Notice of Development of Rulemaking Biomedical
Research Advisory Council
RULE NO.: RULE TITLE:
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.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY
THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND
PLACE SHOWN BELOW:
DATE AND TIME:.Thursday,
PLACE: Department of Health,
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE
DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT IS: Sylvia McDaniel, Office of
Public Health Research, Department of Health,
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 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,
(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 ________.