GEORGETOWN UNIVERSITY LAW CENTER 
WASHINGTON. D. C. 20001 
Patricia King iqto 
ASSOCIATE PROFESSOR OF LAW January 4, 17/0 
Dr. Donald Frederickson 
Director, National Institutes of Health 
Department of Health, Education and Welfare 
Bethesda, Maryland 20014 
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Dear Dr. Frederickson: 
At your request I am putting in writing my comments concerning the proposed 
guidelines on recominant DNA research. At the outset let me say that the NIH 
is to be congratulated for doing such a fine job in handling the recombinant 
DNA issue. Your efforts have certainly helped to allay fears and concerns about 
pursuing this line of scientific inquiry. 
However, if the public and the scientific community are to continue to 
have faith in NIH policy with respect to recombinant DNA research, your policies 
and processes must be improved. They must be improved, because it appears to me 
that confidence in the approach adopted by NIH is largely dependent upon the credi- 
bility of the process that produces the guidelines and revisions. As you are aware, 
I was particularly concerned with the process by which these particular revisions 
were generated. With these general remarks as background, I offer the following 
more specific comments: 
1. The NIH should utilize whatever authority it presently has, or request 
the Congress to grant it such authority, to extend the coverage of the guidelines 
to non- government conducted or sponsored research. 
2. The roles and responsibilities of the NIH committees involved in the 
decision-making process need re-evaluation. 
The structure and operation of the DNA Molecule Program Advisory Com- 
mittee should be re-examined. Consideration should be given to changing its 
composition (I understand it has only two "public" members), and its method of 
operation. I believe that the committee should operate openly, hold public 
hearings and insure that the data forming the basis of its conclusions is 
available to the public. It should in any case have its method of operation 
publicly announced, and be immune from concern about the "political" wisdom 
of its conclusions. 
The role of the Director's Advisory Committee should also be reviewed. 
Although this committee may have many useful purposes, its current structure 
and format are not sufficient in themselves to inspire public confidence. Its 
members (at least some of them) cannot give informed and credible advice based 
upon a day and a half of hearings and reports. 
3. The NIH in guidelines, supplementary issuances or programs should 
promote or take the lead in standardizing such things as training of laboratory 
workers, equipment design, safety procedures, test procedures, operations of 
biohazard committees, etc. 
[Appendix A — 177] 
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