Hvunan Gene Therapy Subcommittee - 7/30/90 
5. That these responses be sent back to the 
reviewers for their final evaluation and 
circulated to all subcommittee members. 
Dr. Mulligan seconded the motion. 
Dr. Mclvor said he would not vote for such a proposal because he 
felt the current system was working well. Dr. Anderson said he 
did not favor the proposal because it sets up a situation whereby 
protocols which become available at different times would not be 
given equal consideration at a meeting merely because there was 
not time to prepare the written comments. 
Dr. McGarrity said that he viewed this as setting up a two-tiered 
system of review and that such a system, in light of an 
increasing workload, would not be feasible. He said he was 
concerned that the subcommittee may turn from being advisory to 
the RAC and the Director of NIH, to being advisory to 
investigators wishing to submit proposals. In essence, primary 
and secondary reviewers might be viewed as co-authoring the 
proposals before they ever come before the full subcommittee. 
Dr. R. Murray said there were two factors that had played a role 
in approvals of prior human gene therapy protocols: (1) Dr. 
Anderson played an integral part in all of the protocols, had 
once been a member of the committee and had in fact helped write 
the "Points to Consider" document; and (2) the subcommittee had 
an interest in promoting work in the field. He said he felt 
there was a need to have a better structure for how protocols 
would be dealt with in the future in order to expedite research. 
Yet the process should be kept open enough so that people who are 
critical of the field can be made well aware of what's going on 
and can understand the process. 
Mr. Brewer and Ms. Areen both suggested that investigators be 
made aware of the benefits of early submission and written review 
but that the process not be made mandatory. Ms. Areen suggested 
that no mandatory time limit be set beyond allowing time for 
primary and secondary reviews. Dr. Parkman supported Dr. 
Epstein's motion. 
Dr. Childress asked whether, if a protocol did not conform to the 
time constraints being discussed, it would not be considered at 
all at a meeting of the HGTS. Dr. Epstein said he did not intend 
this to be the case, but that late protocols would be judged on 
their own merits. Dr. Parkman said that unless it was mandatory, 
as the original motion stated, then scientists would not abide by 
the policy. 
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