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Guidance on Miami-Dade County School Research (10/09)
A guidance document has been added to the FIU website to
assist investigators with submitting applications through
both the FIU IRB and the MDCPS RCC:
Miami-Dade County School Research
IRB Coordinator Added to the Office of Research Integrity
(08/09)
Jada L. Rauls, MPH has joined the Research staff as
Coordinator Research Programs in the Office of Research
Integrity (ORI).
IRB Presentation for Graduate Students & Advisors (04/09)
This human subject research workshop will provide Graduate
Students and Faculty Advisors 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
New IRB Representative from the School of Public Health (02/09)Dr. Mary Jo Trepka has joined
the Institutional Review Board. Her contact information can be
accessed at the following web page:
Board
Membership
New IRB Representative from the College of Medicine (11/08)Dr. Ch. V. Rao has joined the
Institutional Review Board. His contact information can be
accessed at the following web page:
Board
Membership
New IRB Representative from the
College of Medicine (11/08)Dr. Lisa Schneper has joined
the Institutional Review Board. Her contact information can
be accessed at the following web page:
Board
Membership
New IRB Representative from the
College of Medicine (11/08)Dr. Juan Acuna has joined the
Institutional Review Board. His contact information can be
accessed at the following web page:
Board
Membership
New IRB Representative from
Biomedical Engineering (11/08)Dr. Anuradha Godavarty has
joined the Institutional Review Board. Her contact
information can be accessed at the following web page:
Board
Membership
Updates from OHRP on Engagement & Coded Data (11/08)OHRP has posted on its
website a finalized guidance document entitled, “Guidance on
Engagement of Institutions in Human Subjects Research.” The
finalized guidance is on the OHRP website at
http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html
OHRP has also posted a revised version of the “Guidance on
Research Involving Coded Private Information or Biological
Specimens.” The revised “Guidance on Research
Involving Coded Private Information or Biological Specimens”
is on the OHRP website at
http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm
IRB Presentation for Graduate Students (11/08)
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
New IRB Representative from
Labor Center (08/08)
Dr. Dawn Addy has joined the Institutional Review Board. Her contact information can be accessed at the following web page: Board Membership
New IRB Representative from
College of Law (08/08)
Dr. Elizabeth Price Foley has joined the Institutional Review Board. Her contact information can be accessed at the following web page: Board Membership
New IRB Representative from
Psychology (07/08)
Dr. Ronald Fisher has joined the Institutional Review Board. His contact information can be accessed at the following web page: Board Membership
IRB Presentation for Graduate Students (04/08)
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
IRB Presentation for Graduate Students (09/07)
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
New IRB Representative from
History (09/07)
Dr. Kirsten Wood has joined the Institutional Review Board. Her contact information can be accessed at the following web page: Board Membership
New IRB Representative from
Biological Sciences (08/07)
Dr. Bradley Bennett has joined the Institutional Review Board.
His contact information can be accessed at the following web page: Board Membership
New IRB Representative from
Marketing (08/07)
Dr. Kimberly Taylor has joined the Institutional Review Board.
Her contact information can be accessed at the following web page: Board Membership
Data Security (03/07)
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
New IRB Representative from
Psychology (02/07)
Dr. Kevin O'Neil has joined the Institutional Review Board.
His contact information can be accessed at the following web page: Board Membership
New IRB Representative from
Psychology (02/07)
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.
New IRB Chairperson (01/07)
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
New IRB Representative from
Curriculum & Instruction (07/06)
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
New IRB Representative from
Environmental/Occupational Health (03/06)
Dr. Deodutta Roy has joined the Institutional Review Board.
His contact information can be accessed at the following web page: Board Membership
New IRB Representative from International
Relations (02/06)
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.
IRB Presentation for Graduate Students (06/05)
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.
IRB Presentation for Graduate Students (02/05)
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.
New IRB Alternate Representative from
Physical Therapy (02/05)
Dr. Leonard Elbaum has joined the Institutional Review Board. His
contact information can be accessed at the following web page: Board Membership
New IRB Alternate Representative from
School of Public Health (02/05)
Dr. Adriana Campa has joined the Institutional Review Board. Her
contact information can be accessed at the following web page: Board Membership
New IRB Alternate Representative from
Occupational Therapy (01/05)
Dr. Amy Paul-Ward has joined the Institutional Review Board. Her
contact information can be accessed at the following web page: Board Membership
New IRB Representative from Biomedical
Engineering (10/04)
Dr. Wei-Chiang Lin has joined the Institutional Review Board.
His contact information can be accessed at the following web page: Board Membership
New IRB Representative from L.A.C.C. (10/04)
Dr. Michael Collier has joined the Institutional Review Board.
His contact information can be accessed at the following web page: Board Membership
OHRP Revised Decision Charts (09/04)
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
Data Sets Approved for Use without IRB Approval (05/04)
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
Requirements for the Translation of Consent Documents (02/03)
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)
New IRB Forms (10/03)
(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.
Consent Documentation (10/02) 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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