Dr. D. Frederickson 
-3- 
April 14, 1978 
Page 9 , part 5 : In this section the necessity to obtain approval at 
NIH level for changes in currently funded projects is excessively restrictive 
since even the most limited change in DNA, i.e., even one base pair change 
in a DNA segment (as specified in number 5) requires approval at NIH level. 
This restricts individual investigators and interrupts the traditional 
flexibility of the grant system which allows changes and modifications to 
experiments in progress according to the acquisition of new information. 
The requirement to wait and refer every change to NIH and to wait for an 
approved MUA to return imposes exceptional delay. 
We offer these suggestions, particularly the plea for genuine juris- 
diction by local committee, in hope that a more effective system of review 
can be initiated. It is our fear that lessening of authority and discretion 
of local committees will lead to frustration by investigators and reviewers 
alike. In addition, an effective review process should be consistent with, 
rather than contradictory to, the intrinsic nature of scientific work. 
■James E. Cleaver, Ph.D. 
Chairman 
Biosafety Committee 
EH 
CC; Dr, W. Gqrtl^nd 
Dr, D, Kamely 
Vice Chancellor Cha,tep 
Chancellor Sooy 
[Appendix A — 278] 
