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RECOMBINANT DNA EXPERIMENTS QUESTIONNAIRE CLASSES OF EXPERIMENTS COVERED
UNDER NIH GUIDELINES
Please check the appropriate Yes box if the NIH category accurately
describes your experiment.
CLASS III-A
Experiments that require Administrative Panel on Biosafety (APB)
approval, Recombinant DNA Advisory Committee (RAC) review, and NIH
approval before initiation of the experiment.
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No |
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III-A-1 |
Deliberate transfer of a drug resistance
trait to microorganisms that are known to acquire it naturally, if
such acquisition could compromise the use of the drug to control disease
agents in human or veterinary medicine or agriculture. |
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III-A-2 |
Certain experiments involving the deliberate
transfer of recombinant DNA or DNA or RNA derived from recombinant
DNA into one or more human subjects. |
CLASS III-B
Experiments that require NIH / ORDA and APB approval before the initiation
of the experiment.
| Yes |
No |
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III-B-1 |
Deliberate formation of recombinant DNA
containing genes for the biosynthesis of toxin molecules lethal at
an LD50 of less than 100 nanograms per kilogram body weight (e.g.,
microbial toxins such as tetanus toxin). |
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III-B-2 |
Accelerated Review of Human
Gene Transfer Experiments |
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III-B-3 |
Minor Modifications to Human
Gene Transfer Experiments |
CLASS III-C
Experiments that require APB approval before initiation of experiments.
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No |
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III-C-1 |
Experiments using human or
animal pathogens (Class 2, Class 3, Class 4, or Class 5 Agents) as
host vector systems. |
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III-C-1a |
Experiments involving the
introduction of recombinant DNA into Class 2 agents carried out at
biosafety level 2 containment. |
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III-C-1b |
Experiments involving the
introduction of recombinant DNA into Class 3 agents carried out at
biosafety level 3 containment. |
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III-C-2 |
Experiments in which DNA from
human or animal pathogens (Class 2, Class 3, Class 4, or Class 5 Agents)
is cloned in nonpathogenic prokaryotic or lower eukaryotic host-vector
systems. |
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III-C-2a |
Experiments in which DNA from
Class 2 or Class 3 Agents is transferred into nonpathogenic prokaryotes
or lower eukaryotes carried out at biosafety level 2 containment. |
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III-C-3 |
Experiments involving the
use of infectious animal or plant DNA or RNA viruses in the presence
helper virus in tissue culture systems. |
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III-C-3a |
Experiments involving the
use of infectious Class 2 animal viruses in the presence of helper
virus performed at biosafety level 2 containment. |
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III-C-3b |
Experiments involving the
use of infectious Class 3 animal viruses or defective Class 3 animal
viruses in the presence of helper virus carried out at the biosafety
level 3 containment. |
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III-C-3c |
Experiments involving the
use of infectious animal or plant viruses or defective animal or plant
viruses in the presence of helper virus not covered by the above sections
carried out at the biosafety level 1 containment. |
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III-C-4 |
Experiments involving whole
animals in which the animal's genome has been altered by stable introduction
of recombinant DNA, or RNA derived therefrom, into the germ-line (transgenic
animals) and experiments involving viable recombinant DNA- modified
microorganisms tested on whole animals. |
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III-C-4a |
Recombinant DNA, or DNA or
RNA molecules derived therefrom, from any source except for greater
than two-thirds of eukaryotic viral genome transferred to any non-human
vertebrate or any invertebrate organism and propagated under conditions
of physical containment comparable to BL1 or BL1-N and appropriate
to the organism under study. |
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III-C-4b |
Experiments involving recombinant
DNA, or DNA or RNA derived therefrom, involving whole animals, including
transgenic animals, and not covered by Sections III- C-1 or III-C-4a,
carried out at the appropriate containment determined by the APB. |
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III-C-5 |
Experiments to genetically
engineer plants by recombinant DNA methods, to use such plants for
other experimental purposes,(e.g., response to stress), to propagate
such plants, or to use plants together with microorganisms or insects
containing recombinant DNA, conducted under the containment conditions
described in Sections III-C-5a through III-C-5e. |
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III-C-5a |
BL3-P (plants) or BL2-P +
biological containment is recommended for experiments involving most
exotic infectious agents with recognized potential for serious detrimental
impact on managed or natural ecosystems when recombinant DNA techniques
are associated with whole plants. |
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III-C-5b |
BL3-P or BL2-P + biological
containment is recommended for experiments involving plants containing
cloned genomes of readily transmissible exotic infectious agents with
recognized potential for serious detrimental effects on managed or
natural ecosystems in which there exists the possibility of reconstituting
complete and functional genome of the infectious agent by genomic
complementation in planta. |
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III-C-5d |
BL3-P containment is recommended
for experiments involving sequences encoding potent vertebrate toxins
introduced into plants or associated organisms. |
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III-C-5e |
BL3-P or BL2-P + biological
containment is recommended for experiments with microbial pathogens
of insects or small animals associated with plants if the recombinant
DNA-modified organism has a recognized potential for serious detrimental
impact on managed or natural ecosystems. |
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III-C-6 |
Experiments involving more
than 10 liters of culture. The appropriate containment will be decided
by the APB. Where appropriate, Appendix K, Physical containment for
Large Scale Uses of Organisms Containing Recombinant DNA Molecules,
shall be used. Appendix K describes containment conditions Good Large
Scale Practice through BL3-Large Scale. |
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III-C-7 |
Human Gene Transfer Experiments
not covered by Sections III-A-2, III-B-2, or III-B-3. |
CLASS III-D
Experiments that require APB notice simultaneously with initiation.
| Yes |
No |
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III-D-1 |
Experiments involving the
formation of recombinant DNA molecules containing no more than two-thirds
of the genome of any eukaryotic virus |
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III-D-2 |
Experiments involving whole
plants which are not covered under any other section of the Guidelines. |
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III-D-2a |
BL1-P is recommended for all
experiments with recombinant DNA-containing plants and plant- associated
microorganisms not covered in Section III- D-2-b or other sections
of the NIH Guidelines. Examples of such experiments are those involving
recombinant DNA-modified plants that are not noxious weeds or that
cannot interbreed with noxious weeds in the immediate geographic area,
and experiments involving whole plants and recombinant DNA-modified
non-exotic (see Section V-W) microorganisms that have no recognized
potential for rapid and widespread dissemination or for serious detrimental
impact on managed or natural ecosystems (e.g., Rhizobium spp. and
Agrobacterium spp.). |
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III-D-2b(1) |
Plants modified by recombinant
DNA that are noxious weeds or can interbreed with noxious weeds in
the immediate geographic area. |
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III-D-2b(2) |
Plants in which the introduced
DNA represents the complete genome of a non-exotic infectious agent
(see Section V-W). |
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III-D-2b(3) |
Plants associated with recombinant
DNA-modified non-exotic microorganisms that have a recognized potential
for serious detrimental impact on managed or natural ecosystems (see
Section V-W). |
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III-D-2b(4) |
Plants associated with recombinant
DNA-modified exotic microorganisms that have no recognized potential
for serious detrimental impact on natural ecosystems (see Section
V-W). |
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III-D-2b(5) |
Experiments with recombinant
DNA-modified arthropods or small animals associated with plants, or
with arthropods or small animals with recombinant DNA-modified microorganisms
associated with them if the recombinant DNA-modified microorganisms
have no recognized potential for serious detrimental impact on managed
or natural ecosystems (se Section V-W). |
CLASS III-E
Experiments that are exempt from NIH Guidelines. Review / approval from
the APB is not necessary.
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No |
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III-E-1 |
Recombinant DNA molecules
that are not in organisms or viruses. |
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III-E-2 |
Recombinant DNA molecules
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. |
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III-E-3 |
Recombinant DNA molecules
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 cell by well established physiological means. |
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III-E-4 |
Recombinant DNA molecules
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 closely related strain of the same
species). |
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III-E-5 |
Recombinant DNA molecules
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. |
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III-E-6 |
Recombinant DNA molecules
which do not present a significant risk to health or the environment,
as determined by the NIH. |
EXPERIMENTS INVOLVING CLASS 4 OR 5 AGENTS ARE NOT PERMITTED
AT STANFORD UNIVERSITY
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