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临床试验中的利益冲突:伦理和政策问题 被引量:8

Conflicts of Interest in Clinical Research:Ethical and Policy Issues
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摘要 人们对于研究人员、赞助商和研究机构三者之间的经济利益关系给予越来越多的关注。人体试验研究中的经济利益与其他利益有所不同 ,这种经济利益会导致偏见或诱导不正当的行为 ,尤其是当有从研究中获益的机会存在时 ,将会影响到研究人员关于应该选择哪个受试者 ,应该提供给受试者什么样的医疗服务 ,甚至应该如何正确使用受试者保密的健康信息方面的判断。由经济利益引起的明显的风险同样也会威胁公众的学术机构研究使命的支持。从处理临床试验中利益冲突的准则 ,什么样的经济利益是研究中的重大经济利益 ,准则的实施等方面进行了详尽的叙述 ,最后指出没有潜在受试者和公众的信任 ,我们就不能有效地开展研究。 There has been increased scrutiny of the financial relationships between researchers, research funders, and research institutions. Financial interests in human subjects research are distinct from other interests that might impart bias or induce improper behavior. Specifically, opportunities to profit from research may affect - or appear to affect - a researcher's judgments about which subjects to enroll, the clinical care provided to subjects, and even the proper use of subjects' confidential health information. Financial interests also threaten scientific integrity when they foster real or apparent biases in study design, data collection and analysis, adverse event reporting, or the presentation of research findings. Illustrating from the aspects of Guidelines for addressing conflicts of interest in clinical research; What counts as significant financial interests in research and Applying the guidelines, the essay comes to a conclusion that we must remember without the trust of both potential subjects and the public at large, we cannot effectively perform research, since research requires subjects as well as significant public funding to make it possible.
出处 《医学与哲学》 2001年第12期17-20,共4页 Medicine and Philosophy
关键词 利益冲突 信任 风险 临床试验 伦理 政策 conflicts of interest trust risk
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