Required IRB Protocol Modifications for CNI (important)

February 5th, 2020
February 5th, 2020

Dear CNI Users:

The new UHP system being installed at CNI is an investigational device.  IRB protocols listing CNI as a resource facility need to be modified to include the description of this new system, note that the system is an investigational device, and modify consent forms appropriately.

We have a letter from GE qualifying the safety standards the UHP system has met, and we used this letter to obtain an approved modification of the CNI IRB protocol.  Having gone through this stage, we anticipate that your IRB protocol modifications will not need a substantive review.

To see a complete description of the steps required and suggested language. click on modification information on the CNI wiki.
(https://cni.stanford.edu/wiki/IRB)

The CNI Team

 





Posted in: Administrative

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