Old Title vs New Title
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Old Title vs New Title
NIH Guidelines for Research Involving Recombinant DNA Molecules
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Implement by 3/3/13
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Is chemical synthesis covered?
synthesizer
Not until in a …
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III-F Registrations Nothing exempt in Boston
BPHC adopts updated Guidelines unless…
Using nonhazardous plasmids (pBR) to clone gene of interest into host (nonpathogenic E.coli)
Often the first step in creating a transgenic animal
New exemptions for synthetic NA No origin of replication, no integration…
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NIH Guidelines: Definition of rNA
Molecules constructed by joining nucleic acids
& can replicate in a living cell
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NIH Guidelines: synthetic
Nucleic acids that can base pr w naturally occurring nucleic acids
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NIH Definitions Continued
Molecules resulting from replication of rNA or synthetic nucleic acids in past two slides
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Other Changes
Fewer AAV serotypes need review Transfer of drug resistance traits Human Gene Transfer w nucleic
acids
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Risk Assessment & Synthetics
% of genome from each parent Fn/purpose of each sequence
Assume same fn as original host? Synergism between sequences & transgenes
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What Next? - XNA
~6 sugars can form NA bbone
Store & retrieve genetic info
Medical benefit? Slower breakdown in stomach & bloodstream
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Real World Examples
iGEM 2006 Jay Keasling