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This human subject research workshop will provide Graduate Students with a general overview
of the IRB submission process. It will educate students on the
importance of maintaining compliance with the IRB. Time will be
provided at the end of the presentation for questions. More
information regarding the date and location can be obtained at the following web page:
IRB Presentation
This human subject research workshop will provide Graduate Students with a general overview
of the IRB submission process. It will educate students on the
importance of maintaining compliance with the IRB. Time will be
provided at the end of the presentation for questions. More
information regarding the date and location can be obtained at the following web page:
IRB Presentation
Dr. Kirsten Wood has joined the Institutional Review Board. Her contact information can be accessed at the following web page:
Board Membership
Dr. Bradley Bennett has joined the Institutional Review Board.
His contact information can be accessed at the following web page:
Board Membership
Dr. Kimberly Taylor has joined the Institutional Review Board.
Her contact information can be accessed at the following web page:
Board Membership
A document listing tips to manage and protect confidential human
subjects data has been added under the Guidelines and Forms section of
the FIU IRB website:
Data Security Tips
Dr. Kevin O'Neil has joined the Institutional Review Board.
His contact information can be accessed at the following web page:
Board Membership
Dr. Bennett Schwartz has joined the Institutional Review Board.
His contact information can be accessed at the following web page:
Board Membership
The contact information in the Informed Consent Forms has been updated
to reflect the new IRB Chairperson, Dr. Patricia Price. The updated sample
Informed Consent Forms can be
accessed at the following web page:
Sample Consent Forms.
Please ensure that all future Consent Form submissions to the IRB
reflect this updated contact information.
Dr. Patricia Price has been named Chairperson of the the Institutional
Review Board. Her contact information can be accessed at the following web page:
Board Membership. Dr.
Jonathan Tubman has been named the Associate Vice President for
Research, so he will no longer be a voting member on the IRB.
This human subject research workshop will provide Graduate Students with a general overview
of the IRB submission process. It will educate students on the
importance of maintaining compliance with the IRB. Time will be
provided at the end of the presentation for questions. More
information regarding the date and location can be obtained at the following web page:
IRB Presentation
This human subject research workshop will provide Graduate Students with a general overview
of the IRB submission process. It will educate students on the
importance of maintaining compliance with the IRB. Time will be
provided at the end of the presentation for questions. More
information regarding the date and location can be obtained at the following web page:
IRB Presentation
Dr. George O'Brien has joined the Institutional Review Board.
His contact information can be accessed at the following web page:
Board Membership
This human subject research workshop will provide Graduate Students with a general overview
of the IRB submission process. It will educate students on the
importance of maintaining compliance with the IRB. Time will be
provided at the end of the presentation for questions. More
information regarding the date and location can be obtained at the following web page:
IRB Presentation
Dr. Deodutta Roy has joined the Institutional Review Board.
His contact information can be accessed at the following web page:
Board Membership
Dr. Patricia Price has joined the Institutional Review Board.
Her contact information can be accessed at the following web page:
Board Membership
This human subject research workshop will provide Graduate Students with a general overview
of the IRB submission process. It will educate students on the
importance of maintaining compliance with the IRB. Time will be
provided at the end of the presentation for questions. More
information regarding the date and location can be obtained at the following web page:
IRB Presentation
A supplemental project is a small scale project that is based off an
IRB approved faculty research project. The procedures have
changed for students who wish conduct supplemental projects.
All student supplemental submissions will no longer be processed on
a Form B-1 application for IRB approval. Students must now
submit supplemental projects as a normal project on a Form A
application. This will improve ORI's ability to track (and
close) the projects as students graduate and leave the university.
In addition, Form A provides more information regarding the project
than Form B-1 did. This will help IRB members to more
accurately evaluate the application.
This human subject research workshop will provide Graduate Students with a general overview
of the IRB submission process. It will educate students on the
importance of maintaining compliance with the IRB. Time will be
provided at the end of the presentation for questions. More
information regarding the date and location can be obtained at the following web page:
IRB Presentation
Additional guidance to help clarify the issue of IRB review with
ethnographic projects can be accessed
here.
Additional guidance to help clarify the issue of IRB review with
oral history projects has been posted
here.
This human subject research workshop will provide Graduate Students with a general overview
of the IRB submission process. It will educate students on the
importance of maintaining compliance with the IRB. Time will be
provided at the end of the presentation for questions. More
information regarding the date and location can be obtained at the following web page:
IRB Presentation
Projects that previously received an Expedited or Full Board Review
must receive annual renewal prior to the project's expiration date.
The IRB is unable to provide any type of grace period beyond the one
year approval term. The IRB is also unable to re-activate any
projects that expired without renewal. Projects that are not
re-approved prior to the expiration date will be permanently closed.
Investigators are responsible for ensuring that their projects are
submitted to their IRB representative for review and approval prior
to the expiration date. If the approval has expired, but
the project is not complete, then the PI will need to submit the
project to an IRB Representative on a brand new application (Form
A), so it can be reviewed and assigned a new IRB approval number.
The project must be resubmitted as a brand new submission based on
the remaining phase(s) in the project. For example, if the
remaining phase of an interview study only included data analysis,
then the PI would submit the project on Form A to an IRB
Representative as a data analysis study only. It would not be
submitted as an interview study, since that portion of the project
was already closed out and completed.
Projects that previously received an Exempt Review do not need to
submit annual renewal, since the project does not have an expiration
date. However, investigators are still required to submit any
changes or adverse events that occur during the life of the project.
Also, investigators are required to submit a Project Completion Report
to the IRB Office when the project has been finished.
Dr. Leonard Elbaum has joined the Institutional Review Board. His
contact information can be accessed at the following web page:
Board Membership
Dr. Adriana Campa has joined the Institutional Review Board. Her
contact information can be accessed at the following web page:
Board Membership
Dr. Amy Paul-Ward has joined the Institutional Review Board. Her
contact information can be accessed at the following web page:
Board Membership
Dr. Wei-Chiang Lin has joined the Institutional Review Board.
His contact information can be accessed at the following web page:
Board Membership
Dr. Michael Collier has joined the Institutional Review Board.
His contact information can be accessed at the following web page:
Board Membership
OHRP has revised their human subject decision charts. The new
charts provide clearer diagrams to help researchers determine the type
of review and requirements that are applicable to his/her specific
research. The Decision Charts can be accessed at the following
web page: Decision
Charts
A listing of data sets that can be analyzed without the need for IRB
approval can be can be accessed at the following web page:
Data Sets
It is now a requirement of the IRB that all consent document translations be back-translated. A back translation allows the investigator to examine the content, accuracy and clarity of the translated document. The PI is responsible for having the translation and back-translation performed and submitting each document with the Consent Document Translation Affirmation Form to the IRB
for review and approval. The consent document translation
and back-translation MUST be perform by different individuals who are
fluent in that language . The PI can perform the
translation but cannot perform the back-translation. In addition the
back-translator must perform the back-translation without first seeing
the English version of the consent document.
PI is required to submit:
- The English version of the consent document in distribution-ready format (letterhead);
- The translated version of the consent document in distribution-ready format;
- The back-translated version of the consent document;
- The signed affirmation of translation/back translation; and,
-
The Consent Document Translation Affirmation Form with an initial submission
(Form A), modification (Form B-1) or continuation (Form B-2)
)
(IRB Forms)
FORM A is for new or initial submissions to the IRB;
FORM B-1
is for amendments, modifications;
FORM B-2 is for annual renewal or completion submissions; and
FORM C is used with the submission of Data and Safety Monitoring plans.
The FIU IRB, in accordance with federal guidelines, has updated the requirements for consent form language. It is now required that all consent forms be written in 2nd person and that the readability, previously a requirement, be on the 6th grade level. Additional information and tools have been added to assist investigators with meeting these requirements
The IRB proposal outline has been added as a link on the main IRB page.
Students who intend to use human subjects in their research towards the completion of their Masters Thesis or Doctoral Dissertation must submit and receive approval from the IRB for the use of human subjects. The University Graduate School has guidelines for the filing of a thesis/dissertation manuscript. The IRB is only responsible for review of the IRB proposal all other questions involving the submission of paperwork must be directed to the University Graduate School. Students are urged to submit IRB documentation in a timely manner in order to meet deadlines of both the IRB and the Graduate School.
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