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IRB
Institutional Review Board
FWA00001669
Norma Epley
Assistant Director
Henry Zych
Coordinator
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 02
Ex-Officio & Administrative
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If you are new to human subject research at USF or are unsure about what to do next, this guide will help you find your way through the IRB system.
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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 Subject Protections
:: Course Descriptions
:: Schedule and Registration for Live Courses
:: General Request for CE Credit
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Mandatory Investigator Education Policy
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HIPAA Education
Federal Documents
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Belmont Report
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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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National Institutes of Health (NIH)
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Office of Human Research Protections (OHRP) > FAQs
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Office of Human Research Protections (OHRP) > Guidance
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Office of Human Research Protections (OHRP) > Resources
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Office of Human Subjects Research (OHSR)
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Office of Research Integrity (ORI)
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President's Council on Bioethics
-- Replaces National Bioethics Advisory Commission
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 for In Vitro Diagnostic
Device Studies Using Leftover Human
Specimens that Are Not Individually
Identifiable (FDA Guidance)
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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
Newsletter Archive
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News Highlights
Other References
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Association of Clinical Research Professionals
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Bioethics, Seventh USF Symposium on - Reference articles from the conference
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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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IRB Forum
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Nuremberg Code
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Online Ethics Center for Engineering and Science
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PRIM&R - Public Responsibility in Medicine & Research
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President's Apology to Survivor's of Tuskegee Syphilis Study
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Time Line for Significant Events in Evolution of Ethics
Policies and Procedures Manual
Quality Assurance
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Documentation for Studies Recommended by QA
WIRB - Western Institutional Review Board
All Children's Electronic Submission
The Office of the All Children's Hospital Institutional Review Board (IRB) uses iRIS (Integrated Research Information System) for electronic submission of all IRB applications. All IRB applications at ACH must be submitted electronically through iRIS. Paper applications are no longer be accepted.
Training is required prior to using iRIS. Individual and group training continues to be available, as well as Computer Based Training (CBT) at www.allkids.org/iris. To register for the iRIS training please contact Steven Kim, iRIS Contact, (727) 767-6978 or lerouxt@allkids.org.
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Special Events!
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June 3rd
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8th USF Symposium on Bioethics: Medical Ethics in the University Community - A Potpourri
Free event! Tuesday, June 3rd, 3:00 P.M. to 5:30 P.M., at the Museum of Science & Industry. Keynote by Edward C. Halperin, M.D., followed by distinguished panel from USF. More details in Symposium flyer.
Attendance at the Symposium meets the USF IRB requirement for continuing education. For IRB CE credit, please complete the General Request for CE Credit at http://www.research.usf.edu/cs/irbregister-general.htm and be sure to sign in at the event.
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June 3rd
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How Shall We Teach Medical Ethics in the Midst of the War on Terror: Lessons from History.
Dean's Lecture featuring Edward C. Halperin, M.D.
Free event! Tuesday, June 3rd, 6:00 P.M., at the Museum of Science & Industry.
More about the Dean's Lecture:
http://www.cme.hsc.usf.edu/deanslecture/
Readings relevant to medical ethics and the war on terror.
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New IRB Fee Schedule
Studies that are funded through grants or sponsors will be charged a fee for IRB review. The fees go into effect January 1, 2008.
For more information:
IRB Fee Schedule
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On-Line Library
Visit our
On-Line Library for human subject protections information. Browse or search for articles, indexes, archives, and Web links.
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Free Recruitment Brochures
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Now, investigators can offer to potential participants in research these informative brochures designed to answer typical questions about participation in research.
Two versions of these full color brochures are available to USF research investigators at no cost:
- Volunteering for Medical Research
- Volunteering for Social/Behavioral Research
To Order
Send us an e-mail in which you tell us:
- The PI's name
- How many brochures you want (be sure to specify whether medical and/or social/behavioral)
- Where you want them delivered
Click here to e-mail your order.
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