IRB-03 Forms and Documents

If you cannot locate what you need or have questions, please contact the IRB office for assistance.

Preparatory Research Certificate

New Studies

Clinical Trial Website Form
Explicit Change Response

Consents

Informed Consent (with HIPAA language)
*NEW 4/10/13*
Informed Consent (without HIPAA language)
Consent Training Log
Consent to Collect & Store Tissue for Future Research *NEW 05/08/13*
Tissue/Databank Consent *NEW 05/08/13*

Introductory Questionnaires

Expedited and Full Board
Exempt
Retrospective Chart Review
Tissue and Data Bank
IQ Addenda
Protocol Template
Tabled Submission Response
Human Device Exemption

WIRB

Consent Information
IRB checklist
Confidentiality Agreement
Radiation Safety Letter form

Education / Training

Required Training *NEW 3/18/13*
Belmont
CFR
Policies
Researcher Responsibilites
NIH Computer Based Training
CITI

Educational Events
Power Point Presentations
Newsletter Archives
Liaison Support
Education needs assessment
Other resources

Active Studies

Adverse Event Reporting Guide
Serious and unexpected
Non-reportable
AE Summary Table
Temporary Transfer of Responsibilities

Continuing Review Reports [Read]
Expedited and Full Board
Humanitarian Device Exception (HDE) Projects
Retrospective Chart Review
Deviation/ Non-Compliance
Deviation Log

Revision Forms
Revision/Amendment
PI Change

Study Closures

Expedited and Full Board
Retrospective Chart Review Closure

HIPAA

HIPAA WAIVER
HIPAA FAQs
HIPAA Links
HIPAA & WIRB

Other

HURRC
IBC
Confidentiality Agreement
Unaffiliated Investigator Agreement

Researcher Tools

Consent Process Note
Delegation of Study Duties
IRB Submission/Response Tracking Log

Recruiting Research Subjects
UF Regulatory Binder Template
Note to File/Research Chart Doc of the Consent Process

Note:

It is the investigator’s responsibility to renew his/her research before it expires. In order to assist investigators in this task, IRB-03 sends out first and second Expiration notices at 90 and 45 days prior to your study’s expiration. Once your study expires, we then allow an additional 30 days to submit the renewal/closure paperwork, giving investigators 120 days (4 months) to notify us about the status of the research before we make it non-renewable. To further assist investigators we also now offer the ability to view expiration dates year round via UF IRB Web Tracking

Meeting Schedule and Submission Deadlines

Note: All submissions for IRB review require a single electronic copy of all documents to be emailed and a single (signed) original hardcopy be provided to the IRB office. The IRB cannot log in the submission until the paper copy is received.

Resources

News & Announcements

UF College of Medicine-Jacksonville researcher leading faith-based study to try to reduce blood pressure

11/9/2012

An associate professor of medicine from the University of Florida College of Medicine–Jacksonville has been recruiting participants for... [full story]

Shands Jacksonville patients get first dibs on medical trials

3/24/2011

Patients at Shands Jacksonville have the opportunity to get even closer to cutting-edge research thanks to the hospital’s Clinical Rese... [full story]

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