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AN ETHNOGRAPHIC STUDY OF INSTITUTIONAL REVIEW BOARDS

机构审查委员会的民族志研究

基本信息

批准号：
6533065
负责人：
RAYMOND G DE VRIES
金额：
$ 3.07万
依托单位：
ST. OLAF COLLEGE
依托单位国家：
美国
项目类别：
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/6533065
关键词：
behavioral /social science research tag clinical research decision making ethics health science research analysis /evaluation human subject interview

项目摘要

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.

该研究伦理学指导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。这项研究有两个目的：1）促进申请人作为人类受试者研究伦理学学者的发展，2）解决研究伦理学领域的一个重要问题：机构审查委员会（IRB）的行为和有效性。设立机构审查委员会是为了保护人类不被利用为研究对象。尽管几乎普遍认为IRB是保护人类受试者的重要工具。尽管几乎普遍认为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告引起了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IRB的正式规则和条例已经广为人知，但内部决策过程仍然是个谜。已经有大量的研究调查IRB成员，记录和分析被考虑的提案数量，批准的数量。或提出的建议。但是，要彻底了解机构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研究IRB的内部运作，谈判和互动模式，其会议的特点，解释他们的作用的因素，以及IRB在更大的机构的有效性。将对三个IRB进行深入的定性分析，以便隔离解释审查委员会行为的重要变量。本研究采用民族志和历史研究方法，并仔细考虑了几个数据来源，将允许描述社会对IRB的影响和产生的决定。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。

项目成果

期刊论文数量（9）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

The bioethics of business: Rethinking the relationship between bioethics consultants and corporate clients

DOI：
10.2307/3527588
发表时间：
2004-09-01
期刊：
HASTINGS CENTER REPORT
影响因子：
3.3
作者：
De Vries, RG;Bosk, CL
通讯作者：
Bosk, CL

Who decides? A look at ethics committee membership.

DOI：
10.1023/a:1020581131605
发表时间：
2002-09-01
期刊：
HEC forum : an interdisciplinary journal on hospitals' ethical and legal issues
影响因子：
0
作者：
De Vries, Raymond;Forsberg, Carl P
通讯作者：
Forsberg, Carl P

Framing neuroethics: a sociological assessment of the neuroethical imagination.

框架神经伦理学：对神经伦理想象力的社会学评估。