INCONSISTENCY AND INSTITUTIONAL REVIEW BOARDS
INCONSISTENCY AND INSTITUTIONAL REVIEW BOARDS
复制标题
DOI：
10.1001/jama.248.2.197
复制
发表时间：
1982-01-01
影响因子：
120.7
通讯作者：
GOLDMAN, J
中科院分区：
文献类型：
--
作者：
GOLDMAN, J
为了评估人类受试者研究同行评审的充分性，向拥有医学院的主要大学的 32 个机构审查委员会 (IRB) 提交了相同的肿瘤学和麻醉学研究方案。每项协议都提出了严重的道德问题，包含科学设计的缺陷，并提供了不完整的同意书。 22 家 IRB 参与了调查，调查结果显示：3 个方案均未获得批准，IRB 之间在支持类似决定的理由方面存在严重不一致，以及各个审查委员会在应用道德、方法和知情同意标准方面存在严重不一致。为满足特定反对意见而修改协议将导致有缺陷的调查得到批准。
To assess the adequacy of peer review for research on human subjects, identical research protocols in oncology and anesthesiology were submitted to 32 institutional review boards (IRB) at major universities with medical colleges. Each of the protocols posed serious ethical issues, contained flaws in scientific design and provided an incomplete consent form. Twenty-two IRB participated in the investigation, which revealed: consistency in the nonapproval of the 3 protocols, substantial inconsistency among IRB in the reasons offered in support of similar decisions, and substantial inconsistency in the application of ethical, methodological and informed-consent standards for individual review boards. Revision of the protocols to satisfy particular objections would result in approval of flawed investigations.