Attachment VI - Page 14 
II. 
16 
5. Will patients and/or their parents or guardians be informed of their 
nght to withdraw at any time frcm the preposed study and of the 
consequences of withdrawal at the various stages of the experiment? 
State the extent to which subjects will be specifically advised of 
the reversibility or irreversibility of procedures that are performed 
during the course of the experiment. 
F. 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, vhen, or how the identity of 
patients is publicly disclosed? 
2. What provision will be made to maintain the confidentiality of 
research data, at least in cases vhere data could be linked to 
individual patients? 
Social Issues 
The following issues sure beyond the normal purview of local IRBs. However, 
since these issues have arisen in public debates about human gene therapy 
and the potential future applications of genetic techniques, the RAC and 
its working group request that investigators respond to questions A and B 
belcw. 
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