Dr. McGarrity asked if NIH supported development of a 
non-recombinant vaccine, and it goes to a foreign country for 
field testing, what human subjects regulations would be used. 
Mr. Lanman said that Department of Health and Human Services 
funding was tied to DHHS Human Subjects Regulations. Dr. Miller 
said it would also require FDA approval because interstate 
commerce regulations require FDA approval of shipment for use in 
a foreign country. 
Dr. Pagano said he liked the phrasing as proposed. He said if 
the host country did not have guidelines they would need to 
accept whatever is to be tested and this is bolstered by the 
statement whereby the NIH reserved the right to withhold funding. 
He said, "They can review, they should review," but "I don't 
think we can rigidly hold other countries to our standards 
because their problem may be different and there is a risk versus 
benefit to consider here." In other words the host country is 
allowed the leeway to make its own guidelines but if a U.S. 
investigator or institution is introducing a product to a country 
which does not have guidelines, the NIH still has a right and a 
means to prevent it. 
Dr. Childress said he agreed but the phrase "in lieu of 
compliance with the NIH Guidelines" should be worded to indicate 
what was expected was conduct reasonably consistent with the NIH 
Guidelines . 
Mr. Brell, Attorney and Officer for the Foundation on Economic 
Trends said he felt acceptance by an appropriate Government 
agency in the host country after proper scientific consideration 
of risk was necessary. He said he felt the word "connected" 
should be used along with the word "direct," to show that if 
something is part of a larger cohesive whole it must fall under 
the NIH Guidelines as well as if it is predicated on previous or 
simultaneous actions. This language had been defined by the CEQ 
and is used in assessing environmental impact. 
Dr. Gottesman asked for an interpretation of the word "sponsored" 
by the lawyers in the group. She asked if it were too broad a 
term and whether it would be interpreted to include all "direct 
extensions." She said a possible solution to this may be to use 
the term "sponsored by." Dr. Gottesman said that the term 
"connected" may have a legal meaning but that all research is 
predicated on research in the past and tomorrow's research is 
reasonably foreseeable from research going on today. 
Dr. Murray asked how developing or non-industrialized nations 
process requests coming to them for research and what issues come 
up in such a setting, and what obligation a researcher has to 
control the use of materials and results of research. He said he 
believed in the Argentinean field trial the investigators were 
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