Dr. Cohen called the meeting to order at 9 a.m. He cited the proposal of the 
Foundation on Economic Trends and Mr. Jeremy Rifkin to amend Section I-C of the 
National Institutes of Health (NIH) Guidelines for Research Involving Recombinant 
ENA Molecules regarding research projects conducted abroad (Attachment II). 
The Recombinant DNA Advisory Committee (RAC) considered the proposal at its 
meeting on September 21, 1987, and recommended establishment of a working group 
to consider further issues associated with projects conducted outside of the 
United States. Dr. Cohen said that there was general dissatisfaction with the 
proposed amendment at the RAC meeting. 
Dr. Gartland then reviewed the current applicability of Section I-C of the 
NIH Guidelines. Mr. Lanman cited the words "projects" and "supported by NIH 
finds" in Section I-C. He stated that the field trial of a recombinant rabies 
vaccine in Argentina was separable from NIH support for the portion of the 
project carried out in the U.S.; the field trial in Argentina was not supported 
by NIH. 
Dr. Gottesman said that the first issue is whether the working group is 
comfortable with the position the NIH has taken on the field trial in Argentina. 
Dr. Korwek said that this is a very difficult problem, and he is in happy about 
attempting to apply U.S. rules in foreign countries. He said that there may 
be ways to circumvent any proposed language crafted by the working group. 
Dr. Riley raised the issue of countries that have not adopted their own 
guidelines. Dr. Gottesman said that the issue concerns activities that may be 
viewed as an extension of an NIH project. She also noted that the concern is 
about release into the environment of recombinant organisms. 
Dr. Cl ewe 11 then proposed the following sentence: 
"In situations where the NIH nay not be directly finding the testing 
abroad of products developed using NIH monies (e.g., vaccines, drugs, 
insecticides, etc.), formal approval by the ministry of health 
(or equivalent) of the involved cointry is required. Such countries 
should require compliance with the NIH Guidelines or a set of 
equivalent guidelines." 
Dr. Gottesman was not sure about requiring formal approval by the ministry of 
health. Er. Riley liked the idea of bringing projects bo the attention of local 
authorities. 
Mr. Lanman said that the key issue is "support;" NIH has no authority if there 
is no NIH support for a project. Regarding Er. Clewell's proposal, Mr. Lannan 
raised the scenario of a university that sells the rights to a product to a 
company; the product is now fairly far removed from NIH support. He suggested 
focusing on institutions that receive NIH support for recombinant ENA research. 
The NIH Guidelines could be made to apply bo all reccmbinanb DNA research 
conducted at the institution. 
Recombinant DNA Research, Volume 13 
[105] 
