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Institutional Review Board for the Use of Human Subjects


What's New?

 

New IRB Representative from the 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 the 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

 



Updated Informed Consent Forms (01/07)
 

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.

 



IRB Presentation for Graduate Students (10/06)
 

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 (07/06)
 

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

 


 

IRB Presentation for Graduate Students (05/06)
 

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

 


 

IRB Presentation for Graduate Students (01/06)
 

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

 


 

Student Supplement Submissions (10/05)
 

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

 



Ethnographic Research & IRB Review (06/05)
 

Additional guidance to help clarify the issue of IRB review with ethnographic projects can be accessed here.

 


 

Oral History & IRB Review (05/05)
 

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
 



Continuing Review Requirements (02/05)
 

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.
 



Proposal Outline(10/02)

The IRB proposal outline has been added as a link on the main IRB page.



Thesis and Dissertation Submission (01/02)

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.