IV. PROPOSED AMENDMENT OF SECTION I-C OF THE NIH GUIDELINES (tabs 
1310/1, 1317, 1318, 1319, 1320, 1327, and 1328). 
Dr. McGarrity called on Dr. Cohen to begin discussion of this 
agenda item. Dr. Cohen delineated the history of the proposal 
from the Foundation on Economic Trends to amend Section I-C of 
the NIH Guidelines to cover projects conducted abroad if the NIH 
had contributed any developmental funding. He said there was 
general dissatisfaction with the proposal but also with the lack 
of a procedure to prevent recurrences of such things as the 
Wistar rabies vaccine episode. He said a working group had 
convened on February 1, 1988, to address this situation and the 
working group had grappled with several issues involved in this 
proposal . 
The first issue was there are reasons to conduct recombinant DNA 
projects abroad, namely that diseases can be best studied in 
endemic areas and the working group did not believe they could 
propose anything which would stifle such responsible research. 
The working group recognized that the NIH has limited 
jurisdiction over international projects, that foreign 
governments are autonomous, and that NIH jurisdiction pertains 
primarily to institutions and investigators receiving financial 
support from the NIH. Further, the working group recognized many 
problems associated with international research were a result of 
incomplete or inadequate communication. 
Therefore, the purpose of the final proposal (tab 1317) was to 
attempt to facilitate proper communications and ensure 
appropriate approvals for international projects which are 
concerned with deliberate release and human gene therapy. The 
proposal instructs researchers whose projects are a direct 
extension of NIH-funded research to provide NIH with evidence 
that the project is in compliance with the NIH Guidelines, the 
host country's guidelines, or is acceptable by an appropriate 
Government office of the host country. The. aim is to recognize 
the autonomy of foreign governments while assuring proper 
communication occurs and at the same time not hindering 
responsible research. 
Dr. Gottesman said Section I-C of the current NIH Guidelines 
covers all recombinant DNA research within the United States and 
was applicable to projects done abroad if supported by NIH funds. 
The proposal from the Foundation on Economic Trends was in 
response to an experiment which had taken place in Argentina that 
was determined as not falling under the NIH Guidelines because no 
NIH funds were used for the testing abroad. However, the 
development of the recombinant molecules used in the field test 
was performed at an U.S. institution and was funded by the NIH. 
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