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 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, January 16, 2009, 11:00 a.m. – 12:00 Noon (EST)
PLACE: Department of Health, 4030 Esplanade Way, 2nd Floor, Room 280N, Tallahassee, Florida
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 2 days before the workshop/meeting by contacting: Ronique Hall, (850)245-4444, x3927. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Ronique Hall, Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Mail Bin #A24, Tallahassee, FL 32399, (850)245-4444, x3927
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:
64H-2.002 Institutional Review Board Applications.
(1) Requests for Institutional Review Board review shall be submitted electronically using the Departments electronic system. Instructions are available at the following webpage; http://FLpublichealthETHICS.net/instructions. 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, (850)245-4585.
(2) A fee shall be charged for review of each study according to the following schedule: Initial Requests $500, Amendments $100, and Continuing Reviews $500. Continuing Reviews submitted for the sole purpose of closing a study shall not be charged a fee. Requests for Continuing Review are due 60 days prior to study expiration. Studies that expire will be assessed an additional $500 fee.
(3) Fees are due at the time a request for review is made. IRB determinations will not be granted until payment is received by the Department.
(4) Fees are nonrefundable, except if a fee is paid when none is due. Specific instructions on how to pay the fee are available at the website indicated in subsection (1).
(5) Fees do not apply to Department of Health employees, including contracted employees, or investigators conducting research involving human subjects at the request of the Department under a contract, memorandum of understanding, or similar agreement except when the sponsor makes an allowance for fees in the research contract. Fees are waived for any student who is a candidate for a degree at a university located in Florida.
Specific Authority 381.86 FS. Law Implemented 381.86(5) FS. History–New 9-2-08.