Klitzman Robert L
Columbia University, New York, NY, USA.
J Empir Res Hum Res Ethics. 2012 Jul;7(3):50-62. doi: 10.1525/jer.2012.7.3.50.
How IRBs relate to federal agencies, and the implications of these relationships, have received little, if any, systematic study. I interviewed 46 IRB chairs, directors, administrators, and members, contacting the leadership of 60 U.S. IRBs (every fourth one in the list of the top 240 institutions by NIH funding), interviewing IRB leaders from 34 (response rate=55%). IRBs describe complex direct and indirect relationships with federal agencies that affect IRBs through audits, guidance documents, and other communications, and can generate problems and challenges. Researchers often blame IRBs for frustrations, but IRBs often serve as the "local face" of federal regulations and agencies and are "stuck in the middle." These data have critical implications for policy, practice, and research.
机构审查委员会（IRB）与联邦机构之间的关系以及这些关系的影响，即便有过系统研究，也为数不多。我采访了46位IRB主席、主任、管理人员和成员，联系了60个美国IRB的负责人（按美国国立卫生研究院（NIH）资助排名前240的机构名单中的每第四个），采访了34个IRB的负责人（回复率 = 55%）。IRB描述了与联邦机构之间复杂的直接和间接关系，这些关系通过审计、指导文件和其他沟通方式影响IRB，并可能产生问题和挑战。研究人员常常因挫折而指责IRB，但IRB往往是联邦法规和机构的“当地代表”，处于“两难境地”。这些数据对政策、实践和研究具有至关重要的意义。
