Recombinant DNA Research Registration Checklist

This chart serves as a reference for determining if an experiment must be registered with the Institutional Biosafety Committee (IBC) and/or the National Institutes of Health (NIH), and when.

Experiment conditionsRegistration with NIH required?Registration with IBC required?When IBC must receive registration
Cloning of DNA encoding toxin molecules lethal to vertebrates at an LD50 of less than 100ng/kgYesYesPrior to initiation
Human gene therapyYesYesPrior to initiation
Transfer of drug resistance to an organism not known to naturally acquire that trait, if such an acquisition could compromise ability to control the disease in humans, veterinary medicine, or agricultureYesYesPrior to initiation
RG-2 agents as host-vector systemsNoYesPrior to initiation
Cloning of DNA from RG-2 microorganisms into nonpathogenic prokaryotic or lower eukaryotic host-vector systemsNoYesPrior to initiation
Use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systemsNoYesPrior to initiation
Use of transgenic animals at RG-2 or aboveNoYesPrior to initiation
Use of viable rDNA modified microorganisms involving whole animals or whole plantsNoYesPrior to initiation
Administration of rDNA to animals or plantsNoYesPrior to initiation
More than 10L of cultureNoYesPrior to initiation
Propagation and maintenance in tissue culture of rDNA containing 2/3 of the genome of any eukaryotic virus in the demonstrable absence of helper virus or a virus that has been shown to be nonreplicatingNoYesAt initiation
Propagation and maintenance in tissue culture of rDNA containing a virus that has been shown to be nonreplicatingNoYesAt initiation
Formation of rDNA containing no more than 2/3 of the genome of any eukaryotic virusNoYesAt initiation
Use of transgenic animals at RG-1NoNoN/A
rDNA not in an organism or virusNoNoN/A
DNA segments from a single nonchromosomal or viral DNA sourceNoNoN/A
DNA entirely from a prokaryotic host when propagated only in that hostNoNoN/A
DNA entirely from a prokaryotic host when transferred to another host by well-established physiological meansNoNoN/A
DNA from a eukaryotic host when propagated only in that host or a closely related strain of the same speciesNoNoN/A
DNA segments from different species that exchange DNA by known physiological processesNoNoN/A