IRB - PRIM&R Conference for PIs and IRB members
11/17/08 to 11/19/08 at Orlando Swan and Dolphin Hotels.
Save the dates. Agenda will appear on www.primr.org/
in July. 2,700 people attend annually.
Office of Research & Commercialization, 12201 Research Parkway, Suite
501, Orlando, FL 32826-3246
Institutional
Review Board (IRB) Contact Information:
(IORG0000781, IRB00001138, FWA00000351 - Expiration 5/07/10
UCF Terms of Federalwide Assurance
CONGRATULATIONS TO IRB STAFF MEMBERS! Joanne Muratori passed the IRB Certification exam conducted by the National Association of IRB Managers, and Janice Turchin passed the Certified IRB Professional exam conducted by the Council for Certification of IRB Professionals.
Barbara
Ward, CIM
IRB Coordinator
Email: IRB@mail.ucf.edu or bkward@mail.ucf.edu
Phone: 407-882-2276
Fax: 407-823-3299
Joanne Muratori, CIM
IRB Coordinator
Email: IRB@mail.ucf.edu or jmurator@mail.ucf.edu
Phone: 407-823-2901
Fax: 407-823-3299
Janice Turchin, CIP
IRB Assistant
Email: IRB@mail.ucf.edu or jturchin@mail.ucf.edu
Phone: 407-882-2012
Fax: 407-823-3299
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The Institutional Review Board (IRB) uses a web-based system, iRIS™, which was designed to speed up the UCF Institutional Review Board submission and approval process, as well as ensure compliance with regulations regarding research involving human participants. It is our goal to continuously improve our service, and as usual we will appreciate any feedback that can help us improve this new system.
Because the submission application within the system captures more information than what was previously asked on the IRB protocol submission form, the IRB office is encouraging investigators to enter new studies electronically with assistance from the IRB staff as needed. Many of the questions have check boxes for easy answering. Active studies have been migrated into the system and continuing reviews, addendums and adverse event reports can all be done online.
iRIS™ Application Highlights
- Paperless web-based application
- Uses same username and password as My Research, ARGIS and PARIS
- Application Branching – PI will only be asked relevant questions for each submission
- Researchers have complete access to their IRB submissions
- Track Status – including past IRB history
- Important Dates
- Create other online forms
- Addendums
- Adverse Events
- Continuing Reviews/Terminations
- Electronically routes submission for required signatures
- Automatic notifications are sent to researchers via email
- All student research that involves human participants will be processed thru iRIS™, with faculty advisor review and approval
For More information on iRIS™
The ORC wants to assist you or your department/college/institute to get the most out of iRIS™? We can come to your building and give training to your department/college faculty. If you are interested in setting up a session please contact:
Chad Macuszonok
cmacuszo@mail.ucf.edu
407-823-0484
UCF-IRB
Human Subjects Research
Forms:
Required:
- UCF-IRB
Principal Investigator’s Manual:
- Investigator Educational Requirement
Recommended:
UCF-IRB Committee Members and Meeting Dates
UCF IRB Membership Information
IRB Membership Application
List
of UCF-IRB Committee Members
Schedule of IRB Meetings in 2008
Health
Insurance Portability and Accountability Act (HIPAA)
HIPAA
- General Guidelines for Researchers at UCF (Revised
August 11, 2003)
HIPAA Authorization Form
IRB
Waiver Criteria (Revised August 11, 2003)
UCF
- Authorization: General Instructions to Researchers (Revised
August 11, 2003)
UCF - IRB Application for Waiver
of Authorization
is built into iRIS electronic application
New England IRB Use for Phase I/II Drug and Device Trials
When and How to Use the NEIRB
NEIRB Information, Forms and Fee Schedule
Authorization Form for Use of the New England IRB
Society Of Clinical Research Associates (SoCRA)
The SoCRA Clinical Investigator Workshop will be held in Clearwater Beach, FL in December 2008. This program addresses all of the functions of the clinical investigator and the HIPAA requirements.
The SoCRA Certification Program. The SoCRA Certification program offers the designation "Certified Clinical Research Professional" to eligible researchers. Click the calendar for the examination schedule
National Institutes of Health (NIH) - Requirement
for Education on the Protection of Human Subjects
NIH
Announcement NOTICE: OD-00-039 (released June 5, 2000,
revised August 25, 2000)
How
to Access the NIH-Online Computer-Based Training - New March 2008
Human Subject Federal Regulations
45
CFR 46 / "The Common Rule"
Expedited
Categories
FDA
Regulations
Other
Federal Regulations That May Apply to Human Subjects:
Federal Oversight Agencies
Office
of Human Research Protections
FDA
Center for Drug Evaluation and Research (CDER)
FDA
Center for Devices and Radiological Health
DHHS
Office of Research Integrity
Federal Agencies that Have Adopted "The Common
Rule"
Central
Intelligence Agency
NASA
National
Science Foundation
National
Institutes of Health
U.S.
Agency for International Development
U.S.
Department of Agriculture
U.S.
Department of Commerce
U.S.
Department of Defense
U.S.
Department of Education
U.S.
Department of Energy
U.S.
Department of Housing & Urban Development
U.S.
Department of Justice
U.S.
Department of Transportation
U.S.
Department for Veteran Affairs
U.S.
Environmental Protection Agency
U.S.
Food and Drug Administration
U.S.
Product Safety Commission
Additional Guidance and Education Materials
AAAS
Internet Support
The
Belmont Report
Certificates
of Confidentiality - NIH Kiosk
IRB
Guidebook
Inclusion
of Women and Minorities in Research
Inclusion
of Children in Research
OHRP's
Common Findings of Non-Compliance
OHRP
Compliance Determination Letters
OHRP
Online Training - NOT FOR RESEARCHERS - FWA Credentialing Modules
"Recommendation
on Public Use Data Files" - NHRPAC Report
Informed Consent Guidance
Video - Protecting Human Subjects supported by Health Resources and Services Administration (HRSA) Policy
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