An Observational Descriptive Study of IRB Practices

描述（由申请人提供）：机构审查委员会（IRB）是人类受试者研究伦理监管的支柱。监管机构、批评家和伦理学家都依赖IRB作为防止伤害和确保研究伦理质量的主要机制。然而，IRB一直被研究人员严厉批评为官僚主义，伦理学家过度关注同意书的措辞，许多人认为无效。考虑到IRB的重要性和争议性，令人惊讶的是，几乎没有人对他们做出决策的过程进行过研究。批评通常是基于轶事。拟议的研究将提供IRB决策的系统描述。我们将参加10个主要研究机构的不同IRB小组的2次会议，研究会议上讨论的所有新方案。除了在会议上观察外，我们还将在会议后6个月就IRB对方案和摘要记录的处理情况与工作人员和审查员进行访谈。将使用人种学观察和访谈来描述每个地点的组织和文化特征。系统的定性和定量分析将更清楚地了解IRB如何对方案做出决策，并为更好地评估其功能和任何拟议的监管或管理变更提供基础。

DESCRIPTION (provided by applicant): Institutional review boards (IRBs) are the backbone of the ethical regulation of research with human subjects. Regulators, critics and ethicists all rely on IRBs as the primary mechanism to prevent harm and to assure the ethical quality of research. However IRBs have been bitterly criticized by researchers as bureaucratic, by ethicists as excessively focused on consent form wording, and many as ineffective. Given the important and controversial nature of IRBs, it is surprising that almost no research has been done on the processes by which they make decisions. Criticism is usually based on anecdotal accounts. The proposed study will provide a systematic description of IRB decision-making. We will attend 2 meetings of different IRB panels at ten major research institutions, studying all new protocols discussed at the meeting. In addition to observation at the meetings, we will interview the staff and reviewers about the IRB's handling of the protocols and abstract records for changes six months after the meetings. Ethnographic observations and interviews will be used to describe organizational and cultural features of each site. Systematic qualitative and quantitative analysis will provide a clearer picture of how IRBs make decisions about protocols and provide the basis for a better assessment of their functioning and of any proposed regulatory or administrative changes.