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

DEPARTMENT OF HEALTH
Office of Statewide Research

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 requesting Institutional Board 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: 43; Number of entities affected: 10; Dollar impact $27,500; Cost to agency: $5,000 a year;
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: Wednesday, July 15, 2009, 1:00 p.m. – 2:00 p.m.
PLACE: Department of Health, 4030 Esplanade Way, 2nd Floor, Room 258, 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, [phone], 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 IS: Ronique Hall, Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Mail Bin A #24, Tallahassee, FL 32399, [phone], x3927

THE FULL TEXT OF THE PROPOSED RULE IS:

(Substantial rewording of Rule 64H-2.002 follows. See Florida Administrative Code for present text.)

64H-2.002 Institutional Review Board Applications.

(1) Requests for Institutional Review Board review shall be submitted electronically using the Department’s electronic system. Instructions are available at 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, [phone].

(2) Fees are waived for any student who is a candidate for a degree at a university located in Florida.

(3) 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, unless the study is industry sponsored, or sponsored by a for-profit organization. If so, then the fees listed in subsection (5) shall apply.

(4) Requests for review of studies involving Department electronic databases (such as, but not limited to Vital Statistics, Florida Cancer Data System) shall be charged according to the following schedule:

(a) Initial Requests $250.

(b) Amendments $100.

(c) Continuing Reviews $250.

(d) Studies that expire will be assessed an additional $250.

(e) Requests for study closure shall not be charged a fee.

(f) Requests for Continuing Review are due 60 days prior to study expiration.

(5) Requests for review of studies that are industry sponsored, or sponsored by a for-profit organization, shall be charged according to the following schedule:

(a) Initial Requests $2,000.

(b) Amendments $100.

(c) Continuing Reviews $1,000.

(d) Studies that expire will be assessed an additional $2,000 fee.

(e) Requests for study closure shall not be charged a fee.

(f) Requests for Continuing Review are due 60 days prior to study expiration.

(6) Requests for review of all other studies shall be charged according to the following schedule:

(a) Initial Requests $500.

(b) Amendments $100.

(c) Continuing Reviews $500.

(d) Studies that expire will be assessed an additional $500 fee.

(e) Requests for study closure shall not be charged a fee.

(f) Requests for Continuing Review are due 60 days prior to study expiration.

(7) Fees do not apply for non-research determinations or studies that are exempt per 45 CFR 46.101 (b).

(8) 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.

(9) Fees do not apply to studies that are requesting continuing review during the grants no-cost extension period or afterward when the study remains with no funding.

(10) 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).

Rulemaking Specific Authority 381.86 FS. Law Implemented 381.86(5) FS. History–New 9-2-08, Amended________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Ronique Hall
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Jean Kline
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 5, 2009
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: January 9, 2009