Baylor St. Luke’s Medical Center (BSLMC) Administrative Review Process for University of Texas (UT) IRB approved protocols. UT IRB approval is accepted at BSLMC per the Memorandum of Understanding executed October 2008.

Checklist for BSLMC Administrative Review:

  • Clinical Protocols (Human Subject Research)
    • List Angie Esquivel as Administrative Assistant in the iRIS protocol application
    • Complete the Application for Administrative Review of Research form and submit to BSLMC_Research@bcm.edu. Please note: The format of the administrative application was updated May 31, 2016 in order to better capture the needed information. If you have any questions or comments about the revised application, please contact us at BSLMC_Research@bcm.edu
    • Copy of FDA Investigational Device Exemption letter from sponsor if study involves an investigational device
    • Copy of the Clinical Trial Agreement and budget if it is a sponsored study
    • Request for Access to PHI for Research Purposes (includes preparatory to research) 

  • Baylor St. Luke's Administrative Review Process
    • PI emails or faxes Administrative Review Application back to BSLMC Dept. of Research.
    • BSLMC Dept. of Research scans the UT Protocol Summary, Informed Consent and Administrative Review Application and emails the document to the Administrative Review Committee, (Nursing Administration, Pharmacy, Radiology, Pathology, Legal, IRB Chair, Director of Clinical Research.)  The protocol is also sent to the appropriate Service Chief.
    • Research Operations Specialist routes the protocol to all other applicable departments, Managers of all areas that will be affected by the protocol, Medical Records, Patient Financial Services, Patient Access Services.
    • The budget and/or contract is reviewed to ensure billing compliance of any tests and services paid for by the research grant or industry sponsor.
    • Approval of Medicare coverage is obtained for Investigation Devices Exception protocols. Charge codes for investigational devices are requested.
    • Once approval of the IRB Chair, Service Chief and all departments is received an approval letter is sent from the BSLMC Director of Clinical Research to the PI and contact person via email.
    • For studies that will involve research billing, a meeting will be scheduled with the Dept. of Research to review the billing process.  
    • BSLMC Dept. of Research sends an email to PI and Contact listed in iRis submission to initiate review process.  A link to the research website where the Administrative Review Application can be found is sent in the email.
    • New protocol available for review in iRis with Angie Esquivel added as Administrative Assistant.