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Institutional Biosafety Committee (IBC)

Recombinant DNA (rDNA) Definition

Molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell. Molecules that result from the replication of DNA molecules that can replicate in a living cell.

Synthetic DNA segments which are likely to yield a potentially harmful polynucleotide or polypeptide (for example, a toxin or a pharmacologically active agent) are considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, it is exempt from the NIH Guidelines.

Genomic DNA of plants and bacteria that have acquired a transposable element, even if the latter was donated from a recombinant vector no longer present, are subject to the NIH Guidelines if the transposon itself contains recombinant DNA.

Policy on the Use of rDNA

Research involving recombinant DNA conducted at or sponsored by RPI, or research conducted by RPI faculty members or students, must be conducted in a manner that does not pose a significant risk to the health or safety of laboratory workers, others in the Institution, the public, or the environment. Federal law on use of recombinant DNA mandates the establishment of the IBC, which reviews, approves and oversees projects involving recombinant DNA.

  1. All NIH-funded projects involving recombinant DNA techniques must comply with the NIH Guidelines. Non-compliance may result in (i) suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for recombinant DNA research at the Institution, or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the Institution.
  2. All non-NIH funded projects involving recombinant DNA techniques conducted at or sponsored by the Institution must comply with the NIH Guidelines. Noncompliance may result in (i) suspension, limitation, or termination of NIH funds for recombinant DNA research at the Institution, or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the Institution.

NIH rDNA Experiment Classifications

Recombinant DNA experiments have been grouped into six categories by the NIH, five of which (the non-exempt categories) are subject to IBC oversight.

Experiments that require IBC approval, NIH RAC (i.e., Recombinant DNA Advisory Committee) review and NIH Director approval before initiation of experiments (NIH Guidelines Section III-A) 

“Experiments involving 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.”

Experiments that require NIH/OBA and IBC approval before initiation of experiments (NIH Guidelines Section III-B)

“Experiments involving the cloning of toxin molecules with LD50 of less than 100 nanograms per kilogram body weight.”

Experiments that require NIH and IBC approval before initiation of experiments (NIH Guidelines Section III-C)

“Experiments involving the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such transfer could compromise use of the drug to control disease agents.”

“Experiments involving the formation of recombinant DNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100ng/kg body weight (e.g., botulinum toxin, tetanus toxin, diptheria toxin, & shigella dysenteriae neurotoxin).

“Experiments involving the deliberate transfer of recombinant DNA, DNA or RNA derived from recombinant DNA into one or more human subjects.”

RAC approval must be granted before the IBC can approve any such protocol or before the IRB can approve the enrollment of human participants.

Experiments that require IBC approval before initiation (NIH Guidelines Section III-D)

  • 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
  • Experiments involving transgenic animals or plants and experiments involving viable recombinant DNA-modified microorganisms tested on whole animals or plants.
  • 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

Experiments that Require IBC Notice Simultaneous with Initiation (NIH Guidelines Section III-E)

  • 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.  These recombinant DNA molecules may be propagated and maintained in cells in tissue culture using BL1 containment if the cells lack helper virus for the specific families of defective virus being used. 
  • Experiments involving whole plants (involving use of non-pathogenic plant microorganisms, or recombinant plants with non-hazardous properties).
  • Experiments involving transgenic rodents.
  • Experiments involving the generation of transgenic rodents if the experiments require only BL1 containment.
  • Experiments involving whole plants involving rDNA-modified organisms associated either whole plants that do not fall under Sections III-A, III-B, III-D and III-F.

Exempt Experiments

IBC approval or notice is not required by the NIH Guidelines, but annual registration with the IBC is required. (NIH Guidelines Section III-F)

Although the NIH does not require notification of exempt experiments, some granting agencies do require any proposal involving recombinant DNA to be approved by the local IBC.  Therefore, Rensselaer requires the approval of experiments that are exempt from the Guidelines.

The following recombinant DNA molecules are exempt from the NIH Guidelines:

  • Those that are not in organisms or viruses.
  • Those that consist entirely of DNA segments from a single non-chromosomal 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 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).
  • 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 the 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.
  • Experiments not involving introduction of DNA sequences into cells, organisms, or viruses including amplification with no cloning (e.g., PCR product).
  • Cloning of all other DNA in E.coli K12, S. cerevisae, and B. subtilis host-vector.
  • Introduction into cultured cells of any rDNA containing less than half of a eukaryotic viral genome (excluding BL3 or BL4).
  • Experiments that consist entirely of DNA segments from the same or closely related species or different species that exchange DNA by known physiological processes.
  • Those that are not in organisms or viruses.
  • Those that consist entirely of DNA segments from a single non-chromosomal 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 do not present a significant risk to health or the environment, as determined by the NIH Director, with the advice of the RAC.
  • Those that consist entirely of DNA segments from a single non-chromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.
  • Those that consist entirely of DNA segments from 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.
Direct all inquiries to ibc@rpi.edu

Biosafety Overview

Rensselaer Polytechnic Institute IBC Form

IBC Amendment Form

Acquiring Approval and Other FAQs

What Must be Registered

NIH Risk Group Classifications

Recombinant DNA

Shipping and Transportation

Biosafety Links

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