APRIL 27-28-MINUTES OF MEETING 
12 
R. This item (research can begin upon IBC approval without ORDA prior 
approval) was discussed extensively and accepted by the RAC 
since it would mean less unwarranted delay. Among the questions 
that were raised was a concern about the number of MUAs approved 
by iBCs that were later disapproved by ORDA. Dr. Kamely noted 
that some of these were situations not explicitly covered by the 
Guidelines and thus required interpretation, other issues included 
the possibility of research being initiated that was not in com- 
pliance, the inability of NIH to stop funding until the laboratory 
was actually shown to be in non-ccmpl iance , and the fact that not 
all IBCs would have the same attitude toward self-regulation. One 
RAC member did note that approval of human subject experimentation 
was handled effectively at the local level and would set a good 
precedent . 
S. These items (i.e., OREA post- review of ongoing projects 
& and the responsibility of the IBC to modify a research protocol 
T. when OREA finds it is in nonccmpl iance with the Guidelines) were 
endorsed by the RAC. ORDA prereview would still be expected on 
new grant applications. 
U. These items (i.e., change of name to institutional bio - 
Sc safety committee and their mandate to make an independent 
V. evaluation of the containment levels required by the Guidelines) 
were endorsed by the RAC. 
W. This item (i.e., that public membership on the IBC be mandated) 
was discussed extensively. Dr. Bedford suggested that there 
be at least two public members. Dr. Kutter suggested at least 
one laboratory technician. Other RAC members objected strongly 
to NIH telling institutions who should be on their ccmmittees. 
Dr. Adelberg felt it was not an issue on which this scientific 
committee should be giving advice. Amotion by Ear. Bedford that 
it be suggested (not mandated ) that institutions give consider- 
ation to appointing one or more public members and one or more 
laboratory technicians to their IBC passed with 7 in favor and 
5 opposed. 
X. The RAC rejected the suggestion in Attachment II that "seme 
person or persons be collectively responsible for biosafety 
monitoring of recanbinant ENA research at the Pi through P3 
levels and that a special biological safety officer be desig- 
nated with certain responsibilities at the P4 level." They 
preferred the language in the proposed revised Guidelines that 
"each institution in which recombinant DNA research at a P3 or 
P4 containment level is being conducted shall designate a 
biological safety officer." 
[ 528 ] 
