Human Gene Therapy Subcommittee - July 29-30, 1991 
protocol should be allowed to go forward. 
Dr. Erickson said he did not think a formal motion was needed to address the issue of 
local approval. However, he moved that the HGTS advise the RAC to consider ways 
to merge the two committees. The two-tier review process is unnecessary. Mr. Brewer 
seconded the motion. This motion was tabled. 
Dr. Carter asked to comment as Chair of the NIH IBC. Frequently, during the IBC 
initial review of gene therapy protocols, the issues are debated at length, and the 
protocols are frequently disapproved. An IBC needs to be able to signal the HGTS or 
the RAC on specific issues that really need to be discussed. The IBC may state that 
there are experiments or data which should be supplied. However, the HGTS may feel 
these experiments or data are unnecessary and approve the protocol. Then the local 
IBC needs to decide whether to concur with the HGTS decision or to have the 
investigator perform the experiments and supply the data to the local IBC. He would 
not like to see the HGTS insist on a complete and final approval from an IBC before 
submission. 
Dr. Parkman stressed that local groups should reach closure on the issues that they 
want to address. 
Dr. Leventhal noted that different types of reviews are necessary. Occasionally, the 
investigator will not obtain the additional data until the investigator has heard a 
request for the data from several review committees. If only one review were required, 
the investigator might try to convince the committee that the data were not necessary. 
It is easier for the investigator to have notification as soon as possible that certain data 
needs to be collected. 
Dr. Walters summarized the discussion as moving toward being as flexible as possible 
to the investigator in accepting protocols with stipulations from the local committees. 
Mr. Capron added that it should be clear that there are levels of stipulations. Another 
question is whether the RAC will approve a protocol when something substantive has 
been required by the local committee which has not been provided. 
Dr. Neiman said that if the IRB gives conditional approval and transmits a substantive 
concern, that concern should be represented in the material presented to the HGTS. 
Mr. Capron said he would oppose the motion to merge the two committees if it meant 
that the RAC ought to consider how to merge. If the motion means the RAC should 
consider if the process is now duplicative, he could vote for that motion. However, if 
the motion is that both committees do not need to exist, he would be against that 
motion. There are good reasons for both to exist. 
Recombinant DNA Research, Volume 14 
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