Recombinant DNA Safety Program
Preface
A knowledge and understanding of the information presented
in this document is essential for those investigators using or contemplating
the use of recombinant DNA technology in their research.
1.0 Introduction
Research involving recombinant deoxyribonucleic acid (DNA)
shall comply with the National Institute of Health's "Guidelines
for Research Involving Recombinant DNA Molecules" (NIH Guidelines)
as published in the Federal Register (http://www4.od.nih.gov/oba/Rdna.htm).
The recombinant DNA guidelines are applicable to all recombinant DNA research
within the United States or its territories, which is conducted at or
sponsored by an institution that receives any support for recombinant
DNA research from NIH. Any individual receiving support for research involving
recombinant DNA must be associated with or sponsored by an institution
that can and does assume the responsibilities assigned in the guidelines.
The safe conduct of experiments involving recombinant
DNA depends on the individual conducting such activities. The guidelines
cannot anticipate every possible situation. The NIH
guidelines are intended to assist the institution, institutional biosafety
committee (designated as the Recombinant DNA Safety Committee [RDSC] at
Northwestern), Chemical and Biological Safety Officer, and principal investigator
in determining safeguards that should be implemented. It is the responsibility
of Northwestern University and those associated with it to adhere to the
intent of the NIH guidelines as well as to its specifics.
The purpose of the NIH Guidelines is to specify practices
for constructing and handling
- recombinant DNA molecules
- organisms and viruses containing recombinant DNA molecules
In the context of the NIH Guidelines, recombinant DNA molecules
are defined as
- 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 those described
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.
[ Up ]
[ RDNA Safety - 1.0 Introduction ]
[ RDNA Safety - 2.0 Responsibilities ]
[ RDNA Safety - 3.0 Approval Procedures ]
[ RDNA Safety - 4.0 Laboratory Inspections ]
[ Spill Procedures for RDNA Labs ]
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