Page Eight 
September 13, 1978 
Other problems are created by so greatly expanding 
the duties and responsibilities of the IBC's. For one thing 
institutional costs will necessarily be much greater. I 
question whether or not grant overhead funds will realistically 
cover this increase as well as the other institutional costs 
which already are supposed to be covered by overhead. 
An important unanswered question is what sort of oversight 
role NIH will play in guaranteeing that individual IBC's 
are performing according to the intent of the Guidelines. 
Section IV-B-l-f is much too generally stated. The registration 
of projects and ORDA's review of MUA's may not be sufficient 
to determine whether or not an IBC is functioning properly, 
particularly since they are not submitted or reviewed prior 
to the beginning of a project. The current figure of a 
10 - 15% rate of disapproval of MUA's on non-trivial grounds 
would suggest that current IBC's are indeed not perfect. 
And even, if no problems exist with MUA's, is it likely that 
ORDA would ever find out that an IBC was not enforcing training 
in safety practices and techniques? 
My perception of current IBC's is that they range from 
very competent, thorough committees which take their duties 
seriously, to those thrown together for the sole purpose of 
having something to satisfy NIH and sign off on MUA's, while 
generally regarding the Guidelines with contempt. While the 
revised Guidelines represent a more realistic response to 
presumed risk than the old ones, can we really expect more 
uniformity in the quality of IBC’s? 
The new requirements on the membership of IBC's are 
a good addition. I would suggest that NIH require that 
all IBC meetings be open (except when discussing information 
protected by law), and that the IBC be required to respond to any 
reasonable requests for information concerning institutional 
recombinant DNA projects. 
Concerning the membership of the RAC, which has been evolving 
in the right direction, I would add at least one member 
knowledgeable in large scale and mass production processes 
connected with industrial fermentations. 
General Considerations 
Except for the specific points which I raised, and the 
sections which I think need to be made more explicit, my 
principal overall concern with the revised Guidelines is 
not one of intent, or of content. In these respects the 
revised Guidelines represent a highly commendable document. 
[A-135] 
