Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Academic Office Building 1, 12631 E. 17th Avenue, Aurora, CO 80045, USA.
Fertil Steril. 2011 Jul;96(1):15-8. doi: 10.1016/j.fertnstert.2011.05.069. Epub 2011 Jun 8.
Many clinical investigators think that the burden of Institutional Review Board (IRB) requirements has been consistently increasing over recent years, although there are few objective data describing these trends. Over a period of 7 years, the Reproductive Medicine Network observed a significant increase in the size and requirements of IRB submissions and significant variability of IRB performance in reviewing multicenter trials. These additional regulatory and administrative demands represent substantial burdens to researchers and to the IRBs themselves. It is timely to consider whether these changes better protect the interests and safety of human research participants.
ClinicalTrials.gov NCT00068861 and NCT00719186.
许多临床研究人员认为，近年来机构审查委员会（IRB）的要求负担一直在持续增加，尽管很少有客观数据描述这些趋势。在 7 年的时间里，生殖医学网络观察到 IRB 提交的规模和要求显著增加，以及多中心试验审查中 IRB 表现的显著差异。这些额外的监管和行政要求对研究人员和 IRB 本身构成了巨大负担。现在是时候考虑这些变化是否更好地保护人类研究参与者的利益和安全了。
ClinicalTrials.gov NCT00068861 和 NCT00719186。
