Administrative Rule 64H-2.002 Institutional Review Board Fees

Fees for IRB Review by the Department of Health Institutional Review Board

Authority to assess fees

Fees are assess pursuant to Rule 64H-2.002, created to comply with 381.86, Florida Statutes.

64H-2.002 Institutional Review Board Applications

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:
   • Initial Requests $250.
   • Amendments $100.
   • Continuing Reviews $250.
   • Studies that expire will be assessed an additional $250.
   • Requests for study closure shall not be charged a fee.
   • 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:
   • Initial Requests $2,000.
   • Amendments $100.
   • Continuing Reviews $1,000.
   • Studies that expire will be assessed an additional $2,000 fee.
   • Requests for study closure shall not be charged a fee.
   • 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:
   • Initial Requests $500.
   • Amendments $100.
   • Continuing Reviews $500.
   • Studies that expire will be assessed an additional $500 fee
   • Requests for study closure shall not be charged a fee.
   • Requests for Continuing Review are due 60 days prior to study expiration.
   • Fees do not apply for non-research determinations or studies that are exempt per 45 CFR 46.101(b), June 23, 2005.
7. 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.
8. 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.

Note:

• Amendments submitted as part of continuing review are not assessed the amendment fee

How should the fee be paid?

• Download and complete the IRB Fee invoice (excel file). Indicate whether the IRB application is for initial review of a new study, or amendment/modification of an existing study, or continuing review (including closures) of an existing study
• Return the invoice with payment to the Department.
• Make checks payable to: Florida Department of Health, Office of Public Health Research
• Payment must be received prior to IRB approval. Applications may be completed and may be reviewed by the IRB prior to payment being received by the Department, but IRB approval to commence research is contingent upon receipt of payment by the Department.
• Department policy DOHP-400-4.8, Review of Human Subjects Research: Continuing Review, requires applications for continuing review be created no later than 60 days prior to expiration of approval to conduct research.
• Late applications, and expiration of authority to conduct research:
  • Applications that are complete, as determined by the Department, prior to midnight on whatever date is 60 calendar days prior to research expiring are not late applications.
  • Applications created after midnight on whatever date is 60 calendar days prior to research expiring are late applications.
  • Applications created prior to midnight on whatever date is 60 calendar days prior to research expiring that are not complete, as determined by the Department, are defined as late applications.
  • The fee for late applications, or applications that are not complete prior to 60 days prior to the IRB expiration date listed in the approval letter is $1000.

Who to contact for questions or additional information

If you have any questions, please feel free to contact:

Meghan Kennedy
Assistant Director, Office of Public Health Research
IRB Administrator
Florida Department of Health
meghan_kennedy@doh.state.fl.us
850.245.4610 or 850.245.4585