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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This essay recounts the author's experience of diagnosis of a rare respiratory condition in order to invite a broader reflection on the nature of diagnosis. Diagnosis is a pivotal moment in one's illness experience, and it can be viewed as both a closure of possibilities and an opening of new, unanticipated ones. The notion of anticipation is also important to the illness experience, in that anticipation and waiting characterize the illness experience generally--in waiting rooms, anticipating test results--as well as the change in one's attitude towards the future, which becomes fearsome in illness.
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Written behavioral agreements (WBAs) are gaining popularity as part of the effort to manage the alarming increase in prescription drug abuse. The rationale for increased use of WBAs in managing patients with chronic pain is that they are believed to increase adherence to agreed-upon behaviors, reduce addiction to or diversion of prescription drugs, and satisfy informed consent requirements. However, there are no high-quality data to support their widespread use in any of these areas. ⋯ Instead, we contend that WBAs are being used to provide leverage for severing relationships with some of our most challenging patients. We propose that physicians treating patients for chronic pain abandon the use of WBAs. Alternatives include open communication, detailed informed consent processes, carefully documented discussions, and most important, commitment to ongoing relationships even with difficult patients.
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The writings of Henry Beecher (1904-1976) have had an enormous influence on thinking and practice with respect to the ethics of medicine and clinical research. This essay examines the seminal contributions of Beecher as illustrated by four landmark articles concerning the ethics of clinical research, the placebo effect and placebo-controlled trials, the evaluation of invasive procedures, and "brain death" and vital organ transplantation. To appreciate Beecher's legacy, it is salutary to explicate the significance of his enduring contributions and to critically evaluate their limitations.