Recombinant DNA Advisory Committee - 06/1-2/92 
Dr. Geiduschek made a motion to approve the breast cancer protocol. The motion was 
seconded by Dr. Haselkom. The motion to approve the breast cancer protocol passed 
by a vote of 19 in favor, 0 opposed, and no abstentions. 
Dr. Geiduschek made a motion to approve the multiple myeloma protocol. The motion 
was seconded by Dr. Haselkom. The motion to approve the multiple myeloma protocol 
passed by a vote of 19 in favor, 0 opposed, and no abstentions. 
Dr. Geiduschek made a motion to approve the CML protocol. The motion was 
seconded by Dr. Haselkom. The motion to approve the CML protocol passed by a vote 
of 19 in favor, 0 opposed, and no abstentions. 
XII. PROPOSED ADDITION TO THE POINTS TO CONSIDER IN THE DESIGN AND 
SUBMISSION OF PROTOCOLS FOR THE TRANSFER OF RECOMBINANT DNA 
INTO THE GENOME OF HUMAN SUBJECTS REGARDING SUBMISSION 
REQUIREMENTS FOR HUMAN GENE TRANSFER/THERAPY PROTOCOLS: 
Dr. Murray called on Dr. Krogstad to present the next agenda item. Dr. Krogstad 
distributed a draft outline to the committee members regarding submission requirements 
for investigators requesting RAC review of human gene transfer/therapy protocols. The 
proposed outline entitled Strategies for Focusing Discussion at the RAC, provided a format 
for investigators to provide critical information. The proposed format begins with the 
investigator submitted material, including the scientific and lay abstracts. This section 
would be followed by the Points to Consider and curricula vitae (CVs). The CVs would 
be submitted using a biographical sketch format (2 pages maximum). 
Dr. Krogstad stated that there have been numerous complaints among the committee 
members regarding the timeframe for submission of comments. The investigators should 
be required to submit written material to ORDA 6 weeks prior to the meeting date and 
that reviewers comments are due back to ORDA 2 weeks prior to the meeting. 
Dr. Kelley suggested making a substitution of the word must for the word should. 
Mr. Capron suggested that the timeframe for submission of written material should be 
changed to 8 weeks before the meeting and requiring that the reviewers comments are 
submitted 4 weeks prior to the meeting. This timeframe will allow sufficient time for the 
investigators to respond to the reviewers comments. 
Dr. Walters stated that if investigators submitted their protocol 10 weeks in advance, 
perhaps they could be afforded the opportunity of receiving 2 rounds of questions and 
comments by the reviewers. The additional review would provide and incentive for early 
submission. 
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Recombinant DNA Research, Volume 15 
