trying to circumvent mechanisms to inform the Government and 
protect people in order to move the project ahead more rapidly 
than they should have. 
Mr. Lanman said, in response to Dr. Gottesman’s suggestion to use 
the term "sponsored by," that it could be interpreted broadly and 
the toughest part of interpretation would be whether provision of 
research materials alone constitutes sponsorship. He suggested 
an alternative to the use of "direct extension." He said the 
following phrase should be substituted: 
"The research is subject to control through funding, 
sponsorship, or the direct provision of research 
materials by an institution within the United States or 
its territories that receives any support for 
recombinant DNA research from the NIH." 
Dr. McGarrity reiterated his question as to whether this would 
apply to repositories who supply viruses, bacteria, tissue 
samples and cell cultures. Mr. Lanman said another way of doing 
it may be to tie provision of research materials to a formal 
collaboration to prevent a company or organization providing 
research material to an external source to do research in order 
to bypass applicability of the NIH Guidelines. 
Mr. Brewer said he liked Mr. Lanman’ s suggestion in that it would 
solve virtually all of the problems with the exception of people 
who were deliberately trying to get around the NIH Guidelines, 
and that perhaps there were other agencies and institutions of 
the Federal Government more appropriate to handle those 
situations. He said he thought the best NIH could do is try to 
create a situation in which it ties the money it provides to 
researchers and institutions to an understanding that the duty 
falls upon those researchers and institutions to conduct their 
work and oversee it in accordance with the NIH Guidelines. 
Dr. Pramer drew the parallel with human subjects research and 
said that local IRBs are not concerned with where the research is 
taking place, but rather the standard of work, the quality of 
research, and how well confidentiality and protection of health 
and welfare of the human subjects is assured. Furthermore, the 
IRBs are charged by the institution to review all projects which 
are using human subjects, irrespective of funding. 
Mr. Rif kin asked Mr. Lanman if, using his proposed terminology, 
the Wistar Institute gave a vaccine to a private French company 
who in turn gave it to PAHO for a field trial, whether this would 
be a direct provision. 
Mr. Lanman said it would not be direct. 
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Recombinant DNA Research, Volume 13 
