Page Seven 
September 13, 1978 
which, indirectly could affect humans in ways far more serious 
than direct effects on humans, 
IV. Roles and Responsibilities 
The delegation of administrative responsibility to the 
IBC's is, as you know, a concept which is stressed in the 
proposed House Recombinant DNA bill and the accompanying 
report. I strongly endorse revisions in the Guidelines 
which accomplish this. However, in doing so, one must be 
very careful that in the process of redefining the respective 
roles of NIH, the institution and the IBC's, that one does 
not create new administrative problems. 
The revised Guidelines apportion responsibility for 
project approval, inspection of laboratories, decisions on 
individual host-vector systems or containment levels, and 
registration in a way which, under ideal circumstances, should 
work extremely well. My primary concern over this section 
as revised is whether or not the oversight role which must 
be played by NIH will be adequate to keep things from becoming 
too non-ideal. 
I have already mentioned that the discretionary powers 
granted to the IBC's under IV-A-2-b to lower containment by 
one level for experiments with purified DNA and characterized 
clones should be exercised according to criteria much more 
specific than that outlined in section III. Otherwise, 
considerable non-uniformity might be expected in the decisions 
made by different IBC's. For the same reason, the description 
of the IBC's duties under IV-A-2-a should also be more detailed. 
The requirement for the "review and approval of facilities, 
procedures, practices, and the training and expertise of 
recombinant DNA personnel" is rather generally stated and may 
mean different things to different IBC's. 
Does this imply that the IBC maintain constant scrutiny 
over the principal investigator to make sure that he or she 
is always in compliance with the long list of duties set 
forth in IV-A-4? Of particular concern is who bears the 
responsibility for making sure that personnel are trained 
in safety practices and techniques? The principal investigator 
is given that responsibility for those under his or her 
direction. But who sees to it that the principal investigator 
is adequately competent in using and teaching such techniques? 
The IBC? Does the IBC bear the primary responsibility for 
ensuring adequate training? Again, I fear that the wording 
is so general, that a whole spectrum of standards may be 
applied by different IBC's. 
[A-134] 
