Instructions for Submitting to BRANY and St. Luke’s Episcopal Hospital (SLEH) Administrative Review Process for BRANY IRB approved protocols.

BRANY IRB approval is accepted at SLEH per the Agreement executed September 8, 2008.

The website for the BRANY IRB is www.branyirb.com.
On the BRANY website you can find the necessary IRB forms for submitting a protocol, a manual for researchers, IRB meeting schedule, a link to IRB Manager to track your submissions and contact information. Once your protocol submission has been entered in the IRB Manager system, you will be assigned a log in ID and password to track your submission with BRANY.

Checklist for SLEH Administrative Review:

Clinical Protocols (Human Subject Research)

• List Cheryl Fullmer as Institutional Official on #7 on BRANY application
• Complete the Protocol Application for Administrative Review (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 IRB Manager for SLEH.
2. SLEH Dept. of Research sends an email to PI and Contact listed in BRANY 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 Protocol, Project 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, and 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 BRANY IRB, 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.