AN ETHNOGRAPHIC STUDY OF INSTITUTIONAL REVIEW BOARDS

这一研究伦理学指导科学家发展奖将支持机构审查委员会进行详细的、比较的人种学研究。这项研究有两个目的：1)促进申请者在人类学科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(IRBs)的行为和有效性。机构审查委员会的成立是为了保护人类免受作为研究对象的剥削。尽管几乎所有人都同意，国际生物圈保护区已成为保护人类主体的重要工具。尽管几乎普遍认为IRBs已成为保护人类受试者的重要工具，但有关滥用研究的持续报道引起了人们对审查过程中失败的担忧。要改进内部审查机构的审查程序，需要对影响机构间审查的行为、影响其审议的内容和风格以及决定对其建议的遵守程度的变量有经验的了解。管理IRBs的正式规则和条例已经广为人知，但决策的内部过程仍然是一个谜。已经有过多的研究对IRBs的成员进行了调查，并记录和分析了所考虑的、已批准的或提出的建议的数量。但是，要彻底了解机构审查委员会的运作和影响，需要仔细考虑这些小组的日常工作。这项研究使用人种学和历史研究方法来考察IRBs的内部运作、IRBs会议的谈判和互动模式、解释其作用的因素以及IRB在更大机构中的有效性。将对三个IRBs进行深入的定性分析，以便将解释审查委员会行为的重要变量分离出来。这项研究使用了人种学和历史学的研究方法，并仔细考虑了几个数据来源，将能够描述对IRBs的社会影响以及在那里产生的决定。这些发现将提高我们对伦理审查过程的理解，并将使我们更好地实现保护人类主体的目标。

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.