Recombinant DNA Advisory Committee - 12/2-3/93 
Committee Motion 
The RAC approved a motion made by Dr. Carmen and seconded by Dr. Leventhal to 
accept the September 9-10 RAC minutes with the inclusion of minor changes by a vote 
of 15 in favor, 0 opposed, and no abstentions. 
III. CHAIR REPORT ON MINOR MODIFICATIONS TO NIH-APPROVED HUMAN 
GENE TRANSFER PROTOCOLS/DR. WALTERS 
Dr. Walters stated that the RAC had approved minor modifications to the following 
RAC-approved human gene transfer protocols since the September 9-10, 1993, RAC 
meeting (See Attachment III for a complete list of minor modifications approved to 
date): 
PROTOCOL 
PRINCIPAL INVESTIGATOR 
DATE APPROVED 
9212-034 
Ronald G. Crystal 
October 8, 1992 
9212-036 
Michael J. Welsh 
October 18, 1993 
9209-030 
Albert B. Deisseroth 
November 3, 1993 
9209-030 
Albert B. Deisseroth 
November 18, 1993 
9212-034 
Ronald G. Crystal 
November 29, 1993 
9206-019 
Edward H. Oldfield 
November 29, 1993 
Dr. Walters noted that the only major concern in reviewing and approving these minor 
modifications was the addition of bronchial biopsies requested by Dr. Crystal. This 
procedure was not originally approved for this protocol; although other RAC-approved 
cystic fibrosis (CF) protocols include this procedure. After consultation with 
pulmonologists, Dr. Walters concluded that bronchial biopsy, as proposed for this 
protocol, poses less risk to patients than transbronchial biopsy. 
IV. WORKING GROUP ON DATA MANAGEMENT - SEMI-ANNUAL DATA 
REPORT/DR. LEVENTHAL 
Dr. Walters called on Dr. Leventhal to summarize the semi-annual data reports 
submitted by the Pis of NIH-approved human gene transfer protocols. Dr. Leventhal 
stated that some investigators failed to provide adequate responses to the questions 
regarding possible adverse effects and evidence of gene transfer. She recommended that 
the Working Group on Data Management should have an interim meeting to revise the 
reporting requirements. 
A total of 150 patients have been accrued onto the 50 NIH Director-approved protocols 
to date. Of these 50 studies, 7 are closed, 20 have had no patient accrual to date, and 12 
are pending approval by the Food and Drug Administration (FDA). Summarized below 
are the categories of human gene transfer protocols that have been approved by the 
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