Recombinant DNA Advisory Committee - 12/3-4/92 
Dr. D. Miller said that he is entirely uncomfortable proceeding with this protocol. There 
has been no review of efficacy. There has been no review of the possible dangers. 
Although Dr. Royston proposes to use a certified vector, nothing is known about the cell 
line, e.g., is replication competent retrovirus being produced? Dr. Royston stated that 
there must be a rapid review mechanism. Dr. D. Miller explained that there is no 
evidence that the proposed therapy will provide a therapeutic effect. Dr. Royston said 
that the constitutional rights of this patient to receive the therapy that she wants is the 
real issue. 
Dr. Zallen asked if Dr. Royston's protocol has been approved by his IRB? Dr. Royston 
stated that the new protocol has not been approved by the IRB, and he will be subject to 
that approval. 
XVI. FUTURE MEETING DATE OF THE RECOMBINANT DNA ADVISORY COMMITTEE 
Dr. Murray noted that the next meeting of the RAC will be March 1-2, 1993. 
XVII. ADJOURNMENT 
Dr. Murray adjourned the meeting at 3:17 p.m. on December 4, 1992. 
Nelson A. Wivel, M.D. 
Executive Secretary 
Date:3 " /~ *7-3 
I hereby acknowledge that, to the best of my 
knowledge, the foregoing Minutes and Attach- 
ment are accurate and complete. 
1 
Barbara E. Murray, M.D. 
Chair 
Recombinant DNA Advisory Committee 
National Institutes of Health 
Recombinant DNA Research, Volume 16 
[607] 
