For some industry funded studies the IRB application is submitted before an agreement is reached on the final budget. Must the fee be paid at the time of the IRB submission?
A. No, however the PI must provide an appropriate, non-sponsored chart string as a guarantee account. After the protocol is reviewed, the IRB will begin tracking the study to see when the industry-funded contract arrives. This is done by working closely with SPA. If the contract does not materialize within 6 months, the Principal Investigator will receive a notice from the IRB office indicating that the non-sponsored chart string will be used to pay the fee. If SPA verifies that negotiations are still ongoing and a clinical trial agreement can still be expected, this six month period can be extended.