Recombinant DNA Advisory Committee - 7/31/90 
earlier. Dr. McGarrity said that since this issue was deferred, 
the entire discussion should remain within the subcommittee 
minutes. He said he meant to refer only to the ADA and TNF 
sections which would be incorporated in today's minutes, but that 
if she thought it appropriate that this could also be included. 
Dr. B. Murray said she felt if she were going to be a future 
reviewer on this protocol that she would like to see those 
discussions. Dr. McGarrity said the material would be included 
in the minutes of the meeting of the RAC (Attachment D) . 
Dr. Anderson said that as an associate investigator on this 
grant, he was representing Dr. Brenner. He noted that all the 
proposals for human gene therapy to date had come from 
investigators inside the NIH. This represented the first attempt 
by an investigator outside the NIH to seek approval of a human 
gene therapy protocol. This could have been done in two ways. 
One way would have been for everything to have been polished up 
and worked out and had local approvals in place. However, the 
local IRB had been uncertain and said, "This is fine to start, as 
sort of a general concept, to be considered in future years." So 
the intent was to have the investigators go ahead and submit the 
protocol and see how the HGTS and the RAC respond, since they 
will use the same materials and many of the procedures that were 
used in the N2-TIL protocol. 
Dr. Anderson said many other institutions are contemplating 
submitting protocols. However, their local committees are 
equally as uncomfortable about what to do with them. This is why 
he felt that Dr. Parkman's view that protocols be completely 
approved by the local review committees is inappropriate because 
local committees clearly need the experience of the national 
review, at least on initial protocols, to feel comfortable in 
approving them. 
Dr. McGarrity noted that another disadvantage to the local IRBs 
and IBCs is that, in most cases, the local experts are the 
investigators submitting the proposal. Thus, the committees have 
to go off campus to obtain advice on these protocols. 
Dr. Parkman said this issue goes back again to what Dr. R. Murray 
had said about the difference between presenting a protocol and 
presenting an idea. He said this points out that if the charge 
of the HGTS is to be the guardians of the quality of science, 
then it is fair to require finished protocols. However, if there 
is an obligation on the part of the subcommittee and the RAC to 
aid in the development of good science, then it may be worthwhile 
to have people make proposals for research, which is different 
than a finished protocol. He said that if the subcommittee tries 
to deal on both levels, it will produce extra work and must be 
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