Recombinant DNA Advisory Committee - 01/14/93 
9. This policy statement will not include the terms compassionate use or 
compassionate treatment. 
10. A protocol that has been deferred by the RAC in its normal review process will 
not be eligible for expedited review unless it is significantly altered from the 
original submission. 
11. IRB and IBC approval are required prior to making a time-sensitive request from 
gene therapy to the NIH Director. 
12. Any investigator who receives such an approval must report back to the RAC the 
results of the treatment. 
The motion to approve this policy statement for recommendation to the NIH Director 
was approved by a vote of 9 in favor, 3 opposed, and 1 abstentions. 
XVI. ADJOURNMENT 
Dr. Walters adjourned the special meeting of the RAC at 3:52 p.m. on January 14, 1993. 
Executive Secretary 
I hereby acknowledge that, to the best of my 
knowledge, the foregoing Minutes and Attach- 
ment are accurate and complete. 
Date: */' (l3 
LeRoy B^Walters, Ph.D. 
Chair 
Recombinant DNA Advisory Committee 
National Institutes of Health 
[381 
Recombinant DNA Research, Volume 17 
