An Observational Descriptive Study of IRB Practices

IRB 实践的观察性描述性研究

• 批准号: 7425335
• 负责人: Charles W Lidz
• 金额: $ 59.48万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7425335
• 关键词: Accounting; Affect; Attention; Classification; Clinical Research; Communities; Consent Forms; Decision Making; Elderly; Ethicists; Ethics; Ethnography; Government; Individual; Information Resources; Informed Consent; Institution; Interview; Investigation; Lawyers; Mainstreaming; Mentally Ill Persons; Nature; Organizational Decision Making; Placebos; Population; Process; Protocols documentation; Qualitative Research; Records; Regulation; Reliance; Reporting; Research; Research Design; Research Ethics Committees; Research Personnel; Risk; Role; Site; Structure; Techniques; Ursidae Family; Vertebral column; Work; abstracting; base; concept; human subject; member; organizational structure; prevent; theories

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.

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 被研究人员严厉批评为官僚主义，被伦理学家批评为过度关注同意书的措辞，而且许多 IRB 效率低下。鉴于 IRB 的重要性和争议性，令人惊讶的是几乎没有对其决策过程进行研究。批评通常基于轶事报道。拟议的研究将对 IRB 决策提供系统的描述。我们将参加十个主要研究机构的不同IRB小组的两次会议，研究会议上讨论的所有新协议。除了在会议上进行观察外，我们还将在会议后六个月采访工作人员和审阅者，了解 IRB 对协议和变更摘要记录的处理情况。民族志观察和访谈将用于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如何做出有关协议的决策，并为更好地评估其运作以及任何拟议的监管或行政变更提供基础。