COVINGTON & BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Three 
than the initial caution in use of an experimental new drug 
is made foolish by subsequent thought and information demon- 
strating that it is a safe and effective therapy. Public 
policy dictates caution in the face of scientific uncer- 
tainty, particularly when faced with the possibility of 
consequences, however remote they may be, that could have 
enormous public impact. I have heard no one suggest, for 
example, that all of the elaborate precautions taken upon 
the return from the first moon exploration, to assure that 
no virulent organisms would be brought back, were a foolish 
and wasteful extravagance, in light of our present knowledge 
that they were totally unnecessary. 
In summary, the public policy issue is not, and 
never has been, whether there is either evidence or even a 
well-founded apprehension that research on recombinant DNA 
molecules is dangerous. Rather, the issue is one of pro- 
ceeding gradually, on the basis of accumulating knowledge 
and experience which provides ever greater assurance of safety 
in order to satisfy the public that there are no unreasonable 
risks involved. 
II 
Throughout the meeting, and indeed in all of the 
discussion I read and hear about this research, there appears 
to be enormous confusion about the type of "risk" that must 
be considered in evaluating the propriety of research on re- 
combinant DNA molecules. It appears to me that there are 
four risks involved (one of which is simply another way of 
looking at the benefits to be derived from this research) . 
First, there is the risk to an individual labora- 
tory worker. Such risks occur frequently in all types of 
scientific research. If this were the only risk involved, 
it might well be handled simply by obtaining the informed con 
sent of all those exposed to the risk in the laboratory. 
Certainly, public concern about this type of very narrow 
risk would be far less than about risks that are potentially 
of broader applicability to the public at large. 
Second, there is the theoretical risk of unleashing 
a new form of pathogen that would result in an epidemic of 
significant public magnitude. This type of risk, quite 
obviously, cannot be handled by informed consent. It is 
[Appendix A — 241] 
