Recombinant DNA Advisory Committee - 5/30-31/91 
There being no further discussion. Dr. McGarrity put Dr. Mclvor's motion to a vote. The 
motion passed by a vote of 18 in favor, none opposed, and no abstentions. 
Dr. McGarrity noted that the approval of this protocol was important in that it broadens the 
target cells beyond lymphoblastoid cells and expands the diseases being investigated beyond 
cancer and birth defects. He noted that this also provided the field with another center now 
working on human gene therapy which has been dominated by NIH to this point. He thanked 
the investigators and reviewers for their efforts. 
Dr. McGarrity said that the LNL6 vector has become almost analogous to the E. coli in the 
early days of recombinant DNA research. He noted that on the one hand that is good in the 
sense that it is building an historic data base. However, on the other hand, it could 
discourage innovation and development of alternative vectors. He said it was important to 
encourage alternate proposals that may answer some of the questions that LNL6 will be 
unable to address. 
Dr. McGarrity then adjourned the committee for lunch and asked them to reconvene at 2:00 
p.m. 
Dr. McGarrity called the RAC to order at 2:05 p.m. He noted that several members were 
attending their final meeting as members of the RAC. He thanked them for their service and 
presented them with certificates from the NIH commemorating their service to the RAC. 
These members included: Dr. Atlas, Mr. Brewer, Dr. Gellert, Mr. Mannix, Dr. Mclvor and 
Dr. R. Murray. 
Dr. McGarrity then called on Dr. Carmen to continue discussion of Item IV, which had been 
tabled from the morning session pending some changes to be made in the protocol. 
PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A 
HUMAN GENE TRANSFER PROTOCOL ENTITLED THE ADMINISTRATION OF 
INTERLEUKIN-2, INTERLEUKIN-4, AND TUMOR INFILTRATING LYMPHOCYTES TO 
PATIENTS WITH MELANOMA: 
(Continuation of discussion) 
Dr. McGarrity noted that there were two issues still remaining to be discussed on this 
protocol: (1) the informed consent document; and (2) conditional approval pending the receipt 
of quantitative data on the PCR studies. 
Dr. Carmen said he would defer comment to those who had questions on these issues. Dr. 
Post said he would vote to approve the protocol. Dr. R. Murray said he felt that the issue of 
infection related to taking biopsies needed to be clarified and that although the risk was 
minimal, it should be stated clearly in the informed consent document. 
Recombinant DNA Research, Volume 14 
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