I am starting to monitor a new study at 4 Academic Institutions. The Academic Institution Review Boards (IRB) have a reputation for being very stringent and the IRB process can be quite lengthy (not to mention the contracts process and everything else related to start-up). It has been interesting to contrast the reporting and documentation requirements required for these study sites versus other studies I have worked on that used a central IRB. For example, some IRBs don't even want the IND Safety Alert letters submitted to them unless the cause of the Serious Adverse Event is at least possibly related to Study Drug, some IRBs have approved new versions of the ICF and yet only require consenting newly enrolled subjects on the updated version but no re-consenting of currently enrolled subjects, some IRBs don't even want to be informed of the Protocol Deviations unless they directly impacted subject safety or the integrity of the study, etc.
In any case, I came across a media piece about ethics committees this week on Anderson Cooper and found it provocative so I am posting the link for you. These Academic IRBs may be difficult to navigate but at least they aren't fly-by-night operations like the ones shown here. Click here to see the video.
14-Apr-2009: Just a quick update that Coast IRB has been shut down. Here is a link to the Denver news article a friend sent me. Click here to read the story!
Sunday, April 5, 2009
IRB Integrity
2 comments:
Nadia, it's good to see you're still at it! (smile) Some IRB's do tend to skate around the issue. I also audited an IRB that did not want IND reports unless related to drug; no protocol deviations unless impacts subject safety. Technically, they can get away with that. The problem is they are leaving it up to the PI or CRC to decide if the deviation impacts subject safety or not so they in fact end up "policing" themselves. How many do you think will tell on themselves? How many times do you see "related to study drug" for an event? They really need to reevaluate that practice!
As long as IRBs are able to operate as a for-profit business, this will always be an issue. On the other extreme, it seems some LIRBs are SO difficult and picky they are just trying to justify their existence so that sites don't jump to a central. It's a mess, that is for sure. I think the entire structure should be re-thought. IRBs should be non-profit only, not for profit. Really, does it even make logical sense for an "ethics committee" to be taking funds at all?
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