Institutional review board community members: who are they, what do they do, and whom do they represent?
Institutional review board community members: who are they, what do they do, and whom do they represent?
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机构审查委员会社区成员：他们是谁，他们做什么，他们代表谁？
DOI：
10.1097/acm.0b013e3182578b54
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发表时间：
2012-07
期刊：
影响因子：
--
通讯作者：
Klitzman R
中科院分区：
文献类型：
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作者：
Klitzman R
学术医疗中心的非附属和非科学机构审查委员会（IRB）成员的角色受到了一些关注，但问题仍然存在——他们是谁，他们做什么，如果有的话，他们代表谁？作者在2007-2009年间采访了46位IRB主席、董事、行政人员和成员。他联系了60个IRB的领导（在美国国立卫生研究院资助的前240个机构中每四分之一），采访了其中34个机构的IRB领导，然后从这些IRB中再招募了7名成员进行采访。普通的IRB成员经常称这些个人为社区成员，他们对这些成员是谁或应该是谁感到困惑，他们是否代表任何人，或者应该代表谁，如果是的话，是谁。irb在寻找、培训和留住这些社区成员方面遇到了挑战。紧张局势的出现是因为，根据定义，非科学成员没有接受过科学培训，因此他们很难理解协议的关键方面，这使他们感到无权参与审查。irb在鼓励这些成员参与的程度、方式和成功程度上各不相同。在学术医学中心，内部审查委员会在如何看待、选择、雇用和保留非附属和非科学成员方面挣扎，他们在这些方面差异很大。一些irb让这些成员审查整个协议，其他成员只审查有限的部分（特别是阅读同意书以理解）。然而，这些成员的投入有时证明是非常重要的。这些发现对政策、实践和研究具有重要意义。
The roles of nonaffiliated and nonscientific institutional review board (IRB) members at academic medical centers have received some attention, but questions remain—Who are they, what do they do, and whom, if anyone, do they represent? The author interviewed 46 IRB chairs, directors, administrators, and members in 2007–2009. He contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), interviewed IRB leaders from 34 of these institutions, then recruited 7 additional members from these IRBs to interview. Regular IRB members often called these individuals community members and were confused as to who these members were, or should be, and whether they did, or should, represent anyone and, if so, whom. IRBs encountered challenges in finding, training, and retaining these community members. Tensions emerged because nonscientific members, by definition, have no scientific training, so they have difficulty understanding key aspects of protocols, making them feel unempowered to contribute to reviews. IRBs varied in how much they encouraged these members to participate, in what ways, and with what success. At academic medical centers, IRBs struggled with how to view, choose, employ, and retain nonaffiliated and nonscientific members, and they varied widely in these regards. Some IRBs had these members review entire protocols, others only limited parts (particularly reading consent forms for comprehension), pro forma. Yet, at times, these members’ input proved very important. These findings have critical implications for policy, practice, and research.