(1) The Institutional Review Board is created within the Department of Health in order to satisfy federal requirements under 45 C.F.R. part 46 and 21 C.F.R. parts 50 and 56 that an institutional review board review all biomedical and behavioral research on human subjects which is funded or supported in any manner by the department.
(2) Consistent with federal requirements, the State Surgeon General shall determine and appoint the membership of the board and designate its chair.
(3) The department’s Institutional Review Board may serve as an institutional review board for other agencies at the discretion of the State Surgeon General.
(4) Each board member is entitled to reimbursement for per diem and travel expenses as provided in s. 112.061 while carrying out the official business of the board.
(5) The department shall charge for costs it incurs for the research oversight it provides according to a fee schedule, except that fees shall be waived for any student who is a candidate for a degree at a university located in this state. The fee schedule shall provide fees for initial review, amendments, and continuing review. The department may adopt any rules necessary to comply with federal requirements and this section. The rules must also prescribe procedures for submitting an application for the Institutional Review Board’s review.
History.—s. 10, ch. 2004-350; s. 27, ch. 2008-6.
Structure Florida Statutes
Chapter 381 - Public Health: General Provisions
381.001 - Public Health System.
381.0011 - Duties and Powers of the Department of Health.
381.0012 - Enforcement Authority.
381.0016 - County and Municipal Regulations and Ordinances.
381.0018 - Application for and Acceptance of Gifts or Grants.
381.0019 - Disposition of Equipment and Material; Transfers to County Health Departments.
381.002 - Grant of Title to Prescriptive Medical Personal Property to Client.
381.0021 - Client Welfare Accounts.
381.0022 - Sharing Confidential or Exempt Information.
381.003 - Communicable Disease and AIDS Prevention and Control.
381.0031 - Epidemiological Research; Report of Diseases of Public Health Significance to Department.
381.00315 - Public Health Advisories; Public Health Emergencies; Isolation and Quarantines.
381.00316 - Covid-19 Vaccine Documentation.
381.00317 - Private Employer Covid-19 Vaccination Mandates Prohibited.
381.00319 - Prohibition on Covid-19 Vaccination Mandates for Students.
381.0034 - Requirement for Instruction on HIV and Aids.
381.0038 - Education; Sterile Needle and Syringe Exchange Programs.
381.0039 - Oversight of AIDS Education Programs.
381.0041 - Donation and Transfer of Human Tissue; Testing Requirements.
381.0042 - Patient Care for Persons With HIV Infection.
381.0043 - Blood Donor Protection Act; Blood and Blood Component Donors; Confidentiality.
381.0045 - Targeted Outreach for Pregnant Women.
381.0046 - Statewide HIV and AIDS Prevention Campaign.
381.005 - Primary and Preventive Health Services.
381.0053 - Comprehensive Nutrition Program.
381.0055 - Confidentiality and Quality Assurance Activities.
381.0056 - School Health Services Program.
381.0057 - Funding for School Health Services.
381.0059 - Background Screening Requirements for School Health Services Personnel.
381.00591 - Department of Health; National Environmental Laboratory Accreditation; Application.
381.00593 - Public School Volunteer Health Care Practitioner Program.
381.006 - Environmental Health.
381.0061 - Administrative Fines.
381.0062 - Supervision; Private and Certain Public Water Systems.
381.0063 - Drinking Water Funds.
381.0065 - Onsite Sewage Treatment and Disposal Systems; Regulation.
381.00651 - Periodic Evaluation and Assessment of Onsite Sewage Treatment and Disposal Systems.
381.00652 - Onsite Sewage Treatment and Disposal Systems Technical Advisory Committee.
381.0066 - Onsite Sewage Treatment and Disposal Systems; Fees.
381.0072 - Food Service Protection.
381.0075 - Regulation of Body-Piercing Salons.
381.00771 - Definitions of Terms Used in Ss. 381.00771-381.00791.
381.00773 - Application of Ss. 381.00771-381.00791; Exemption.
381.00775 - Tattoo Artists; Licensure; Registration of Guest Tattoo Artists.
381.00777 - Tattoo Establishments; Licensure; Temporary Establishments.
381.00779 - Practice Requirements.
381.00781 - Fees; Disposition.
381.00783 - Grounds for Discipline; Administrative Penalties.
381.00785 - Criminal Penalties.
381.00787 - Tattooing Prohibited; Penalty.
381.00791 - Local Laws and Ordinances.
381.008 - Definitions of Terms Used in Ss. 381.008-381.00897.
381.0082 - Application for Permit to Operate Migrant Labor Camp or Residential Migrant Housing.
381.0083 - Permit for Migrant Labor Camp or Residential Migrant Housing.
381.0084 - Application Fees for Migrant Labor Camps and Residential Migrant Housing.
381.0085 - Revocation of Permit to Operate Migrant Labor Camp or Residential Migrant Housing.
381.0086 - Rules; Variances; Penalties.
381.0087 - Enforcement; Citations.
381.00893 - Complaints by Aggrieved Parties.
381.00895 - Prohibited Acts; Application.
381.00896 - Nondiscrimination.
381.00897 - Access to Migrant Labor Camps and Residential Migrant Housing.
381.009 - Toilets Required by Department Regulations; Charge for Use of Prohibited.
381.0101 - Environmental Health Professionals.
381.0201 - Technical and Support Services.
381.0202 - Laboratory Services.
381.02035 - Canadian Prescription Drug Importation Program.
381.0205 - Emergency Medical Services.
381.026 - Florida Patient’s Bill of Rights and Responsibilities.
381.0261 - Summary of Patient’s Bill of Rights; Distribution; Penalty.
381.028 - Adverse Medical Incidents.
381.0303 - Special Needs Shelters.
381.0402 - Area Health Education Center Network.
381.0405 - Office of Rural Health.
381.0406 - Rural Health Networks.
381.04065 - Rural Health Network Cooperative Agreements.
381.0601 - Self-Derived and Directed-Donor Blood Programs.
381.06014 - Blood Establishments.
381.06015 - Public Cord Blood Tissue Bank.
381.06016 - Umbilical Cord Blood Awareness.
381.4018 - Physician Workforce Assessment and Development.
381.4019 - Dental Student Loan Repayment Program.
381.40195 - Donated Dental Services Program.
381.735 - Office of Minority Health and Health Equity.
381.7351 - Short Title; Closing the Gap Act.
381.7352 - Legislative Intent.
381.7355 - Project Requirements; Review Criteria.
381.7356 - Local Matching Funds; Grant Awards.
381.739 - Short Title; Charlie Mack Overstreet Brain or Spinal Cord Injuries Act.
381.7395 - Legislative Intent.
381.74 - Establishment and Maintenance of a Central Registry.
381.745 - Definitions; Ss. 381.739-381.79.
381.75 - Duties and Responsibilities of the Department.
381.755 - Benefits Not Assignable.
381.76 - Eligibility for the Brain and Spinal Cord Injury Program.
381.765 - Retention of Title to and Disposal of Equipment.
381.775 - Applicant and Recipient Records; Confidential and Privileged.
381.78 - Advisory Council on Brain and Spinal Cord Injuries.
381.785 - Recovery of Third-Party Payments for Funded Services.
381.79 - Brain and Spinal Cord Injury Program Trust Fund.
381.815 - Sickle-Cell Program.
381.82 - Ed and Ethel Moore Alzheimer’s Disease Research Program.
381.84 - Comprehensive Statewide Tobacco Education and Use Prevention Program.
381.853 - Florida Center for Brain Tumor Research.
381.8531 - Florida Center for Brain Tumor Research; Public Records Exemption.
381.86 - Institutional Review Board.
381.88 - Emergency Allergy Treatment.
381.885 - Epinephrine Auto-Injectors; Emergency Administration.
381.887 - Emergency Treatment for Suspected Opioid Overdose.
381.89 - Regulation of Tanning Facilities.
381.895 - Standards for Compressed Air Used for Recreational Diving.
381.91 - Jessie Trice Cancer Prevention Program.
381.911 - Prostate Cancer Awareness Program.
381.915 - Casey Desantis Cancer Research Program.
381.922 - William G. “Bill” Bankhead, jr., and David Coley Cancer Research Program.
381.92201 - Exemptions From Public Records and Public Meetings Requirements; Peer Review Panels.
381.925 - Cancer Center of Excellence Award.
381.93 - Breast and Cervical Cancer Early Detection Program.
381.931 - Annual Report on Medicaid Expenditures.
381.9312 - Uterine Fibroid Research Database; Education and Public Awareness.
381.9315 - Gynecologic and Ovarian Cancer Education and Awareness.
381.932 - Breast Cancer Early Detection and Treatment Referral Program.
381.933 - Mammography Reports.
381.95 - Medical Facility Information Maintained for Terrorism Response Purposes; Confidentiality.
381.96 - Pregnancy Support and Wellness Services.
381.981 - Health Awareness Campaigns.
381.984 - Educational Programs.
381.986 - Medical Use of Marijuana.