IRB-03 Forms and Documents

Mandatory Training

Starting July 1, 2013 IRB-03 will require mandatory training for all study staff on new protocols.

Who can be a PI?

Working with the three UF IRB's (IRB-01, 02, 03), faculty stakeholders, and research deans in affected colleges, the Office of Research has developed guidelines to better define the qualifications needed to be a Principal Investigator (PI) of a human subjects research project. Read more

Protocol Development Assistance

The Center for Health Equity and Quality Research (CHEQR) is an important research resource for the UF Health Jacksonville. One of the primary goals of CHEQR is to provide research design and analysis consultation services to faculty, residents and fellows including help with IRB preparation and submission, development of protocols, grant development, data collection, data analysis and report generation.
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
Mentor Agreement Letter *NEW 10/28/2013*

Consents

Informed Consent (with HIPAA language)
*NEW 7/16/14*
Informed Consent (without HIPAA language)
*NEW 7/16/14*
Consent Training Log
Consent to Collect & Store Tissue for Future Research *NEW 05/08/13*
Tissue/Databank Consent *NEW 05/08/13*
When subjects cannot read or speak English

Introductory Questionnaires

Expedited and Full Board *NEW 8/25/14*
Exempt
Retrospective Chart Review *NEW 10/10/13*
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 & 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

Kaunitz continues research efforts following receipt of prestigious UF accolade

8/15/2014

Andrew Kaunitz, MD, is widely respected in the arena of women’s health. His extensive research in obstetrics and gynecology has b... [full story]

Simulations, presentations, awards highlight Medical Education Week

4/29/2014

A pregnant woman comes to UF Health Jacksonville, where she undergoes a C-section delivery. The baby is doing well. The same can’... [full story]

Wears presents patient-safety research at national conference in Gainesville

11/22/2013

More attention given to shift changes among medical staff can ensure greater patient safety in hospital emergency departments. That’s... [full story]

Upcoming Events

Oct 27

Our Community, Our Health

From 4:30 PM until 7:00 PM

Oct 28

IRB Meeting

From 12:00 PM until 2:00 PM

Nov 25

IRB Meeting

From 12:00 PM until 2:00 PM

Dec 9

IRB Meeting

From 12:00 PM until 2:00 PM