Submission Process and Forms

New Study Approval and Submission:

(Applies to non-regulated, non-human, exempt, expedited or full board studies)

UTHSCSA IRB Study Submission Requirements: (http://research.uthscsa.edu/irb/)

The UHS research office will receive IRB documents directly from the UTHSCSA IRB.

• Forms required by UHS:                         
• UHS Institutional Assurance/Supplemental Conditions
       UHS Assurance Form
  Supplemental Conditions
       UT Health SA Confidentiality Agreement Research Monitor
       UT Health SA Employee Confidentiality Agreement for
          External Research Monitor
  


• If applicable:    
• Sunrise orders
• Release of Specimens Request Form
• For Data Request/Footprints please visit:
• https://itservices/MRcgi/MRentrancePage.pl
• Product Evaluation Approval (Only if UHS required to pay for device)

Requirements for Research Personnel

• Credentialing:
• All personnel conducting research must be employed or credentialed with
  the University Health System. Students MAY be exempt from this requirement.
  Please contact the UHS Research Office for verification at (210)-743-6450 or research@uhs-sa.com

• Research Scope of Practice (rScOP) Requirements:
• Combined VA/UHS/UTHSCSA Research Scope of Practice (http://research.uthscsa.edu/ocr/ScopePractice.shtml)
  

Research Scope of Practice (rScOP) form is required for the following personnel that will be interacting or intervening with living individuals:

• Students (Medical, Nursing, Allied Health, etc.)
• Residents
• Fellows
• Non-licensed MD
• Research Assistants
• Other Non-licensed professionals/personnel credentialed by UHS

Research Scope of Practice (RScOP) is not required for:

• Licensed personnel credentialed by UHS (MD, RN, RRT, RPh, etc.)
• UHS employees
• Personnel not interacting or interviewing with living individuals or if your protocol
  is determined as exempt or a chart review study