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Perspectives in Biology and Medicine

Scott Y Kim
Fifty years after Beecher's landmark article, an old question is being debated anew: is it ethical to conduct clinical research without consent? This paper provides a systematic analysis of this question. First, it describes five clinical trials that have either been conducted (or proposed) without the subjects providing consent. Second, it reviews a number of conditions that are often provided to justify bypassing of consent and finds that only some of them qualify as necessary conditions for bypassing consent...
2016: Perspectives in Biology and Medicine
Christine Grady, Anthony S Fauci
In his famous 1966 New England Journal of Medicine article, Henry Beecher concluded that a critical safeguard for protecting human participants, more reliable than informed consent, was the "presence of an intelligent, informed, conscientious, compassionate, responsible investigator." This article examines Beecher's appeal to reliance on the "virtuous" investigator in light of the critical role that investigators play in research ethics and the systems of research protections that have been developed since Beecher's writing...
2016: Perspectives in Biology and Medicine
Jonathan D Moreno
Henry Knowles Beecher, an icon of human research ethics, and Timothy Francis Leary, a guru of the counterculture, are bound together in history by the synthetic hallucinogen lysergic acid diethylamide (LSD). Both were associated with Harvard University during a critical period in their careers and of drastic social change. To all appearances the first was a paragon of the establishment and a constructive if complex hero, the second a rebel and a criminal, a rogue and a scoundrel. Although there is no evidence they ever met, Beecher's indirect struggle with Leary over control of the 20th century's most celebrated psychedelic was at the very heart of his views about the legitimate, responsible investigator...
2016: Perspectives in Biology and Medicine
John Lantos
Henry K. Beecher was a pioneer of research ethics and a prominent whistleblower with regard to ethically problematic studies. Most of his work focused on research in adults, not children, but he did speculate about the implications of his ethical concerns for research in minors. This paper reviews Beecher's response to Krugman's studies of hepatitis at the Willowbrook State School and the debate that Beecher's article stimulated between Ramsey and McCormick. That debate shaped the terms that were used in current federal regulations for research in children...
2016: Perspectives in Biology and Medicine
Franklin G Miller
Henry Beecher is an iconic figure in research ethics, best known for blowing the whistle on unethical clinical research in 1966. This article traces the evolution of Beecher's view on consent to research and juxtaposes these views with his own practices relating to informed consent in the conduct of clinical research. Additionally, critical examination of Beecher's conception of informed consent as an ideal has important implications for contemporary research ethics.
2016: Perspectives in Biology and Medicine
Alexander Morgan Capron
The modern history of experimentation with human beings is notable for its ethical lacunae, when even the clearest directives fail to prevent violations of subjects' rights and welfare. One such lacuna occurred during the 25 years between 1947, when the Nuremberg Code was articulated in the judgment passed on the men who had performed medical experiments in the Nazi concentration camps, and 1972, when the revelation of the 40-year-long Tuskegee Syphilis Study shocked the public and pushed Congress to adopt legislation that eventually transformed the governance of human subjects research...
2016: Perspectives in Biology and Medicine
E C Fox
The value and belief questions with which bioethics deals have social, cultural, moral, and societal implications that are not confined to certain spheres of biology and medicine, health and illness, and the delivery of medical care. And yet, throughout its history, the field has continued to be focused on a narrow array of medically associated phenomena to which it has applied a limited set of ethical precepts that originate in Western and American philosophical thought. It has done so in an intellectual atmosphere that has not been characterized by vigorous debate...
2016: Perspectives in Biology and Medicine
Fabrizio Benedetti
Among the many contributions by Henry Beecher to science and clinical practice, pain and the placebo effect certainly represent two of the most important aspects. On the one hand, Beecher considered the pain experience not only as arising from the peripheral injured tissues, but also as an emotional experience that is capable of modulating the nociceptive input. On the other hand, he analyzed the placebo effect at an unprecedented level for that time. His ideas sparked from his work on wounded soldiers during World War II...
2016: Perspectives in Biology and Medicine
Susan E Lederer
Henry K. Beecher (1904-1976) played an important role in the development of bioethics. His 1966 article "Ethics and Clinical Research" in the New England Journal of Medicine intensified concern about the welfare of patients participating in clinical research, and his leadership in the 1968 Harvard Ad Hoc Committee on Brain Death redefined the determination of death. Beecher deserves, and even demands, explanation and explication. This essay offers a biographical perspective on the Harvard professor. In addition to his early life and education in both Kansas and Boston, the essay explores how Beecher's experiences in World War II and in the new geopolitical realities of the Cold War shaped his views about the ethical dilemmas of clinical research...
2016: Perspectives in Biology and Medicine
Robert M Veatch
In the 1950s and '60s, Henry Beecher pioneered the discussion of the ethics of clinical research, leading eventually to the publication of the famous New England Journal of Medicine article summarizing 22 research studies that Beecher suggests were unethical. Those studies generally showed a pattern of posing serious risks to subjects without anticipated proportional benefit. Beecher famously claimed that the problem was not that researchers were malicious or evil; rather, he claimed the problem was they manifested thoughtlessness or carelessness...
2016: Perspectives in Biology and Medicine
Franklin G Miller, John Lantos
No abstract text is available yet for this article.
2016: Perspectives in Biology and Medicine
Jeffrey Goldhagen
The Symposium on "The Interface of Child Rights and Pediatric Bioethics in the Clinical Setting" brought together a diverse group of pediatric bioethicists and child rights advocates to explore how the junction of these disciplines could inform their respective work. In retrospect, it is clear how the diversity of personal histories, professional disciplines, knowledge, experience, language, culture, and politics of the participants influenced the outcomes of the Symposium and provided both challenges and opportunities for further collaboration...
2016: Perspectives in Biology and Medicine
Jeffrey P Brosco
Why might pediatric bioethicists in the United States reject the U.N. Convention on the Rights of the Child (CRC) as a framework for resolving ethical issues? The essays in this issue present arguments and counterarguments regarding the usefulness of the CRC in various clinical and research cases. But underlying this debate are two historical factors that help explain the seeming paradox of pediatric bioethicists' arguing against child's rights. First, the profession of clinical bioethics emerged in the 1970s as one component of modern medicine's focus on improving health through the application of technologically sophisticated treatments...
2016: Perspectives in Biology and Medicine
Katherine Wade, Armand H Antommaria
The U.N. Convention on the Rights of the Child (CRC) recognizes children as independent rights holders and articulates 38 substantive rights, including four general principles. It obligates states parties to realize these rights. The U.N. Committee on the Rights of the Child (Committee) oversees implementation of the CRC and can draw attention to areas requiring improvement. Many of the CRC's rights have implications for clinical research. While they justify some nontherapeutic research, they also require participants' protection...
2016: Perspectives in Biology and Medicine
Seema K Shah, Benjamin S Wilfond
The proposed study would be a single-arm interventional trial in a community where HIV is endemic. Beginning with a high-dose triple-drug treatment right after birth, treatment would continue in those who test HIV positive for the next two years and then stop to see if HIV has been eradicated. While we believe the general approach can be justified, and some important questions about this study have already been raised in the literature, three additional questions need to be addressed to determine an ethically sound study design...
2016: Perspectives in Biology and Medicine
Seema K Shah, Benjamin S Wilfond
No abstract text is available yet for this article.
2016: Perspectives in Biology and Medicine
Katherine Wade, Irene Melamed, Jeffrey Goldhagen
This analysis adopts a child rights approach-based on the principles, standards, and norms of child rights and the U.N. Convention on the Rights of the Child (CRC)-to explore how decisions could be made with regard to treatment of a severely impaired infant (Baby G). While a child rights approach does not provide neat answers to ethically complex issues, it does provide a framework for decision-making in which the infant is viewed as an independent rights-holder. The state has obligations to develop the capacity of those who make decisions for infants in such situations to meet their obligations to respect, protect, and fulfill their rights as delineated in the CRC...
2016: Perspectives in Biology and Medicine
Douglas S Diekema, Benjamin S Wilfond
We argue that medical decisions on behalf of children should be made with the welfare of the child as the primary interest, that parents should generally be allowed to determine which options optimize the interests of their child, and that those decisions should be formally challenged only when the parental decision places the child at substantial risk of a serious harm as compared to the option favored by the health-care provider. In situations where moral ambiguity exists and no possible solution could unequivocally be declared the right or good one, a parental decision favoring one or the other of the reasonable options should be supported...
2016: Perspectives in Biology and Medicine
D Micah Hester, Cheryl D Lew, Alissa Swota
Children born with severe handicapping conditions, where survival and quality of survival is indeterminate, present special challenges for families and health-care professionals tasked with deciding the best courses of treatment and care. The case of Baby G presents an opportunity to compare the relative effectiveness of ethical versus rights theories in providing guidance about what obligations are owed to such children at bedside and how those obligations pertain to broader societal duties in a rights framework...
2016: Perspectives in Biology and Medicine
Alissa Swota, Cheryl D Lew, D Micah Hester
No abstract text is available yet for this article.
2016: Perspectives in Biology and Medicine
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