DeWitt Stetten, Jr. 
Page 4 
March 26, 1976 
(3) Representing the United States in informational 
exchanges and negotiations with scientists or 
governments in other countries. 
(4) Obtaining adherence to the guidelines in all 
recombinant research in any kind of institution or 
by any person in the U.S. 
This problem cannot be evaded. The public 
and its representatives in government will prob- 
ably believe that education and peer opinion alone 
are inadequate protection. The possibility of li- 
censing of laboratories or researchers, or materials, 
has been suggested. Licensing is a severe require- 
ment because it implies approval or nonapproval; and 
hence possibilities for delay, frustration of sci- 
entific initiative and progress^ and bureaucratic 
limitation of freedom. There are other alternatives, 
less severe and less likely to impair freedorr\ in 
research. Two deserve reference as possibilities: 
One is a monetary penalty for violation of 
the guidelines. The other is a registration re- 
quirement, sanctioned by a monetary penalty. A 
registration requirement would have two advantages: 
it would provide knowledge in the science commun- 
ity of all recominant reserach under way or to be 
undertaken; it would be an effective means of ob- 
taining compliance with theguidelines . 
The registration would not delay research, nor 
require approval , and could be made on a rather 
simple form. It would tell the nature of the pro- 
ject, the materials used and the laboratory type; 
it could also certify that all requirements in the 
guidelines were known and would be followed. 
(b) It is not likely that the policy objectives 
can be achieved without additional administrative 
arrangements. Immediately, voluntary adoption of 
guidelines by other agencies for their grants or 
inhouse research, or requirement by executive order 
of use of the guidelines, may be achieved. But 
this would not reach research conducted without 
the aid of national funds. Moreover, the agencies 
are not likely to accept voluntarily guidelines, 
and amendments thereof, for a long period without 
their participation, or extension of NIH ' s authority. 
[ 505 ] 
