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

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 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

 

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 OCRMail@uthscsa.edu