Office of Clinical Research (OCR)

Western IRB (WIRB)

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).

  • WIRB Review Fees
  • 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)
    • If your study is eligible for deferral to WIRB, you will receive an UTHSCSA letter providing approval for submission to WIRB (this letter must be included with the submission to WIRB).
    • 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
    • Complete your submission via WIRB's web portal: https://connexus.wirb.com/
      • If you need additional assistance:
    • Must use consent form with local contact info/HIPAA that was reviewed by OCR
    • Include UTHSCSA letter provided by OCR approving submission to WIRB
  4. Stage 4
    • Provide IRB approval letter
    • Provide IRB approved Informed Consent document(s) with local contact info/HIPAA
    • 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/ Link

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 is 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 OCR Mail@uthscsa.edu

Links & Files for the WIRB Submission

  WIRB Connexus Submission Website Login to this site to complete your submission to WIRB
Webpage
  WIRB Institution (UTHSCSA) Context Requirements Use the local boilerplate language from this document in the informed consent document. WIRB will not approve the consent form without this language.
doc for PC