190 
and Agreement has been submitted and approved by the NIH. The latter foot- 
note is used in cases where the investigator may be proposing recombinant 
DNA research in a future year of a proposed project period, or, for example, 
where a certain facility is not quite ready. 
In October of 1977 all of these requirements were stated in the NIH Guide 
for Grants and Contracts . So I think that is a summary of the implementation 
procedures chronologically that we have at the NIH, and where we are right 
now. 
DR. FREDRICKSON: I suspect that we have been overwhelmingly bureau- 
cratic, and I would offer the Committee an opportunity for clarification 
if it wanted to get into any issues before we have Dr. Walters. 
Dr. Sturgis. 
DR. STURGIS: Who from NIH has the responsibility of this independent 
check of the physical and biological containment to which you referred? 
DR. GARTLAND: Well, there are checks at a number of levels. The first 
check comes at the level of the study section, which makes an independent 
assessment of what they feel is required and whether the investigator meets 
that. Then there is an additional independent review in the Office of Recom- 
binant DNA Activities, where, prior to award, a determination is made whether 
the application is in compliance. So there are a number of levels of review. 
DR. FREDRICKSON: Dr. Sinsheimer. 
DR. SINSHEIMER: As a person who served on one of these biohazard com- 
mittees until fairly recently, I was always troubled by the phrase, "monitor 
the research to be conducted in the laboratory." I wonder if you have any 
definition of what is really meant by that. 
DR. GARTLAND: There are two general types of monitoring, one of which is 
the formal monitoring, which is the requirement that at every 12-month inter- 
val there has to be a re-review of a Memorandum of Under standing and Agree- 
ment by the biohazards committee. There is this second area of ongoing 
monitoring, which I suspect is what you are referring to, which is not very 
clearly specified in the Guidelines. 
DR. FREDRICKSON: Dr. Neel. 
DR. NEEL: I am once again struck by the paradox of the very elaborate 
procedures that you have described, and that those of us in universities 
are so familiar with, and the lack of any procedures for the pharmaceutical 
industry. What is the thinking about how they are brought into the fold, 
if not through national legislation? 
DR. FREDRICKSON: Dr. Neel, I wonder if I might ask us to set aside that 
question and return to it? It is, of course, an important question, but it 
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