Procedural Guide

Applications

Form B - For Protocol Amendment/ Modification, Continuation and Termination Submissions

Procedures

• Preparation
• Submission
• Review & Approval
• Considerations
• Pertinent Information
• Training Information
  

Application Preparation

1. Determine if you are performing animal subject research.   Consult with your advisor, an IACUC representative, the Coordinator or Chairperson if additional guidance is required.

2. Download the appropriate forms or guidance document(s) needed for submission.

3. Complete the application paying special attention to the checklist that provides guidance for all attachments needed in order to submit a complete application for review and approval.

4. Provide your signature and (as applicable) obtain your faculty advisor's signature.

Application Submission

1. Fill-out the appropriate protocol application.

2. Send an electronic version of the protocol application via email attachment to the IACUC Office (irbiacuc@fiu.edu).

3. Please do not send a hard copy anywhere until after the IACUC has approved the protocol. At that point, you will be asked to send a signed hard copy to the IACUC Office (MARC 430).
   
   

Application Review & Approval

1. Applications receive primary review to ensure all pertinent information has been provided.  

2. If determined to be applicable for Expedited review the application is reviewed and approved by designated representatives

3. If determined to require review by the convened board the proposed research is placed on the next agenda (determined by the time of receipt in the IACUC Office)

4. Written communication is provided to the investigator (and faculty advisor) as to the status of the review.  Upon approval written documentation is provided.  

5. Approvals are granted for one (1) year.  Please note that Form B annual renewals can only be submitted twice after the initial approval year of Form A, since all projects have a maximum life term of three years (e.g. 1st year: submit Form A, 2nd year: submit Form B, 3rd year: submit Form B). After that three year period ends the project will be closed out and can no longer be renewed on Form B. The investigator must then rewrite the protocol and resubmit the project as a brand new submission to the IACUC on Form A.

Other Considerations

1. FIU requires that approval be obtained from the IACUC prior to commencing the research project.  Retrospective approval CAN NOT be granted for research already conducted.

2. If you are seeking funding determine if there are additional requirements of the funding agency

3. Appropriate documentation is required by the University Graduate School for the submission of Form C when animal subjects are involved.   Data collected without prior approval may not be accepted for use with a thesis or dissertation.
   
   ** UGS submission requirements regarding research involving human and animal subjects are located in Chapter IV - Filing the Manuscript and the Checklist for Thesis/Dissertation Preparation .

4. Establish a timeline for submission of documents to meet ALL deadlines.

Application Use and Pertinent Information

• IACUC Form A - for Initial Submissions
• IACUC Form B - for Protocol Amendment/ Modification, Continuation and Termination Submissions
• IACUC Tissue Only Form - (Get form)
• IACUC Attending Veterinarian Training Verification Form (AV Form) - to provide specialized training for personnel
• Animal Purchase Request Form - for ordering animals to the Animal Care Facility - Please also view the Animal Procurement Policy - (View Policy)

Training Information

The FIU IACUC requires ALL persons participating in research involving animal subjects to receive Animal Care and Use Training.  All persons performing animal research in a facility must also complete Safety and Health Training.   Documentation of such certification is required when submitting an IACUC application for review and approval. In addition, if specialized training is required, the PI must arrange for such training to be provided and documented on the AV Form.  

Please visit our Animal Training web page, which provides more information on how to register for the courses.  The web page can be accessed here: (Link to Training Page)