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 Fee Schedule
    • IMPORTANT NOTE: The PI is responsible for any WIRB fees incurred prior to a fully executed contract with the Sponsor.

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

Instructions for submission:

  • Stage 1
  • Stage 2
    • Complete your submission via WIRB's web portal: https://connexus.wirb.com/
    • Must use consent form with local contact info/HIPAA that was reviewed by OCR
    • Include UTHSCSA letter provided by OCR approving submission to WIRB
  • Stage 3
    • Provide IRB approval letter
    • Provide IRB approved Informed Consent document(s) with local contact info/HIPAA
    • 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

Required Forms for Initial Submission

Institutional Research Application for non-clinical trials

for non-clinical trials only
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

Inst-M - Personnel Form

*Required for all submissions

Form A - Signature Assurance Sheet

*Required for all submissions

How to digitally sign Adobe forms

Protocol *Required for all submissions

Consent Form with  local contact info/HIPAA

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

Form t-Inst - Institutional Treatment Form

*Required only for Treatment Use / Expanded Access of Drug or Device Studies.
Note: This form should be used instead of the Institutional Research Application and Inst-M Personnel Form.

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

Form CC - Investigator Brochure

 

Form Inst-F - Investigational Drug Information Record Form

 

Form O - Drug or Biologic Being Tested in Research

 

Form P - Use of an Investigational Device in Research

 

Form Inst-H - Local Investigator FDA-Sponsor Form

 

Form L-1 - Find a Study Recruitment Website

 

Form NN - Use of Technology in Research

 

Form Q - Use of Radiation in Human Research Studies

 

Form Q-1 - Gene Transfer Therapy in Human Research Studies

 

Form X - Protocol-Related Conflict of Interest

 

Form Inst-J - Request for Approval - Research Involving Child Protective Services

 

Form Inst - G - Pharmacy LOU

 

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.

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

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.