The purpose of this rule is to provide an application mechanism and fee schedule for requesting Institutional Review Board review, pursuant to the provisions of Section 381.86(5), F.S.

Notice of Development of Rulemaking

DEPARTMENT OF HEALTH

Biomedical Research Advisory Council

381.86(5), F.S.

381.86(5) FS.

4030 Esplanade Way, 2nd Floor, Room 280N, Tallahassee, FL

64H-2.002 Institutional Review Board Applications.

(1) Applications for Institutional Review Board review shall be submitted electronically using the IRBWiseÔ system available at the department's website http:// www.doh.state.fl.us/execstaff/irb/index.html. The website address is also available by contacting: Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Bin #A-24, Tallahassee, Florida 32399, [phone].

(2) An application fee shall be charged according to the following schedule: Initial Applications $1,500, Amendments $500, and Continuing Reviews $500. Application fees are due at the time of submission and applications will not be processed until payment is received by the department. Application fees are waived for any student who is a candidate for a degree at a university located in this state.

Specific Authority 381.86 FS. Law Implemented 381.86(5) FS. History–New ________.