280 
With respect to whether or not you intend to have guidelines as op- 
posed to regulation, I think the process might have been helped, or at 
least there may have been a greater sense of a credible process in the mind 
of the public, if the NIH would articulate standards. You don't have to 
make them regulations. But I have in mind, for example, if you did more 
articulating what kind of training you wanted, how to monitor, how you 
would like a biohazards committee to monitor, how you want information 
conveyed to workers, how you want to monitor health in the laboratories, 
then that would have been helpful. They don't have to be mandatory, but 
it seems to me if you are giving guidance, the more specific guidance you 
can give, the better your process. 
I have some procedural concerns in other areas, I am not opposed to 
having a classification and a definition of novel versus non-novel experi- 
ments. I have a great deal of difficulty saying that that should be done 
when one does not have a procedure for establishing what are non-novel exper- 
iments. Now, I heard last night how difficult that was. I am not suggesting 
standards, I am now talking about procedures. It might be helpful in your 
Guidelines to say what procedure you are going to set up to evaluate experi- 
ments and to have them excluded, if you can't at this time set down standards 
by which you will decide that some experiments are non-novel. I think that 
that will inspire confidence, because otherwise people will be fearful that 
it is going to be a one-on-one ad hoc process without any parameters. So I 
am really asking for a few parameters in terms of saying how you intend to 
go about deciding what is novel and what is non-novel. 
I might also say that I endorse strongly the ability of the Director 
to create exceptions to those experiments that are prohibited. I might also 
stress, as I did yesterday, however, that I at least would like to see that 
discretion exercised in conjunction with some group, not necessarily this 
Committee, either, but some group that would operate in public and would give 
you at least a consensus view in public, or at least where the public could 
participate in the open, and I would leave it to the Director to make an 
appropriate decision. You might have to do that in conjunction with other 
agencies as well as the public. I think I indicated what I had in mind the 
other day. 
I would also urge, as I did this morning — and I am happy, so I would en- 
dorse what you have already suggested, Dr. Fredrickson — that the institutional 
assurance, as I understand it, be changed so as to apply to institutional 
research that is not NIH-sponsored , if that can be legally done. 
I have no recommendations with respect to industrial research that is 
not conducted in institutions, perhaps because I am not sure what authority 
we have to do anything about that anyway. To the degree that you have some 
authority that I am not aware of, I think it should be exercised. I think it 
would be a pity to have to set up a separate system parallel to the one that 
NIH has established to monitor a small — in terms of percentage of total 
research — body of research, but a body of research that at least may in the 
public mind continue to promote public fears and misunderstanding about this 
entire area. 
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