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 conditions Registration 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/kg Yes Yes Prior to initiation
Human gene therapy Yes Yes Prior 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 agriculture Yes Yes Prior to initiation
RG-2 agents as host-vector systems No Yes Prior to initiation
Cloning of DNA from RG-2 microorganisms into nonpathogenic prokaryotic or lower eukaryotic host-vector systems No Yes Prior to initiation
Use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems No Yes Prior to initiation
Use of transgenic animals at RG-2 or above No Yes Prior to initiation
Use of viable rDNA modified microorganisms involving whole animals or whole plants No Yes Prior to initiation
Administration of rDNA to animals or plants No Yes Prior to initiation
More than 10L of culture No Yes Prior to initiation
Propagation and maintenance in tissue culture of rDNA containing No Yes At initiation
Propagation and maintenance in tissue culture of rDNA containing a virus that has been shown to be nonreplicating No Yes At initiation
Formation of rDNA containing no more than 2/3 of the genome of any eukaryotic virus No Yes At initiation
Use of transgenic animals at RG-1 No No N/A
rDNA not in an organism or virus No No N/A
DNA segments from a single nonchromosomal or viral DNA source No No N/A
DNA entirely from a prokaryotic host when propagated only in that host No No N/A
DNA entirely from a prokaryotic host when transferred to another host by well-established physiological means No No N/A
DNA from a eukaryotic host when propagated only in that host or a closely related strain of the same species No No N/A
DNA segments from different species that exchange DNA by known physiological processes No No N/A