|
NIH Guidelines For Research
Involving Recombinant
DNA Molecules (NIH Guidelines)
April 2002
Section I-B. Definition of Recombinant DNA Molecules
In the context of the NIH Guidelines, recombinant DNA molecules are defined as either:
- molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
- molecules that result from the replication of those described in above.
Synthetic DNA segments which are likely to yield a potentially harmful
polynucleotide or polypeptide (e.g., 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
not subject to the NIH Guidelines unless the transposon itself contains
recombinant DNA.
Visit NIH's Office of Biotechnology Activities
(OBA) web site
for current information on guidelines, protocols,
principal investigators, meetings, and information about upcoming gene therapy
policy conferences.
Related Sites
|
