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Views and Approaches Toward Research Integrity Among IRBs

IRB 对研究诚信的看法和方法

基本信息

批准号：
7287439
负责人：
ROBERT L KLITZMAN
金额：
$ 28.04万
依托单位：
NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-19 至 2009-08-31
项目状态：
已结题

项目摘要

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.

描述（由申请人提供）：IRB 在观察和应对主要研究者 (PI) 的研究诚信 (Rl) 问题方面可以发挥至关重要的作用，但这些委员会如何看待和处理这些角色尚未得到认真研究。我们的试点数据表明，IRB 通常参与监控和应对 Rl 问题（例如，PI 不合规、利益冲突 (COI)、不良事件和多站点协作中的问题）。但 IRB 面临着不确定性，并且在定义其与 Rl 相关的角色方面存在差异。在一个机构中，IRB 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IRB可能会受到制度、社会、教育和心理因素的影响，成为障碍或促进因素。成员的背景、培训、价值观和团体规范各不相同。不幸的是，关于 IRB 的实证研究很少。我们没有发现他们如何看待和处理这些紧迫的 Rl 问题（例如，他们面临哪些 Rl 问题，多久一次，他们如何应对，或认为他们应该做出反应，以及他们可能需要哪些进一步的指导、培训或资源来最大化 Rl）。本研究旨在确定和描述 IRB 中关于 Rl 的一系列观点、问题、障碍、促进因素和方法，以改善 IRB、PI 和其他人的教育，完善指南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) 他们遇到了哪些 Rl 问题？ 3）涉及哪些因素？ 4) 对教育和指导方针有何影响？具体目标： 1) 记录并了解 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 Pi 的制裁以及向机构或外部实体报告 Rl 问题； 3) 记录和理解 IRB 响应中涉及的因素，重点关注以下特征：i) 机构（例如规模、过去的 Rl 违规行为），ii) IRB。（例如，员工支持、后勤、IRB 角色、职责和标准的看法，以及与合规办公室、COI 委员会和机构领导层的关系），以及 iii) 与 Rl 问题相关的协议（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 名成员进行每次 2-3 小时的深入电话采访，对大型研究密集型机构和小型机构的 IRB 进行抽样和比较。我们预计这项研究的数据将成为重要的基础，通过指导方针、教育和其他能力建设来协助未来的研究和改进 Rl。