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Recombinant DNA Categories
As described in Section III of the NIH Guidelines for Research Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html), 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
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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 RAC. |
NIH Guidelines Section III-B: Experiments That Require NIH/OBA and Institutional Biosafety Committee Approval Before Initiation
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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
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Experiments Involving the Deliberate Transfer of Recombinant DNA or DNA or RNA Derived from Recombinant DNA 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
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Experiments Using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as Host-Vector Systems
Experiments in Which DNA From Risk Group 2, Risk Group 3, Risk Group 4, or Restricted 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 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 plant microorganisms/insects, or recombinant plants with potentially hazardous properties)
Experiments Involving More than 10 Liters of Culture |
NIH Guidelines Section III-E: Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation
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Experiments not included in categories A-D or F, are considered in category E. All such experiments may be conducted at BL1 containment. For example, experiments in which all components derived from non-pathogenic prokaryotes and non-pathogenic lower eukaryotes may be conducted at BL1 containment.
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 (involving use of non-pathogenic plant microorganisms, or recombinant plants with non-hazardous properties)
Experiments Involving Transgenic Rodents |
NIH Guidelines Section III-F: Exempt Experiments
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The following recombinant DNA molecules are exempt from the NIH Guidelines and only Annual Registration with the IBC is required:
Those that are not in organisms or viruses.
Those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent. Note that cloned DNA segments from eukaryotic viruses fall under category E
Those that consist entirely of DNA 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 DNA 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 will be prepared and periodically revised by the NIH Director with advice of the RAC.
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. |
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