The American journal of bioethics : AJOB
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Surveys and routine clinical procedures applied in research protocols are typically considered only minimally risky to participants. The apparent benign nature of "minimal risk" tasks increases the chance that investigators and Institutional Review Boards (IRBs) will overlook the probability that clinical tools will identify signs, symptoms, or definitive test results that are clinically-relevant to subjects' welfare. "Minimal risk" procedures may also pose a particular hazard to participants in clinical research by increasing the therapeutic misconception because the tasks mimic clinical care and are often conducted in clinical settings. Investigators should anticipate which measures could yield clinically-important findings and should describe explicit plans for data monitoring, disclosure, and follow-up. Protocols that include reliable and valid clinical measures should prompt a more detailed risk assessment by the IRB, even when the tasks meet the regulatory criteria for minimal physical, psychological, or emotional risk.
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Malpractice insurance rates have created a crisis in American medicine. Rates are rising and reimbursements are not keeping pace. ⋯ As with any prima facie obligation, there are justifying conditions that may override the moral prohibition, but I will argue that the current malpractice crisis does not rise to the level of such a justifying condition. While the malpractice crisis demands and justifies a political response on the part of the nation's physicians, strikes and slow-downs are not an ethically justified means to the legitimate end of controlling insurance costs.