Human Gene Therapy Subcommittee - 7/30/90 
the patients who will be entering the protocol are terminal 
cancer patients, she felt the risks involved were worth the 
possible benefits, and they should be given a chance to undergo 
this therapy. 
Dr. R. Murray asked Dr. Rosenberg to elaborate on the conditional 
approval from the NHLBI IRB which is contingent on primate 
toxicity studies that are underway. Dr. Rosenberg said that this 
protocol was approved by all local committees contingent upon 
HGTS and RAC approval. He said the primate toxicity data is now 
available and with HGTS and RAC approval they will return to the 
local IRBs and IBC for final approval before proceeding with the 
protocol. Dr. Murray said he understood that the protocol had 
been approved at the local level. Dr. Rosenberg said this 
protocol was no different from other protocols which ^the HGTS and 
RAC had approved, in which local approval was contingent upon 
HGTS and RAC approval of the protocol. 
Dr. Parkman said he felt the one contingency of HGTS/RAC approval 
was what was anticipated, but the fact is that there is a list of 
contingencies contained in the approval by the local committees. 
He felt the HGTS needed to consider whether they should accept a 
conditional approval from an IRB or IBC that contains any 
conditions other than HGTS/RAC approval. Dr. Mahoney suggested 
that the subcommittee determine whether the three contingencies 
of the IRB and IBC had been met and that a vote be taken on the 
protocol . 
Dr. Leventhal said she felt there were enough data on toxicity in 
humans and that waiting for data from two or three more monkeys 
was pointless when data already existed on TNF toxicity in 86 
human beings. Dr. R. Murray said that the "Points to Consider" 
asks for preclinical animal data as a criterion for approval of a 
human gene therapy protocol. He said that the subcommittee was 
deviating from those guidelines if it approved a protocol when 
there were outstanding concerns over issues of safety. He said 
if there were no concerns as to safety, then the subcommittee 
could consider the protocol for approval. 
Dr. Epstein made the following motion: 
"I move that we approve this protocol contingent upon 
final approval by the all institutional committees and 
contingent upon changes in the consent forms to be 
specified. " 
Ms. Areen seconded the motion. 
Recombinant DNA Research, Volume 14 
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