Office of Clinical Research (OCR)

OCR - SMART IRB Agreement

 

Download the UTHSA Institutional Profile to be used with potential reviewing IRBs/potential relying IRBs.       ------>

UTHSA Institutional Profile
     

 

The SMART IRB’s Online Reliance System (SIORS) allows for investigators to request, track, and document reliance arrangements.

 

The following institutions have signed the SMART IRB Agreement that may allow the IRB from one site to review and approve a research study for all sites participating in the study: https://smartirb.org/participating-institutions/


SMART IRB video: https://vimeo.com/207505758

 

Available sites in San Antonio are limited to: UTHSA, others that have signed the SMART IRB Agreement

 

In what cases will UTHSA IRB consider deferring to another IRB: Multi-site research where the non-HSC IRB is a part of an institution that has an active FWA. It is preferred that the IRB has been accredited by the Association for Accreditation of Human Research Protection Programs (AAHRPP) or a similar designation of IRB quality with the exception of minimal risk studies. Minimal risk studies will be evaluated on a case by case basis. The non-HSC, IRBs which have not been accredited by AAHRPP will be asked to complete the AAHRPP IRB Evaluation Checklist and the completed checklist will be evaluated for AAHRPP standards before the HSC IRB will agree to defer responsibility.

 

Pre-submission: OCR Consultation
Determine who should initiate submission to SMART IRB (normally the Lead PI)

 

Instructions for submission to SMART IRB:

IMPORTANT: Submission to the OCR (see below) is required within 24 hours of submitting through  SMART IRB.   Do not submit to SMART IRB prior to OCR consultation.

 

Instructions for submission to OCR:

  • Stage 1
  • Stage 2
    • Submit to the IRB of record for approval through the Overall PI/Coordinating Center (include consent form [with local contact info/HIPAA] provided/reviewed by OCR staff)
  • Stage 3
    • Submit IRB Approval Letter and Informed Consent Document(s) 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