Dr. Donald S. Fredrickson 
Page Six 
F. Implementation 
I am quite concerned with what the guidelines say initially about 
implementation. Once a bureaucracy is established, it will be difficult 
to undo it. I hope and know you agree that we don't have to suffer the 
consequences of overkill. 
There are several concerns: 1) The needed expertise to review 
and judge questions of experimental design, hazard and what to do about 
each does not exist at too many institutions and, for some time to come, 
is likely to be uneven in quality at different locations. Therefore, empow- 
ering local committees to approve anything more than compliance with 
clearly written guidelines is fraught with danger; 2) The NIH guidelines 
should be clear and forceful enough to discourage local option to impose 
stricter or more lenient containment requirements. That would be most 
destructive; 3) Investigators should be encouraged but not required to 
seek advice from any experts on the local Biohazard committee. The in- 
vestigator should have the responsibility for experimental design and 
assessment of risk and level of containment (this is reviewed by study 
sections or in special cases by NIH committee) and the local committee 
should be apprised of these evaluations, and be responsible for monitor- 
ing the facilities, activities and keeping records of progress. Because 
of the uneveness I spoke of above, I can't see how local committees can 
"share responsibility" in evaluating risk and determining adequate con- 
tainment. 
It seems reasonable for the present to have investigators in the 
field obtain clearance from the committee concerning clones made earlier. 
This will not be a recurring function after the guidelines are promulgated. 
The suggestion of cooperation with EMBO along the lines you men- 
tioned at the top of page 10 seems excellent. 
I also concur with the suggestion about describing containment 
methods used in a proscribed project when the work is published. 
Is it within the NIH's purview to recommend committees for indus- 
try, agriculture and defense? I can't see any reason against such a rec- 
ommendation. 
I have written at much greater length than I intended but I hope 
these thoughts are helpful to you in resolving the issue and getting things 
underway. 
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