9 
and it was agreed that more precise language would be developed for further 
consideration. (Discussion of this proposal continues in Section XVI). 
IX. PROPOSED CHANGES IN REGISTRATION REQUIREMENTS 
Dr. Maxine Singer introduced her proposal (tabs 917, 931/8, 934, 935, 938, 
942-948, 952) to anend administrative requirements of the Guidelines. 
Dr. Singer said her proposal was intended to (1) eliminate the requirement 
for central registration of recombinant DNA projects at NIH, and (2) 
disengage the review of recombinant ENA proposals from the grant review 
process. She felt that safety is primarily maintained in the laboratory 
and reviewers close to the experimental locale render more meaningful 
review in terms of safety. She added that Genetic Manipulation Advisory 
Group (GMAG) in the United Kingdom has transferred the responsibility for 
categorization of most experiments to the local biosafety committees 
(tab 950). Dr. Wright said that the C34AG situation and the NIH situa- 
tion are not analogous. She pointed out that GMAG clearly defines the 
composition of the biosafety committee and that British laboratories 
are regulated and inspected by the government, unlike laboratories in 
the United States. Dr. Singer agreed. 
I 
Dr. Harris said that she believed that the NIH is approaching a point in 
experience and history where Dr. Singer's proposal would be reasonable. 
She noted that the issue revolves around RAC perception of and comfort 
with the sophistication and rigor with which IBCs pursue review. In 
light of the upcoming review of IBC performance she recommended delay until 
the IBC survey is completed. 
Dr. Gottesman suggested that Dr. Singer's proposal could be divided into 
two parts; i.e., the elimination of registration with NIH, and the elim- 
ination of IBC prior review. Er. Mason said he would feel comfortable 
eliminating NIH registration, but opposed allowing the investigator to 
bypass the IBC. Drs. Harris and Williams agreed with Dr. Mason. 
Dr. Goldstein expressed reservation. Dr. Goldstein noted that IBC effic- 
iency has not yet been evaluated. Dr. Krimsky concurred saying that 
evidence for evaluating IBC efficiency is, at the moment, very sparse. 
He questioned whether elimination of QRDA review will increase or decrease 
an IBC's sense of responsibility. 
Dr. Singer said that it is not the intent of her proposal to eliminate IBC 
review of registration documents. It would, however, allow the investigator 
to begin the experiment upon submission of the registration documents to 
the IBC, without waiting for IBC review. Dr. Goldstein expressed reser- 
vations; he noted that at the present time IBC effectiveness has hot 
been fully evaluated. Dr. Fedoroff and Ms. King said they believed that 
IBCs are functioning well. Dr. Berns said he is aware of specific instances 
in which the investigator and the IBC disagreed on interpretation of the 
Guidelines. He opposed the elimination of IBC prior review. 
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