James F. Childress

The circulatory-respiratory determination of death in organ donation

Objective:Death statutes permit physicians to declare death on the basis of irreversible cessation of circulatory–respiratory or brain functions. The growing practice of organ donation after circulatory determination of death now requires physicians to exercise greater specificity in circulatory–respiratory death determination. We studied circulatory–respiratory death determination to clarify its concept, practice, and application to innovative circulatory determination of death protocols. Results:It is ethically and legally appropriate to procure organs when permanent cessation (will not return) of circulation and respiration has occurred but before irreversible cessation (cannot return) has occurred because permanent cessation: 1) is an established medical practice standard for determining death; 2) is the meaning of “irreversible” in the Uniform Determination of Death Act; and 3) does not violate the “Dead Donor Rule.” Conclusions:The use of unmodified extracorporeal membrane oxygenation in the circulatory determination of death donor after death is declared should be abandoned because, by restoring brain circulation, it retroactively negates the previous death determination. Modifications of extracorporeal membrane oxygenation that avoid this problem by excluding brain circulation are contrived, invasive, and, if used, should require consent of surrogates. Heart donation in circulatory determination of death is acceptable if proper standards are followed to declare donor death after establishing the permanent cessation of circulation. Pending additional data on “auto-resuscitation,” we recommend that all circulatory determination of death programs should utilize the prevailing standard of 2 to 5 mins of demonstrated mechanical asystole before declaring death.

The Data and Safety Monitoring Board and Acquired immune deficiency syndrome (AIDS) clinical trials

The urgency of the Acquired immune deficiency syndrome (AIDS) epidemic has mandated that multiple therapeutic approaches be developed and that these approaches be evaluated through clinical trials. To oversee these trials, the National Institute of Allergy and Infectious Diseases (NIAID) has created three large clinical trial programs monitored by a Data and Safety Monitoring Board (DSMB). For each clinical trial, this Board uses a standardized approach employing contemporary biostatistical, medical, and ethical principles. The DSMB is responsible for reviewing interim data on clinical trial performance, treatment safety and efficacy, and overall study progress. If interim results provide convincing evidence of either excessive adverse effects or significant treatment benefit, the DSMB may recommend early termination of the trial to the NIAID and the study investigators. The responsibility, organization, and operating procedures of this DSMB are presented and illustrated through three clinical trials sponsored by NIAID and monitored by the Board. The rationale and operational model for the DSMB may be a useful example for the development of similar review processes in other HIV clinical trial settings.

Organ Donation after Circulatory Determination of Death: Lessons and Unresolved Controversies

This article responds to the four pieces in this special symposium of the Journal of Law, Medicine & Ethics on uncontrolled organ donation following circulatory death (uDCD). The response will focus on lessons and debates about the kinds of consent necessary and sufficient for temporary organ preservation in the context of DCD and for organ donation itself; on conflicts of obligation, loyalty, and interest in DCD and ways to address those conflicts; and on benefit, cost, risk assessments of uDCD programs, including measures to achieve a more favorable balance of benefits, costs, and risks.

Ensuring care, respect, and fairness for the elderly.

Discrimination against the elderly in the allocation of health care resources has been suggested to control medical expenditures. Using the example of Britains unofficial age criterion for renal dialysis, which effectively prevents patients over 65 from receiving treatment, the author asks whether age discrimination is morally justifiable. He discusses health care for the aged in the contexts of the distribution of care throughout life and of a political-legal right to care. Childress argues that our cultural view of medicine has negative implications for the elderly in terms of resource allocation, and that our failure to acknowledge individual differences among the aged often results in paternalistic interventions. What is needed in discussions of health care for the elderly is a balancing of care and concern with respect for autonomy.

Priorities in the Allocation of Health Care Resources

Students of biomedical ethics have traditionally concentrated on issues in the patient-physician relationship. In recent years, however, they have devoted increasing attention to issues in biomedical ethics in public policy. Public policies, defined as “whatever governments choose to do or not to do” ([7], p. 1), typically involve regulation (e.g., prohibition and control of an activity) and allocation and distribution of benefits (e.g., goods and services) and burdens (e.g., taxation). Issues in the allocation of resources for and within health care are among the most difficult from the standpoint of ethics. My task is to analyze some of these issues in allocation. Although I shall argue for positions at several points, my main intention is to provide a map of several major issues. I shall emphasize the content of public policies, not the processes by which they are formulated and implemented.2 I shall also avoid some broad and important questions of social ethics regarding the structure of the health care system in the United States (e.g., whether the current mix of private and public is desirable). While some policies may imply changes in the structure of the health care system, I shall limit my attention and analysis to policies of allocation of resources for and within health care.

Putting Patients First in Organ Allocation: An Ethical Analysis of the U.S. Debate

Organ allocation policy involves a mixture of ethical, scientific, medical, legal, and political factors, among others. It is thus hard, and perhaps even impossible, to identify and fully separate ethical considerations from all these other factors. Yet I will focus primarily on the ethical considerations embedded in the current debate in the United States about organ allocation policy. I will argue that it is important to put patients first —in the language of the title of one of the major public hearings—but even then significant ethical questions will remain about exactly how to put patients first.

Scripture and Christian Ethics Some Reflections on the Role of Scripture in Moral Deliberation and Justification

The use of Scripture for deliberation and justification in making moral judgments is a crucial and neglected function of the Bible in Christian ethics

Rights to Health Care in a Democratic Society

This essay will analyze and critically assess some major arguments regarding rights to receive (and obligations to provide) health care in modern democratic societies 1 First I will briefly analyze the language of rights, distinguishing moral from legal—political rights, and rights to health care from rights in health care. Then I will consider the putative grounds for a right to health care, particularly the ground provided by the principle of fairness in conjunction with an interpretation of health needs as distinctive in relation to other needs and desires. Even if several moral arguments support a legal—political right to health care, there are major moral disputes about the content and scope of such a right.2 Problems of content and scope include determination of criteria for allocation of resources for and within health care, as well as the acceptability of denying health care to those who have voluntarily taken health risks. Finally, I will consider the question of the bearer of the duty to provide health care and the role of the government in discharging this duty.

Sources of Stem Cells: Ethical Controversies and Policy Developments in the United States

The bioethical controversy about public policy in the United States regarding human stem cell research, particularly with regard to several potential sources of stem cells, including aborted fetuses, unimplanted embryos following in vitro fertilization (IVF), and embryos created through IVF or cloning for research purposes is examined. On the one hand, the debate about the use of federal funds for this research was not resolved by President Bush’s policy, announced in August 2001, because only a few cell lines are available under this restrictive policy. On the other hand, debate persists about whether the US should adopt a prohibitive, regulatory, or permissive policy toward the deliberate creation of embryos for biomedical research through somatic cell nuclear transfer. Although there is a wide consensus about the need to ban cloning-for-reproduction, there is deep division, reflected in the work of the President’s Council on Bioethics, about a possible ban on cloning-for-biomedical research. The author concludes that ethical controversy will probably persist about both types of policy, and that the policy stalemate will probably also continue, because of fundamental disagreements about the moral status of the early embryo.

Ethical Theories, Principles, and Casuistry in Bioethics: An Interpretation and Defense of Principlism

For the last several years a debate has raged about methods in general ethics, whether theological or philosophical, and in bioethics as one area of applied or practical ethics. It has often focused on what has been characterized as the dominant paradigm in bioethics — the appeal to principles. This approach has recently been disparagingly labelled “principlism” [18]. As a defender of principles in bioethics, I will nevertheless use this label of “principlism” as a short-hand expression for a position that I have presented in several works, especially in Principles of Biomedical Ethics ([3], [4], [5]) — hereafter PBE — which I co-authored with Tom L. Beauchamp.1