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Belmont Revisited
Ethical Principles for Research with Human Subjects
James F. Childress, Eric M. Meslin, and Harold T. Shapiro, Editors
Georgetown University Press, 2005

Research with human subjects has long been controversial because of the conflicts that often arise between promoting scientific knowledge and protecting the rights and welfare of subjects. Twenty-five years ago the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research addressed these conflicts. The result was the Belmont Report: Ethical Principles and Guidance for Research Involving Human Subjects, a report that identified foundational principles for ethical research with human subjects: respect for persons, beneficence, and justice.

Since the publication of Belmont, these three principles have greatly influenced discussions of research with human subjects. While they are often regarded as the single-most influential set of guidelines for biomedical research and practice in the United States (and other parts of the world), not everyone agrees that they provide adequate guidance. Belmont Revisited brings together a stellar group of scholars in bioethics to revisit the findings of that original report. Their responses constitute a broad overview of the development of the Belmont Report and the extent of its influence, especially on governmental commissions, as well as an assessment of its virtues and shortcomings.

Belmont Revisited looks back to reexamine the creation and influence of the Belmont Report, and also looks forward to the future of research—with a strong call to rethink how institutions and investigators can conduct research more ethically.

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Catastrophic Diseases
Who Decides What?
Jay Katz
Russell Sage Foundation, 1975
People do not choose to suffer from catastrophic illnesses, but considerable human choice is involved in the ways in which the participants in the process treat and conduct research on these diseases. Catastrophic Diseases draws a powerful and humane portrait of the patients who suffer from these illnesses as well as of the physician-investigators who treat them, and describes the major pressures, conflicts, and decisions which confront all of them. By integrating a discussion of "facts" and "values," the authors highlight the forces which affect new developments in medicine—such as kidney and heart transplants—and the controversial issues they generate. Katz and Capron explore these issues through the use of dual conceptual perspectives. Their study first examines and evaluates the authority which should be vested in each of the chief participants in the catastrophic disease process—the physician-investigator, the patient-subject and his relatives, the professionals, and the state. Challenging questions are raised concerning medical education, informed consent, and professional responsibility. The authors next explore how the roles and capacities of the participants vary not only according to the basic issues they face but also according to the point in decision-making at which these issues arise. The process of investigating and treating catastrophic diseases, the authors believe, can thus usefully be divided into three decision-making stages—the formulation of policy, the administration of research and therapy, and the review of the decisions and their consequences. In conclusion, Katz and Capron demonstrate the need for a variety of individuals and groups with diverse values to be involved in decision-making in a manner which will not unnecessarily impede the scientific investigation of these diseases.
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Experimentation with Human Beings
The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process
Jay Katz
Russell Sage Foundation, 1972
In recent years, increasing concern has been voiced about the nature and extent of human experimentation and its impact on the investigator, subject, science, and society. This casebook represents the first attempt to provide comprehensive materials for studying the human experimentation process. Through case studies from medicine, biology, psychology, sociology, and law—as well as evaluative materials from many other disciplines—Dr. Katz examines the problems raised by human experimentation from the vantage points of each of its major participants—investigator, subject, professions, and state. He analyzes what kinds of authority should be delegated to these participants in the formulation, administration, and review of the human experimentation process. Alternative proposals, from allowing investigators a completely free hand to imposing centralized governmental control, are examined from both theoretical and practical perspectives. The conceptual framework of Experimentation with Human Beings is designed to facilitate not only the analysis of such concepts as "harm," "benefit," and "informed consent," but also the exploration of the problems raised by man's quest for knowledge and mastery, his willingness to risk human life, and his readiness to delegate authority to professionals and rely on their judgment.
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Replacement Parts
The Ethics of Procuring and Replacing Organs in Humans
Arthur L. Caplan, James J. McCartney, and Daniel Reid, Editors
Georgetown University Press, 2016

In Replacement Parts, internationally recognized bioethicist Arthur L. Caplan and coeditors James J. McCartney and Daniel P. Reid assemble seminal writings from medicine, philosophy, economics, and religion that address the ethical challenges raised by organ transplantation. Caplan's new lead essay explains the shortfalls of present policies. From there, book sections take an interdisciplinary approach to fundamental issues like the determination of death and the dead donor rule; the divisive case of using anencephalic infants as organ donors; the sale of cadaveric or live organs; possible strategies for increasing the number of available organs, including market solutions and the idea of presumed consent; and questions surrounding transplant tourism and "gaming the system" by using the media to gain access to organs.

Timely and balanced, Replacement Parts is a first-of-its-kind collection aimed at surgeons, physicians, nurses, and other professionals involved in this essential lifesaving activity that is often fraught with ethical controversy.

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