The organization of organ procurement

The American organ procurement system has improved and matured in the last five years. At the same time, the basic challenges facing it have remained substantially the same because the moral and legal framework of the system has not changed. Success at organ procurement continues to depend on the voluntary cooperation of medical professionals and the families of potential organ donors. The generosity of the American public is so great that the primary challenge facing organ procurement agencies is obtaining cooperation from hospitals and medical professionals. This calls for a "marketing" orientation aimed at those hospitals and professionals who are most likely to treat potential donors. The last five years have seen a more general acceptance of this appreciation of the central task of organ procurement. As a result, the overall effectiveness of the system has improved, as measured by the number of organs procured on a per capita basis and by the number of multiorgan donors obtained. Much of this improvement can be attributed to the diffusion of organizational techniques and approaches, and this diffusion has been encouraged by the involvement of national organizations and public bodies in the organ procurement community. The system remains uneven in its effectiveness and further improvement is possible. It is also possible that the next general round of improvement will result from the application of businesslike information management and marketing techniques.     

Indigenous self-determination in an age of genetic patenting: recognizing an emerging human rights norm

This Note explores how the law can help indigenous people obtain meaningful control of their genetic material. Part I will briefly discuss the background of genetics, life patents, and indigenous groups. Part II sets out the domestic common law and international human rights law and demonstrates that neither currently provide adequate protection for indigenous peoples. Part III considers the human right of self-determination in the context of indigenous research and patenting, and illustrates that an emerging international norm recognizes an indigenous people's right to control their genetic material. Part IV argues that Congress should pass legislation to adequately meet the human rights needs of indigenous peoples generated by the rapid advancement of biotechnology. This Note concludes that congressional action to protect indigenous peoples is consistent with domestic and international law, and is a natural advancement of human rights and responsible state action.     

The economics and ethics of markets for human organs

In 1984, federal legislation outlawing payment for human organs for transplantation was adopted after only cursory discussion of the underlying policy issues. More considered analysis suggests that this prohibition may be overly broad. It appears possible to design suitably regulated market-type approaches to the acquisition and allocation of cadaveric organs (and perhaps of organs from living donors as well) that will be neither unduly offensive to ethical sensibilities nor easily abused and that may yield significant improvements over the existing system of organ procurement, which presents important ethical and practical problems of its own. Moreover, whatever ultimate judgment we reach concerning the merits of markets for transplantable organs, analysis of the sources of the initial moral resistance to the commercialization that lies behind measures such as the 1984 legislation offers insights into the respective roles of market and nonmarket institutions in general.     

Bioethical and legal considerations in increasing the supply of transplantable organs: from UAGA to "Baby Fae"

In the last 35 years, organ transplant technology has advanced greatly. The major problem associated with organ transplantation is organ availability, and not surgery-related mortality. This article examines current organ procurement procedures and technologies, legislative responses to the scarcity of transplantable organs, as well as the psychological barriers to organ donation. Issues of fairness in the allocation of scarce economic and social resources, the role of religion and ethics in organ donation and transplantation decision, and the impact of the media are also considered.     

To solve a deadly shortage: economic incentives for human organ donation

In this article Dr. Harris and attorney Alcorn propose the establishment of a governmentally regulated, posthumous organ market, with economic incentives for the donors, in order to increase the supply of transplantable organs. The authors review transplant technology, provide a short history of donation and sale of organs, tissues, and cells, discuss the various legislative approaches that have been made to increase the supply of organs, and analyze the problems with the open market approach. They conclude with a proposal for a regulated posthumous organ market.     

Organ harvests from the legally incompetent: an argument against compelled altruism

Organ transplants may offer the best hope of long term survival for individuals afflicted with certain cancers or other debilitating diseases. The hope that a transplant may inspire in an organ recipient should not, however, be the determinative factor when the proposed source of the organ is incompetent. Competent adults are not compelled to act altruistically by undergoing a surgical invasion for the benefit of third parties. Children and mentally incompetent adults should likewise be protected from such compelled altruism. Case by case adjudication of petitions to harvest organs from incompetents are inevitably driven by a concern for the recipient and an unwarranted deference to parental authority, and not by concerns for the autonomy and well being of the incompetent donor. This Note argues that organ harvests from legal incompetents should be statutorily prohibited.     

"Body property": challenging the ethical barriers in organ transplantation to protect individual autonomy

One of two articles related to the current organ shortage, this article advocates the need for legislation to recognize organs and tissues separated from the body as a distinct category of personal property. After addressing the legislative history of organ procurement and psychological barriers to donor consent, the article examines the importance of separating the lifetime rights of ownership in our own bodies from postmortem rights. Ultimately, the author proposes a futures market approach to this problem in which individuals before death, or surviving family members after death, are permitted sell the decedent's organs in a private contract.     

The law and economics of organ procurement

This paper presents an economic analysis of the organ procurement system in the U.S. and examines proposals to alleviate the shortage of transplantable organs. The paper's principal conclusions are: (1) Although non-market solutions deserve the highest priority, demand increases fueled by improvements in transplant technology will probably make some market-based solution necessary in the future. (2) Quality deterioration and coercion will not necessarily be worrisome problems under a market-based procurement system.     

A new test for evaluating Eighth Amendment challenges to lethal injections

An explosion of Eighth Amendment challenges to lethal injection protocols has struck the federal courts. The Supreme Court's recent decision in Hill v. McDonough,1 which empowered prisoners to bring challenges to lethal injection procedures under 42 U.S.C. para. 1983, has facilitated a flood of new lethal injection cases. In response, several courts have ordered states to alter their protocols, spurring other capital inmates to litigate such challenges. Distressingly, the courts evaluating these claims have almost no law to guide them. The last Supreme Court decision applying the Eighth Amendment to a method of execution was written in 1947; that case, Louisiana ex rel. Francis v. Resweber,2 occurred before the Eighth Amendment was applied to the states and resulted in a 4-1-4 split. Although lower courts have heard numerous challenges to execution methods, few have analyzed the constitutional validity of a method of execution in detail. Making matters worse, courts that find Eighth Amendment violations must craft equitable remedies that often amount to entirely new execution protocols. No clear precedent exists to guide courts in formulating such remedies. This Note proposes a legal standard for the administration of Eighth Amendment method-of-execution claims, focusing on lethal injection cases. Part I describes lethal injection procedures and summarizes recent litigation. Part II discusses the difficulty of evaluating lethal injection claims, analyzing both general difficulties in interpreting the Eighth Amendment and specific difficulties associated with lethal injection cases. Part III proposes a standard for addressing method-of-execution claims that attempts to balance a prisoner's interest in a painless execution with a state's interest in conducting executions efficiently. Part IV discusses remedies for unconstitutional procedures. Part V concludes.     

Ethical criteria for procuring and distributing organs for transplantation

This article provides an ethical analysis and assessment of various actual and proposed policies of organ procurement and distribution in light of moral principles already embedded in U.S. institutions, laws, policies, and practices. Evaluating different methods of acquisition of human body parts--donation (express and presumed), sales, abandonment, and expropriation--the author argues for laws and policies, including required request, to maintain and facilitate express donation of organs by individuals and their families. Such laws and policies need adequate time for a determination of their effectiveness before society moves to other major alternatives, such as a market. In organ allocation and distribution, which have close moral connections with organ procurement, the author defends the judgment of the federal Task Force on Organ Transplantation that the community should have dispositional authority over donated organs, that professionals should be viewed as trustees and stewards of donated organs, and that the public should be heavily involved in the formation of policies of allocation and distribution. Concentrating on policies being developed in the United Network for Organ Sharing, the author examines the point system for cadaveric kidneys, the access of foreign nationals to organs donated in the U.S., and the multiple listings of patients seeking transplants. He concludes by identifying two major problems of equitable access to donated organs that will have to be addressed by social institutions other than UNOS: access to the waiting list for donated organs and the role of ability to pay in extrarenal transplants.     

National Association of Medical Examiners position paper on the medical examiner release of organs and tissues for transplantation

The medical examiner community plays a key role in the organ and tissue procurement process for transplantation. Since many, if not most, potential organ or tissue donors fall under medicolegal jurisdiction, the medical examiner bears responsibility to authorize or deny the procurement of organs or tissues on a case-by-case basis. This responsibility engenders a basic dichotomy for the medical examiner's decision-making process. In cases falling under his/her jurisdiction, the medical examiner must balance the medicolegal responsibility centered on the decedent with the societal responsibility to respect the wishes of the decedent and/or next of kin to help living patients. Much has been written on this complex issue in both the forensic pathology and the transplantation literature. Several studies and surveys of medical examiner practices, as well as suggested protocols for handling certain types of cases, are available for reference when concerns arise that procurement may potentially hinder medicolegal death investigation. It is the position of the National Association of Medical Examiners (NAME) that the procurement of organs and/or tissues for transplantation can be accomplished in virtually all cases, without detriment to evidence collection, postmortem examination, determination of cause and manner of death, or the conducting of criminal or civil legal proceedings. The purpose of this position paper is to review the available data, the arguments for and against medical examiner release, and to encourage the release of organs and tissues in all but the rarest of circumstances.     

Medicare and Medicaid programs; conditions of coverage for organ procurement organizations--HCFA. Interim final rule with comment

This interim final rule with comment sets forth changes to the conditions of coverage for organ procurement organizations (OPOs). It redefines an OPO service area, revises the qualifications for the Board of Directors, specifies the assistance to be provided by an OPO to hospitals in establishing and implementing protocols governing organ procurement activity, requires an OPO to establish criteria for allocating organs, and requires an OPO to ensure that tests are performed on prospective organ donors to prevent the acquisition of organs that are infected with the etiologic agent for Acquired Immune Deficiency Syndrome. These changes are required by the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) and the Transplant Amendments Act of 1990 (Public Law 101-616). We also clarify the distinction between certification and designation and amend the criteria with respect to compliance with performance standards, change of ownership, and termination procedures.     

Revisiting the legal standards that govern requests to sterilize profoundly incompetent children: in light of the "Ashley Treatment," is a new standard appropriate?

This Note discusses the recent controversy surrounding a six-year-old girl named Ashley, whose parents chose to purposefully stunt her growth and remove her reproductive organs for nonmedical reasons. A federal investigation determined that Ashley's rights had been violated because doctors performed the procedure, now referred to as the "Ashley Treatment," without first obtaining a court order. However, the investigation did not make any conclusions regarding whether the "Ashley Treatment" could present a legally permissible treatment option in the future. After discussing the constitutional rights that the "Ashley Treatment" implicates and the current legal standards in place, this Note examines how courts have applied these legal standards to cases involving extreme requests. Drawing upon legal commentators, this Note concludes that a court could approve a request for the "Ashley Treatment" in appropriate and limited cases where the parents have presented clear and convincing evidence before a court that the benefits that the "Ashley Treatment" would provide to the child and her family outweigh the risks associated with the procedure. This Note argues that those benefits may include extrinsic considerations, but courts should remain cautious when considering such evidence and be sure that the evidence as a whole supports their conclusions.     

由谁来行使知情同意的权利:患者还是家属?

知情同意权是患者的一项基本权利,但是在我国目前的医疗实务中,该项权利却普遍地由患者的家属予以行使。本文围绕应当由谁来行使“有同意能力的患者”的知情同意权这一问题,由现行法的态度出发,从正反两个角度论证了应当由患者本人行使其知情同意权的观点。     

Informed Consent: Physician Inexperience is a Material Risk for Patients

This paper examines the case for an expanded interpretation of the concept of "material risk" such that it necessitates voluntary disclosure of physician inexperience with a specific medical procedure. Informed consent law in the United States, Canada, and most commonwealth jurisdictions has become a driver of standards of risk disclosure by physicians during the informed consent process. The legal standard of risk disclosure expected of a physician hinges on the interpretation of the entity called "material risk." Any impairment of the physician related to drug usage, disease, or alcohol which compounds the risk of a procedure is very likely to be considered material by a patient. This paper argues that physician inexperience is a factor that a reasonable patient would attach significance to and that it should therefore be viewed as a "material risk" requiring disclosure.     

Non-Heart-Beating Organ Donation: A Defense of the Required Determination of Death

The family of a patient who is unconscious and respirator-dependent has made a decision to discontinue medical treatment. The patient had signed a donor card. The family wants to respect this decision, and agrees to non-heart-beating organ donation. Consequently, as the patient is weaned from the ventilator, he is prepped for organ explantation. Two minutes after the patient goes into cardiac arrest, he is declared dead and the transplant team arrives to begin organ procurement. At the time retrieval begins, it is not certain that the patient's brain is dead or that cardiac function cannot be restored. Procurement follows uneventfully, and two transplantable kidneys are retrieved .     

Assisting altruism: evaluating legally binding consent in organ donation policy

The growing need for organ and tissue transplants has led a number of states to enforce a policy that views a donor's declared intent to be an organ donor as legally binding. This allows health officials to harvest organs without the permission of the next of kin. Legally binding consent is controversial because of concerns that it may anger family members, lead to negative publicity, and discourage potential donors. We use interviews and a pooled time-series data set of cadaveric donation rates in U.S. states to evaluate the effectiveness of this policy. Our research indicates that enforcement of legally binding consent has marginally increased cadaveric donations while not significantly affecting donor registration. We also find evidence that the effect of the policy might be greater if it were more fully implemented and coordinated with efforts to improve public acceptance and awareness.     

Forced organ donation: the presumed consent to organ donation laws of the various states and the United States Constitution

The issues presented in this Comment pertain to whether there are substantive limits imposed by the Fourteenth Amendment upon the state legislatures which would defeat the recent, tentative steps of many states to pass laws authorizing presumed consent to organ donation. The final and perhaps least effective presumed consent law creates a presumption of consent to organ donation. The potential organ donor makes the choice whether to donate or not during his lifetime. This form of the presumed consent law would probably have the least impact on increasing the number of available donor organs. It permitted the coroner to harvest the eyes and corneas of deceased individuals if the coroner was unaware of objections from either the decedent or the family of the decedent. Presumed consent statutes should be found unconstitutional because they infringe upon a family's property interest in a deceased relative's corpse. However, due to the family's property interest in a relative's deceased body, as set forth in the next section, the result is that presumed consent statutes are unconstitutional. In order to find the presumed consent law unconstitutional, the Court would have to find that either: (a) the Fourteenth Amendment's liberty component included the family's right to determine what happens to a relative's body after death, or (b) that the property component included a vested state law property interest in the dead body.     

Regulating Political Donations by Companies: Challenges and Misconceptions

This paper analyses the regulation of company political donations in the UK. It argues that UK policy makers have failed to understand the nature of company donors and, consequently, that the UK Companies Act 2006 requirement for shareholder consent for company donations is not an effective solution to concerns about company donors. To this end, the paper presents a comprehensive empirical analysis of company donations to show that the vast majority of donor companies are closely held or owner‐managed entities where shareholder consent rules are ineffective. The paper highlights particular concerns that arise with donation by such companies and argues for a more accurate understanding of company donations in order to formulate effective policy responses to concerns about the role of company donors.     

Proposal for a future delivery market for transplant organs

Improvements in surgical procedures and immunosuppressive practices have greatly increased the range and success rate of organ transplants. Unfortunately, supply does not meet demand, and demand is increasing. This paper documents the current level of unsatisfied demand for several transplantable organs, and argues that the extant system of altruistic organ donation is unlikely ever to provide adequate supply because of lack of incentives to donate and the ambiguity surrounding property rights over transplantable organs. A greater reliance on markets would help attenuate these problems. However, unorganized private spot markets for human organs are likely to be both inefficient and inequitable, and are perceived as morally offensive. A feasible alternative is an organized, publicly operated future delivery market, wherein an individual can contract, for valuable consideration, with a government agency for delivery of a specific organ upon death. The implementation of such a market would encounter difficult (but not intractable) problems such as price determination, the selection of a medium of exchange, and contractual issues, particularly the role of minors in such a system. Finally, it is argued that such a market is superior to the much-discussed compulsory expropriation alternative.