29 
So I urge that everyone here really take it to heart in their comments 
that these Guidelines not be finally revised until all the language is gone 
over in such a way as to make it meaningful. It does us no good to have 
revised Guidelines that cannot be held up as a standard for later action. 
I urge that especially if these NIH Guidelines or the authority of NIH is 
to be extended to industry, and to be kept in NIH in any legislative action, 
it will be essential to show that these Guidelines can serve as an enforce- 
ment manual. 
The second point I would like to make--which Nancy had mentioned — is 
about the inclusion of public participation in the process. I think it is 
unreasonable to expect, even though I hope it will be true, that advisory 
committees are in a position to really step in and make broad changes in 
suggested policy. You are being given, a few days before you get here, a 
bunch of information, Guidelines that were revised after days of delibera- 
tion, and it is really just unrealistic to expect substantial changes to be 
made through that way. The DNA Advisory Committee — and I will talk about 
this in more detail later — only has two out of 14 public representatives. 
It is unclear, even to some of the people in the Office of Recombinant DNA 
Research, how many of these members have been involved in recombinant DNA 
research themselves. It is clear that there is no adequate public repre- 
sentation on that Committee. It is also clear that there is nobody there 
who has experience in writing regulations, or writing legislation that 
later has to be transformed into law. That might be some type of expertise 
that should be included on the Committee. I think that we should have 
public representation on the subcommittee, the recombinant DNA subcommittee 
that is responsible for revising these Guidelines. But despite what I have 
said, I would urge you all to try and make as much as you can — the public 
representatives here — as much as you can of the opportunity that has been 
given you, and to strongly critique and go over what is being presented. 
Thank you. 
MR. HELMS: I might ask you the same thing that we asked Ms. Pfund, 
if you would be kind enough to submit some language that you think would be 
more appropriate and more enforceable. That might be useful to review. 
MR. DACH : I would be glad to. 
DR. FREDRICKSON: Dr. Gustafson. 
DR. GUSTAFSON: I have a question, I think for Dr. Fredrickson as well 
as for you. I think that there is a difference between guidelines and law, 
and that the intention of a guideline is to put more responsibility on the 
primary agents involved in the research, and try to claim some self-disci- 
pline on their part, whereas the intention of law is to use external force 
to put pressure on things. 
Now, I would like to ask Dr. Fredrickson first, if I may, is that 
a meaningful distinction in the eyes of the NIH and the people who have 
developed these? 
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