Blackwood R Alexander, Maio Ronald F, Mrdjenovich Adam J, VandenBosch Terry M, Gordon Patricia S, Shipman Emily L, Hamilton Ted A
a University of Michigan Medical School , Ann Arbor , Michigan , USA.
Account Res. 2015;22(4):237-45. doi: 10.1080/08989621.2014.956866.
The University of Michigan Human Research Protection Program formed a six-member committee to analyze the nature of Institutional Review Board (IRB) staff and board contingencies for the approval of informed consent documents. Of the 100 studies examined, 87% had one or more informed consent contingencies. "Omissions" in documentation (40%) and "better clarity" (24%) accounted for the majority, while "word-smithing" accounted for only 10%. This is one of the first studies to examine the nature of IRB contingencies as they relate to informed consent documents. Educational efforts targeting completeness in documentation and clarity on the part of study teams, and discouraging "word-smithing" on the part of IRBs, could reduce the number of informed consent contingencies and expedite the IRB approval process.
密歇根大学人类研究保护项目成立了一个六人委员会，以分析机构审查委员会（IRB）工作人员的性质以及批准知情同意文件时的委员会意外情况。在审查的100项研究中，87%存在一个或多个知情同意意外情况。文件中的“遗漏”（40%）和“表述更清晰”（24%）占了多数，而“文字修饰”仅占10%。这是首批研究IRB意外情况与知情同意文件之间关系性质的研究之一。针对研究团队文件完整性和清晰度的教育工作，以及不鼓励IRB进行“文字修饰”，可能会减少知情同意意外情况的数量，并加快IRB的批准过程。
