16 
Dr. Fildes said the Institutional Biosafety Conmittee (IBC) plays a key role 
in the NIH Guidelines. IBA experience with IBCs has been favorable and IBA 
meiTbers believe that IBCs are the most appropriate entity for the detailed 
monitoring of large-scale procedures. The IBA strongly recommends their 
continued use. IBA members have generally found the IBCs to be useful and 
productive. For example, IBCs are valuable in assuring the canmuiity that 
independent review of experiments exists. Dr. Fildes said that v*iile worldwide 
experience convinces IBA members that recombinant INA research is safe, the 
IBCs will help establish an expanded data base to further demonstrate the 
safety of this work. In addition, IBCs bring together many different expertises 
and allow all safety issues to be addressed in a single forum within a company. 
Dr. Fildes noted that most of the work being performed by IBA member companies 
is classified as exempt or PI. The IBA feels that a full-scale IBC review 
prior to initiation of an exempt large-scale experiment is not necessary, and 
recommends that exenpt experiments should require only simultaneous notification 
of the IBC and not prior ^proval by the IBC. This ^proach is appropriate as 
the exetipt classification means that the safety issue has been fully addressed. 
Moreover, large-scale experiments will be performed in a facility which has 
previously been approved by the IBC. Within the IBA there is significant 
sentiment tor requiring only simultaneous IBC notice (as opposed to prior 
approval) for PI experiments as well as for exempt experiments. 
Mary IBA members supplement IBC review with frequent monitoring by various other 
safety committees. These committees nonitor the experiments on a day to day 
basis. At the same time, use of internal safety committees alleviate concerns 
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