July 30, 1990, Human Gene Therapy Subconmi ttee 
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 caimot 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. 
Whereupon, there being no further discussion on the motion, Dr. Walters called for a 
vote. The motion passed by a vote of 12 in favor, none against, and 1 abstention. 
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Recombinant DNA Research, Volume 14 
