Cho M K, Shohara R, Schissel A, Rennie D
Stanford University Center for Biomedical Ethics, 701 Welch Rd, Suite 1105, Palo Alto, CA 94304, USA.
JAMA. 2000 Nov 1;284(17):2203-8. doi: 10.1001/jama.284.17.2203.
Despite federal regulations on faculty conflicts of interest in federally funded research, academic-industry ties are common, and evidence exists that financial considerations bias the research record. Public scrutiny of these ties is increasing, especially in cases where researchers have financial interests in the corporate sponsors of their clinical research.
To review policies on conflict of interest at major biomedical research institutions in the United States.
Cross-sectional survey and content analysis study conducted from August 1998 to February 2000.
The 100 US institutions with the most funding from the National Institutes of Health in 1998 were initially sampled; policies from 89 institutions were available and included in the analysis.
Process for disclosure, review, and management of conflicts of interest and specified management strategies or limitations, according to the institutions' faculty/staff conflict of interest policies.
Content of the conflict of interest policies varied widely across institutions. Fifty-five percent of policies (n = 49) required disclosures from all faculty while 45% (n = 40) required them only from principal investigators or those conducting research. Nineteen percent of policies (n = 17) specified limits on faculty financial interests in corporate sponsors of research, 12% (n = 11) specified limits on permissible delays in publication, and 4% (n = 4) prohibited student involvement in work sponsored by a company in which the faculty mentor had a financial interest.
Most policies on conflict of interest in our sample of major research institutions in the United States lack specificity about the kinds of relationships with industry that are permitted or prohibited. Wide variation in management of conflicts of interest among institutions may cause unnecessary confusion among potential industrial partners or competition among universities for corporate sponsorship that could erode academic standards. It is in the long-term interest of institutions to develop widely agreed-on, clear, specific, and credible policies on conflicts of interest. JAMA. 2000;284:2203-2208.
尽管联邦政府对由联邦资金资助的研究中教职人员的利益冲突有相关规定,但学术机构与产业界的联系却很常见,而且有证据表明经济因素会影响研究记录。公众对这些联系的审查日益增加,尤其是在研究人员对其临床研究的企业赞助商有经济利益的情况下。
回顾美国主要生物医学研究机构的利益冲突政策。
1998年8月至2000年2月进行的横断面调查和内容分析研究。
最初抽取了1998年从美国国立卫生研究院获得资金最多的100家美国机构;89家机构的政策可供使用并纳入分析。
根据各机构的教职员工利益冲突政策,利益冲突的披露、审查和管理流程以及特定的管理策略或限制。
各机构利益冲突政策的内容差异很大。55%的政策(n = 49)要求所有教职员工进行披露,而45%(n = 40)只要求首席研究员或进行研究的人员进行披露。19%的政策(n = 17)规定了教职员工在研究企业赞助商中的经济利益限制,12%(n = 11)规定了允许的发表延迟限制,4%(n = 4)禁止学生参与由教职员工导师有经济利益的公司赞助的工作。
在我们对美国主要研究机构的抽样中,大多数利益冲突政策对于允许或禁止的与产业界的关系类型缺乏明确性。各机构在利益冲突管理方面的巨大差异可能会在潜在的产业合作伙伴之间造成不必要的混乱,或者导致大学之间为企业赞助而竞争,这可能会侵蚀学术标准。制定广泛认可、清晰、具体且可信的利益冲突政策符合各机构的长期利益。《美国医学会杂志》。2000年;284:2203 - 2208。