64H-2.002: Institutional Review Board Applications
PURPOSE AND EFFECT: The purpose of this rule is to provide an application mechanism and fee schedule requesting IRB review pursuant to the provisions of Section 381.86(5), F.S.
SUMMARY: Rule 64H 2.002, F.A.C., adopts a fee schedule for review of human subjects research pursuant to Section 381.86(5), F.S.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: Number of people affected: 46; Number of entities affected: 10; Dollar impact $26,400; Cost to agency: $10,000 first year and $7,000 thereafter;
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 381.86 FS.
LAW IMPLEMENTED: 381.86(5) FS.
A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: May 8, 2008, 10:00 a.m. – 11:00 a.m.
PLACE: Conference Room 280N, 4030 Esplanade Way, Tallahassee, FL 32399
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE 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 FULL TEXT OF THE PROPOSED RULE IS:
64H-2.002 Institutional Review Board Applications.
(1) Requests for Institutional Review Board review shall be submitted electronically using the IRBWise system available at the program’s website http://FLpublichealthETHICS.net/. 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 for full board or expedited review $500, Amendments $100, and Continuing Reviews $500. Requests for continuing review are due 60 days prior to study expiration; requests for review after a study has expired will be assessed a $1,000 fee.
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. Fees are nonrefundable, except if the investigator pays a fee when none is due. Specific instructions on how to pay the fee are available at the website indicated in subsection (1).
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. Fees are waived for any student who is a candidate for a degree at a university regardless of location.
Specific Authority 381.86 FS. Law Implemented 381.86(5) FS. History–New_________.