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IRB
Institutional Review Board
FWA00001669
Non-Compliance
Concerns & Complaints
Joanna Haller
(813) 974-7821
Questions? Please Contact Us!
Participants in research, researchers, and others who have questions, problems or concerns, who want to obtain information, or who want to offer input should feel free to contact the USF IRB Staff.
Send Us Your Feedback!
Mailing Address:
12901 Bruce B. Downs Blvd., MDC35
Tampa, FL 33612-4799
Office Location:
3702 Spectrum Blvd.
Suite 155
USF Research Park
Tampa, FL
Map
Phone:
(813) 974-5638
Fax: (813) 974-5618
Phone and E-mail Directory
Board Meeting Schedule
Board Rosters (PDF)
IRB 01 A
IRB 01 B
IRB 01 C
IRB 01 D
IRB 01 T
IRB 02
Ex-Officio & Administrative
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New to human subject research at USF?
This explains how to get started with the IRB process.
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Application Forms and Templates
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Applications and Forms (01 & 02)
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Informed Consent Templates (01 & 02)
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Veterans Administration
Education - Human Participant Protections
:: Courses, Registration, & Certificates
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Mandatory Investigator Education Policy
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HIPAA Education
Federal Documents
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Federalwide Assurance - OHRP Approval of USF IRBs
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Federalwide Assurance - Terms (OHRP Web Site)
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Title 21 CFR - FDA Regulations
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Title 21 CFR Part 50 - FDA Policy on Informed Consent
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Title 21 CFR Part 50D - FDA: Additional Safeguards for Children
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Title 21 CFR Part 56 - FDA Policy on IRBs
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Title 38 CFR Part 16 - Veterans Affairs Protection of Human Subjects
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Title 45 CFR Part 46 - DHHS Policy on IRBs
Federal Agencies
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Food and Drug Administration (FDA)
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Office of Human Research Protections (OHRP) > Resources
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Office of Human Subjects Research (OHSR)
Information Guides
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Quick Start Guide
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Coded Private Information on Biological Specimens (OHRP Guidance)
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Conflict of Interest in Research Program
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Documentation for Studies as Recommended by QA
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Exempted Categories
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Expedited Review Categories (OHRP Guidance)
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FDA Information Sheets and Guidance
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Forms Instructions
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HIPAA Program
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Informed Consent, Required Elements of
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Investigator Responsibility Certification
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Off-Site Research
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Protocol Guidelines
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Quick Reference Guide
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Readability Test via MS Word Spell Check
Other References
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Belmont Report
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Declaration of Helsinki
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International Research - OHRP Compilation of regulations, guidelines, and Websites for foreign countries & international agencies [pdf]
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Nuremberg Code
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Electronic Submission Is Here!
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After months of development and testing, our new eIRB web-based submission system has arrived! eIRB will streamline the review of human research at USF!
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- October 1, 2009 - open for new applications
- January 1, 2010 - mandatory for new applications
- Spring 2010 - Begin transition of existing paper applications to eIRB
REGISTER & LOGIN HERE
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IRB Fee Schedule
Studies that are funded through grants or sponsors are charged a fee for IRB review (effective January 1, 2008).
For more information:
IRB Fee Schedule
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USF Investigators and Non-USF IRBs
- Western IRB (WIRB): USF investigators performing eligible multi-center clinical trials may use WIRB.
- All Children's Hospital (ACH): USF investigators performing research at ACH should use the ACH IRB.
- University Community Hospital (UCH): USF investigators performing research at UCH no longer need to seek approval from both IRBs, UCH will accept approvals by the USF IRB.
For more information, please contact Henry Zych at (813) 974-7454
or hzych@research.usf.edu
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