6 
Dr. Gottesman questioned whether the guidelines adequately addressed the question 
of virus hybrids created in vitro . Dr. Martin said no viable hybrids have been 
created by recombinant DMA technology. Lr. Gottesman asked if a hybrid virus 
containing a human oncogene could be created. Dr. Martin said the human onco- 
genes are very large, with introns, and that creation of a viable hybrid was 
not possible. LT. Gottesman asked Dr. Martin if he thought the current guide- 
lines were adequate except for intentional creation of hybrids. Dr. Martin 
replied that they were, helper virus would be required for propagation of the 
defective viruses created by introduction of the large cDNA coding for 
human oncogenes; this is covered by Section III-B-3. 
Proposal to Incorporate the Physical Gontainment Recommendations for Large-Scale 
Uses of Organisms Containing Recombinant DMA Molecules into the Guidelines. 
Dr. Nightingale noted that the Large-Scale Review Working Group had forwarded 
to the Working Group on Revision of the Guidelines a proposal made at the 
October 26, 1982, meeting of the Large-Scale Review Working Group. That proposal 
would incorporate the Physical Gontainment Recommendations for Large-Scale 
Uses of Organisms Containing Recombinant DNA Molecules into the NIH Guidelines. 
Dr. Nightingale asked why the Large-Scale Recommendations had not been incorpor- 
ated into the NIH Guidelines; she asked if there were any advantages to keeping 
the Recommendations a separate document. Dr. Milewski replied that the Recom- 
mendations, when formulated in 1980, applied primarily (and still do) to industry. 
Since industry is covered under Part VI of the Guidelines, voluntary Compliance, 
including the Recommendations in the Guidelines was perceived as possibly 
inappropriate. Dr. Gottesman added that in 1980 it was thought leaving the 
Recommendations as recommendations would facilitate modification of the document. 
Dr. Nightingale asked if any modifications to the Recommendations were required 
before they could be incorporated into the Guidelines. Dr. Gartland suggested 
that the language of the Recommendations was flexible and would not require 
substantive amendment. Drs. Milewski and Tblin said that the Recommendations 
required editorial updating and that this should be done before the Recommend at ions 
are incorporated into an Appendix of the Guidelines. Or. Milewski said she 
would go through the Recommend at ions and send a memorandum to RAC for the next 
meeting concerning necessary editorial changes. The Working Group on Revision 
of the Guidelines agreed that the updated Recommendations might be added as an 
Appendix to the Guidelines. 
Procedures for Reviewing Proposals Between RAC Meetings. 
Dr. Nightingale noted that the period of time elapsing between RAC meetings is 
increasing. She wondered if 9ome type of expedited review procedure, such as 
action by mail, phone, or by subcommittee or executive group, should be 
considered . 
Dr. Gottesman suggested that if mail notification is used, any one RAC member 
might have veto power; the proposal would then be held for full RAC discussion 
and review. Dr. Nightingale agreed that one individual should have the authority 
to hold a proposal for RAC review and evaluation. Lr. Gottesman asked what 
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