COVINGTON 5. BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Eight 
V 
As stated in my letter of February 20, 1976, these 
Guidelines should properly be regarded as "regulations," 
which impose substantive obligations upon researchers work- 
ing pursuant to NIH grants and contracts. In that letter I 
said that "No one should be misled into believing that they 
will not be rigidly and completely enforced, through the 
grant and denial of NIH funds." I also pointed out that, 
from a legal standpoint, "there is a substantial possibility 
that a court would determine that these guidelines may not 
be enforced by NIH even for funding purposes unless they are 
proposed for comment and adopted through publication in the 
Federal Register." 
Some of the concerns that I perceived at that time 
are now becoming far more troublesome. By persisting in 
calling these "Guidelines," it appears that some people may 
be misled into believing that in fact they will not be 
rigidly and completely enforced. One can hardly blame re- 
searchers from taking this document at face value, i.e‘. , by 
interpreting them to be merely "Guidelines" and not be be 
legally binding regulations. I find it difficult, as others 
must, to reconcile your statements that these are mere "Guide- 
lines" with your statements that all NIH-supported researchers 
must comply with them. 
I therefore believe that it is time to stop this 
pretense. Calling them "Guidelines" has done far more harm 
than good. They should, in my judgment, forthrightly be pro- 
posed and promulgated as formal binding regulations on the 
basis of which NIH funds will be granted or denied, and with 
which all NIH-supported research must comply. 
In February 1976 I recommended that these require- 
ments be promulgated as legally binding upon all research on 
recombinant DNA molecules in this country pursuant to Section 
361 of the Public Health Service Act, 42 U.S.C. 264, and I 
reiterated that viewpoint at the December 1977 meeting. You 
stated, at that time, that the Interim Report of the Federal 
Interagency Committee on Recombinant DNA Research, dated 
March 15, 1977, was not sanguine about the use of Section 361. 
The wording of that Report (at page 35) is as follows: 
[Appendix A — 246] 
