Views and Approaches Toward Research Integrity Among IRBs

IRB 对研究诚信的看法和方法

• 批准号: 7124890
• 负责人: ROBERT L KLITZMAN
• 金额: $ 28.7万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-19 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7124890
• 关键词: clinical research; conflict; education; interview; leadership; motivation; role; training

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可以在观察和应对主要研究者（pi）的研究诚信（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研究。我们的试点数据表明，irb通常参与监测和响应Rl问题（例如，PI不遵守、利益冲突（COI）、不良事件和多站点合作中的问题）。但是irb与不确定性作斗争，并且在如何广泛地定义他们在Rl中的角色方面存在差异。在一个机构中，内部审查委员会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。但是，企业内部审查可能受到制度、社会、教育和心理因素的阻碍或促进。成员的背景、训练、价值观和群体规范各不相同。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强化学习问题（例如，他们面临的强化学习问题，频率，他们如何回应，或者他们应该如何回应，以及他们可能需要进一步的指导方针，培训或资源来最大化强化学习）。本研究旨在识别和描述有关irb中Rl的各种观点、问题、障碍、促进因素和方法，以改善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在监测和响应Rl缺失方面有何不同？2)他们遇到了哪些现实问题？3)涉及哪些因素？4)这对教育和指导方针有什么影响？具体目标：1)记录和理解irb面临的Rl问题的类型和频率，重点关注：不遵守、不良事件和COI；2)记录和理解IRB对Rl问题的回应类型和频率，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；3)记录和理解IRB响应中涉及的因素，重点关注以下特征：1)机构(例如；（规模，过往违反条例），ii) IRB。（例如，员工支持、后勤、IRB角色、职责和标准的观点，以及与合规办公室、COI委员会和机构领导的关系），以及iii)与Rl问题的协议（例如，PI和资金）。我们将对80位内部审查委员会主席和40位成员进行深入的电话采访，每个人2-3小时，使用半结构化仪器，抽样并比较大型研究密集型机构和小型机构的内部审查委员会。我们期望本研究的数据将作为一个重要的基础，通过指导、教育和其他能力建设来协助未来的研究和改进Rl。