Views and Approaches Toward Research Integrity Among IRBs

描述(由申请人提供)：IRBs可以在观察和回应主要研究人员(PI)的研究完整性(RL)问题方面发挥重要作用，但这些委员会如何看待和处理这些角色尚未得到认真审查。我们的试点数据表明，IRBs通常参与监控和响应RL问题(例如，PI不遵守、利益冲突(COI)、不良事件和多站点协作中的问题)。但IRBs正在与不确定性作斗争，它们在多大程度上定义了自己在RL方面的角色不同。在一个机构中，IRBs通常是协议的唯一详细审查者，因此在RL方面具有潜在的重要作用。但IRBs可能会受到体制、社会、教育和心理因素的影响，成为障碍或促进者。成员的背景、培训、价值观和团体规范各不相同。不幸的是，对IRBs进行的实证研究很少。我们还没有发现他们如何看待和处理这些紧迫的RL问题(例如，他们面临什么RL问题，以及他们多频繁地遇到RL问题，他们如何回应或感觉他们应该这样做，以及他们可能需要进一步的指导、培训或资源来最大限度地提高RL)。本研究旨在确定和描述IRBs中关于RL的观点、问题、障碍、促进者和方法的范围，以改进IRB、PIS和其他人的教育，完善指导方针，并促进进一步的研究。研究问题：1)IRB在监测和应对RL失误方面有何不同？2)他们遇到了什么RL问题？3)涉及哪些因素？4)对教育和指导方针有什么影响？具体目标：1)记录和了解IRB面临的RL问题的类型和频率，重点关注：不合规、不良事件和COI；2)记录和了解IRB对RL问题的响应类型和频率，重点是：审计、对PIS的制裁，以及向机构或外部实体报告RL问题；以及3)记录和了解IRB响应中涉及的因素，重点关注：i)机构(例如，规模，过去的RL违规)，ii)IRB。(例如，工作人员支持、后勤、对IRB角色、责任和标准的看法，以及与合规办公室、COI委员会和机构领导层的关系)，以及iii)存在RL问题的协议(例如，PI和资金)。我们将使用半结构化工具，对80名IRB主席和40名成员进行深入的电话采访，每个人2-3个小时，抽样并比较大型、研究密集型机构和较小机构的IRBs。我们预计，这项研究的数据将成为帮助未来的研究和通过指导方针、教育和其他能力建设来改进RL的重要基础。

DESCRIPTION (provided by applicant): IRBs can play vital roles in observing and responding to research integrity (Rl) issues among principal investigators (PIs), yet how these boards view and approach these roles has not been seriously examined. Our pilot data indicate that IRBs commonly are involved in monitoring and responding to Rl problems (e.g., PI non-compliance, conflicts of interest (COI), adverse events, and problems in multi-site collaborations). But IRBs wrestle with uncertainties, and differ in how broadly they define their roles concerning Rl. In an institution, IRBs are often the only detailed reviewer of protocols, and thus have potentially important roles concerning Rl. But IRBs may be affected by institutional, social, educational and psychological factors as barriers or facilitators. Members range in background, training, values, and group norms. Unfortunately, little empirical research has been conducted on IRBs. and we have found none on how they view and approach these pressing Rl issues (e.g., what Rl problems they confront, and how frequently, how they respond, or feel they should, and what needs they may have for further guidelines, training or resources to maximize Rl). This study aims to identify and describe the range of views, problems, barriers, facilitators, and approaches concerning Rl among IRBs, in order to improve education of IRBs, Pis and others, refine guidelines, and foster further research. Research Questions: 1) How do IRBs differ in monitoring and responding to lapses in Rl? 2) What Rl issues do they encounter? 3) What factors are involved? 4) What are the implications for education and guidelines? Specific Aims: 1) Documenting and understanding the types and frequencies of Rl issues IRBs face, focusing on: non-compliance, adverse events, and COI; 2) Documenting and understanding the types and frequencies of IRB responses to Rl problems, focusing on: auditing, sanctions against Pis, and reporting of Rl problems to institutional or external entities; and 3) Documenting and understanding factors involved in IRB responses, focusing on characteristics of: i) the institution (eg., size, past Rl violations), ii) the IRB. (e.g., staff support, logistics, views of IRB roles, responsibilities, and standards, and relationships with compliance offices, COI committees, and institutional leadership), and iii) protocols with Rl problems (e.g., the PI, and funding). We will conduct in-depth phone interviews with 80 IRB chairs and 40 members for 2-3 hours each, using a semi-structured instrument, sampling and comparing IRBs from larger, research intensive vs. smaller institutions. We anticipate that the data from this study will serve as a significant foundation in assisting future research and the improvement of Rl through guidelines, education and other capacity building.