November 22, 1982 
William J. Gartland, Jr., Ph.D. 
Page Two 
B . What things are taking large amounts of time ? 
Only two things require large amounts of "working" time: Experiments 
as required in paragraphs III-B-4-a and III-B-2-a and keeping up with re- 
visions and changes in the Guidelines. 
There is still considerable "non-working" time lost between P.I. re- 
quests and IBC approvals for recombinant DNA experiments when such approval 
is required before initiation of the experiment. 
C. What things are taking inappropriate amounts of time ? 
I feel the experiments required in paragraph III-B-4-a and requests for 
some experiments requiring prior IBC approval (see Recommendations ) take 
unnecessary amounts of time. 
D. In what areas do you disagree with the RAC with regard to containment 
for a particular experiment ? 
In paragraph III-B-2-a I feel that experiments with DNA from Class 2 and 
subgenomic (e.g. < 3/4) fragments of Cl-ass 3 and 4, as well as Class 5 organisms 
if certified virus-free, should be allowed at PI. 
E . In what ways are the Guidelines too stringent or too relaxed ? 
I feel the Guidelines are too stringent in the following ways: Prior 
approval by the whole IBC is required for experiments whose classification 
and containment is well defined. 
Individual large scale experiments require evaluation and classification when 
the real concern should be given to the facilities and equipment. 
Small companies may have difficulty complying with paragraph IV-B-2-d, where 
an IBC chairman may also be a PI as well as a stockholder in the company. 
F. How frequently does your IBC meet ? 
In the past we had been averaging about two formal meetings, with all 
members present, and an additional informal telephone meeting per year. 
However, within the last year we have had only two informal telephone meetings. 
G. Does your IBC have other responsibilities at your institution? Is it a 
general biosafety committee? If not, is it because of the way in which 
the NIH Guidelines are written, or is it because your institution has 
chosen to function this way ? 
Our IBC has no other responsibilities at our institution, nor is it a 
general biosafety committee although our Safety Administrator is an IBC 
member. It is felt that a committee of several members, including some 
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