Carline Jan D, O'Sullivan Patricia S, Gruppen Larry D, Richardson-Nassif Karen
Box 357240, University of Washington, Seattle, WA 98195, USA.
Acad Med. 2007 Oct;82(10 Suppl):S57-60. doi: 10.1097/ACM.0b013e31813e66d4.
Medical educational researchers face frustration with IRBs for activities that formerly were exempt from review or were not treated as biomedical research with patients. The authors sought to identify methods for improving relationships between IRBs and medical education researchers.
The authors conducted interviews with medical school representatives about factors leading to relationships in which all parties feel that their concerns are being met, subjects are appropriately protected, and that the progress of evaluation or research activities is not unnecessarily inhibited.
Successful relationships require efforts at education of the IRB and the researchers. All institutions acknowledged the need to establish and maintain good communication. Some schools developed structures or procedures that resulted in more rapid review and increased satisfaction that interests of all parties were protected.
A relationship must be crafted between medical education researchers and the IRB. The authors found key elements to successful approaches.
医学教育研究人员对机构审查委员会(IRB)在处理以前可豁免审查或不被视为涉及患者的生物医学研究的活动时感到沮丧。作者试图确定改善IRB与医学教育研究人员之间关系的方法。
作者就导致各方都感到其关切得到满足、受试者得到适当保护且评估或研究活动进展未被不必要地阻碍的关系的因素,对医学院代表进行了访谈。
成功的关系需要IRB和研究人员双方进行教育努力。所有机构都承认需要建立和保持良好的沟通。一些学校制定了结构或程序,从而实现了更快的审查,并提高了各方利益得到保护的满意度。
医学教育研究人员与IRB之间必须建立一种关系。作者发现了成功方法的关键要素。