COVINGTON 5, BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Fourteen 
appears to me within the NIH authority to require that all 
research on recombinant DNA molecules conducted in any 
institution that receives any NIH money whatever must, as 
a condition for receiving any NIH money (including money 
used for purposes other than research on recombinant DNA 
molecules), be in compliance with the Guidelines. This 
would mean that no institution which undertakes any research 
on recombinant DNA molecules could obtain any money for any 
purpose whatever from NIH without agreeing to follow the 
Guidelines, even if the research on recombinant DNA molecules 
itself was financed from non -government sources. Since 
both industry and other private research organizations have 
stated that they intend fully to comply with the Guidelines 
with respect to all research on recombinant DNA molecules, 
such a provision would work no hardship whatever and would 
have the salutary benefit of reassuring the public on this 
matter. 
8. There appeared to be a scientific consensus 
at the December 1977 meeting about the need for greater 
flexibility to permit experimentation on animal viruses. 
I obviously am not qualified to offer any judgment on this 
issue. The public and scientific concern about SV-40 virus 
which I expressed in my letter of February 20, 1976, leads 
me to suggest that some care must be taken in differentiating 
between different animal viruses. Although classification 
of this experimentation in P4 should not be done for "politi- 
cal" reasons, the depth of prior public concern about this 
matter because of the charge that the SV-40 contamination of 
polio vaccine did in fact result in harmful effects in 
children requires, in my opinion, substantial scientific 
discussion and justification before reclassification of that 
particular experimentation to P3 is undertaken. Ultimately, 
scientific judgment rather than "political" considerations 
must prevail, but quite clearly the "political" concerns 
must be taken into account in determining the extent and 
depth of scientific justification needed before reclassifica- 
tion can be achieved. 
B . Procedural Issues . 
The Guidelines exhibit remarkable scientific 
ingenuity. This undoubtedly reflects the extraordinary 
knowledge and background of the scientists who contributed 
to their development during the past few years. 
[Appendix A — 252] 
