Recombinant DMA Advisory Committee - 3/3-4/94 
semi-annual data reporting of any possible adverse events are mandated by the Points to 
Consider for Protocols for the Transfer of Recombinant DNA into the Genome of Human 
Subjects (Points to Consider). 
A motion was made by Dr. Parkman and seconded by Dr. Dronamraju to send follow-up 
requests for information to Dr. Cornetta and Drs. Galpin and Casciato. If responses are 
not received by the June 9-10, 1994, RAC meeting, the RAC will reconsider approval of 
these protocols. The motion passed by a vote of 12 in favor, 1 opposed, and no 
abstention. 
Dr. Walters presented an updated list of approved human gene transfer protocols. The 
RAC has reconunended approval of 67 human gene transfer protocols to date, 59 of 
these studies have been subsequently approved by the NIH Director, and 8 protocols are 
contingently approved pending the submission of additional data. 
III. DECEMBER 2-3, 1993, RAC MINUTES 
The RAC approved a motion made by Dr. Zallen and seconded by Dr. DeLeon to 
accept the December 2-3, 1993, RAC minutes with the inclusion of minor changes 
suggested by Drs. Chase, Zallen, and Hirano, by a vote of 13 in favor, 0 opposed, and no 
abstentions. 
IV. CHAIR REPORT ON MINOR MODIFICATIONS TO NIH-APPROVED HUMAN 
GENE TRANSFER PROTOCOLS/DR. WALTERS 
Dr. Walters stated that 11 minor modifications were approved to the following human 
gene transfer protocols since the December 2-3, 1993, RAC meeting (Attachment II): 
DATE 
PROrrOCOL# 
INVESnCATOR 
1/6/94 
9206-023 
Cynthia Dunbar 
1/6/94 
9206-024 
Cynthia Dunbar 
1/6/94 
9206-025 
Cynthia Dunbar 
2/4/94 
9212-034 
Ronald Crystal 
2/17/94 
9007-003 
Steven Rosenberg 
2/17/94 
9303-042 
Richard Boucher/Michael Knowles 
2/17/94 
9312^7 
Michael Welsh 
2/25/94 
93064)44 
Albert Deisscroth 
2/25/94 
9306-044 
Albert Deisseroth 
2/25/94 
9209-027 
Friedrich Schuening 
2/25/94 
9209-028 
Friedrich Schuening 
Responding to the question raised by Dr. Smith during his report concerning the vector 
Recombinant DNA Research, Volume 19 
[19] 
