Attachment II - Page 11 
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(4) The adequacy of a consent form in explaining who will bear the 
costs of gene therapy 
D. [Data Monitoring 
The IRB shall determine that: 
"(6) Where appropriate, the research plan makes adequate provision 
for monitoring the data collected to insure the safety of 
subjects. " 
This point is self-explanatory. 
E. Privacy and Confidentiality 
The IRB shall determine that: 
"(7) Where appropriate, there are adequate provisions to protect the 
privacy of subjects and to maintain the confidentiality of 
data. " 
A specific point regarding gene therapy that follows frctn this general 
requirement is that pediatric patients treated by means of gene therapy 
should be protected by their parents and by clinical investigators fran 
public attention that could adversely affect the success of their 
treatment. 
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