Investigators may not initiate any institutional changes for external IRBExternal IRBAn IRB operated by an organization other than UTHealthSA studies without prior OCR review and approval.
Submit the following to OCRmail@uthscsa.edu
Revised approved forms (using tracked changes in the most current approved forms (which were emailed to you with the approval letter) or new forms as applicable
The PI must be copied on the submission.
OCR does not require a copy of amendments submitted to an external IRB strictly for regulatory review.