Updated COI Review Process for External IRB Submissions
The Office of Research Subjects Protection (ORSP) will initiate a process change for all External IRB Submissions beginning September 6, 2016. External IRB submissions will only be approved and returned to the Principal Investigator for submission to the external IRB after a Conflict of Interest (COI) review is complete. The current process allows the ORSP to approve these submissions as long as the COI review has been requested but may not have been completed. This change is being made for several reasons. First, the reviewing IRB must be informed of any identified conflicts of interest and have the opportunity to approve or augment a COI management plan. The current process does not allow the reviewing IRB the opportunity to review a management plan prior to making a study approval decision. Secondly, this process update enhances consistency in how internal reviews are conducted by ensuring that all ancillary reviews (other institutional requirements such as CITI training, pharmacy, and scientific review) are complete prior to clearing the study for submission to the external IRB.
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