Dr. Cohen called the meeting to order at 9:00 a.m. 
Dr. Gartland summarized the history of the proposed revision of 
Section I-C of the National Institutes of Health (NIH) Guidelines 
for Research Involving Recombinant DNA Molecules starting with 
the revision proposed by the Foundation on Economic Trends and 
Mr. Jeremy Rif kin in January 1987. The proposal was considered 
in September 1987 by the Recombinant DNA Advisory Committee (RAC) 
which recommended establishment of a working group to develop a 
proposal and report back to the full RAC. This working group met 
on February 1 , 1988, and developed a proposal which was published 
for comment and considered by the RAC in June 1988. After 
extensive discussion and attempts to redraft language, the RAC 
referred the matter to this subcommittee for further 
consideration prior to the October 3, 1988, RAC meeting. 
Dr. Gartland raised the question of whether the Argentine field 
trial in question could be covered by the NIH Guidelines under 
any circumstances. Mr. Lanman responded that if there is a 
signed agreement with a party over which NIH has jurisdiction 
then the situation could be covered. In the absence of these 
circumstances, it would be difficult for the NIH to assert 
jurisdiction. 
Dr. Pramer noted that it is impossible to deal with all 
situations. Dr. Korwek said that language could be drafted to 
cover all situations, but the subcommittee surely does not want 
to cover everything. 
Dr. Vidaver raised the issue of limiting the time frame for 
covering these kinds of situations. Dr. Korwek noted that the 
RAC does not want to cover materials being shipped from 
repositories . 
Dr. Atlas said that any proposal should cover the Argentine field 
trial in question, and any proposed language should be tested 
against the facts of the Argentine case. He said he was 
comfortable with an exemption for research which is not a direct 
extension of domestic research. Dr. Cohen said that the role of 
the subcommittee is to develop a proposal which will clarify the 
role of the NIH Guidelines and the role of the principal 
investigator. Dr. Korwek raised the issue of transfer of 
materials through multiple parties. 
Dr. Pramer said that it will stifle research if the original 
investigator is held responsible. Dr. Korwek said that 
regulations often impose responsibilities on the originator. 
Dr. Pramer responded that that is inconsistent with the practice 
of science. Dr. Cohen said that the NIH Guidelines can impose 
penalties but that investigators consider the NIH Guidelines to 
be a framework for responsible research. 
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Recombinant DNA Research, Volume 13 
