Human Gene Therapy Subcommittee - 7/30/90 
chairs and considered by the chairs as to whether it 
needs to be presented to the full committee at a 
regular meeting." 
Dr. R. Murray seconded the motion. 
Dr. McGarrity noted that a proposal for dealing with minor 
modifications was on the agenda for the RAC meeting the next day 
and he was not comfortable with assuming the proposal would be 
accepted by the RAC. He suggested that Dr. Leventhal amend her 
motion to allow for this contingency. 
Dr. Leventhal amended her motion to say that: 
"This be considered a minor modification in terms of 
the wording to be considered by the RAC tomorrow and 
that, if for some reason that is not passed, that it 
be treated according to the wording of that 
suggestion. " 
Dr. Murray concurred with the amended motion. 
Mr. Brewer said that any investigator was free to present any 
change to a protocol as being minor, but he thought the sense of 
the motion was to presuppose the chairs would agree that this 
would be a minor modification, and therefore would require the 
chairs to view it as such. 
Dr. Leventhal said she agreed in principle. However, since the 
HGTS had discussed the issue specifically, this was not the case. 
She said the chairs would still have the option of deciding that 
this was not a minor modification and therefore could ask the 
full committee to look at the issue. 
Dr. Parkman said that the current protocol contains the option of 
i.p. administration and the entire protocol is being considered. 
Since the HGTS cannot deal with only portions of the protocol, it 
must find a way to deal with the issue of i.p. administration. 
Dr. McCarthy said there were rules requiring modifications of 
protocols to be approved by local IRBs, and there was no question 
that such a modification would have to be approved by the IRB. 
Dr. Parkman noted the entire protocol, including the option for 
i.p. administration, had already been approved by the NCI IRB and 
the NHLBI IRB without stipulation. Therefore there would be no 
reason to return to the IRBs for approval. Dr. McKay said the 
issue was clouded somewhat by a lack of inclusion of the i.p. 
route of administration in the informed consent documents. 
Recombinant DNA Research, Volume 14 
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