A revised IRB Policy 8.1, titled “Modifications to Previously Approved Research,” is hot off the presses and posted on the IRB’s website. The changes are mostly formatting related, although we did make a few minor content changes (e.g. we don’t, in fact, require a copy of the updated FDA Form 1572 with a PI change modification, so we deleted that language). Overall, the content will remain familiar to those routinely submitted protocol modifications for review.
Questions about protocol mods or anything else IRB-related? Send us an email at irb@uams.edu.