Recombinant DNA Advisory Committee - 06/1-2/92 
a vote of 14 in favor, 6 opposed, and no abstentions, the RAC voted to call the question. 
Committee Motion 
Mr. Capron moved to approve the protocol. Dr. Brinckerhoff seconded the motion. The 
motion to approve the protocol passed by a vote of 20 in favor, 0 opposed, and no 
abstentions. The RAC suggested that the following items be submitted; however, these 
suggestions are not a requirement for approval: (1) a simplified informed consent 
document, and (2) a document summarizing the entire informed consent process, i.e., 
forms, videotapes, interviews, etc. 
VIII. REPORT FROM THE WORKING GROUP ON DATA MANAGEMENT: 
Report-Dr. Leventhal 
Dr. Murray called on Dr. Leventhal to provide an update on the Working Group on 
Data Management. Dr. Leventhal stated that there is increasing need to obtain data 
from the gene transfer/therapy protocols that have been approved by the RAC. The 
principal investigators of these protocols are beginning to submit abstracts that contain 
important data. These investigators should also forward copies of these relevant data to 
the RAC. The Working Group on Data Management devised a form that the 
investigators would be required to complete regarding the status of patients and result 
obtained. However, the consensus of the RAC at that time was that these investigators 
were already required to submit reports for other purposes, e.g., FDA review, and that 
requiring investigators to complete an additional form would place too many demands on 
them. Consequently, the RAC has received no reports at all; this is inadequate. 
Dr. Wivel proposed that the Office of Recombinant DNA Activities (ORDA) send a 
letter to all of the principal investigators who have had gene transfer/therapy protocols 
approved requesting a compendium of all abstracts on presented material to date. This 
information should be submitted on a periodic basis. Dr. Leventhal suggested that a 
request for annual IRB and FDA reports should be included. 
Dr. Leventhal stated that the Working Group on Data Management will be responsible 
for reviewing these reports. She noted that the Points to Consider in the Design and 
Submission of Protocols for the Transfer of Recombinant DNA into the Genome of Human 
Subjects (Points to Consider) requires that an annual report be submitted to RAC. 
Dr. Post inquired if submission of IRB annual reports would cause problems with 
confidentiality of information? Dr. Parkman noted that an annual report is required in 
the Points to Consider which means that one of the conditions of having RAC approval is 
submission of this information. 
Recombinant DNA Research, Volume 15 
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