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 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 nonreplicating | 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 |