Per NIH regulations, items listed in section III-F (as shown below) are exempt from IBC oversight. However, all PI’s at TAMUSA are strongly encouraged to contact the IBC chair or IBC office for confirmation.

Section III-F. Exempt Experiments The following recombinant or synthetic nucleic acid molecules are exempt from the NIH Guidelines and registration with the Institutional Biosafety Committee is not required; however, other federal and state standards of biosafety may still apply to such research (for example, the Centers for Disease Control and Prevention (CDC)/NIH publication Biosafety in Microbiological and Biomedical Laboratories).

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 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 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.

Molecules that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (SNA).

Molecules that result from the replication of those described above.

Examples include:

• Plasmids introduced into bacteria, living cells, animals, or plants.
• Viral vectors introduced to bacteria, living cells, or animals.
• Genetically modified microorganisms or cell lines (regardless of whether the material was modified by the researchers or already received in a modified form).
• Genetically modified plants or animals.
• Nanotechnology used to deliver rDNA/SNA to living cells or animals.

Organisms are classified into various risk levels depending on the harm to humans and the environment.

• RG1 – Are not associated with disease in healthy adult humans or animals.
• RG2 – Are associated with a disease which is rarely serious and for which preventative or therapeutics is often available.
• RG3 – Are associated with serious or lethal human disease for which preventative or therapeutics may be available.
• RG4 – Are associated with lethal human disease for which preventative or therapeutics are not readily available.

TAMUSA requires PI to submit risk assessment for all microorganisms listed in the protocol.

Per federal and state regulations, and the TAMUSA rule, TAMUSA Institutional Biosafety Committee (IBC) is required to review, approve, and maintain documentation on all protocols involving recombinant DNA or requiring at least BSL-2 precautions. If you are intending to use certain biological agents, pathogens and toxins, IBC registration is required.

If you want to amend a previously approved protocol, submit an amendment form before you begin the work. Work may not begin until written approval is obtained. To close out an approved protocol, please submit the closure form. All forms can be located under the forms tab of the IBC website.

I share a lab with an investigator who is already registered with the IBC. Doesn't that protocol registration apply to my work in the shared lab?

No. Each principal investigator is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research and with university biosafety requirements. Investigators may not “piggy-back” on the existing IBC approvals. Therefore, a separate protocol application must be completed for each Principal Investigator. A shared space form must be submitted with the protocol.

Experiments involving the following types of research must be registered with the IBC irrespective of the source of funding (this list is not exhaustive. Contact the IBC office (ibc@tamusa.edu) for clarification).

Pathogens affecting humans, animals or plants.

Materials potentially containing human pathogens (e.g., unfixed human specimens, human blood, human tissue, tissue/fluids from experimental animals).

Recombinant and synthetic nucleic acid molecules including viral systems.

Mammalian cells and cell lines

Nonhuman primate materials (including live animals, all fluids, tissues, excretions, secretions, or cell lines)

De novo generation of transgenic animals (Animal's genome has been altered by the stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived there from, into the germ-line).

Examples include:

• Direct microinjection of a chosen gene construct from another member of the same species or from a different species into a proto nucleus of a fertilized ovum;
• Insertion of the desired DNA sequence by homologous recombination into a culture of embryonic stem cells;
• Use of a plasmid of virus to transfer genetic material into germ cells.
• Breeding or crossbreeding of animals which were originally created using recombinant DNA technology AND which are genetically different from each other.
• Backcrossing transgenic animals that were originally created using recombinant DNA with wild type animals.
• Creation and generation of genetically modified animals, genetically modified microbes and genetically modified plants.
• Clinical studies involving the introduction of Recombinant or Synthetic nucleic acid molecules (plasmids), or gene transfer vectors (including viral vectors) into human subjects with or without specimen analysis.
• Clinical studies involving introduction of genetically engineered microorganisms or infectious agents into human subjects (including live vaccines if they are experimental in nature and/or not FDA-approved for use in the specific study population) with or without specimen analysis.

TAMUSA IBC follows the NIH definition as detailed below.

Molecules constructed by joining nucleic acid molecules and that can replicate in a living cell (rDNA).

Nucleic acid molecules that are chemically amplified or synthesized by other means.

Training requirements can be located on the IBC website under the training link.