Dr. Donald S. Fredrickson 
November 30, 1977 
Page Two 
other ambiguities in the guidelines or deficiencies in procedure have 
been the subject of complaints or inquiries to NIH? How have these 
problems been corrected? 
Second, it is obvious that no one will be held accountable if no action 
is taken with respect to alleged violations of the guidelines. Accord- 
ing to your testimony, NIH officials first learned of the UCSF incident 
from inquiries by the reporter for Science . Nonetheless, no form* 1 
inquiry was made to UCSF until October, after publication of the 
Nicholas Wade article. Finally, in characterizing the incident as a 
failure of communication , NIH evidently regarded the response from Drs. 
Cleaver, Goodman and Rutter as a full and adequate explanation requiring 
no further investigation. 
Why did NIH make no inquiry or investigation in this case until it had 
been widely publicized? What procedures should be followed in the 
event of future allegations of violations? Will researchers be given 
adequate notice of these procedures? 
Third, perhaps most disturbing is the lack of clear responsibility 
within the institution conducting recombinant DNA research. According 
to the testimony, no single individual was responsible for the work 
in question in the extended absence of the principal investigator. Dr. 
Goodman. Mo one was responsible for reporting the use of the plasmid 
to NIH, and no one was responsible for informing members of the 
institutional biosafety committee. As a result, it is not clear who, 
if anyone, approved the premature use of pBR322. Members of the 
insulin research team knew that the vector had not been certified a 
full month before the experiments were stopped. The biosafety 
committee was not informed of the incident until three months later 
and their discussion at that time appears to have been perfunctory. 
Neither the committee nor, apparently, any other member of the 
department reported the incident to university or NIH officials. 
Do the proposed revisions of the NIH guidelines purport to ensure 
that such incidents will be reported to responsible people at the 
institution who will take appropriate action? Will you review the 
proposed revisions in order to clarify further the responsibilities 
of the head of the institution, the principal investigator, individual 
researchers, and the chairman and members of the biohazards committee? 
Finally, it has been suggested that the NIH Office of Recombinant DNA 
Activities does not have adequate staff to maintain close communication 
with researchers, monitor compliance with the guidelines, and undertake 
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