Recombinant DNA Advisory Committee - 12/3-4/92 
CALL TO ORDER 
Dr. Murray (Chair) called the meeting to order. She noted that the notice of meeting 
was published in the Federal Register 15 days prior to December 3 as required by the 
National Institutes of Health Guidelines for Research Involving Recombinant DNA 
Molecules (NIH Guidelines). The RAC serves as advisor to the NIH Director. The 
Director may accept, reject, or send the RACs recommendations back to the committee 
for further deliberation. 
Dr. Murray stated that a quorum was present and outlined the order in which speakers 
would be recognized. The primary and secondary reviewers will present their reviews of 
the protocol, followed by responses from the principal investigators of the protocols. 
The Chair will then recognize other RAC 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. 
MINUTES OF THE SEPTEMBER 14-15, 1992, MEETING 
Dr. Murray called on Dr. Doi to review the minutes of the September 14-15, 1992, 
meeting of the RAC. Dr. Doi stated that the minutes were an accurate reflection of the 
committee's deliberations. 
For the purpose of clarification, Dr. Doi inquired about the final review of protocols that 
have received approval contingent on the submission of additional information. Do the 
RAC members have the primary responsibility for the review of this additional 
information before the protocol can be initiated? Dr. Wivel responded that the primary 
reviewers of the protocol are responsible for the review and approval of the additional 
material. Dr. Wivel stated that additional information could be forwarded to all RAC 
members if requested. Dr. Dronamraju concurred with Dr. Doi regarding the accuracy 
of the minutes noting one minor correction. 
A motion was made by Dr. Doi and seconded by Dr. Dronamraju to approve the 
September 14-15, 1992, RAC minutes. The motion passed by a vote of 16 in favor, 0 
opposed, and no abstentions. 
PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING 
A HUMAN GENE THERAPY PROTOCOL ENTITLED: RETROVIRAL MEDIATED 
TRANSFER OF THE HUMAN MULTI-DRUG RESISTANCE -1 GENE INTO 
HEMATOPOIETIC STEM CELLS DURING AUTOLOGOUS TRANSPLANTATION 
AFTER INTENSIVE CHEMOTHERAPY FOR BREAST CANCER /DR. 
O'SHAUGHNESSY 
Recombinant DNA Research, Volume 16 
[537] 
