AN ETHNOGRAPHIC STUDY OF INSTITUTIONAL REVIEW BOARDS

机构审查委员会的民族志研究

• 批准号: 6171688
• 负责人: RAYMOND G DE VRIES
• 金额: $ 12.29万
• 依托单位: ST. OLAF COLLEGE
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6171688
• 关键词: behavioral /social science research tag; clinical research; decision making; ethics; health science research analysis /evaluation; human subject; interview

This Mentored Scientist Development Award in Research Ethics will support detailed, comparative ethnographic research of Institutional Review Boards. The research has two aims: 1) to promote the development of the applicant as a scholar in the ethics of research on human subjects, and 2) to address an important problem in the field of research ethics: the behavior and effectiveness of Institutional Review Boards (IRBs). Institutional Review Boards were created to protect humans from exploitation as research subjects. Although there is near universal agreement that IRBs have been an important tool for the protection of human subjects. Although there is near universal agreement that IRBs have been an important tool for the protection of human subjects, continuing reports about research abuses have created concern about failures in the review process. Improvement of the IRB review process requires empirical knowledge of the variables that shape the conduct of IRBs, that affect the content and style of their deliberations, and that determine levels of compliance with their recommendations. The formal rules and regulations that govern IRBs are well publicized, but the internal processes of decision making remain a mystery. There has been a plethora of research surveying members of IRBs and recording and analyzing the number of proposals considered, numbered approved., or recommendations made. But a thorough understanding of the operation and effect of Institutional Review Boards requires careful consideration of the day-to-day work of these groups. This research uses ethnographic and historical research methods to examine the inner workings of IRBs, the negotiations and patterns of interaction that characterize their meetings, the factors that explain their role, and effectiveness of IRBs in the larger institution. In-depth qualitative analysis of three IRBs will be done allowing important variables that explain the behavior of review boards to be isolated. This study, with its use of ethnographic and historical research methods and its careful consideration of several sources of data, will allow description of the social influences on IRBs and the decisions generated there. These findings will improve our understanding of the ethics review process and will allow us to better realize the goal of protecting human subjects.

这项指导的研究伦理学科学家发展奖将支持机构审查委员会的详细，比较人种学研究。该研究的目的有两个：1）促进申请人作为人类受试者研究伦理学的学者的发展，以及2）解决研究伦理领域的重要问题：机构审查委员会（IRB）的行为和有效性。建立了机构审查委员会，以保护人类免受研究对象的剥削。尽管几乎普遍同意IRB是保护人类受试者的重要工具。尽管几乎普遍认为IRB是保护人类受试者的重要工具，但有关研究滥用的持续报告引起了人们对审查过程中的失败的关注。 IRB审查过程的改进需要对影响IRB的行为的变量的经验知识，影响其审议的内容和样式，并决定遵守建议的水平。统治IRB的正式规则和法规已得到充分宣传，但决策的内部过程仍然是一个谜。已经有大量的研究调查成员，并记录和分析了所考虑的建议，已批准或建议的建议数量。但是，对机构审查委员会的操作和影响有透彻的了解需要仔细考虑这些群体的日常工作。这项研究使用人种学和历史研究方法来检查IRB的内部工作，互动的谈判和模式，这些互动的特征是他们的会议，解释其作用的因素以及IRB在较大机构中的有效性。将对三个IRB进行深入的定性分析，允许重要的变量解释隔离审查板的行为。 这项研究借助人种学和历史研究方法及其对几种数据来源的仔细考虑，将允许描述社会对IRB的影响以及那里产生的决定。这些发现将提高我们对道德审查过程的理解，并使我们能够更好地实现保护人类受试者的目标。