Industry-sponsored studies and prereviews

In an attempt to reduce the number of times study teams have to get with sponsors regarding consent form changes, the IRB is changing its prereview of sponsored studies. When a new industry-sponsored study arrives at the IRB for review (remember that it may stop at several other offices before getting to the IRB), we will still do our regular prereview. However, if our only prereview contingencies involve changes to the consent and HIPAA authorization, or minor changes to the new submission form, we will send it on for full board IRB review rather than sending it back to you for corrections first. The IRB will have all of the draft prereview contingencies as it reviews the study, and may add additional contingencies after its review as well. You’ll therefore get a single IRB letter after the full-board review, rather than one before and one after IRB review. Yes, that letter may look long, but the prereview process will still only generate minor contingencies. That way you can make all the consent form changes in a single round, rather than risking having to change the consent form at least twice during the approval process.

Please note that if a submission has some larger problem that makes it impossible for the convened IRB to review the study, prereview *will* send it back to you for correction before sending it to the full board for review. These problems include things like missing required documents.