4/22/09, 02/16/10, 8/26/11
UAB Policy on Reporting to Institutional Officials and Regulatory Agencies
It is UAB policy that UAB officials, regulatory and other federal regulatory agencies, and sponsors will receive reports of the following IRB determinations:
The IRB Chair (or designee) and the OIRB Director (or designee) will report all of the above determinations in writing to UAB’s Institutional Official within 10 working days of the decision. The report will contain the following information:
Also, the IRB will send a copy of the letter notifying the principal investigator of any of the above determinations to the principal investigator’s departmental chair or other institutional official, as appropriate.
When the IRB makes a determination of suspension or termination of IRB approval, the IRB Chair (or designee) will notify the Institutional Official immediately.
Following receipt of a report of one of the above determinations, the UAB Institutional Official within 10 working days will notify, in accordance with OHRP guidance on reporting incidents (http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html), the following entities or individuals:
Approved on August 26, 2011, by:
Richard B. Marchase, PhD
Vice President for Research and Economic Development
Ferdinand Urthaler, MD
Denise Ball, CIP
OIRB Interim Director