Office of Clinical Research (OCR)

National Cancer Institute Central IRB (NCI CIRB)

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).

 

The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI) in consultation with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). The NCI CIRB will serve as the IRB of record for these studies.

  • UTHSCSA will accept NCI CIRB review for all NCI sponsored cooperative group cancer trials
    • Check the NCI CIRB website (https://www.ncicirb.org/) and confirm the study to be opened is on the NCI CIRB menu. Select “Current List of Studies Under CIRB Review”
  • Available sites are in San Antonio limited to: UTHSCSA, University Health System (UHS), Doctors Hospital at Renaissance (DHR)

Instructions for submission:

 

 

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 boilerplate language

*Required for all submissions
NCI IRB approved informed consent document should be submitted with local boilerplate language provided here.
Note - Also use the boilerplate Spanish version if applicable.

Form H-UT HIPAA authorization

*Required for all submissions

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

Form H-UT HIPAA authorization (Spanish version)  
Form H-1 Translation Certification To be submitted with Form H-UT HIPAA authorization Spanish version

Form CC - Investigator Brochure

 

Form Inst-F - Investigational Drug Information Record Form

 

Form J - HIPAA Waiver of Authorization

If accessing PHI prior to obtaining signed HIPAA authorization

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 for the NCI CIRB Submission

Annual PI Worksheet About Local Context

For first time users or to provide an annual update, complete an Annual PI Worksheet About Local Context. Use the UTHSCSA Specific Information Template to complete this worksheet.

NCI CIRB Study-Specific Worksheet About Local Context

For assistance with NCI Forms, got to https://www.ncicirb.org/ - Select “How it Works”, Then “Independent Model Information”