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本文引用的文献

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Research-related injury compensation policies of U.S. research institutions.美国研究机构的科研相关伤害补偿政策。
IRB. 2014 Jan-Feb;36(1):12-9.
2
Do U.S. research institutions meet or exceed federal mandates for instruction in responsible conduct of research? A national survey.美国研究机构是否符合或超过联邦关于负责任研究行为教学的规定?一项全国性调查。
Acad Med. 2012 Sep;87(9):1237-42. doi: 10.1097/ACM.0b013e318260fe5c.
3
Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors. Final rule.寻求公共卫生服务资金的研究以及负责的潜在承包商的申请人在促进研究客观性方面的责任。最终规则。
Fed Regist. 2011 Aug 25;76(165):53256-93.
4
Managing conflicts of interest in clinical care: a national survey of policies at U.S. medical schools.管理临床医疗中的利益冲突:对美国医学院政策的全国性调查。
Acad Med. 2011 Mar;86(3):293-9. doi: 10.1097/ACM.0b013e3182087156.
5
The death of Jesse Gelsinger: new evidence of the influence of money and prestige in human research.杰西·盖辛格之死:金钱与声望对人体研究影响的新证据。
Am J Law Med. 2010;36(2-3):295-325. doi: 10.1177/009885881003600202.
6
Responses of medical schools to institutional conflicts of interest.医学院校对机构利益冲突的应对措施。
JAMA. 2008 Feb 13;299(6):665-71. doi: 10.1001/jama.299.6.665.
7
Pharmaceutical company funding and its consequences: a qualitative systematic review.制药公司的资金投入及其影响:一项定性系统综述
Contemp Clin Trials. 2008 Mar;29(2):109-13. doi: 10.1016/j.cct.2007.08.001. Epub 2007 Aug 16.
8
Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments.美国卫生与公众服务部员工道德行为补充标准及财务披露要求。征求意见的暂行最终规则。
Fed Regist. 2005 Feb 3;70(22):5543-65.
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Conflict of interest and the university.利益冲突与大学
Account Res. 2002 Jan-Mar;9(1):45-64. doi: 10.1080/08989620210356.
10
Protecting subjects, preserving trust, promoting progress II: principles and recommendations for oversight of an institution's financial interests in human subjects research.保护受试者、维护信任、推动进步II:关于监督机构在人体研究中的财务利益的原则与建议
Acad Med. 2003 Feb;78(2):237-45.

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.

DOI:10.1097/ACM.0000000000000980
PMID:26535868
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4731244/
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。