Dr. Fedoroff suggested two ways of solving the inconsistency 
between the NIH Guidelines and what other countries find 
acceptable and that is: 
1. Ask whether the NIH Guidelines make sense, given 
what we now know about recombinant DNA; and 
2. What is our current level of experience with 
recombinant DNA technology. 
Dr. Fedoroff said she felt we had enough knowledge base and 
experience to be able to apply the NIH Guidelines to research 
abroad as well as in the U.S., and this was reasonable. However, 
she said she thought changes in the NIH Guidelines lagged behind 
what is currently known about recombinant DNA and what is going 
on in research today. 
Dr. Gottesman said she wanted the group to get away from the 
particular wording of the proposed amendment and to consider the 
issue of the definition of "project," and that the NIH Guidelines 
as written allow an investigator to follow the rules set up by 
foreign governments. This addresses one of the major issues. 
She felt there was difficulty in subdividing a project. She used 
vaccine development as a case in point and asked if the committee 
was happy with defining development of the vaccine as one project 
and the testing of that vaccine as another regardless of where 
the funding comes from for either phase. She said if the 
committee was not happy with such an interpretation and 
development and testing should be considered one project, then 
perhaps that could be given as advice to the NIH Director without 
actually changing the NIH Guidelines. 
Dr. Epstein said he felt deliberate release of agents developed 
in this country was the real issue. If the country in which the 
release takes place has their own guidelines, then they should 
apply. The problem is in the case of a country that has no 
guidelines. Perhaps the RAC should consider whether it is 
necessary to address this issue specifically. 
Dr. Davis said testing of a vaccine was merely one of the steps 
in the overall development of a vaccine and cannot be taken to be 
a separate project. However, he agreed with Dr. Fedoroff that 
the NIH Guidelines are slow to evolve. The proposed amendment 
would impose the NIH Guidelines on other countries possibly to 
their detriment, and other governments may not react favorably to 
such restrictions being imposed on them. 
Dr. McGarrity took issue with the portion of the proposed 
amendment which speaks to "in-kind support" regarding supplies, 
equipment, use of facilities, and biological research materials. 
He pointed out that such language could be difficult to supervise 
and administer in the field of cell cultures. Most of the major 
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