MEMORIAL SLOAN-KETTERING GANGER CENTER 
1275 YORK AVENUE. NEW YORK. NEW YORK 10021 
To: All SKI Staff 
From: 
Paul V. O'Donnell, Ph.D. 
Chairman, Institutional Biosafety Committee 
Re: NIH Guidelines for Research Involving Recombinant DNA Molecules 
Effective 21 April 1982 
The following summary is intended as a guide to investigators in determining 
whether their experiments are covered by the NIH Guidelines and therefore require 
appropriate registration and containment. It is not exhaustive, and investigators 
working with or planning to work with recombinant DNA molecules are reminded of 
their responsibility to be familiar with the existing NIH Guidelines. 
Categories of experiments : 
1 . Experiments that require RAC review and NIH and IBC approval prior to initiation 
a) recombinant DNAs containing genes for biosynthesis of toxins lethal to 
vertebrates 
b) deliberate release of organisms containing recombinant DNA into the 
envi ronment 
c) deliberate transfer of a drug resistance trait to microorganisms not known 
to acquire it naturally. 
2. Experiments that require IBC approval prior to initiation 
a) use of CDC class 2, 3, 4 or 5 agents as host-vector systems 
b) cloning of DNA from CDC class 2, 3, 4 or 5 agents in non-pathogenic pro- 
karyotic or lower eukaryotic host-vector systems 
c) use of infectious animal or plant viruses (or defective animal or plant 
viruses in the presence of helper viruses) as cloning vectors in tissue 
culture systems 
d) experiments involving whole animals and plants 
e) large scale experiments ( > 1 0 1 of culture) 
3. Experiments that require IBC notice simultaneously with initiation 
a) all components derived from non-pathogenic prokaryotes and non-pathogenic 
lower eukaryotes which are not already listed as exempt 
b) use of defective animal or plant viruses (in the absence of helper virus) 
as cloning vectors in tissue culture systems. 
[ 606 ] 
