1751 N STREET. NW WASHINGTON. DC 
20036 202 872-0670 
CENTER 
FOR 
LAW 
AND 
SOCIAL 
POLICY 
October 25, 1978 
Dr. Donald S. Fredrickson 
Director 
National Institute of Health 
Bethesda, MD 20014 
Dear Dr. Fredrickson: 
James N Barnes 
Randy I Bellows# 
Nancy Dull Campbell 
Clihon E Curtis 
Roger S Foster 
L Thomas Galloway 
John W Garland 
Marcia D Greenberger 
Margaret A Kohn 
J Davitt McAteer# 
RiChardS McMHIm 
Leonard C Meeker 
Sanford A Newman# 
Carol Oppenheimer 
Marilyn G Rose 
Andrew Jay Schwartzman 
Herbert Semmel 
Harvey J Shulman 
AltO»n#w #1 L#i# 
• Not #dmrtte<J #» o c 
We are writing to expand upon our earlier comments 
regarding enforcement of recombinant DNA research guide- 
lines. In our last letter, we suggested a number of 
alternatives to the necessary but inflexible sanction 
of fund termination. In addition to those alternatives, 
the Guidelines should provide for local sanctions to be 
imposed by the institution against the principal investi- 
gator or other researchers. 
It is also imperative that the Guidelines: 1) explain 
what steps must be taken to notify NIH of violations; 2) explain 
the impact of violations upon ongoing research; 3) establish 
procedures and time limits for resolution of complaints; and 
4) provide for enforcement by private parties. 
Violations of the guidelines will be discovered either 
by the researchers themselves, by the institution at which 
the research is being conducted, by NIH review of IBC 
decisions or by NIH investigation of complaints from 
other sources. The Guidelines should require the principal 
investigator and other researchers immediately to notify 
the IBC of any violations and stop operations until the 
violation is corrected. Similarly, when violations, are 
discovered either by the institution or by NIH, immediate 
cessation of operations should be required. It would be 
foolhardy to allow operations to continue pending completion 
of administrative procedures. While it may be possible for 
NIH to identify some specific minor technical violations 
which would not warrant cessation of operations in cases 
where such a cessation would jeopardize major research 
investments, such exceptions should be established only 
after additional notice and comment, and should be clearly 
described in the regulations. Indeed, even if it is decided 
that additional flexibility is needed to permit continuation 
of some experiements in the face of violations which do not 
fall within such express exceptions, the Guidelines should 
at a bare minimum provide that such continuation may be 
permitted only if the Director of NIH certifies that continu- 
ation poses no danger under the circumstances. 
[A-437] 
