Industry-Sponsored Research Contracts:..Phase II

描述(由申请人提供)：本申请申请资金，用于管理两个关于伦理规范、政策和实践的调查，这些调查涉及在学术研究人员和赞助商之间分配对行业资助的临床试验的各个方面的控制权。调查工具的开发是由2001年关于“研究诚信研究”的RFA资助的。行业资金已成为生物医学研究不可或缺的一部分，占美国临床药物试验资金的70%。尽管学术与行业研究伙伴关系带来了巨大的好处，但学术机构与赞助商之间的合同条款如果限制了研究人员的学术自由，可能会对研究的完整性构成威胁。关于这些法律关系的性质和后果，几乎没有经验数据。这项研究探讨了五个研究问题：(1)教职研究人员和机构研究管理人员在多大程度上认为将临床试验的各个方面的控制权让给行业赞助商是可以接受的或不能接受的？(2)关于可接受的赞助商控制的规范在教职调查人员之间是否有所不同(根据学术级别、从行业获得的研究资金的百分比和机构规模)，还是在研究管理者中(通过机构规模和从行业获得的机构研究资金的百分比)？(3)关于可接受的赞助商控制的规范在教师调查人员和研究管理者之间是否存在差异？(4)行业赞助的临床试验引起的紧张和冲突的性质是什么？(5)学术医学中心有什么制度结构(如正式政策和法律顾问的使用)来确保行业赞助的临床试验的完整性并防止相关冲突？我们假设，将临床试验许多方面的控制权分配给行业赞助商将被视为可接受的，但大型机构、对行业赞助研究拥有正式政策的机构、初级教职员工以及几乎没有行业资金的教职员工和机构将不太可能认为赞助商控制是可接受的。我们进一步假设，一些研究人员的道德规范将与研究管理者的道德规范背道而驰。这些假设将通过对学术医学中心的临床教师和研究管理人员进行自我管理的调查来验证。调查主题包括机构政策和程序、特定类型的赞助商控制的可接受性、赞助商、调查人员和管理人员之间紧张和冲突的来源，以及研究环境中感知到的压力。

DESCRIPTION (provided by the applicant): This application requests funding to administer two surveys on ethical norms, policies, and practices concerning the allocation of control over various aspects of industry-funded clinical trials between academic investigators and sponsors. The development of the survey instruments was funded under the 2001 RFA on "Research on Research Integrity." 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 if they restrict investigators' academic freedom. There exists little empirical data on the nature and consequences of these legal relationships. This study explores five research questions: (1) To what extent do faculty investigators and institutional research administrators view it as acceptable or unacceptable to cede control over various aspects of clinical trials to industry sponsors? (2) Do norms regarding acceptable sponsor controls vary among faculty investigators (by academic rank, percentage of research funding received from industry, and institutional size), or among research administrators (by institutional size and percentage of institutional research funding received from the industry)? (3) Do norms regarding acceptable sponsor controls differ between faculty investigators and research administrators? (4) What is the nature of tensions and conflicts arising from industry-sponsored clinical trials? (5) What institutional structures (such as formal policies and the use of legal counsel) are in place in academic medical centers to ensure the integrity of industry-sponsored clinical trials and prevent related conflicts? We hypothesize that the allocation of control over many aspects of clinical trials to industry sponsors will be seen as acceptable, but that large institutions, institutions with formal policies on industry-sponsored research, junior faculty, and faculty and institutions with little industry funding will be less likely than other faculty and institutions to view sponsor controls as acceptable. We further hypothesize that the ethical norms of some investigators will diverge from those of research administrators. These hypotheses will be tested through self-administered surveys of clinical faculty and research administrators at academic medical centers. Survey topics include institutional policies and procedures, the acceptability of specific types of sponsor controls, sources of tensions and conflicts between sponsors, investigators, and administrators, and perceived pressures in the research environment.