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how basic research in this area is to be carried out. 
As one who has been through each phase in the formulation of the 
proposed guidelines, I cannot emphasize too strongly the tendancy to dic- 
tate how experiments must be carried out in order to make the document 
specific, i.e., "to plug loopholes". Because this tendancy violates a 
basic principle of good research, particularly as the hazards that induce 
it are speculative, it can be respected and therefore be useful only if 
the document is considered as a guide. If on the other hand it is considered 
as a set of rules by the NIH, it will be treated with disrespect, and, in 
my opinion, its inherent discrepancies will become a target for legitimate 
ridicule and confrontation. 
The containment principles in the guidelines will be effective only 
if they earn the respect of the scientists carrying out the experiments 
and this respect cannot be gained by fixed rules that in many instances 
appear arbitrary. By contrast, it can be gained if NIH makes clear that 
it wishes to involve these scientists in the decision making process, ac- 
knowledges possible discrepancies, and will conscientiously consider al- 
ternate evaluations and procedures. Hence, Peter Hutt's contention that 
it is fictional to consider the document as a set of guidelines rather than 
rules is an inversion; rather I think it is a figment of legalistic imagina- 
tion to believe that effective safeguards can be attained by the imposition 
of a set of fixed rules applied to such a vast area of basic research, and 
in the absence of demonstrated hazards. 
III. Finally, I believe it is vital that the proposed guidelines be 
accepted by the NIH without further delay. The previous delays have en- 
gendered a confusion that has been harmful in many ways. Scientists wish- 
ing to carry out certain experiments have not been able to plan the appro- 
priate safeguards, or feel they have been misled in regard to the plans 
they have made. And I should imagine that the concerns of the public and 
Congress are exacerbated unnecessarily by continued delay. Given that they 
are acknowledged as approximations and are considered as guides, not rules, 
I think the guidelines should be promulgated in their present form immediately. 
I do not think that revision of the containment conditions recommended for 
the different classes of experiments should be considered at the next meet- 
ing of the NIH Recombinant DNA Molecule Program Advisory Committee in April, 
much as I and others on the committee would like to advocate certain changes 
in the near future. Rather, I think the wisest course is to proceed with 
the present guidelines along the lines given in I and II, above, and allow 
some time for the development of the flexible procedures we require^ and for 
everyone, including the study panels, to become acquainted with the guide- 
lines . 
I hope these comments are of some use to you. I have enclosed a copy 
of the talk I gave to your Advisory Committee on Feb. 9, 1976, for the record. 
Cordially , 
fJ 
David S. Hogness 
DSH:m 
[461] 
