72 
The key part of this is, of course, introducing it into a bacterium 
which can amplify and clone various segments, and thereby provide a vehicle 
for transmitting it to the outside. I think that is the hazard. 
DR. FREDRICKSON: Mr. Ladwig has a question? 
MR. LADWIG: In the guidelines there is not anything spelled out about 
what happens if somebody goes beyond the guidelines, and what if somebody 
gets really excited about what he is doing and goes past that, what has been 
outlined here. What kind of penalty clause is there going to be? Does he 
just lose his grant? Or is he getting involved in a criminal type area? 
Was any thought given to that in these guidelines, or is that not a 
question for this board. 
DR. FREDRICKSON: Dr. Stetten, would you or a member of the committee 
like to respond? 
DR. STETTEN: I believe it reflects the committee's belief that any 
significant alteration in the protocol from that upon which the approval 
was ordered must be reported back to the study section and re-evaluated. 
Of course, the NIH in general lacks an effective police arm, and pre- 
cisely how this can be enforced, I don't know. The only sanction that I 
know of that the NIH can ever exert, is to withhold funds. 
MR. LADWIG: But is that enough? 
DR. STETTEN: It is all we have got. 
DR. FREDRICKSON: I think, Dr. Stetten, that Mr. Ladwig' s question is 
a very good one, and I think that at some point in our discussion we will 
describe a little bit further for you the nature of our guidelines and 
where they might go. I think this is a part of your question. 
Mrs. Peterson? 
MRS. PETERSON: That relates somewhat to my question a little bit. I 
guess it is in two parts. First, are there any formal restraints now for 
all of this kind of experimenting and investigation that we have seen, and 
then the second part of that which would relate to it is I don't know what 
the ballpark is, I guess I should say. Are all these experiments only under 
grants from the NIH, or are people free on the side to go and experiment 
whenever they want? 
DR. FREDRICKSON: Dr. Jacobs? 
[213] 
