In their article in this issue of The Journal,1 Sherertz and Streed provide a case study of an instance in which their institutional review board (IRB) came close to approving a clinical study on the mistaken belief that it was a nonsignificant risk study, whereas in fact it would be considered a significant risk study under Food and Drug Administration (FDA) regulations and policies.
See also p 955.
The extent to which other investigators and IRBs experience the same problem as the authors is not known, but the FDA is aware of other such cases. In fact, the FDA is sufficiently concerned about this matter to have initiated a project in which the experience of IRBs over the last 2 years is being examined. Regardless of the extent of the problem, it is a serious one whenever it occurs. We welcome the opportunity to discuss the topic of significant