institution that developed those 
materials sponsors or participates in 
those projects. Participation includes 
research collaboration or contractual 
agreements, but not mere provision of 
research materials. 
"If the host country has established rules for the 
conduct of recombinant DNA projects, then the project 
must be in compliance with those rules. If the host 
country does not have such rules, the proposed project 
must be reviewed by an NIH approved IBC or equivalent 
review body and accepted in writing by an appropriate 
national governmental authority. The safety practices 
to be employed abroad must be reasonably consistent 
with the NIH Guidelines." 
Dr. Cohen said this proposal was published in the Federal 
Register and attempts to accomplish several things. It defines 
which of the international activities it does and does not 
affect. The first group pertains to projects supported by NIH 
funds, and the second group are projects involving deliberate 
release or human gene therapy experiments. The proposed language 
also makes it clear that the mere provision of research materials 
does not imply participation. Finally, the proposal addresses 
the presence or absence of guidelines in the host country. 
Dr. Cohen said the intention of the proposed amendment was to 
provide guidance to researchers who develop potentially useful 
vaccines, treatments, or microorganisms so that responsible 
international projects in controversial areas such as deliberate 
release or human gene therapy can proceed with the knowledge and 
approval of the host country. 
Dr. Atlas reminded the participants that debate at the last RAC 
meeting had centered around the terms "connected" and "direct 
extension of research." The Working Group then developed a sense 
of what the words "participation" and "responsibility" meant and 
to clarified the issue surrounding exchange of scientific 
materials. He said there was concern also as to how review 
committees could be established for looking at such problems, but 
that international IBCs exist in some countries. Where they do 
not, it was feasible for IBCs at U.S. institutions to accomplish 
such reviews rather than forcing every foreign country to 
establish an IBC to comply with the NIH Guidelines. 
Dr. Clewell said he agreed with both Drs. Cohen and Atlas as to 
the aims of the proposed amendment. An effort was made to define 
what was meant by "extension of research" done domestically with 
NIH funds and the issue of "acceptance by an appropriate 
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