Dr. Donald Frederickson 
Page 2 
B. Implementation 
This is an area in which I have serious questions about the adequacy 
of the proposed guidelines, as well as some of the alternatives discussed 
during the meeting. Perhaps it has been a naive dream, but throughout 
the last several years I have hoped that the required implementation 
and enforcement could be achieved with a minimum of centralized and 
overbearing bureaucracy. The atmosphere engendered by such a situation 
is not conducive to open, high quality scholarship. Furthermore, the 
evidence from unrelated areas does not afford much confidence in the 
efficacy of centralized, highly structured regulation. Nevertheless, 
the proposals contained in the guidelines seem to me insufficient in 
several ways. 
1. The structure which relies on the primary responsibility of 
the investigator, with existing study sections as review bodies, is 
basically sound and administratively efficient. It could, however, be 
more effective if the proposed role of institutional or regional 
Biohazard Committees was strengthened. The guidelines take a negative 
approach to the local Committees (p. 44) in stating that it is not their 
responsibility to determine required containment. Perhaps the guidelines 
should state that local committees may , with the investigator, undertake 
determination of required containment. This would still allow flexibility, 
and would permit the Committees to function in a variety of ways in re- 
sponse to particular local situations. In fact, I think it likely that 
universities and other institutions will insist on some official interest 
in these determinations since they will clearly bear responsibilities in 
case of possible injury. Given this inevitable interest of the univer- 
sities and institutions, it seems to me that their role, combined with 
that of the investigators, the study sections, and local committees 
affords a series of independent checks on compliance with the guidelines. 
2. The important role of peer pressure in compliance will be 
most effective if the recommendations concerning publication are 
heeded. Perhaps a special effort at soliciting the cooperation of 
the Journals could be made, by the NIH. 
3. I believe it essential that the NIH assume leadership in assuring 
that the guidelines apply to all possible situations, not just NIH grants. 
And this should be done simultaneously with your decision on the guide- 
lines. First, it must be clear that NIH contracts also will be covered. 
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