Florida Regulations 64H-2.002: Institutional Review Board Applications
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(1) Requests for Institutional Review Board review shall be submitted electronically using the Department’s electronic system. For access to the Department’s electronic system, contact the Office of Public Health Research, Florida Department of Health, (850)245-4585. Payment shall be remitted to the Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Bin #A-24, Tallahassee, Florida 32399, (850)245-4585.
(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 only confidential information, and where there is no direct intervention or interaction with human subjects, and where the information is collected by the Department under statutory authority that provides for release of identifiable private information for research purposes shall be charged according to the following schedule:
(a) Initial Requests $250.00.
(b) Amendments $100.00.
(c) Continuing Reviews $250.00.
(d) Studies that expire will be assessed an additional $250.00.
(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 $2,000.00.
(b) Amendments $100.00.
(c) Continuing Reviews $1,000.00.
(d) Studies that expire will be assessed an additional $2,000.00 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 $500.00.
(b) Amendments $100.00.
(c) Continuing Reviews $500.00.
(d) Studies that expire will be assessed an additional $500.00 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 C.F.R. § 46.101(b), June 23, 2005.
(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.
(9) Fees are nonrefundable, except if a fee is paid when none is due.
Rulemaking Authority 381.86 FS. Law Implemented 381.86(5) FS. History-New 9-28-09, Amended 12-10-09.
Terms Used In Florida Regulations 64H-2.002
- Contract: A legal written agreement that becomes binding when signed.
(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 only confidential information, and where there is no direct intervention or interaction with human subjects, and where the information is collected by the Department under statutory authority that provides for release of identifiable private information for research purposes shall be charged according to the following schedule:
(a) Initial Requests $250.00.
(b) Amendments $100.00.
(c) Continuing Reviews $250.00.
(d) Studies that expire will be assessed an additional $250.00.
(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 $2,000.00.
(b) Amendments $100.00.
(c) Continuing Reviews $1,000.00.
(d) Studies that expire will be assessed an additional $2,000.00 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 $500.00.
(b) Amendments $100.00.
(c) Continuing Reviews $500.00.
(d) Studies that expire will be assessed an additional $500.00 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 C.F.R. § 46.101(b), June 23, 2005.
(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.
(9) Fees are nonrefundable, except if a fee is paid when none is due.
Rulemaking Authority 381.86 FS. Law Implemented 381.86(5) FS. History-New 9-28-09, Amended 12-10-09.