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Procedures & Practices

All work involving the following must be registered through the IBC:

  1. Use of Risk Group 2 infectious biological agents pathogenic to otherwise healthy humans. Risk Group 3 or Risk Group 4 are not allowed at MS&T.
  2. Analysis of samples known or highly suspected to be contaminated with Risk Group 2 infectious biological agents pathogenic to otherwise healthy humans (clinical specimens from presumed healthy individuals do not meet this definition).
  3. Culturing/propagating unknown or uncharacterized microorganisms.
  4. Use of a virus (e.g., EBV, SV40) to immortalize cell lines or use of immortalized cell lines capable of producing infectious virus(es)
  5. Analysis of specimens (e.g., blood, tissues, saliva, feces) from Old World monkeys (macaques, baboons).
  6. Use of acute biological toxins (LD50 ≤ 100 µg/kg body weight) or export-controlled toxins.
  7. Work that requires federal or state permits/notifications pertaining to regulated infectious materials (plant, animal, human pathogens), vectors, or genetically modified organisms.

rDNA/sNA experiments requiring review and approval by IBC prior to initiation:

  1. Experiments Using Risk Group 2, or Restricted Agents, as Host-Vector Systems.
  2. The deliberate transfer of rDNA/sNA into humans. NOTE: The 3 types of experiments above must also be approved by the NIH RAC (Recombinant Advisory Committee) and/or OBA (Office of Botechnology Activities).
  3. The cloning of toxin molecules with LD50 of less than 100 ng/kg body weight.
  4. The intentional introduction of drug-resistance traits into microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the drug to control human, animal, or plant diseases, even in a niche population.
  5. The cloning of DNA from Risk Group 2 or restricted organisms into non-pathogenic prokaryotic or lower eukaryotic host-vector systems.
  6. The use of infectious or defective DNA or RNA viruses in the presence of a helper virus in tissue culture systems.
  7. rDNA/sNA experiments involving whole animals.
  8. rDNA/sNA experiments involving whole plants consistent with Section III-D-5 of the Guidelines.
  9. rDNA/sNA experiments involving more than 10 liters of culture
  10. Experiments involving recombinant or synthetic influenza viruses.
  11. Experiments involving Select Agents (also requires approval from USDA and/or CDC).

Note: Experiments involving Risk Group 3 or Risk Group 4 agents are not allowed at MS&T.

While these experiments do not require IBC approval prior to initiation, the IBC nevertheless reviews and approves the following:

  1. The projects not included in the above categories in which all components are derived from non-pathogenic prokaryotes and lower eukaryotes.
  2. The projects involving the formation of rDNA/SNA molecules consisting of no more than 2/3 of the genome of any eukaryotes.
  3. The projects involving the rDNA/sNA in whole plants are consistent with Section III-E-2 of the Guidelines.
  4. The projects involving the generation of transgenic rodents de novo.

rDNA/sNA experiments are exempt from the NIH Guidelines but may require registration with the IBC:

  1. Synthetic nucleic acids that (1) can neither replicate nor generate nucleic acids that can 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 < 100 ng per kg bw.
    • 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.
  2. rDNA/sNA molecules that are not in organisms or viruses, and not modified to penetrate cells
  3. Nucleic acid molecules that consist entirely of a single DNA segment from a single non-chromosomal or viral DNA source, though one or more may be a synthetic equivalent that exists in nature
  4. Nuclei acid molecules that consist entirely of DNA from a single prokaryotic host (including its plasmids or viruses) when propagated only in that host (or closely related strain) or when transferred to another host by well-established physiological means.
  5. Nucleic acids that consist entirely of DNA from a single eukaryotic host (including chloroplasts, mitochondria, or plasmids) when propagated only in that host (or closely related strain).
  6. Nucleic acid molecules that consist 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.
  7. Genmic DNA that has acquired a transposable element, provided the element does not contain rDNA/sNA.
  8. Nucleic acids that do not present a significant risk to health or the environment (NIH Guidelines Appendix C).

Polices & Guidelines

This section is currently under construction. Check back soon for updates!