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.

Pre-submission: 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 MS Word/ PDF

Required Forms for Initial Submission

 

Institutional Research Application for non-clinical trials

*Required
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
doc for PC
  Inst-M - Personnel Form *Required doc for PC
 

Form A - Signature Assurance Sheet

*Required

How to digitally sign Adobe forms

pdf for PC
  Protocol *Required  
  Consent Form with local contact info/HIPAA *Required
Informed consent document should be submitted with local contact info/HIPAA information provided here.
 

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

  Form CC - Investigator Brochure    
 

Form Inst-F - Investigational Drug Information Record Form

  doc for PC
  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   doc for PC
  Form P - Use of an Investigational Device in Research   doc for PC
  Form Inst-H - Local Investigator FDA-Sponsor Form   doc for PC
 

Form L-1 - Find a Study Recruitment Website

  doc for PC
  Form Q - Use of Radiation in Human Research Studies   doc for PC
  Form Q-1 - Gene Transfer Therapy in Human Research Studies   doc for PC
  Form X - Protocol Related Conflict of Interest   doc for PC
  Form Inst-J - Request for Approval Research involving Child Protective Services   doc for PC
  Form Inst-G - Pharmacy LOU   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 OCRMail@uthscsa.edu