in molecular biology. Despite position restrictions, we are seeking 
more help for ORDA. There is no question, however, that the Guidelines 
administration will be revised along with the standards, in order to 
minimize delays and confusion. 
11. What would be the effects of legislation that extends the scope of 
this administrative process to all research in this country? How many 
individuals would be required for reviewing and approving initial 
Memoranda of Understanding and Agreement and any subsequent modifications 
in protocols? 
A. If prior approval were required at the national level for all 
recombinant DNA research protocols including modifications, whether 
major or minor, an enormous and unnecessary regulatory burden would be 
placed on the Federal agfency responsible for administration. The intent 
of the October 1977 document promulgating NIH procedures was to clarify 
when prior approval was required; for example, modifications in the 
source of DNA to be used or in the use of a new host-vector system. 
12. Have the newly implemented NIH administrative procedures taken away 
any of the responsibility for review from local committees? 
A. The document published in the NIH Guide to Grants and Contracts in 
October 1977 did not affect the authority of the local institutional 
biohazards committees under the current Guidelines. The original 
drafters of the Guidelines did not favor leaving responsibility for 
project review to the institutional committees. However, under considera- 
tion is a proposed revision to the Guidelines that would delegate 
authority to the local biohazards committees for review, approval, and 
monitoring of all recombinant DNA research, subject to NIH review, as 
explained in the answer to question 10. 
13. Is there any safety advantage to the U.S. public in having tighter 
controls on the research in this country than are applicable in other 
major nations? 
A. There is no safety advantage to having greater restrictions imposed 
on this research in the U.S. than are applicable in other major nations. 
Scientific evidence over the past year and a half has demonstrated the 
safety df much of the work involving recombinant DNA research with E). 
coli K-12. There is a general international scientific consensus, 
however, that safety standards and procedures should continue for 
certain experiments until scientific evidence is presented on the safety 
or demonstrable hazards involved in this work. 
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