Dr. Cohen said there were three reasons to conduct research 
abroad rather than in the U.S.: (1) cases in which a disease, 
condition, or circumstance which you want to test exists in more 
abundance in another country; (2) to avoid unrealistic delays in 
the regulatory process; (3) and finally a case in which someone 
intentionally wishes to avoid adherence to the NIH Guidelines. 
Dr. Cohen said he felt the first circumstance can properly be 
addressed by requiring investigators to get approval of a 
country's ministry of health by merely a letter stating that the 
research is in accordance with either their guidelines, their 
cultural mores, and their concepts as to the rights of 
individuals. In the second case, unrealistic delays in 
regulation must be improved and avoided. However, if someone 
were to attempt to intentionally avoid the NIH Guidelines, then 
only NIH itself could address this problem, not the RAC. 
Dr. Musgrave said he thought the administrative policies of NIH 
were at the heart of Mr. Rifkin's proposed amendment. Mr. Rif kin 
believes the NIH should have overall project funding by grants. 
When in reality, grants are funded in compartmentalized segments 
in the form of different projects which have clearly delineated 
administrative beginnings and ends. 
Dr. Korwek said the sentence in the first paragraph of Section 
I-C which reads: 
"The Guidelines are also applicable to 
projects done abroad if they are supported by 
NIH funds." 
is more than administrative. The effect of it, as it stands now, 
is that the word "projects" is interpreted to mean "research 
grants." If a new interpretation is needed, then changes would 
have to be made to the wording of that sentence. 
Mr. Rif kin asked the RAC not to table this topic as it had been a 
long process in getting it to the RAC's attention. He felt it 
was something of "paramount importance in terms of the 
interpretation of these Guidelines." Furthermore, he said he 
would be open to amending his proposal and believed it to be the 
responsibility of the RAC to help in this effort. 
Dr. Pirone offered the following wording to replace the sentence 
in Section I-C: 
"The Guidelines are also applicable to 
projects done abroad if they are an integral 
part of, or a continuation of, research 
supported by NIH funds." 
Recombinant DNA Research, Volume 13 
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