Instructions for Submitting to BRANY and Baylor St. Luke’s Medical Center (BSLMC) Administrative Review Process for BRANY IRB approved protocols. BRANY IRB approval is accepted at BSLMC 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 BSLMC Administrative Review:
- Clinical Protocols (Human Subject Research)
- Baylor St. Luke's Administrative Review Process
- New protocol available for review in IRB Manager with BSLMC selected as a site where research will be performed.
- BSLMC Dept. of Research sends an email to PI and Contact listed in the BRANY submission to initiate review process. A link to the research website where the Administrative Review Application can be found is sent in the email. PI emails or faxes Administrative Review Application back to BSLMC Dept. of Research.
- BSLMC Dept. of Research scans the BRANY 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.