272 
Turning to procedures, I have been keenly disappointed in the way that 
these proposed revisions have been brought forward. I think there has been 
undue, unseemly, and totally unnecessary haste in the way it has been done. 
The preamble to the September 27 document did not state what the proposed 
revisions were with clarity and in a way that could be understood by people 
like myself; did not explain the reasons for them — for example, the recent 
scientific data which greatly alleviate some of the original scientific 
concerns; did not put on display and offer to send to anyone the transcript 
of the Falmouth Conference, which could have been obtained; did not, for 
example, make available the four pieces of unpublished data on which reliance 
was made. I don't think that was necessary. It could have been done. After 
all, part of that exercise was done in the Green Book, and if it could be done 
for the Green Book, presumably it could be done for the Federal Register . 
I do have a very specific recommendation in connection with that. I 
think that problem can be overcome. I would urge that you consider publish- 
ing a new notice in the Federal Register which would state what I think should 
have been stated here, and give an additional 30 days for public comment on 
the additional information that is still at this point not yet available. 
The problem I had, for example, with the Falmouth Conference was not that 
the whole world wasn't invited. The problem is that once it was decided to 
use that conference, and its proceedings and data, for public regulatory 
purposes (and I will come back to the word "regulatory" in a moment) — once 
that was decided, then there was an obligation to make that conference and all 
of the information in it available to the public so that it could scrutinize 
it and determine the relevance itself. 
Now, the use of the word "regulatory" there brings me back to another 
point that I made as strongly as I could some 18 months ago. That is that 
these are regulations, these are not guidelines. I think that probably more 
confusion and harm has been done by calling them guidelines than has been — 
well, maybe it may take years to overcome that. 
In my letter back in February of '76, I said, "I recognize that the 
scientific community does not like the term 'regulation' and, indeed, that 
NIH abhors the idea that it might in any way be an enforcement agency. If it 
is useful from a psychological standpoint to preserve this fiction, I see no 
objection to continuing to call these requirements 'guidelines.' At the same 
time, however, no one should be misled into believing that they will not be 
rigidly and completely enforced through the grant and denial of NIH funds." 
Well, from what I am seeing now, I would change my view on that in one 
respect. I think there is affirmative harm in calling these "guidelines," 
because it is possible that people in universities may take the word "guide- 
lines" seriously , and say these are not necessarily intended to be followed, 
but simply are intended to be persuasive. That may indeed have happened at 
Harvard, or in the Miles situation, or elsewhere. Moreover, it has resulted 
in what I believe — and I will go on to this — to be very severe procedural 
[ 476 ] 
