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Views of IRBs Concerning Their Local Ecologies: Perceptions of Relationships, Systems, and Tensions Between IRBs and Their Institutions

机译:内部评级法关于其本地生态的观点:对内部评级法及其机构之间的关系,系统和张力的看法

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Background: Research has generally examined institutional review boards (IRBs) in isolation, but critical questions arise of how these entities fit into the larger institutional contexts in which they operate and what the implications may be. Methods: Semistructured interviews were conducted with leaders of IRBs from among the top 240 institutions receiving funding from the National Institutes of Health. Results: Interviewees felt that institutions may affect IRBs through both broad, indirect features (e.g., size, type of research, and culture of the institution), and more direct, IRB-related factors (e.g., amount of leadership and resource support for the IRB). Interviewees thought that institutional support of IRBs ranged from financial to nonfinancial, and direct to indirect, and that these institutional factors can mold amounts of IRB staff and education, audits, education of principal investigators (PIs), and tensions IRBs had to address. Respondents felt that these factors can in turn potentially affect IRB reviews of protocols and interactions with PIs.Within the complex systems of an institution, IRBs felt that PIs' experiences and complaints about the IRB to institutional leadersmay also shape how the institution related to the IRB. Conclusions: These data are the first to show how IRBs perceive themselves as working within the contexts of dynamic local institutional relationships and systems that pose challenges and tensions that can potentially affect critical aspects of IRB functioning. The findings have implications for practice, future research, and policy.
机译:背景:研究通常是单独检查机构审查委员会(IRB)的,但提出了一些关键问题,这些机构如何适应其运作所在的更大机构环境以及可能产生的影响。方法:对接受了美国国立卫生研究院资助的前240家机构中的IRB负责人进行了半结构化访谈。结果:受访者认为,机构可能通过广泛,间接的特征(例如机构的规模,研究类型和文化)以及更直接的与IRB相关的因素(例如对机构的领导能力和资源支持)来影响IRB。 IRB)。受访者认为,IRB的机构支持范围从财务到非金融,从直接到间接,这些机构因素会影响IRB员工的数量以及教育,审计,主要调查员(PIs)的教育,以及IRB必须应对的紧张局势。受访者认为,这些因素可能反过来可能会影响IRB对协议和与PI的交互的审查。在机构的复杂系统中,IRB认为PI对机构领导者的IRB经验和投诉也可能会影响该机构与IRB的关系。结论:这些数据是第一个显示IRB如何在充满活力的地方机构关系和系统的背景下工作的机构,这些机构和系统构成挑战和紧张关系,并可能影响IRB运作的关键方面。研究结果对实践,未来研究和政策都有影响。

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