Lo B, Wolf L E, Berkeley A
Medical Ethics, Center for AIDS Prevention Studies, University of California at San Francisco, USA.
N Engl J Med. 2000 Nov 30;343(22):1616-20. doi: 10.1056/NEJM200011303432206.
There is substantial concern that financial conflicts of interest on the part of investigators conducting clinical trials may compromise the well-being of research subjects.
We analyzed policies governing conflicts of interest at the 10 medical schools in the United States that receive the largest amount of research funding from the National Institutes of Health. These institutions are Baylor College of Medicine, Columbia University College of Physicians and Surgeons, Harvard Medical School, Johns Hopkins University School of Medicine, the University of Pennsylvania School of Medicine, the University of California at Los Angeles School of Medicine, the University of California at San Francisco School of Medicine, the University of Washington School of Medicine, Washington University School of Medicine at St. Louis, and Yale University School of Medicine.
All 10 universities required that faculty members disclose financial interests to university officials. Only four required disclosure by all members of the research staff. Five universities required disclosure of all financial interests, even though federal regulations specify a threshold for disclosure. Six universities required disclosure to the institutional review board as well as to a committee on conflicts of interest or a university official. Four universities had stricter requirements for investigators conducting clinical trials than required by federal regulations. One university prohibited investigators from having stock, stock options, consulting agreements, or decision-making positions involving a company that sponsored the research. A second university prohibited researchers from trading stock or stock options in a company that sponsored the research or sold the product or device under study. Two universities ordinarily did not allow faculty members to participate in clinical research if they had what federal regulations refer to as a "significant" financial interest in the company owning the product or device being studied, but exceptions were allowed.
Policies governing conflicts of interest at leading medical schools in the United States vary widely. We suggest that university-based investigators and research staff be prohibited from holding stock, stock options, or decision-making positions in a company that may reasonably appear to be affected by the results of their clinical research. Of the 10 medical schools we studied, only 1 had a policy that was close to this standard.
人们高度关注开展临床试验的研究人员的经济利益冲突可能会损害研究对象的福祉。
我们分析了美国从国立卫生研究院获得最多研究资金的10所医学院关于利益冲突的政策。这些机构包括贝勒医学院、哥伦比亚大学内外科学院、哈佛医学院、约翰霍普金斯大学医学院、宾夕法尼亚大学医学院、加州大学洛杉矶分校医学院、加州大学旧金山分校医学院、华盛顿大学医学院、圣路易斯华盛顿大学医学院以及耶鲁大学医学院。
所有10所大学都要求教职员工向学校官员披露经济利益。只有4所大学要求所有研究人员披露。5所大学要求披露所有经济利益，尽管联邦法规规定了披露的门槛。6所大学要求向机构审查委员会以及利益冲突委员会或学校官员披露。4所大学对开展临床试验的研究人员的要求比联邦法规更严格。一所大学禁止研究人员持有赞助研究的公司的股票、股票期权、咨询协议或决策职位。另一所大学禁止研究人员交易赞助研究的公司或销售所研究产品或设备的公司的股票或股票期权。两所大学通常不允许教职员工参与临床研究，如果他们在拥有所研究产品或设备的公司中有联邦法规所指的“重大”经济利益，但允许有例外情况。
美国顶尖医学院关于利益冲突的政策差异很大。我们建议禁止大学研究人员和研究人员在可能合理地被认为会受到其临床研究结果影响的公司中持有股票、股票期权或担任决策职位。在我们研究的10所医学院中，只有1所的政策接近这一标准。
