Industry-Sponsored Research Contracts:..Phase II

行业资助的研究合同：..第二阶段

• 批准号: 6683865
• 负责人: Michelle Marie Mello
• 金额: $ 13.47万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-15 至 2005-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6683865
• 关键词: administrative personnel; behavioral /social science research tag; clinical research; clinical trials; data collection methodology /evaluation; ethics; health care policy; health economics; health science research analysis /evaluation; human subject; industry; organized financing; population survey; psychological values

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.

描述（由申请人提供）：本申请请求资金来管理两项关于道德规范、政策和实践的调查，这些调查涉及学术研究人员和申办者之间对行业资助的临床试验各个方面的控制权分配。 调查工具的开发由 2001 年 RFA 的“研究诚信研究”资助。 行业资助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%。虽然学术与行业研究合作伙伴关系带来巨大好处，但学术机构和赞助商之间的合同条款如果限制研究者的学术自由，可能会对研究诚信构成威胁。 关于这些法律关系的性质和后果的实证数据很少。 本研究探讨了五个研究问题：（1）教师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各个方面的控制权交给行业赞助商是可接受或不可接受的？ (2) 关于可接受的资助者控制的规范在教师研究者之间（按学术等级、从行业获得的研究经费的百分比和机构规模）或研究管理人员之间（按机构规模和从行业获得的机构研究经费的百分比）是否有所不同？ (3) 关于可接受的申办者控制的规范在教师研究者和研究管理人员之间是否有所不同？ (4) 行业赞助的临床试验引起的紧张和冲突的本质是什么？ (5) 学术医疗中心有哪些制度结构（例如正式政策和聘请法律顾问）来确保行业资助的临床试验的完整性并防止相关冲突？ 我们假设，将临床试验的许多方面的控制权分配给行业申办者将被认为是可以接受的，但大型机构、对行业资助的研究有正式政策的机构、初级教职人员以及行业资金很少的教职人员和机构将比其他教职人员和机构更不可能认为申办者控制是可接受的。 我们进一步假设一些研究人员的道德规范将与研究管理人员的道德规范有所不同。 这些假设将通过对学术医疗中心的临床教师和研究管理人员进行的自我调查进行检验。 调查主题包括机构政策和程序、特定类型的申办者控制的可接受性、申办者、研究者和管理人员之间紧张和冲突的根源，以及研究环境中感受到的压力。