St. Luke’s Episcopal Hospital (SLEH) Administrative Review Process for Baylor College of Medicine (BCM) IRB approved protocols BCM IRB approval is accepted at SLEH per the Memorandum of Understanding executed April 2, 2005.


Checklist for SLEH Administrative Review:

Clinical Protocols (Human Subject Research)

• Check the box for St. Luke’s Episcopal Hospital as a site on the BRAIN protocol submission
• Complete the BCM SLEH Research Administrative Approval Application (MS Word ) form and submit to SLEHAdminReview@sleh.com
• Complete the Investigational Drug Data Sheet (MS Word ) if protocol involves an investigational drug
• 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

SLEH Administrative Review Process

1. New protocol available for review in BRAIN with SLEH selected as a site where research will be performed.
2. SLEH Dept. of Research sends an email to PI and Contact listed in BRAIN submission to initiate review process.  The Administrative Review Application (2 page) is attached in email.
3. PI emails or faxes Administrative Review Application back to SLEH Dept. of Research.
4. SLEH Dept. of Research scans the BCM 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.
5. Director of Clinical Research 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.
6. 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.
7. All necessary research accounts are set up, approval of Medicare coverage is obtained for Investigation Devices Exception protocols.
8. Once approval of the IRB Chair, Service Chief and all departments is received an approval letter is sent from the SLEH Director of Clinical Research to the PI and contact person via email.
9. For studies that will be using Research Contract Accounts or Research Plans, a meeting will be scheduled with the Dept. of Research to review the billing process.