AN ETHNOGRAPHIC STUDY OF INSTITUTIONAL REVIEW BOARDS

这项研究伦理指导科学家发展奖将支持机构审查委员会详细的、比较的民族志研究。本研究有两个目的：1)促进申请人在人类受试者研究伦理方面的发展；2)解决研究伦理领域的一个重要问题：机构审查委员会（irb）的行为和有效性。机构审查委员会的建立是为了保护人类免受作为研究对象的剥削。尽管几乎普遍认为irb是保护人类受试者的重要工具。尽管几乎所有人都同意irb是保护人类受试者的重要工具，但关于研究滥用的持续报道已经引起了人们对审查过程失败的担忧。IRB审查过程的改进需要对影响IRB行为的变量的经验知识，这些变量影响其审议的内容和风格，并决定对其建议的遵守程度。管理内部审查委员会的正式规则和条例被广泛宣传，但是决策制定的内部过程仍然是一个谜。已经有大量的研究调查了内部审查委员会的成员，并记录和分析了考虑的提案数量，编号批准。，或提出的建议。但是，要彻底了解院校审查委员会的运作和效果，就需要仔细考虑这些小组的日常工作。本研究使用民族志和历史研究方法来检查内部审查委员会的内部运作，谈判和互动模式表征他们的会议，解释他们的作用的因素，以及在更大的机构中，内部审查委员会的有效性。将对三个内部审查委员会进行深入的定性分析，从而分离出解释审查委员会行为的重要变量。这项研究使用了民族志和历史研究方法，并仔细考虑了几个数据来源，将能够描述对irb的社会影响以及由此产生的决定。这些发现将提高我们对伦理审查过程的理解，并使我们能够更好地实现保护人类受试者的目标。

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.