The ethical analysis of risk
The ethical analysis of risk
复制标题
DOI：
10.1111/j.1748-720x.2000.tb00686.x
复制
发表时间：
2000-12-01
影响因子：
2.1
通讯作者：
Weijer, C
中科院分区：
文献类型：
--
作者：
Weijer, C
机构审查委员会(IRB)是负责保护研究对象的社会监督机制。要胜任这项任务，IRB需要仔细审查知情同意程序、风险和潜在利益的平衡，以及研究方案中的受试者选择程序。不幸的是，可以说，IRBs花了太多的时间编辑知情同意书，而花在分析研究带来的风险和潜在好处的时间太少。这一次的管理不善清楚地反映在研究伦理文献中。例如，对1979年至1990年发表在《IRB：人类受试者研究综述》上的文章进行了回顾，发现大量关于知情同意和保密的文章(142篇)，而关于风险和潜在危害的评估(40篇)、研究设计(20篇)和受试者选择程序(5篇)的文章要少得多。
The institutional review board (IRB) is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality (142 articles) and considerably fewer on the assessment of risks and potential harms (40), study design (20), and subject-selection procedures (5).