Rule 64H-2.002 Institutional Review Board Applications

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

Why is the Department charging a fee for IRB review?

To comply with requirements of 381.86, Florida Statutes, the Department adopted Rule 64H-2.002, Institutional Review Board Applications. The rule states that the following fees are charged for the review of each study:

• Initial Review: $500
• Continuing Review: $500
• Amendments: $100
• Expired studies: $1,000

Fees do not apply to the following:

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.

How should the fee be paid?

• Download and complete an invoice. 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.
• 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:

Robert Hood, Ph.D., CIP

Assistant Director, Office of Public Health Research

Florida Department of Health

robert_hood@doh.state.fl.us

850.245.4044 or 850.245.4585

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 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