaire individually. The questionnaire was divided into 4 sections. The first dealt with general ethical issues in medicine. In the second part, attitudes of the respondents about receiving or donating organs were explored. The third section dealt first with the scenario of brain death and solicited reactions to 2 further scenarios involving patients who were not brain dead. The first of these scenarios (Scenario 1) described a patient without hope of recovery who would “never regain consciousness or leave the intensive care unit” (see Appendix). In the second scenario (Scenario 2), the patient was described as “drifting in and out of consciousness, but doctors believed that the patient would never again know who they are or where they are and would always need to be institutionalized” (see Appendix). In addition to opinions about the legitimacy of withdrawing life support and considering organ donation in these scenarios, factors that should, and currently do, help in the decision to withdraw life support were explored. In the final section, characteristics of respondents that might influence their responses, including previous experience with terminally ill patients and withdrawal of life support, were elicited. Answers were either “yes/no” or consisted of a 5- to 6-point Likert scale. For clarity, this article reports on the second and third sections of this questionnaire alone.
NON–HEART-BEATING CADAVER DONOR
Analysis
31 Table 1. Description of Questionnaire Respondents
After data checking and cleaning, the database was transported into a statistical program, Statistical Analysis System 6.0 (SAS Institute Inc., Cary, NC). Answers to each question were summarized by using descriptive statistics, including mean and standard deviation and median and range where appropriate. Categoric data were analyzed by using the 2 statistic. Continuous data were analyzed by using the Student’s t test where the sampling mean was normally distributed, or the appropriate nonparametric test where the normal approximation was suspect. The primary comparison was between the responses of health care workers and members of the general public.
RESULTS
Preliminary Information Gathering From discussions with former patients and relatives of patients, it was apparent that we could not approach the topic of non–heart-beating cadaver donation in isolation. All respondents felt that the major issue was determining when further care was truly futile and, therefore, withdrawal of life support was justified. This small group generally felt that if withdrawal of life support were appropriate, then organ donation should be considered regardless of whether the patient fulfilled the criteria for brain death. Description of Questionnaire Participants A total of 60 members of the general public and 68 health care workers completed the questionnaire (Table 1). The general public group had a greater proportion of men, participants over 50 years of age, family incomes of less than $50,000 per annum, and a different distribution of formal education attained (Table 1). Of the 68 health care workers who participated, 26 (38%) were nurses; 18 (26%) were physicians; 7 (10%) performed clerical duties; and the remaining 17 (25%) included 4 physiotherapists, 2 pharmacists, 2 social workers, 2 hospital managers, 2 respiratory therapists, 2 chaplains, 1 attendant, 1 research technician, and 1 dietitian. Attitudes Toward Receiving or Donating Organs Members of the general public tended to be more willing than health care workers to receive (85% general public vs 68% health care workers would always wish to receive an organ, P .09), but less likely to donate an organ (40% general public vs 81% health care workers were always willing to donate an organ upon death, P .05). Health care workers were more likely to have expressed their
Number Sex (% men)* Age 50 yrs† Income 50,000‡ Close friend/relative has had terminal illness Close friend/relative has been in ICU or coronary care unit Close friend/relative donated an organ after death Close friend/relative received an organ after death Experience death of someone close in the past 1 yr 1-5 yrs 5 yrs Education level attained§ Completed College/University Some College/University High School or less
General Public
Health Care Workers
60 45% 25% 62% 30%
68 21% 19% 34% 24%
68%
58%
22%
15%
28%
24%
18% 42% 48%
24% 47% 35%
40% 27% 33%
87% 27% 26%
*P .004. † P .02. ‡ P .009. § P .001.
wishes regarding organ donation to friends or family (72% health care workers vs 48% general public, P .006). Interestingly, the difference in communication appeared to be among patients not wishing to be organ donors, given that similar proportions of the general public and health care workers who wished to donate their organs claimed to have recorded their wishes in writing (77% general public and 87% health care workers). Awareness of Brain Death Criteria and Attitudes to Withdrawal of Life Support and Organ Donation for the 2 Scenarios Although the majority of both groups were aware that brain death criteria existed, a significantly greater proportion of health care workers were (97% health care workers vs 77% general public, P .001). Similarly, most respondents (but a greater proportion of health care workers) were aware life support could be withdrawn for patients who were brain dead (99% health care workers vs 83% general public, P .005) or clinically similar to patients described by Scenario 1 (94% health care workers vs 75% general public, P .007, see Fig 1). Furthermore, both groups agreed they would
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KEENAN ET AL
Fig 1. The proportion of health care workers and members of the general public who completed the questionnaire who were aware that life support could be withdrawn in the setting of brain death, Scenarios 1 and 2. , Health care workers; , general public.
both groups felt that if the decision to withdraw support had been made, the patients should be allowed to donate their organs (94% health care workers and 98% general public for Scenario 1 and 87% health care workers and 81% general public for Scenario 2).
want the opportunity to have life support withdrawn from themselves under the circumstances presented in Scenario 1. The proportion of subjects who were aware that life support could be withdrawn in Scenario 2 was also greater among health care workers (78% health care workers vs 34% general public, P .001, see Fig 1). When we compared the responses to the 2 scenarios, we found that fewer respondents in each group were aware that life support could be withdrawn in Scenario 2 (P .012 health care workers and P .00003 general public). In both scenarios health care workers were more likely than members of the general public to feel that the decision to withdraw life support would be made in the best interests of the patient (87% health care workers vs 66% general public, P .007, in Scenario 1 and 52% health care workers vs 34% general public, P .011 in Scenario 2). Within each group of respondents, however, confidence in this decision was less for Scenario 2 (P .0001 health care workers and P .001 general public). In both scenarios, the majority of subjects from
Factors That Should Affect Physicians’ Decisions to Consider Withdrawing Life Support Future quality of life was the most important factor that both groups of respondents felt should influence physicians’ decisions to consider limiting further life support (Table 2). After quality of life, the next 3 factors were the patient’s values, the family’s values, and the patient’s age, respectively. Interestingly, this order was reversed when these groups reported the extent to which they think physicians actually are influenced by these factors. Of some concern was the finding that physician’ values and characteristics were felt to have a greater degree of influence on the decisionmaking process than they should. For example, 58% of health care
Table 2. Factors That Should Versus Do Influence Physicians’ Decisions to Withdraw Life Support “To a Great Extent” General Public
Health Care Workers
Factors
Should Influence
Does Influence
Should Influence
Does Influence
Future quality of life Patient’s values Family’s values Patient’s age Physician’s values FInancial considerations Nonphysician health care worker’s values Physician’s characteristics (age, type of training) Availability of ICU beds
95% 88% 62% 61% 17% 18% 14% 12% 12%
87% 62% 67% 70% 38% 32% 14% 37% 19%
99% 77% 75% 62% 17% 10% 13% 18% 17%
91% 58% 63% 76% 58% 16% 30% 58% 12%
NON–HEART-BEATING CADAVER DONOR
workers felt both physician values and characteristics influence the decision process, whereas only 17% and 8% felt physician values and characteristics should influence this process (P .0001 for both). Attitudes Toward and Opinions About the Process of Deciding When Care is Futile and Life Support Should Be Withdrawn Although most subjects believed that formal hospital policies exist to guide physicians in making decisions about whether further care is futile (63% health care workers and 79% general public), the vast majority felt such policies should be available (90% health care workers and 94% general public; Table 3). Despite this, the majority of health care workers (59%) and many members of the general public (41%) conceded that it would be impossible to develop a set of clinical practice guidelines that would cover all situations. Both groups felt physicians should be prepared to make recommendations to the family regarding withdrawal of life support (99% health care workers and 95% general public) and that family members should be able to participate in discussions and influence the decisions (100% health care workers and 93% general public). However, though a majority of both groups believed that family members should make the final decision, a sizable proportion in each group did not, with a trend toward less support among health care workers (78% agree general public vs 60% agree health care workers, P .078). Both groups believed that an independent second opinion should be obtained, though a significantly greater proportion of the general public supported this action (96% general public vs
33
79% health care workers, P .009). Most subjects agreed that it was permissible to introduce the idea of organ donation if family members had not previously asked about it after further care had been agreed by all to be futile (75% general public and 67% health care workers). However, there was less support for discussing organ donation and the issue of the futility of further care at the same time (60% general public and 49% general public) or by the same physician (62% general public and 48% health care workers). DISCUSSION
Organ transplantation is now the established treatment of choice for many situations of end-stage organ failure owing largely to significant advances in both surgical technique and the ability to prevent rejection.1,2 The primary factor limiting this form of therapy is the availability of donor organs.1-8,39 This discrepancy between organ supply and demand has emphasized the importance of increasing the donor pool. Efforts have been focused in 2 primary areas: first, to maximize recruitment of potential donors among those considered traditional candidates, the brain-dead patient with intact circulation; and second, to explore other possible sources of donor organs. The non–heart-beating cadaver donor represents 1 potential source of donor organs that is not currently generally available. Patients who have life support measures withdrawn but still have brain activity (ie, not brain dead by standard criteria) at the time of withdrawal of support usually undergo circulatory arrest soon after. These patients have been considered as potential organ donors in some European countries from the early 1980s and in certain centers in the United States since the late 1980s
Table 3. Issues Supported by the Majority of Respondents to Consider When Developing Guidelines for Withdrawal of Life Support and Discussion of Organ Donation Withdrawal of life support Physicians should be prepared to make recommendations to family regarding withdrawal of life support Family members should participate in discussion and have influence on the final decision regarding withdrawal of life support Family members should have the final decision An independent opinion should be obtained from a second physician regarding the appropriateness of withdrawal of life support Discussions of organ donation The subject of organ donation should be introduced by physicians if family does not raise the issue on their own Issues of organ donation should ideally be discussed separately from issues regarding the appropriateness of withdrawing life support Discussions on issues regarding organ donation should be undertaken by a physician other than the physician directly involved in the patient’s care and discussions of withdrawal of life support.
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and early 1990s.12-26 Patients have their life support measures withdrawn in an operating room and are observed until they have a circulatory arrest. After a variable period of time that is considered of adequate duration to represent irreversible circulatory arrest, measures are undertaken to restore circulatory flow and oxygen delivery for the purposes of organ preservation while the patient’s organs are quickly harvested. However, the use of non–brain-dead patients as potential sources of transplantable organs has raised serious concerns among ethicists regarding whether these patients are truly dead donors (ie, is spontaneous circulation and breathing truly irreversible at the time resuscitation is started to preserve organs?26-39). It seems unlikely that these concerns will ever be refuted adequately to satisfy all. However, our study found that the majority of members of the general public and health care workers completing our questionnaire considered the acceptability of organ donation to be directly linked to the acceptability of the withdrawal of life support in both scenarios. When the decision to withdraw life support was considered appropriate, organ donation, whether from a brain-dead patient or an asystolic patient, was generally felt to be acceptable. This finding strongly suggests that society is ready to accept organ donation from a non–heart-beating cadaver source. Although we believe that our findings of general support for the adoption of non–heart-beating cadaver donors among our study subjects is internally valid, the generalizability of these results to those not participating in the study has to be considered. Our population was not a true random selection from the general public because it was drawn from a specific consumer group’s database. This approach was used as these subjects went on to participate in focus groups to discuss these issues in more depth (not reported here). To try to control as much as possible for a sampling bias we did randomly sample from the database and used a sampling process that matched our general public group for age, sex, and income with the city from which they were drawn (London, Ontario). Although a similar approach was originally tried to obtain health care workers, the relatively small number to draw from within the database required recruitment from other sources. Although we recognize that a sampling bias exists, the signal we found was so strong that we believe the attitudes are generaliz-
KEENAN ET AL
able to our health care system. Other health care systems may not share the same views. The major obstacle to improving recruitment of potential donors from traditional sources, or successfully adopting non–heart-beating donors, is society’s discomfort with the decision process leading to the withdrawal of life support. A majority of study participants supported the development of guidelines to aid the decision-making process, but at the same time they conceded that it would be difficult to define futile care in a way that would be applicable to all cases. Although there have been attempts in the literature to define futile care in substantive terms, ranging from individual opinions41-47 to consensus statements by professional societies,48-50 a recent survey found significant disparity among the opinions of Canadian physicians about the appropriateness of continuing life support in a number of different patient scenarios.51 Our study found similar variation in the opinions of both health care workers and members of the general public about the appropriateness of withdrawing life support in 2 patient scenarios. It appears that it will be difficult, if not impossible, to define futile care in a manner acceptable to the medical profession, let alone all of society. For this reason, we support the development of guidelines to establish a procedure or process for determining when further care is futile that can be followed on a case-by-case basis. A procedural approach would, for example, identify the individuals who should participate in the discussion (eg, patient, family, physicians, nurses, social workers, ethicists), specify how and how often they should meet, and establish a method for resolving potential conflicts. The use of such a process would render decision making about the withdrawal of life support more transparent and more consistent and thus would instill more confidence in the objectivity and reliability of the outcomes. Explicitly incorporating the beliefs, values, and preferences of the patient and family into the process would provide further assurance. Fischer and Raper46 propose an approach that moves from medical consensus to medical and nursing consensus and then to the identification of other persons who should be involved in discussions about the appropriateness of withdrawing life support. Qualitative research in this area provides evidence of the importance of early and frequent communication and the participation of the patient and family members in the decision-
NON–HEART-BEATING CADAVER DONOR
35
making process.42,52-54 Moreover, the Society of Critical Care Medicine’s Ethics Committee recently adopted such a procedural approach in a consensus statement regarding futile and other possibly inadvisable treatments.49 From our study, it appears that a group composed only of health care workers should not develop procedural guidelines. We found that the attitudes of health care workers and the general public differ to such an extent that one could not expect guidelines developed by 1 group alone to satisfy the other. A truly multidisciplinary group should be assembled, including appropriateness representation from the general public. Educational sessions aimed at making everyone familiar with the current practice of withdrawing life support and organ donation would have to be conducted, and the appropriate literature reviewed. The existence and progress of this endeavor should be disclosed to the public to encourage debate and to solicit assessments of recommendations. In conclusion, for our respondents the acceptability of organ donation was closely tied to how comfortable they felt about decisions to withdraw life support. The possibility of using non–heartbeating cadaver donors as a source of transplantable organs should not, therefore, be pursued without allaying general concerns about the manner in which decisions to withdraw life support are made. ACKNOWLEDGMENTS The authors would like to thank Terry Green and Insights Inc. for their part in organizing and conducting the focus group discussions and initial summary of the results. The authors would
also like to acknowledge the aid of Jennifer Kossuth with the literature searches.
APPENDIX
Scenario 1 In some other cases, where there is some brain activity and brain death cannot be declared, breathing machines are still turned off, and patients are allowed to die. This could happen if doctors believed that, despite all of their efforts, there was no chance of the patient improving or recovering at all. They would either die in the near future or spend the rest of their life “as a vegetable,” never regaining consciousness or leaving the intensive care unit. The doctors would explain all of this to the patient’s family, telling them that further care was futile or hopeless. If the family chose, the breathing machines would be turned off and the patient allowed to die. They would be declared dead by the doctors when their heart stopped beating and their lungs stopped breathing. Scenario 2 This is just like the previous example in the sense that there is some brain activity and brain death cannot be declared. This time, the patient may drift in and out of consciousness, but doctors feel that the patient would never again know who they are or where they are—and would always need to be institutionalized. In such cases, if the doctors and family agreed, the breathing machines would be turned off and the patient allowed to die.
REFERENCES 1. DeVita MA, Snyder JV, Grenvik A: History of organ donation by patients with cardiac death. Kennedy Inst Ethics J 3: 113-129, 1993 2. Hauptman PJ, O’Connor K: Procurement and allocation of solid organs for Transplantation. N Engl J Med 336:442-431, 1997 3. Peters TG, Kittur DS, McGaw LJ, et al: Organ donors and nondonors: An American dilemma. Arch Intern Med 156:24192424, 1996 4. Council on Ethical and Judicial Affairs, AMA: Strategies for cadaveric organ procurement: Mandated choice and presumed consent. JAMA 272:809-812, 1994 5. Spital A: Mandated choice: The preferred solution to the organ shortage? Arch Intern Med 152:2421-2424, 1992 6. Spital A: Mandated choice of organ donation: Time to give it a try. Ann Intern Med 125:66-69, 1996 7. Baer N: Canada’s organ shortage is severe and getting worse. Can Med Assoc J 157:179-182, 1997
8. Klassen AC, Klassen DK: Who are the donors in organ donation? The families perspective in mandated choice. Ann Intern Med 125:70-73, 1996 9. Siminoff LA, Arnold RM, Caplan AL, et al: Public policy governing organ and tissue procurement in the United States: Results from the National Organ and Tissue Procurement Study. Ann Intern Med 123:10-17, 1995 10. Broelsch CE, Burdelski M, Rogiers X, et al: Living donor for liver transplantation. Hepatology 20:49S-55S, 1994 11. Starnes VA, Barr ML, Cohen RG, et al: Living-donor lobar lung transplantation experience: Intermediate results. J Thor Cardiovasc Surg 112:1284-1291, 1996 12. Arnold RM, Youngner SJ: Back to the future: Obtaining organs from non-heart-beating cadavers. Kennedy Inst Ethics J 3:103-111, 1993 13. DeVita MA, Snyder JV: Development of the University of Pittsburgh Medical Center policy for the care of terminally ill patients who may become organ donors after death following the
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