tag:blogger.com,1999:blog-525778292565554519.post6548441023944238708..comments2018-01-03T07:02:32.059-05:00Comments on Institutional Review Blog: Minimal Risk Approval: 27 months, $170,000Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-525778292565554519.post-9417935904996931142012-06-01T15:52:21.619-04:002012-06-01T15:52:21.619-04:00Thanks for this comment. My guess is that if the r...Thanks for this comment. My guess is that if the researchers were to provide a careful analysis of the causes of the delay, we'd learn something. For example, it would be interesting to know if all the IRBs involved met only on a monthly schedule, so that every modification took at least a month to be considered and sent back, or if some reviewers were willing to engage in a constant back-and-forth with the researchers. Maybe a follow-up article for Petersen et al.?Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-43903258358246334432012-06-01T15:40:27.414-04:002012-06-01T15:40:27.414-04:00Even if hard data did exist about how much time th...Even if hard data did exist about how much time the ball was in the "PI's court" as opposed to the "IRB's court," would that significantly reduce the perceived severity of this case, or eliminate it as an excellent example of why the IRB system needs major improvement? I'm not convinced it would.<br /><br />I believe the time it takes PIs to respond to IRB requests is directly related to the reasonableness and consistency of the IRB's demands. Of course, I have no evidence to back that up -- only my experience as an IRB staffer communicating such demands to researchers.Dylannoreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-19295743536443599422012-05-31T14:30:04.723-04:002012-05-31T14:30:04.723-04:00Thanks for this comment. Dr. Silverstein also note...Thanks for this comment. Dr. Silverstein also notes the desirability of such data. <br /><br />That said, the authors do offer some data on the <a href="http://annals.org/content/156/10/728/F2.expansion.html" rel="nofollow">variability of approval times</a>. Three sites approved the study in less than 50 days. If we take that as a baseline, we need to explain the variability among the other sites.Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-65584927318195983612012-05-31T14:18:54.335-04:002012-05-31T14:18:54.335-04:00Part of the IRB review process is the back and for...Part of the IRB review process is the back and forth between study team and IRB. In this summary, there is no discussion of the time the PI took to respond to IRB issues. Often PI's will complain the approval took 6 months when they sat on IRB comments for 5 months. Perhaps the original article has data on study team turnaround times to IRB comments? if not, their conclusions are suspect...Anonymousnoreply@blogger.com