15 
Operational Difficulties in Implementing the Proposed Guidelines 
(1) Delegation of authority . Up until now, controls on recombinant 
DNA research have been based largely on principles of self-regulation and 
peer review. As noted above, experience during the past year at two 
prestigious schools has shown that irresponsible or thoughtless actions 
can occur under this form of control. However, the response of the NIH in 
the Guideline revisions has been to propose to enhance the responsibilities 
of local institutions rather than to balance or safeguard against such 
irresponsibility. At this time, I do not believe that sweeping delegation 
of authority for initial approval of experiments should be made from the 
NIH to IBCs. My comments above about the unrepresentative composition of 
IBCs, both to date and as contemplated under the revised Guidelines, are 
relevant here. In addition, the whole question of the most appropriate 
balance of authority between a central federal agency (which could assure 
that requisite technical and policy considerations are brought to bear on 
aspects of the regulatory process) and local IBCs (which could assusre 
sensitivity to local conditions and provide extended means of public par- 
ticipation in the regulatory process) needs to be further developed. 
The Guideline revisions require (FR 33085) that "the committee has 
the experience and the expertise- to assess the safety of proposed recombinant 
DNA research projects and any potential risks to public health and the 
environment." Again let me emphasize the distinction between risk and safety 
which I made above..- While I believe that IBCs can have the competence to 
assess safety, the assessment of risk is another matter. Risks generally 
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