1751 N STREET. NW WASHINGTON. DC 20036 
202 872 0670 
CENTER 
FOR 
James N Barnes 
Randy I Bellows • 
Nancy Duff Campbell 
Clifton E Curtis 
Roger S Foster 
L Thomas Galloway 
John W Garland 
Marcia D Greenberger 
Margaret A Kohn 
J Davitt McAteer • 
RichardS McMillin 
Leonard C Meeker 
Carol Oppenheimer 
Marilyn G Rose 
Herbert Semmel 
Harvey J Shulman 
Attorneys at Law 
• Not admitted mDC 
Dear Dr. Fredrickson: 
LAW 
AND 
SOCIAL 
POLICY 
Dr. Donald S. Fredrickson September 25, 1978 
Director 
National Institute of Health 
Bethesda, MD 20014 
We submit for your consideration the comments of the 
Consumer Coalition for Health on the proposed revisions in 
the Recombinant DNA Research Guidelines. 
The Coalition's comments focus upon issues of public 
participation in decision-making. Because these issues recur 
throughout the health system and because they are so central 
to the purposes of the Coalition, it has adopted an official 
public participation policy, and directed its officers to 
effectuate that policy. The enclosed comments a>~e submitted 
pursuant to that directive. 
In addition, we would like to add on our own behalf as 
individuals a comment regarding section IV-D-1, which deals 
with enforcement of the Guidelines. Our suggestions stem 
from considerable experience regarding enforcement problems, 
and we hope that you may find them useful. 
The only enforcement mechanism which NIH appears to have 
considered is the possibility of suspending, limiting, or 
terminating research funds to non-complying institutions. 
Fund termination is an essential but inherently inflexible 
remedy which is at once too strong and too weak to carry the 
full burden of enforcement. On the one hand, it is a drastic 
sanction which often hurts not only the recipient of federal 
funding but also the public interests that funding was designed 
to serve. As a result, some violations which are significant 
and may be dangerous but which are not thought sufficiently 
grave to warrant termination, may be allowed to continue 
without any sanction whatever. 
On the other hand, fund termination and specific enforce- 
ment proceedings are too weak in that they are purely prospective 
in effect. NIH concedes that it does not have the resources 
to effectively oversee compliance, and that primary enforcement 
responsibility must be placed on the recipient institutions 
themselves. Assuming, however, that violators will be given an 
opportunity to come into voluntary compliance before enforcement 
[A-374] 
