Attachment V - Pago 2 
l H 
5. 'i pit tents and/or the i t (mii'iiL:; o: guardians l>: 1 1 1 fV>i n»jr) : 
a. That some of the procedures fxirfoniux! in the study will 
bo irreversible. 
b. That following the po rfonnance of such procedures it could rot 
I 
be medically advisable for patients :o withdraw from the studyf. 
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#. 
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^li 
(This stipulation is included because an accurate detennination 
of the precise cause of a patient's death could 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 cell as to maintain the confi- 
dentiality of research data. 
1. that provisions will be made to lonor tlva wishes of individual 
patients (and the parents or guardians of pediatric or mentally 
hanlicapfxad patients) as to whether, chon, or low the identity of 
pit; rents is publicly disclosed? 
[ 356 ] 
