COVINGTON & BURLING 
Donald S. Fredrickson, M.D. 
February 20, 1976 
Page Six 
7. I am uncertain whether other concepts were also 
included in the minutes of the drafting committee but were not 
incorporated into the guidelines themselves. The guidelines 
should be a self-contained document; the minutes have no official 
status. I would suggest that the minutes be reviewed in detail 
to make certain that additional material was not lost in this 
manner . 
8. I believe it would be helpful to state explicitly 
both that all grant and contract requests must contain a full 
analysis of the benefit/risk issues involved in the proposed 
experiments, and that this analysis will be made publically 
available . 
9. Public participation in decisions with respect to 
these experiments should be substantially strengthened. Unfortu- 
nately, there was no discussion of this specific matter during 
the meeting, and thus it is not feasible to offer concrete 
suggestions with assurance that they are practicable. It 
appeared to me that public representatives should be added to 
the NIH Advisory Committee which will revise and implement 
these guidelines (e.g., people with the sensitivity and stature 
of Mrs. Esther Peterson) and that public representatives should 
also sit on the local biohazard committees. It was also my 
impression that the function of the local biohazard committees 
should be substantially broadened, in the way that the functions 
of peer review committees for drug investigations and similar 
activities have been broadened in the past few years. On the 
other hand. Dr. Hogness raised with me after the meeting some 
potential practical difficulties with some of these suggestions, 
and I realize that further discussion might well lead to other 
means of obtaining this same objective. My principal concern is 
that this objective should be addressed and implemented in some 
way. 
10. Substantial reconsideration of the P-1 through P-3 
requirements should be undertaken. One possibility would be to 
collapse P-1 and P-2 into a single strengthened level of physical 
containment. A second possibility would be to upgrade some of 
the experiments to a P-3 or P-4 level until greater experience 
is obtained with them. 
In any event, it is quite clear to me that the present 
provisions in the guidelines do not adequately describe the 
intended requirements for P-1 through P-3. The experience of 
the Food and Drug Administration in issuing similar requirements 
for "good manufacturing practices" has been that general require- 
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