Industry-Sponsored Research Contracts:An Empirical Study

描述（由申请人提供）：本研究的目的是检查有关学术研究者和申办者之间对行业资助的临床试验各个方面的控制分配的政策、实践和制度规范。 产业资助已成为生物医学研究中不可或缺的一部分，在美国占临床药物试验资金的70%。虽然学术-产业研究伙伴关系带来了巨大的好处，但学术机构和赞助商之间的合同条款可能会限制研究人员的学术自由，从而对研究诚信构成威胁。 关于这些法律的关系的性质和后果的经验数据很少。 本研究探讨了五个研究问题：（1）在学术医疗中心，为行业赞助的临床试验谈判合同，有什么样的制度结构（如正式的政策和与法律的顾问的协商）？ (2)学术机构与行业申办者之间的合同中包含与数据控制、试验实施控制、出版控制和保密相关的条款的频率如何？ (3)在何种程度上，合同人员和教职员工认为将临床试验的这些方面的控制权交给行业申办者是可以接受或不可接受的？ (4)与行业赞助商的纠纷发生率和性质如何？ (5)问题1至4的答案是否因机构和教师的特征（机构规模、教师学术排名、教师专业和行业资助比例）而异？ 我们假设，受访者将报告说，分配控制临床试验的许多方面，以行业赞助商是可以接受的，但大型机构，机构的正式政策管理行业赞助的研究，教师与高级学术排名，教师与行业资金很少将不太可能比其他机构和教师，以查看申办者控制是可以接受的。 我们进一步假设，使用正式的政策将与较低的发生率的赞助商赞助商的纠纷。 这些假设将通过邮寄调查的赠款和合同管理人员和临床教师在学术医疗中心进行测试。 调查将收集有关机构政策和程序的信息，特定类型的赞助商控制的可接受性，与赞助商的纠纷，以及研究环境中的感知压力。将采用卡方检验和回归分析对数据进行连续性分析。

DESCRIPTION (provided by the applicant): The aim of this study is to examine policies, practices, and institutional norms concerning the allocation of control over various aspects of industry-funded clinical trials between academic investigators and sponsors. Industry funding has become an indispensable part of biomedical research, accounting for 70% of the funding for clinical drug trials in the U.S. While academic-industry research partnerships carry great benefits, the terms of the contracts between academic institutions and sponsors pose a possible threat to research integrity in that they may restrict investigators' academic freedom. There exists scant empirical data on the nature and consequences of these legal relationships. This study explores five research questions: (1) what institutional structures (such as formal policies and consultation with legal counsel) are in place in academic medical centers to negotiate contracts for industry-sponsored clinical trials? (2) How frequently do contracts between academic institutions and industry sponsors contain provisions relating to control over data, control over the conduct of the trial, control over publication, and confidentiality? (3) To what extent do contract officers and faculty view it as acceptable or unacceptable to cede control over each of these aspects of clinical trials to industry sponsors? (4) What is the incidence and nature of disputes with industry sponsors? (5) Do the answers to Questions 1 through 4 vary according to institutional and faculty characteristics (institutional size, faculty academic rank, faculty specialty, and percentage of funding from industry)? We hypothesize that respondents will report that allocation of control over many aspects of clinical trials to industry sponsors is acceptable, but that large institutions, institutions with formal policies governing industry-sponsored research, faculty with senior academic rank, and faculty with little industry funding will be less likely than other institutions and faculty to view sponsor controls as acceptable. We further hypothesize that the use of formal policies will be associated with a lower incidence of investigator-sponsor disputes. These hypotheses will be tested through a mailed survey of grants and contracts administrators and clinical faculty at academic medical centers. The survey will gather information on institutional policies and procedures, the acceptability of specific types of sponsor controls, disputes with sponsors, and perceived pressures in the research environment. The data will be analyzed descriptively and with chi-squared tests and regression analysis.