Recombinant DNA Advisory Committee - 5/30-31/91 
approval, while poorer proposals may move slower, but that overall this would be an 
advantage to the field by having the good proposals being more quickly approved. 
As far as the disadvantages to abolishing the HGTS, he said it could be viewed by some that 
this was resulting in less review and many critics of human gene therapy could be expected 
to say it is too early to abbreviate the review process. However, Dr. Anderson said he did not 
think the general public knew or cared who actually performed the review, so long as there 
was not a perception that it was a less careful review. He said that on the other hand this 
would send a signal to investigators, pharmaceutical companies and research institutes who 
may be interested in moving into this area, that the process is straightforward and appropriate 
and is being made more efficient by abolishing the HGTS. 
Others criticize that to dissolve the HGTS would be to make the review process less intense. 
Dr. Anderson underlined that at present any protocol must undergo review many times at 
several levels, both local and national, and that by dissolving the HGTS it would not make 
the review any less intense, it would only make the process more efficient by taking out an 
intermediate step in the review at the national level. 
Dr. Gellert noted that no one who had supplied written comments had thought it a good idea 
to abolish the HGTS and he said he personally did not see much redundancy in the reviews 
done by the HGTS and the RAC. He noted that the membership of the HGTS provided 
more specialized expertise to review these protocols and that with its limited role its schedule 
provided for more in-depth review of them than could be done in light of the already tightly 
constrained schedule of the RAC. He noted that several written responses had in fact 
suggested the distinction between the RAC and HGTS be made greater, allowing the HGTS 
to look into these proposals more on the lines of a study section. He also pointed to the fact 
that in the past the protocols that had come in would not have been able to be approved 
without the in-depth technical discussions which the HGTS had undertaken before they were 
approved. He noted the many revisions that each approved protocol had undergone. He 
concluded by saying that he would hate to see the HGTS abolished or even weakened at this 
point because he felt the protocols were not sufficiently routine to be able to be approved 
without the in-depth discussion of technical issues. However, he said he felt the RAC could 
consider how to make the workings of the subcommittee more efficient.Dr. Anderson said that 
one advantage of the proposal would be to make the RAC the primary body with the ability 
to make the most informed decision on a human gene therapy protocol. He said at present 
the subcommittee goes through the technical details and when the protocol comes before the 
RAC it merely sees a summary of what has happened and is asked to ensure that any 
questions posed by the subcommittee are answered. He said he did not believe that the RAC 
is making the kind of informed decision that it could and should be making on these 
protocols. 
Dr. Walters noted that of the 11 letters which ORDA had received relative to this proposal, 
3 came from members who currently served on both the RAC and the HGTS, 3 came from 
members of the subcommittee who were formerly RAC members, 4 came from members of 
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