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美国学术研究机构的机构利益冲突政策。

Institutional Conflict of Interest Policies at U.S. Academic Research Institutions.

作者信息

Resnik David B, Ariansen J L, Jamal Jaweria, Kissling Grace E

机构信息

D.B. Resnik is a bioethicist, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina. J.L. Ariansen is a first-year law student, North Carolina Central University, Durham, North Carolina. J. Jamal is a licensed attorney, Durham, North Carolina. G.E. Kissling is a biostatistician, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina.

出版信息

Acad Med. 2016 Feb;91(2):242-6. doi: 10.1097/ACM.0000000000000980.

Abstract

PURPOSE

Institutional conflicts of interest (ICOIs) occur when the institution or leaders with authority to act on behalf of the institution have conflicts of interest (COIs) that may threaten the objectivity, integrity, or trustworthiness of research because they could impact institutional decision making. The purpose of this study was to gather and analyze information about the ICOI policies of the top 100 U.S. academic research institutions, ranked according to total research funding.

METHOD

From May-June 2014, the authors attempted to obtain ICOI policy information for the top 100 U.S. academic research institutions from publicly available Web sites or via e-mail inquiry. If an ICOI policy was not found, the institutions' online COI policies were examined. Data on each institution's total research funding, national funding rank, public versus private status, and involvement in clinical research were collected. The authors developed a coding system for categorizing the ICOI policies and used it to code the policies for nine items. Interrater agreement and P values were assessed.

RESULTS

Only 28/100 (28.0%) institutions had an ICOI policy. ICOI policies varied among the 28 institutions. Having an ICOI policy was positively associated with total research funding and national funding ranking but not with public versus private status or involvement in clinical research.

CONCLUSIONS

Although most U.S. medical schools have policies that address ICOIs, most of the top academic research institutions do not. Federal regulation and guidance may be necessary to encourage institutions to adopt ICOI policies and establish a standard form of ICOI review.

摘要

目的

当机构或有权代表机构行事的领导者存在利益冲突(COI)时,就会发生机构利益冲突(ICOI),这种利益冲突可能会威胁研究的客观性、完整性或可信度,因为它们可能影响机构决策。本研究的目的是收集并分析美国排名前100的学术研究机构(按总研究经费排名)的ICOI政策信息。

方法

2014年5月至6月,作者试图从公开网站或通过电子邮件询问获取美国排名前100的学术研究机构的ICOI政策信息。如果未找到ICOI政策,则检查这些机构的在线COI政策。收集了每个机构的总研究经费、国家经费排名、公立与私立状况以及参与临床研究的数据。作者开发了一个编码系统来对ICOI政策进行分类,并使用它对九个项目的政策进行编码。评估了评分者间一致性和P值。

结果

100所机构中只有28所(28.0%)有ICOI政策。28所机构的ICOI政策各不相同。拥有ICOI政策与总研究经费和国家经费排名呈正相关,但与公立与私立状况或参与临床研究无关。

结论

虽然大多数美国医学院校都有处理ICOI的政策,但大多数顶尖学术研究机构却没有。可能需要联邦法规和指导来鼓励机构采用ICOI政策并建立标准的ICOI审查形式。

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