Public health ethics. Public justification and public trust.

Viewing public health as a political and social undertaking as well as a goal of this activity, the authors develop some key elements in a framework for public health ethics, with particular attention to the formation of public health policies and to decisions by public health officials that are not fully determined by established public policies. They concentrate on ways to approach ethical conflicts about public health interventions. These conflicts arise because, in addition to the value of public health, societies have a wide range of other values that sometimes constrain the selection of means to achieve public health goals. The authors analyze three approaches for resolving these conflicts (absolutist, contextualist, and presumptivist), argue for the superiority of the presumptivist approach, and briefly explicate five conditions for rebutting presumptions in a process of public justification. In a liberal, pluralistic, democratic society, a presumptivist approach that engages the public in the context of a variety of relationships can provide a foundation for public trust, which is essential to public health as a political and social practice as well as to achieving public health goals.

The failure to give: reducing barriers to organ donation.

Moral frameworks for evaluating non-donation strategies to increase the supply of cadaveric human organs for transplantation and ways to overcome barriers to organ donation are explored. Organ transplantation is a very complex area, because the human body evokes various beliefs, symbols, sentiments, and emotions as well as various rituals and social practices. From a rationalistic standpoint, some policies to increase the supply of a transplantable organs may appear to be quite defensible but then turn out to be ineffective and perhaps even counterproductive because of inadequate attention to these rich and complex features of human body parts. Excessively rationalistic policies neglect deep beliefs, symbols, sentiments, and emotions and the like, and that deficiency marks many actual and proposed policies. In addition, policies are often too individualistic and too legalistic.

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.

Non-heart-beating donors of organs: are the distinctions between direct and indirect effects & between killing and letting die relevant and helpful?

This essay analyzes the principle of double effect and, to a lesser extent, the distinction between killing and letting die in the context of the Pittsburgh protocol for managing patients who may become non-heart-beating donors or sources of organs for transplantation. It notes several ambiguities and unresolved issues in the Pittsburgh protocol but concludes that neither the principle of double effect nor the distinction between killing and letting die (with the prohibition of the former and the allowance of the latter under some circumstances) erects insurmountable obstacles to the implementation of the protocol. Nevertheless, the requirement of the principle of double effect that the intended good effects outweigh the unintended side effects necessitates careful attention to the probable overall impact of the proposed policy on organ procurement, particularly because public mistrust plays such a significant role in limiting the number of organ donations.

The place of autonomy in bioethics.

KIE: Childress defends the principle of respect for personal autonomy as one among several important moral principles in biomedical ethics. His main argument focuses on the autonomy principle as "an important moral limit and as limited." As a moral limit, the principle of respect for personal autonomy constrains actions, but is itself limited in scope and weight, as well as being complex in its application. Childress argues that both critics and defenders of personal autonomy tend to neglect these senses of limit in their focus on an "oversimplified, overextended, overweighted principle of respect for autonomy."^ieng

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.