Human Gene Therapy Subcommittee - July 29-30, 1991 
IBC approval signifies to the HGTS. 
Dr. Parkman said the HGTS review is most efficient when it has a complete document 
that includes the scientific issues and human investigational issues. Protocols have 
been submitted to the HGTS with provisional approval from local committees but also 
solved issues. If the HGTS members are to evaluate a protocol where there are 
outstanding issues, it is difficult to come to quick closure. Protocols should not proceed 
to the HGTS until they have complete approval at the local level. Unfortunately, the 
local committees may not have the expertise to ask the right questions, and they may 
defer the review of the protocol to the HGTS. An efficient review can be 
accomplished when complete protocols are submitted to the HGTS. 
Dr. Leventhal said she is against this proposal. If the investigator had received full 
IRB approval for a protocol and then the HGTS changed the consent form, the 
protocol would have to go back to the IRB. This may streamline the meeting of the 
HGTS, but it would certainly not streamline the process for the investigator. 
Dr. D. Miller said the subcommittee should allow some flexibility, e.g., if one more 
experiment needs to be completed and the results brought before the subcommittee. 
However, if there are major scientific concerns raised by the local IRB, the protocol 
should not come to the HGTS. 
Dr. Neiman said often there is a substantive issue such as in a new technology being 
introduced. It is not clear to the local IRB whether the protocol is ready for human 
experimentation. The IRB has an opinion, but it also wants the protocol to be 
reviewed by the HGTS and the RAC. The IRB should complete its work to the best 
of its abilities. Any external peer reviews should be documented. 
Dr. Parkman said he would like to avoid situations where protocols are forwarded to 
the HGTS with unresolved scientific issues that should be handled at the local level. 
Dr. H. Miller said the review process will be delayed significantly if it is required to 
become strictly sequential. 
Dr. Rosenberg agreed that this proposal would not streamline the review process. It 
would only further delay the review process and the ability to proceed with these 
protocols. 
Dr. R. Murray said that a way to resolve this issue would be to consider the risks and 
benefits. There needs to be a balance between the risks patients might be subjected to 
if all of the safety issues are not resolved and the risks of postponing treatment. There 
needs to be some flexibility employed. Where there is a clear scientific problem, the 
requirement of local approval should be enforced. If it is a minor procedural issue, the 
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Recombinant DNA Research, Volume 14 
