An Observational Descriptive Study of IRB Practices

描述(由申请者提供)：机构审查委员会(IRBs)是对人类受试者进行研究的道德规范的支柱。监管者、批评者和伦理学家都依赖IRBs作为防止危害和确保研究的伦理质量的主要机制。然而，研究人员强烈批评IRBs官僚作风，伦理学家认为IRBs过于注重同意书的措辞，许多人认为IRB无效。鉴于IRBs的重要性和争议性，令人惊讶的是，几乎没有人对IRBs做出决策的过程进行研究。批评通常基于轶事。拟议的研究将为内部评级机构的决策提供系统的描述。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，我们还会在会议结束六个月后，就IRB处理规程和更改的摘要记录的情况采访员工和审查员。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机构如何就议定书作出决定，并为更好地评估其运作和任何拟议的监管或行政改革提供基础。

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.