The current Guidelines provide little discretion for considering possible 
modification of these standards for individual experiments. Under the 
proposed revisions of the Guidelines currently under consideration, such 
discretion would be provided in conformance with certain standards and 
procedures. For such purposes, there will be a review of individual 
cases by the NIH. 
10. Is it correct that the newly implemented NIH administrative regula- 
tions require that approval be obtained from the Office of Recombinant 
DNA Activities in order for a scientist to carry out minor modifications 
of an experiment protocol, regardless of the level of risk involved in 
the experiment? How many people in the Office of Recombinant DNA 
Activities are involved in reviewing such requests? What are the 
qualifications and training of these persons? What is the "turn-around" 
time for decisions of this type to be made (range and average)? Is it 
true that some research is being brought to a halt because the awarding 
of scientifically approved grants is being delayed by the NIH by the 
current administrative process? 
A. In October 1977, a document was published in the NIH Guide to Grants 
and Contracts to clarify the roles and responsibilities of the NIH and 
local institutions for the implementation of the NIH Guidelines. The 
document was not intended to require NIH approval for all modifications 
of a research protocol, although it could be read that way literally. 
NIH has received a number of letters requiring clarification of what 
modifications would require prior approval, and we are considering these 
requests as part of our revisions to the NIH Guidelines. Indeed, a 
possible revision is one that would permit research to proceed once the 
local institutional biohazards committee has given its approval. Actions 
by the IBC, however, will be reviewed at the NIH to ensure these actions 
are in compliance with the Guidelines. It will be the responsibility of 
the local institution and the principal investigator to modify the 
protocol if the NIH determines standards for the Guidelines have not 
been met. 
In terms of current NIH implementation, all new grant applications go 
through a nine-month process of evaluation by the NIH peer review system. 
Review of Memoranda of Understanding and Agreement for grants involving 
recombinant DNA experiments by the Office of Recombinant DNA Activities 
(ORDA) takes approximately two to five days. In circumstances where 
ongoing research grants are being modified for purposes of recombinant 
DNA research, review by ORDA generally is completed in two to five days. 
However, there have been unfortunate delays, often of several weeks, 
sometimes up to two months, before the modified protocol is transmitted 
from the local institutions through the individual Institutes of the NIH 
prior to receipt by ORDA. Currently, two individuals are responsible 
for reviewing all MUA’s in ORDA. Both are scientists with a background 
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