Office of Clinical Research (OCR)

Other External IRB - No existing agreement

 

 

Download the UTHSA Institutional Profile to be used with potential reviewing IRBs/potential relying IRBs. -->

UTHSA Institutional Profile

 

If you are utilizing an external IRB for the first time, contact the OCR staff prior to submitting (210-567-8555 or OCRMail@uthscsa.edu).

 

Available sites in San Antonio are limited to: UTHSCSA, University Health System (UHS)

 

Instructions for submission:

  • Stage 1
  • Stage 2
    • Submit to the IRB of record for approval through the Overall PI/Coordinating Center (include signed Reliance Agreement/Checklist and consent form (with local contact info/HIPAA provided/reviewed by OCR staff)
  • Stage 3
    • Provide IRB approval letter
    • Provide IRB approved Informed Consent document(s) with local contact info/HIPAA
    • Signed IRB Authorization Agreement
    • Submit all forms to assigned OCR analyst
  • Stage 4
    • An institutional activation letter from each participating site (i.e. UTHSCSA, UHS) is required prior to initiating your research.

     

  Form Instructions MS Word/ PDF

Required Forms for Initial Submission

 

Institutional Research Application for non-clinical trials

*Required
Note: If this study is a clinical trial, do not download/complete this form. Complete and submit the Institutional Clinical Trial Research Application received from the CTO office instead. CTO Portal
doc for PC
  Inst-M - Personnel Form *Required doc for PC
 

Form A - Signature Assurance Sheet

*Required

How to digitally sign Adobe forms

pdf for PC
  Protocol *Required  
 

Consent Form with  local contact info/HIPAA

*Required
Informed consent document should be submitted with local contact info/HIPAA information provided here.
 

Submit as applicable - Submit these forms if applicable to your research

  Form CC - Investigator Brochure    
 

Form Inst-F - Investigational Drug Information Record Form

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  Form J - HIPAA Waiver of Authorization If the IRB of record does not provide, use the HSC Form J  
  Form O - Drug or Biologic Being Tested in Research   doc for PC
  Form P - Use of an Investigational Device in Research   doc for PC
  Form Inst-H - Local Investigator FDA-Sponsor Form   doc for PC
 

Form L-1 - Find a Study Recruitment Website

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  Form Q - Use of Radiation in Human Research Studies   doc for PC
  Form Q-1 - Gene Transfer Therapy in Human Research Studies   doc for PC
  Form X - Protocol Related Conflict of Interest   doc for PC
  Form Inst-J - Request for Approval Research involving Child Protective Services   doc for PC
  Form Inst-G - Pharmacy LOU   doc for PC

Request for Modification to External IRB Study - Submit if applicable

  Request for Modification to External IRB Studies for Local UTHSCSA Approval This form should be submitted if a modification is requested. doc for PC

Forms should be submitted as attachments in an e-mail to OCRMail@uthscsa.edu