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Biomedical subjects

J F Childress

Publications and source records attributed to J F Childress.

At least 19 recordsLinked to original sources
PubMed1995

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.

Advisory Committees↗
PubMed1993

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.

Cause of Death↗
PubMed1989

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.

Beneficence↗
PubMed1986

The gift of life. Ethical problems and policies in obtaining and distributing organs for transplantation.

The supply of organs and tissues is inadequate to meet the need and demand for transplantation. The article argues for an effective and efficient system for obtaining cadaveric organs that can reduce and perhaps even eliminate scarcity, without violating the principles of justice and respect for persons. The article also examines policies and problems regarding living donors, and analyzes some issues in macroallocation and microallocation.

Beneficence↗
PubMed1985

Civil disobedience, conscientious objection, and evasive noncompliance: a framework for the analysis and assessment of illegal actions in health care.

This essay explores some of the conceptual and moral issues raised by illegal actions in health care. The author first identifies several types of illegal action, concentrating on civil disobedience, conscientious objection or refusal, and evasive noncompliance. Then he sketches a framework for the moral justification of these types of illegal action. Finally, he applies the conceptual and normative frameworks to several major cases of illegal action in health care, such as "mercy killing" and some decisions not to treat incompetent patients.

Abortion, Illegal↗