American Thoracic Society Documents
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Clinical research involving critically ill patients is necessary to reduce the extreme morbidity and mortality encountered in the intensive care unit (ICU). Yet such research is ethically challenging because critically ill patients usually are unable to consent for research participation, because conflicts of interest occur among investigators, and because discovering new knowledge while simultaneously protecting research participants from risk may be difficult to achieve. To explore these and other challenges and to elucidate ways of meeting them, the American Thoracic Society (ATS) sponsored a conference on the ethical conduct of clinical research involving critically ill patients on November 21 and 22, 2003 in Washington, DC. The conference was initiated in response to a request for proposals from the Association of American Medical Colleges (AAMC), which hoped professional societies would educate their members about the ethical challenges of clinical research. After the AAMC decided to support the conference, further funding was obtained from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), and the ATS. At the conference, experts in clinical investigation, patient advocacy, ethics, and research oversight explored various aspects of clinical research with a general audience and a writing committee. The writing committee in turn authored this document. The purpose of the document is to present a series of principles that govern the ethical conduct of clinical research involving critically ill patients and to make specific recommendations based on these principles. Prominent among the recommendations is the use of ethical checklists as tools to assist in clinical trial design, implementation, and monitoring by investigators and independent reviewers of research. Although these recommenda-
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تاریخ انتشار 2004