Dr. Gottesman said the problem was in definition of the term 
"project." The NIH defines a project in terms of what appears in 
a grant application. The working group felt some discomfort that 
a "project" could be defined to suit the purposes of an 
investigator and bypass applicability of the NIH Guidelines by 
moving portions of an experiment to a foreign country. On the 
other hand, the working group did not want to dictate to foreign 
governments what appropriate safety conditions were required. 
Therefore, the final proposal defined a project as research done 
using "materials containing recombinant DNA developed with NIH 
funds and the research is a direct extension of the development 
process." This definition has been criticized by some as too 
vague and by others as being too narrow. There has also been 
criticism of allowing for written acceptance by a foreign 
government in lieu of compliance with the NIH Guidelines. Dr. 
Gottesman said the working group’s major concern was that the 
foreign government be aware of the research and to allow them to 
make an appropriate decision on safety issues. 
Dr. Korwek said that criticisms by both the Food and Drug 
Administration and the Foundation on Economic Trends were valid 
but that by closing some loopholes others may be opened and 
therefore he welcomed suggestions for amending the proposed 
language for Section I-C. 
Mr. Lanman said he was interested in how this provision was to be 
enforced as currently the only mechanism for enforcement was 
through curtailment of NIH funding to violating institutions and 
investigators. He suggested the following wording to tie in NIH 
funding of recombinant DNA research to the NIH Guidelines: 
"The NIH Guidelines are also applicable: (1) to 
projects done abroad if they are supported by NIH funds 
or (2) to research done abroad if it involves 
deliberate release into the environment or testing in 
human beings of materials containing recombinant DNA if 
the research is a direct extension of research 
conducted at or sponsored by an institution that 
receives any support for recombinant DNA research from 
the NIH." 
Mr. Lanman proposed a major change in the working group's 
proposed wording to make foreign applicability rules the same as 
domestic applicability rules. That is, he proposed replacing the 
entire first sentence of the proposed paragraph with the 
following : 
"The NIH Guidelines are also applicable to projects 
done abroad if they are supported by NIH funds or 
conducted at or sponsored by an institution that 
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