Perspectives in biology and medicine
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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. ⋯ The present analysis may be useful in the interpretation of the current U. S. regulations that provide for waivers and alterations of informed consent.
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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. ⋯ In particular, it focuses on benefits and harms to the exclusion of other moral criteria. However, both research subjects and public regulators are also concerned about autonomy and the consent requirement, confidentiality, and fairness in subject selection and research design. The movement in the 1970s toward more public scrutiny was critical, even though Beecher was right in holding that it was not "vicious disregard for subject welfare" that explained unethical protocols.
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Perspect. Biol. Med. · Jan 2016
ReviewTrains Departing from Different Stations: Being Mortal and Dying in the 21st Century.
While physician-writers and medical humanists both characterize contemporary deaths as train wrecks, they sometimes disagree about what causes such consistent wreckage. In Being Mortal (2014), the surgeon-writer Atul Gawande attributes the wreckage to forces that so reduce aging and dying persons' autonomy that they prevent those persons from being themselves. For the leading medical humanists in Dying in the Twenty-First Century (2015), edited by Lydia Dugdale, it is our emphasis on autonomy over interdependence that causes contemporary death and dying to go off the rails. To understand the gap between these two accounts, their implicit conversation is compared to the explicit dialogue between a previous generation's leading surgeon-writer and medical humanists: How We Die (1993) by Sherwin Nuland and Facing Death (1996), edited by Howard Spiro and colleagues.