Office of Clinical Research (OCR)

Other External IRB - No existing agreement

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:

 

1. Stage 1

    • Complete Research Common Application Step 1 Form
    • Submit to OCR via the automated email (include copy of protocol and consent form)
    • The Office of Clinical Research (OCR) in collaboration with the Office of the Institutional Review Board (IRB) will review to determine if an agreement should be negotiated.
    • NOTE: Stage 1 Forms can be submitted alone for early notification, otherwise submit in combination with Stage 2 Forms

     

2. Stage 2

3. Stage 3

  • Submit to the IRB of record for approval through the Overall PI
    • Must use consent form with local contact info/HIPAA that was reviewed by OCR

4. Stage 4

  • 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

5. Stage 5

  • 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

 

Research Common Application Step 1 Form

*Required doc for PC
 

Research Common Application Step 2 Form

*Required doc for PC
  Inst-M - Personnel Form *Required with Step 2 Form doc for PC
 

Form A - Signature Assurance Sheet

*Required with Step 2 Form

How to digitally sign Adobe forms

pdf for PC

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

 

Form Y - Monitoring Plan - Lead PI

This form should be submitted with Step 1 Form, as applicable. Guidance and form link contained within the Step 1 Form. doc for PC
 

Form Inst-F - Investigational Drug Information Record Form

This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. doc for PC
  Form O - Drug or Biologic Being Tested in Research This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. doc for PC
  Form P - Use of an Investigational Device in Research This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. doc for PC
  Form Inst-H - Local Investigator FDA-Sponsor Form This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. doc for PC
  RABT (Research Activity & Billing Trigger)
(available on the CTO website)
This form can be submitted with Step 1 or Step 2 Form, as applicable.  Guidance and form links are contained within the Step 1 Form. Do not resubmit with Step 2, if already submitted with Step 1 form. Webpage
 

Form L-1 - Find a Study Recruitment Website

This form should be submitted with Step 2 Form, as applicable. Guidance and form links are contained within the Step 2 form. doc for PC
  Form Q - Use of Radiation in Human Research Studies This form should be submitted with Step 2 Form, as applicable. Guidance and form links are contained within the Step 2 form. doc for PC
  Form Q-1 - Gene Transfer Therapy in Human Research Studies This form should be submitted with Step 2 Form, as applicable. Guidance and form links are contained within the Step 2 form. doc for PC
  Form X - Protocol Related Conflict of Interest This form should be submitted with Step 2 Form, as applicable. Guidance and form links are contained within the Step 2 form. doc for PC
  Form Inst-J - Request for Approval Research involving Child Protective Services This form should be submitted with Step 2 Form, as applicable. Guidance and form links are contained within the Step 2 form. doc for PC
  Form Inst-G - Pharmacy LOU This form should be submitted with Step 2 Form, as applicable. Guidance and form links are contained within the Step 2 form. 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