government authority" meaning approval by an NIH recognized IBC. 
These points added strength to the proposal. 
Mr. Lanman, who had just joined the group, said he supported the 
proposal. He said it was clear, sets a reasonably enforceable 
guideline, and is fairly consistent with what was originally 
proposed. 
Dr. Pramer said he believed the Working Group was able to develop 
language which would cover situations similar to the Wistar 
incident while at the same time not constraining exchange of 
scientific material and keeping the number of reviews for such 
proposals to a minimum. 
Dr. Riley supported the proposal and said the ambiguities and 
problems in phraseology which were discussed at the last RAC 
meeting had been resolved. 
Dr. Davis said he felt the scientists and lawyers in the Working 
Group had taught each other something about the language, and he 
was happy with the product. 
Dr. Childress asked for clarification of changes from the 
existing NIH Guidelines which appeared to be omitted from the new 
language. He said it appeared that a proposal could be reviewed 
by an NIH approved IBC and accepted in writing by an appropriate 
national governmental authority without notification to NIH that 
this process had taken place. Secondly, there was no mention of 
sanctions in the new language, which is defined by another 
section of the NIH Guidelines, and may not be explicit enough. 
Dr. Cohen said there was no need to repeat the sanctions in this 
section since they were already in the NIH Guidelines. As for 
the notification of NIH, Dr. Cohen explained this was the 
responsibility of the institution and the researcher. It was not 
necessary to provide such information to the NIH. 
Dr. Shibley asked for clarification of the meaning "equivalent 
review body." Dr. Cohen said the implication was that an IBC or 
an equivalent body functioning as a review body would approve the 
proposals. This could be a local IBC. 
Dr. Shibley said that in the case of an experimental biologic, it 
would need not only IBC approval but would also require U.S. 
Department of Agriculture (USDA) approval for export. Dr. Cohen 
said the NIH Guidelines did not conflict with this in any way. 
Dr. McGarrity said the proposed amendment did not usurp the 
authority of any other Federal regulatory agency in this country 
or abroad, and it does not imply that these are the only 
guidelines that must be followed. 
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Recombinant DNA Research, Volume 13 
