Attachment II - Page 18 
18 
5. How will patients and/or their parents or guardians be informed: 
a. That some of the procedures performed in the study ray 
be irreversible? 
b. That following the performance of such procedures it would not 
be medically advisable for patients to withdraw from the study? 
c. That a willingness to cooperate in long-term follow-up (for 
at least three to five years) will be a precondition for 
participation in the study? 
d. That a willingness to permit an autopsy to be performed in the 
event of a patient's death following treatment is also a 
precondition for a patient's participation in the study? 
(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? 
[ 437 ] 
