3 
to review proposals in the bicmedical area, and a local IBC may not have avail 
able to it the requisite ecological expertise. The IBC should have the option 
of either reviewinq and approving the protocol or of sending the protocol to 
the NTH for review before IBC review. 
Or. Cart land said IBC review is easier to unhinge from RAC review if no language 
indicatina the review sequence is included in the draft document (Attachment II). 
Dr. Gottesman felt the IBC or the investigator would decide on the order of 
review in the absence of language prescribing the review procedure. 
Dr. Miller said his experience at the Food and Drug Administration (FDA) 
with Institutional Review Boards (IRBs) and with review of protocols inuolving 
use of human subjects indicates that flexibility of approach is important; 
different IRBs have different expertise and different perceptions of their 
role. Seme IRBs prefer that FDA first review the proposal; other IRBs prefer 
to perform their own review before sending the protocol to the FDA. He felt 
proposals might be needlessly delayed if the IBC hesitates to review the pro- 
tocol and is not permitted to send the protocol to the NIH for review. 
Dr. Colwell thought the IBC should not feel obliged to approve a proposal 
simply because RAC approves. He pointed out that the IBC might possess special 
knowledge of local conditions. Dr. Pirone thought the working group draft 
(Attachment II) should explicitly require that information on local conditions 
be submitted to the working group and RAC for review. 
Dr. Gottesman suggested language be added to the preamble which would indicate 
the IBC must make an independent evaluation of the proposal; this review might 
be concurrent with, before, or subsequent to NIH review. The Vforking Group on 
Release into the Ehvirorment should receive all pertinent data and information 
including local conditions necessary for an evaluation. 
Dr. Colwell asked why the IBCs were originally formed. Dr. Gottesman replied 
that the IBCs were originally instituted to ensure that laboratories were 
operating under the laboratory containment conditions specified in the NIH 
Guidelines. 
Dr. Colwell asked how NIH ascertains that an IBC is qualified to evaluate a 
proposal involving field testing of genetically modified microorganisms. 
Dr. Gartland said the NIH certifies the IBCs. 
Dr. Levin asked if IBC review of field testing protocols is required under the 
NIH Guidelines. Dr. Gottesman said IBC review is required under Section III-A-2 
of the NIH Guidelines. 
Dr . Levin did not think the IBC should have to review a proposal subsequent to 
review by RAC, the national body. Dr. Gottesman disagreed; while the RAC and 
its working group may be setting national standards, the working group should 
not preempt the right of local ccrrrriittees to regulate affairs at their institu- 
tions. She said the IBC plays an important role in the review process. 
Dr. Levin suggested IBCs could review the proposal and state their concerns; 
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