What the ANPRM missed: additional needs for IRB reform.
What the ANPRM missed: additional needs for IRB reform.
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ANPRM 错过了什么：IRB 改革的额外需求。
DOI：
10.1111/jlme.12050
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Garverich,Suzanne
中科院分区：
文献类型：
--
作者：
Lidz,CharlesW;Garverich,Suzanne
联邦共同规则管理人类受试者的研究行为，规定了机构审查委员会（IRB）审查此类研究的标准和程序。尽管人们普遍认为，IRB或世界上大多数国家所称的研究伦理委员会对于确保人类受试者的研究符合共同的伦理标准至关重要，但IRB总是受到相当大的批评。一些人批评IRB对重要资源的使用效率低下，包括研究人员在提交申请、修改和报告方面投入大量时间，以及在赠款和合同提供的有限时间内推迟数据收集的开始。其他人则批评了对多地点项目审查的不一致性。
The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards (IRBs) should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects.