cell culture collections are subsidized by the NIH and the 
Federal government. More than 1,000 cell cultures are shipped 
overseas each year to a variety of investigators working on 
numerous projects. If those cell lines eventually were used in 
recombinant DNA research under the proposed amendment, all of the 
research, whether it takes place this year, next year, or in 
1995, would fall under the NIH Guidelines. He added the same 
case could be made for bacterial cultures, virus stocks, and 
animals strains used in research. 
Dr. McGarrity asked, "where you have a viable research material, 
how long does NIH own that if you go by the strict definition of 
this?" And further, "If I give it to you as an investigator in 
England and you pass it on to a friend or a colleague and each 
laboratory propagates that for 5 years, 10 years, is that still 
NIH-supported material?" He said from both technical and 
administrative standpoints it would be difficult, if not 
impossible, to supervise. 
Dr. Walters said there were two levels of scrutiny for NIH-funded 
research, one for the U.S. on an institution-by-institution basis 
and one abroad on a project-by-project basis. He suggested the 
possibility of rewriting the first paragraph of Section I-C so 
that no matter where NIH money is going the institution-by- 
institution standard would apply. He said this would mean if an 
institution in India, Japan, or Latin America received any money 
from NIH for recombinant DNA research, all of their research 
would fall under the NIH Guidelines; and this would not be 
reasonable. He said he believed the current standard of project- 
by-project scrutiny is reasonable for research conducted abroad. 
Dr. Johnson said he agreed with Dr. Korwek's comments, and he 
felt the RAC didn't have the legal right or authority to govern 
what occurs in another country. 
Dr. Joklik said he believed the methods proposed by the amendment 
were excessive. The amendment's description of "project" would 
have a, "chilling effect on research, as indeed is substantiated 
by the letters from responsible people that we've got here." He 
said he agreed that we did not have the right to impose our NIH 
Guidelines on foreign governments. He expressed sympathy to the 
concept but felt the proposal was unworkable. 
Dr. Rapp said that despite not wanting to tell other countries 
what to do, he thought the NIH and RAC could set guidelines for 
their own investigators regardless of where the investigators 
carried out their research. He said he believed that in vaccine 
development, as the example cited, it was obvious that testing is 
the aim of the program and it is part of the same research 
program. 
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Recombinant DNA Research, Volume 13 
