Obtaining Initial FIU IBC Approval

The following steps are provided to assist investigators with submitting applications to the FIU IBC for review and approval.

Step 1: Determine if You Need IBC Review

IBC approval is required for all research involving Recombinant, Synthetic Nucleic Acid molecules or DNA or RNA derived from Synthetic Nucleic Acid Molecules.  Please see the definitions below.

Recombinant DNA

  • DNA in which one or more segments or genes have been inserted, either naturally or by laboratory manipulation, from a different molecule or from another part of the same molecule, resulting in a new genetic combination.
  • DNA molecules that are extracted from different sources and chemically joined together; for example DNA comprising an animal gene may be recombined with DNA from a bacterium.

Synthetic Nucleic Acid Molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:

  • Contain more than 100 nucleotides; or
  • Possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or
  • Have the potential to replicate in a cell; or
  • Can be translated or transcribed. [Section III-C].

For additional information, please click on the links below.

Definition of Recombinant or Synthetic Nucleic Acid Molecules
Does My Work Require IBC Approval?

Step 2: Complete the CITI Online IBC Training Course

All research personnel that will be engaged in conducting research with recombinant or Synthetic Nucleic Acid are required to complete the CITI Online ‘Biosafety & Biosecurity’ Course.

Instructions to Sign Up for CITI Online IBC Training

Step 3: Review the Guidelines and Policies

The Investigator is required to follow guidelines set forth by the NIH and the IBC in conducting research with recombinant or Synthetic Nucleic Acid.

Access IBC Regulations, Policies & Procedures

Step 4: Submit an Application

FIU IBC applications need to be submitted through the online TOPAZ Electronic Protocol Application System.

Investigators should complete one of the following forms:

  • IBC Approval Form (For obtaining approval on research conducted with Recombinant or Synthetic Nucleic Acid Molecules that are not exempt)
  • IBC Exemption Form (For obtaining exempt review)

Information on the TOPAZ Electronic Protocol Application System

Step 5: Application Review Process

  • Admin Review: Your submission is first pre-evaluated by the IBC Coordinator for completeness.
  • Pre-Review: The IBC looks over the application prior to the Full Board Meeting. The Members have the opportunity to request clarification prior to the meeting. This ensures a more timely review process.
  • Designated Review: Exempt protocol applications. This review will normally take at least 5 business days, but can vary depending on the complexity of the submission and the current workload of submissions. In addition, a request for revisions can be made and will require the PI to address.
  • Full Board Review: If it is determined that Full Board Review is necessary, the protocol will be placed on a meeting agenda. You should expect the Full Board process to take at least 1 month.
  • Final Approval: You will need to wait until you receive an email containing the final approval letter before you can begin your research.

Access the TOPAZ online protocol application system