Dr. Cohen raised a concern about situations in vhich a principal investigator 
is a collaborator in a project conducted abroad. Dr. Shykind of the Department 
of Commerce said that there would have to be a cut off time at sore point in 
the progress of a project. Dr. Cchen stated that a board determines if the 
level of informed consent is adequate in international projects conducted by 
the Centers for Disease Control. 
Dr. Cohen suggested that researchers could notify NIH of preposed international 
research. Dr. Gottesman questioned vhether this would be just for certain 
classes of research. Dr. Vidaver questioned what NIH would do with the informa- 
tion. Dr. Korwek raised the issue of when does NIH support begin and end. 
Dr. Gartland stated he could discern at least four levels of activity at the 
international level: (1) exchange of research materials when there is no intent 
to collaborate, (2) exchange of research materials with an intent to collaborate 
but NIH funds are not expended in the foreign country, (3) exchange of research 
materials with intent to collaborate and expenditure cf NIH finds in the foreign 
country, and (4) award of an NIH grant or contract to an institution in a foreign 
country. The third and fourth cases are clearly already covered by the NIH 
Guidelines. 
Dr. Clewell suggested focusing on "release" experiments; Dr. Vidaver suggested 
focusing on "first release" experiments. Mr. Lanman raised the issue of vhich 
institution would be the responsible institution. 
Dr. Cohen expressed concerns about attempting to extend the NIH Guidelines to 
foreign countries; perhaps there could be a statement that foreign governments 
should be notified regarding field trials. 
Dr. Gartland questioned how any such proposal would affect private companies 
which voluntarily comply with NIH Guidelines. Dr. Vidaver suggested that there 
should be a notification requirement. 
After further discussion and drafting of language, the working group voted 7 in 
favor, none opposed, and no abstentions to publish for comment the following 
proposed revision of the third paragraph of Section I-C of the NIH Guidelines: 
"The NIH Guidelines are also applicable: (1) to projects done abroad 
if they are supported by NIH finds or (2) to research done abroad if it 
involves deliberate release into the environment or testing in humans of 
materials containing recombinant ENA developed with NIH finds and the 
research is a direct extension of the development process. If the host 
country, however, has established rules for the conduct of recombinant 
DNA projects then a written assurance of compliance with those rules may 
be submitted to NIH in lieu of compliance with the NIH Guidelines. 
Alternatively, if the host country does not have such rules, written 
acceptance by an appropriate government office of the host country is 
necessary in lieu of compliance with the NIH Guidelines. The NIH 
reserves the right to withhold funding if the safety practices to be 
employed abroad are not reasonably consistent with the NIH Guidelines." 
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Recombinant DNA Research, Volume 13 
