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Prereview of industry-sponsored studies

In an attempt to streamline the overall approval process of industry-sponsored studies, ┬áIRB office prereviews of those studies will be handled a little differently In the future. When our only prereview contingencies involve changes to the consent or HIPAA authorization forms, we will send those studies to the full board for review with those contingencies drafted in CLARA, but not yet returned to the PI. The full board can then add any other contingencies and send a single letter back to the PI for a response that includes both the board’s and the prereview contingencies. The intent of this change is to minimize the number of times the study team has to get the sponsor’s approval for consent and HIPAA authorization form changes.

Note that studies will only be sent forward if all the prereview contingencies are minor enough that they don’t affect the board’s ability to review the study. If the new submission is seriously flawed, e.g. it’s missing an investigational brochure, we will send it back for correction before sending it to the board.