AN ETHNOGRAPHIC STUDY OF INSTITUTIONAL REVIEW BOARDS

机构审查委员会的民族志研究

• 批准号: 2831800
• 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/2831800
• 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.

这项研究伦理领域的导师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。该研究有两个目的：1）促进申请人作为人类受试者研究伦理方面的学者的发展，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。机构审查委员会的成立是为了保护人类免遭剥削作为研究对象。尽管几乎普遍认为 IRB 是保护人类受试者的重要工具。尽管人们几乎普遍认为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道引起了人们对审查过程失败的担忧。改进 IRB 审查流程需要对影响 IRB 行为、影响其审议内容和风格以及决定其建议遵守程度的变量有经验知识。管理 IRB 的正式规则和条例已广为人知，但决策的内部流程仍然是个谜。已经有大量研究调查了 IRB 成员，并记录和分析了考虑的提案、批准的编号或提出的建议的数量。但要彻底了解机构审查委员会的运作和效果，需要仔细考虑这些小组的日常工作。本研究使用人种学和历史研究方法来研究 IRB 的内部运作、其会议特征的谈判和互动模式、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，从而分离出解释审查委员会行为的重要变量。 这项研究利用人种学和历史研究方法，并仔细考虑了多个数据来源，将能够描述社会对 IRB 的影响以及其中产生的决策。这些发现将提高我们对伦理审查过程的理解，并使我们更好地实现保护人类受试者的目标。