Recombinant DNA Advisory Committee - 06/7-8/93 
I. CALL TO ORDER 
Dr. Walters (Chair) called the meeting to order and stated that notices of the meeting 
were published in the Federal Register on May 4, 1993 (58 FR 26676) and May 28, 1993 
(58 FR 31045) as required by the National Institutes of Health Guidelines for Research 
Involving Recombinant DNA Molecules (NIH Guidelines). He noted that a quorum was 
present and outlined the order in which speakers would be recognized. The primary and 
secondary reviewers will present their comments regarding the protocol, followed by 
responses from the principal investigators (Pis). The Chair will then recognize other 
committee members, ad hoc consultants, other NIH and Federal employees, the public 
who have submitted written statements prior to the meeting, followed by the public at 
large. 
Dr. Walters thanked Dr. Wivel and his staff for handling a large volume of protocol 
materials and the RAC members for their timely review of the proposals. Dr. Walters 
reminded everyone to adhere to the schedule as outlined in the agenda. Dr. Wivel 
introduced a new staff member of the Office of Recombinant DNA Activities (ORDA), 
Dr. Thomas Y. Shih. Dr. Shih is a senior NIH research scientist who is well recognized 
for his work on ras oncogenes. His scientific background is most pertinent to his new 
position in ORDA 
II. MINUTES OF THE MARCH 1-2, 1993, MEETING 
Dr. Walters called on Ms. Grossman to review the minutes of the March 1-2, 1993, RAC 
meeting. Ms. Grossman stated that the minutes were an accurate reflection of the 
March meeting. Minor corrections were submitted by Drs. Hirano and Miller. The 
RAC unanimously approved a motion made by Dr. Dronamraju and seconded by Dr. 
Smith to accept the March 1-2, 1993, RAC minutes, with the inclusion of minor 
grammatical changes, by a vote of 19 in favor, 0 opposed, and no abstentions. 
III. DATA MANAGEMENT REPORT-REVIEW OF SEMIANNUAL REPORT FORMS FOR 
NIH-APPROVED HUMAN GENE TRANSFER PROTOCOLS/DR. LEVENTHAL 
Dr. Leventhal summarized the semiannual report on RAC-approved human gene 
transfer protocols (Attachment II). The report period was for the 6 months prior to 
April 1, 1993. A total of 92 patients have been entered into the 36 RAC-approved 
protocols. The median time for these protocols to be activated was 8 months after the 
date of RAC approval. Of these 36 studies, 33 protocols are currently open. She noted 
that one of the report questions asking for evidence of gene expression was ambiguous. 
This question will be clarified to indicate that the PI must provide evidence of in vivo 
gene expression in the patient. In vivo evidence of gene transfer has been observed in 10 
of the protocols; however, gene expression was not demonstrated in all cases. Two 
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