(This stipulation is included because an accurate determination 
of the precise cause of a patient's death would be of vital 
importance to all future gene therapy patients.) 
E. Privacy and confidentiality 
Indicate what measures will be taken to protect the privacy of gene 
therapy patients and their families as well as to maintain the confi- 
dentiality of research data. 
1. What provisions will be made to honor the wishes of individual 
patients (and the parents or guardians of pediatric or mentally 
handicapped patients) as to whether, when, or how the identity of 
patients is publicly disclosed? 
2. What prevision will be made to maintain the confidentiality of 
research data, at least in cases where data could be linked to 
individual patients? 
Special Issues 
Although the following issues are beyond the normal purview of 
local IRBs, the RAC and its working group request that investigators 
respond to questions A and B below. 
A. What steps will be taken, consistent with point I-E above, to ensure 
that accurate information is made available to the public with respect 
to such public concerns as may arise fron the proposed study? 
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