3 
The NIH Guidelines currently refer only to recanbinant DNA and do not refer to 
recombinant RNA although RNA viruses have been c eve red under case law. She 
said a RAC subworking group had developed a proposal to modify the NIH Guidelines 
to cover explicitly reccmbinant FNA (Attachment II), and the Working Group on 
Viruses would evaluate this proposal. 
Dr. Gottesman asked Dr. Simpson, the Chair of the NIH IBC, to describe the 
issues he wished the working group to address. 
Dr. Simpson said the NIH Office of Reccmbinant CNA Activities (ORDA) has been 
informing investigators that experiments involving human oncogenes should be 
performed under BL2 containment. ORDA does not address, however, experiments 
involving oncogenes frem other animal sources. He suggested the working group 
address the issue of how oncogenes should be handled under the NIH Guidelines. 
Dr. Simpson also suggested the working group consider whether experiments 
involving single viral genes, e.g., the Herpes simplex thymidine kinase (TK) 
gene, in tissue culture should be registered with IBCs or whether such experi- 
ments might be exempted fran the NIH Guidelines under Appendix C, Exemptions 
Under Section III-D-5 . 
Dr. Dan Liberman of the Massachusetts Institute of Technology (MIT) asked the 
working group to reevaluate the use of viral vectors with viral gene inserts 
in liaht of recent developments. 
Dr. Gottesman asked the working group to begin by addressing the proposal 
(Attachment II) to modify the NIH Guidelines to specifically refer to reccmbinant 
RNA. She asked the workina group whether this proposal would adeguately address 
the use of RNA viruses under the NIH Guidelines. The working group agreed the 
proposal (Attachment II) was appropriate. 
Dr. Gottesman asked the working group to next address the issue of v^ether 
experiments involving single viral genes in tissue culture should be exempt 
frem the NIH Guidelines. She said under Appendix C, experiments involving the 
clonira of fragments of less than two-thirds of a virus in an _EL_ coli K-12 
host-vector system are exempt; however, if a viral gene is introduced into 
eukaryotic cells in tissue culture, the experiments must be registered with 
the IBC. She did not think tissue culture experiments involving single genes 
of viral oriain need to be registered with the IBC. Dr. Grodzicker agreed. 
Dr. Joklik said two issues must be considered in evaluating experiments involving 
viruses: (1) the intrinsic infect ivity of the virus; and (2) the rescuability 
of the virus by helper virus. The working group could address viral intrinsic 
infectivity by limiting the fraction of the gencme that can be introduced and 
propagated in tissue culture systems. 
Dr. Gottesman said the working group might suggest the NIH Guidelines be modify' 
so as not to recruire IBC registration of tissue culture experiments involving 
less than one-third of a virus of a single Fanily. 
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