64H-2.002: Institutional Review Board Applications
PURPOSE AND EFFECT: 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.
SUBJECT AREA TO BE ADDRESSED: Institutional Review Board.
SPECIFIC AUTHORITY: 381.86 FS.
LAW IMPLEMENTED: 381.86(5) FS.
A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: Friday, August 3, 2007, 10:00 a.m. – 11:00 a.m. (EST)
PLACE: Department of Health, 4030 Esplanade Way, 2nd Floor, Room 280N, Tallahassee, Florida
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Sylvia McDaniel, Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Mail Bin #A24, Tallahassee, FL 32399, (850)245-4585
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:
64H-2.002 Institutional Review Board Applications.
(1) Applications for Institutional Review Board review shall be submitted electronically using the IRBWise system available at the program’s website http://FLpublichealth ETHICS.net/. The website address is also available by contacting: Office of Public Health Research, Department of Health,
(2) An application fee shall be charged according to the following schedule for researchers not affiliated with the Department of Health: Initial Applications $350, Amendments $350, and Continuing Reviews $350. Continuing Review Applications are due 60 days prior to study expiration; late applications will be assessed a $700 fee. 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________.