IBC Review Process

The IBC meeting schedule and submission deadlines are posted on the Committee Meeting page. A complete application must be submitted at least two weeks prior to the next meeting date in order to be considered for the next meeting.

IBC Review Process

In order to conform with section IV-B-2-b-(1) of the NIH guidelines, a full IBC review should include an independent assessment of required containment levels for the proposed research, an assessment of facilities, procedures, practices, training and expertise of all personnel involved in recombinant DNA research, assurance that all aspects of Appendix M have been appropriately addressed by the PI, as well as several requirements concerning human gene transfer experiments and coordination with the RAC (Recombinant DNA Advisory Committee).

Additional IBC responsibilities associated with the review process are specified in sections IV-B-2-b-(2) through IV-B-2-b-(7). These include the responsibility to notify the PI of results of the IBC review and approval process, the lowering of containment levels for certain experiments as specified in section III-D-2-a, setting containment levels as specified in Sections III-D-4-b periodic review of recombinant or synthetic nucleic acid molecule research at FIU to ensure compliance with NIH guidelines, and adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant or synthetic nucleic acid molecule research.

Investigators are required to promptly notify the IBC of any Adverse Events or Protocol Deviations that occur during the life of the project. There is an IBC Event Report Form within the TOPAZ system that will allow you to report the event online. If for any reason, you are unable to report the event through the online TOPAZ system, please contact Barbara Rodriguez at bllane01@fiu.edu or 305-348-2494, so she can provide you with an alternative method for reporting the event. Serious events need to be submitted within 24 hours.

Finally, it is the duty of the IBC to report any significant problems with or violations of the NIH Guidelines and any significant research-related accidents, or illnesses to the appropriate institutional official and NIH/OBA within 30 days, unless the IBC determines that a report has already been filed by the PI.
Help with IBC Submission FormsIf you have questions after reading over the information and forms on this site, please contact the IBC committee member in your Department or College for assistance. If your questions are technical in nature, please contact the Chair of the IBC, Dr. Kathleen Rein at reink@fiu.edu.

IBC Review Guidelines

Exemptions

FIU requires that all use of recombinant or Synthetic Nucleic Acid Molecules at the University be registered with the Institutional Biosafety Committee. Many common uses of recombinant or synthetic nucleic acid, however, qualify for exemption under Section III-F of the NIH Guidelines. So, the first question to ask is “Is my use of recombinant or synthetic nucleic acid molecules exempt from the NIH guidelines?” The following recombinant or synthetic nucleic acid molecules are exempt:

Section III-F-1. Those synthetic nucleic acids that: (1) can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight. If a synthetic nucleic acid is deliberately transferred into one or more human research participants and meets the criteria of Section III-C, it is not exempt under this Section.

Section III-F-2. Those that are not in organisms, cells, or viruses and that have not been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.

Section III-F-3.  Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature.

Section III-F-4.  Those that consist entirely of nucleic acids from a prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well-established physiological means.

Section III-F-5.  Those that consist entirely of nucleic acids from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).

Section III-F-6. Those that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. A list of such exchangers will be prepared and periodically revised by the NIH Director with advice of the RAC after appropriate notice and opportunity for public comment (see Section IV-C-1-b-(1)-(c), Major Actions). See Appendices A-I through A-VI, Exemptions under Section III-F-6–Sublists of Natural Exchangers, for a list of natural exchangers that are exempt from the NIH Guidelines.

Section III-F-7.  Those genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA. 

Section III-F-8.  Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c) Major Actions), as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment. See Appendix C, Exemptions under Section III-F-8 for other classes of experiments which are exempt from the NIH Guidelines.  For a convenient risk group database which is searchable by organism click here: http://www.absa.org/riskgroups/index.html

If your use of recombinant or synthetic nucleic acid molecules qualifies for an exemption under these criteria, please fill out an IBC Exemption Form, since the IBC will be required to make the Exemption determination. A copy of the Exemption Approval will be sent to you at the end of the review process.

If your use of recombinant DNA does not meet any of the exemption criteria above you must submit an application and undergo a full review by the IBC.

Recombinant and Synthetic Nucleic Acid Molecules Research Subject to NIH Guidelines

If your use of recombinant molecules does not meet any of the exemption criteria specified in the Exemption section above, you must submit an application and undergo a full review by the IBC. You will need to fill out an IBC Approval Form. The majority of studies will fall under sections III-D and III-E.
Coordination with IACUC for Research Involving Animals. If your study also requires IACUC approval, please note that IACUC approval must be sought separately, and is explicitly not covered by an IBC approval.

IACUC review can take place prior to, or concurrently with, IBC review. Both IACUC and IBC approval are required prior to initiation of a study, requiring coordination among these committees.

Coordination with IRB for Research Involving Humans

If your study also requires IRB approval, please note that IRB approval must be sought separately, and is explicitly not covered by an IBC approval.

IRB review can take place prior to, or concurrently with, IBC review. Both IRB and IBC approval are required prior to initiation of a study, requiring coordination among these committees.