As described in Section III of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the Institutional Biosafety Committee functions on behalf of the Institution, with responsibility for overseeing all experimentation that involves the use of recombinant DNA.
Recombinant DNA experiments have been grouped into the following six categories by NIH. The first five (non-exempt) categories are subject to IBC oversight.
NIH Guidelines Section III-A
Experiments that Require Institutional Biosafety Committee Approval, RAC Review, and NIH Director Approval Before Initiation
The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture, will be reviewed by the NIH Recombinant DNA Advisory Committee (RAC).
NIH Guidelines Section III-B
Experiments That Require NIH/OBA and Institutional Biosafety Committee Approval Before Initiation
Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 Nanograms per Kilogram Body Weight.
NIH Guidelines Section III-C
Experiments that Require Institutional Biosafety Committee and Institutional Review Board Approvals and RAC Review Before Research Participant Enrollment
Experiments Involving the Deliberate Transfer of Recombinant or Synthetic Nucleic Acid Molecules, or DNA or RNA Derived from Recombinant or Synthetic Nucleic Acid Molecules into One or More Human Research Participants. Note that RAC approval must be granted before the IBC can approve any such protocol.
NIH Guidelines Section III-D
Experiments that Require Institutional Biosafety Committee Approval Before Initiation
Experiments Using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents (i.e. Select Agents) as Host-Vector Systems.
Experiments in Which DNA From Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents (i.e. Select Agents) is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems.
Experiments Involving the Use of Infectious DNA or RNA Viruses or Defective DNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems.
Experiments Involving Whole Animals. Experiments in which the animal's genome has been altered by stable introduction of recombinant DNA, or DNA derived therefrom, into the germ-line (transgenic animals) and experiments involving viable recombinant DNA-modified microorganisms tested on whole animals.
Experiments Involving Whole Plants (involving use of pathogenic/exotic plant infectious agents/insects, or recombinant plants with potentially hazardous properties).
Experiments Involving More than 10 Liters of Culture.
Experiments involving Influenza Viruses.
NIH Guidelines Section III-E
Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation
Experiments not included in Sections III-A, III-B, III-C, III-F are considered in Section III- E. All such experiments may be conducted at BL1 containment. For Experiments in this category a registration document (i.e. IBC Protocol) shall be dated and signed by the investigator and filed with the local IBC at the time the experiment is initiated.
Experiments Involving the Formation of Recombinant DNA Molecules Containing No More than Two-Thirds of the Genome of any Eukaryotic Virus.
Experiments Involving Whole Plants: Except those that fall under Section III-A, III-B, III-D or III-F.
Experiments Involving Transgenic Rodents: Only Experiments that require BL1 containment are covered under this section. Experiments that require BL2, BL3 or BL4 containment are covered under section III-D.
NIH Guidelines Section III-F
Exempt Experiments
The following recombinant DNA molecules are exempt from the NIH Guidelines and registration with the IBC is not required:
Those synthetic nucleic acids that:(1) can neither replicate in any living cell, 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 of body weight.
Those that are not in organisms, cells or viruses and that have not been modified or manipulated to render them capable of penetrating cellular membranes.
Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exist contemporaneously in nature.
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.
Those that consist entirely of nucleic acids from an 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).
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 is prepared and periodically revised by the NIH Director with advice of the RAC.
Those genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA
Those that do not present a significant risk to health or the environment, as determined by the NIH Director, with the advice of the RAC.
