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Its no secret that the process of obtaining informed consent for research involving human subjects is never easy. The process is even more complicated, however, when the proposed study participant is a newborn.
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A proposal to create a new category of Food and Drug Administration (FDA) licensure for drugs used by the Department of Defense (DoD) against nuclear, biological, and chemical threats has caused a stir in human research circles.
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At the Dana-Farber Cancer Institute in Boston, human subjects protection is treated as a quality assurance issue. The institute takes steps to ensure that protections are extended throughout protocols through data monitoring and auditing and is working to improve informed consent through a validated questionnaire.
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Synopsis: When RALES and EPHESUS are considered together, one clearly can recommend the use of an aldosterone receptor blocker for all very ill patients with congestive heart failure and significant LV dysfunction, whether or not related to acute myocardial infarction.
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In one of the more bizarre stories of the year, the FDA has uncovered files of counterfeit Procrit (epoetin alfaJohnson & Johnson) in routine surveillance. To make matters worse, the fake vials have been contaminated with bacteria and many contain no active ingredient.
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Editors Note: The following reports from the annual scientific sessions of the American College of Cardiology held March 30 to April 2, 2003, were obtained by handwritten notes, press releases, and news reports.
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Docetaxel is active in paclitaxel-resistant ovarian and peritoneal cancer, but, in view of significant hematologic toxicity, further study is warranted to ascertain its optimal dose and schedule.