186 
The meeting was called to order at 9:00 a.m. , December 16, 1977, by 
Dr. Fredrickson, Chairman, presiding. 
DR. FREDRICKSON: Good morning, ladies and gentlemen. We return to our 
agenda on schedule, and we will save a good deal of the first part of it by 
omitting the summary and comments by the Director. Today we are going to take 
up that portion of the Guidelines for which revision has been suggested, and 
which begins, for matters of reference, on Federal Register page 49604, column 
one — that section dealing with roles and responsibilities. 
In one sense the NIH Guidelines are in two parts. They attempt to 
provide a set of standards for the use of recombinant DNA techniques, and 
they deal with matters of implementing those standards, parochially cast in 
the language of the Guidelines, referring only to NIH grantees. This imple- 
mentation section, in a way, is separate, but by no means separable from 
the remainder of the Guidelines. It should be noted, however, that the other 
principal conductors and supporters of this kind of research in the Federal 
Government, which to date are the National Science Foundation and the Depart- 
ment of Agriculture, have their own adaptations of this implementation sec- 
tion, although I think in general they adhere very closely. 
Nevertheless, there is reference to study section review, the review 
of the intent of the grantee, and so forth, which is carried out according 
to the practices and styles of those supporting agencies. To a certain 
extent, as more and more operators representing different sectors of the 
research community, profit as well as non-profit, should come under the 
coverage of the Guidelines in the sense of standards, so too will the imple- 
mentation section have to be adapted to that responsibility. 
Today we thought we would begin not exactly as defined, but rather before 
we ask Dr. LeRoy Walters to speak on the proposed revisions to this section — 
to summarize them — that we first ask Dr. William Gartland, who is the head of 
the Office of Recombinant DNA Activities (ORDA) at NIH, to outline for you in 
brief terms the administrative practices for implementation as they exist at 
NIH, and he will also attempt to do this in somewhat of a chronological order, 
as you will see how these administrative practices have evolved over the last 
year or so since the Guidelines were put in place. 
Following Dr. Gartland we will not query him at that point or take time 
for discussion, but move to Dr. Walters. Dr. Gartland, in other words, is 
going to provide a backdrop to put what Dr. Walters has to say in somewhat 
better perspective. 
Dr. Gartland. 
Oh, may I also announce that all of the materials which you didn't have 
when you arrived yesterday and which were referred to during the meeting, I am 
told, have been duplicated and are available in Room 8. 
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