Donald S. Fredrickson, M. D. 
September 25, 1978 
Page Two 
ponderous as to lessen initiative and motivation for the conduct 
of such work. Furthermore, regulation of recombinant DNA research 
should not become the precedent for regulating other areas of 
basic scientific inquiry. Therefore, NIH's guidelines should be 
kept to a minimum with sufficient flexibility to adapt rapidly to 
the needs of creative research endeavors. 
We believe that these proposed revised guidelines are a 
substantial improvement over the original 1976 NIH recombinant DNA 
research guidelines. As the preamble to the proposed guidelines 
indicates, new information about the risks and the benefits of 
recombinant DNA research is becoming available at an ever increasing 
rate. More research is providing experience on techniques for both 
physical and biological containment of recombinant DNA molecules. 
In fact, certain of the scientists who originally expressed grave 
concern about recombinant DNA research and its potential impacts 
on the environment have indicated that their concerns have lessened 
based upon the experience of recent years. 
Therefore, the increased flexibility at the local and at the 
national level to modify procedures under the guidelines is encouraging 
We believe that it is appropriate to provide the Director of NIH with 
the flexibility to exempt certain recombinant DNA research from 
the guidelines as well as allowing certain prohibited research 
to take place after an individual case by case analysis of risks 
and benefits. We also believe that the reliance on local institu- 
tional bio-hazard committees is proper based upon their performance 
in supervising viral research. 
The American Medical Association believes that regulation of 
basic research should be kept to an absolute minimum in order to 
prevent limitations on free inquiry and scientific freedom. When 
certain research presents an unusual risk of hazard to the public, 
only the minimum controls necessary to protect the public should 
be imposed. We believe that the proposed revised guidelines for 
recombinant DNA research meet this criteria. As new information 
becomes available concerning the risks and benefits of recombinant 
DNA research, we would expect continued modification to the guidelines 
to insure that they represent the minimum amount of control necessary 
to protect the public based upon the state of the art of recombinant 
DNA research. 
Very truly yours, 
f J James H. Sammons, M. D. 
[A-363] 
