UNIVERSITY OF CALIFORNIA 
SAN FRANCISCO 
ACADEMIC SENATE 
April 14, 1978 
Dr. Donald S. Frederickson 
Room 124, National Institutes of Health 
9000 Rockville Pike 
Bethesda, Maryland 20014 
Dear Dr. Frederickson: 
RE: Recombinant DNA approval procedures as described in 
NIH Guide for Contracts 6 Grants, February 15, 1978 
The NIH Guidelines for Recombinant DNA are a unique example of 
self -regulation within the scientific community. Investigators have, 
of their own volition, called attention to potential hazards in biological 
research and instituted a procedure of self control to regulate the 
limits within which safe experimentation can proceed. We, as members of 
the UCSF Biosafety Committee, wish to express concern that there are now 
cwo divergent systems to which attention must be paid. On the one hand 
the NIH Guidelines dictate the general areas of classification of physical 
and biological containment and prescribe the use of the certified vectors 
and host cells by which research may be locally regulated. On the other 
hand the procedural mechanism by which these guidelines are administered, 
as described in the NIH Guide for Grants and Contracts, Volume 7, Number 3, 
February 15, 1978, establish a restricted centralized system of regulation. 
Our concern is that although the original intention of the NIH guidelines 
was to depend upon the self -regulatory concept underlying the peer review 
system of scientific investigation, in practice the Guide for Grants and 
Contracts sets out a procedure which removes self -regulatory authority from 
local committees and centralizes power for recombinant DNA experiments in the 
hands of a small number of people in the Office for Recombinant DNA Activity 
(ORDA) in Washington. No experiments in recombinant DNA can be carried 
out on federally-funded grants without the prior approval of the individual 
experiments by ORDA, NIH. The centralization of such power undermines 
both individual investigator's responsibility and Biosafety Committee 
responsibility. In effect, the local committee is now required to act as 
a dummy committee since local approval of any recombinant DNA experiment 
has no authority. The local committee can only funnel a request to ORDA 
and await their disposition. The frustration of this situation has already 
led to one resignation from our committee with threats of more resignations. 
There are already examples of self -regulatory committees that have 
local authority to deal effectively with more serious and obvious human 
hazards than recombinant DNA, e.g., radioisotope committees and human research 
committees. These are accorded considerable authority and their determinations 
are challenged at the national level only in the most obviously problematic 
cases. In the case of research involving human subjects the Office for 
[Appendix A — 276] 
