Attachment II - Page 10 
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any medical treatments are available if injury occurs and, if 
so, vvhat they consist of, or where further information nay be 
obtained; 
"(7) An explanation of vshcm to contact for answers to pertinent ques- 
tions about the research and research subjects' rights, and 
'whom to contact in the event of a research-related injury to 
the subject; and 
"(8) A statement that participation is voluntary, refusal to partici- 
pate will involve no penalty or loss of benefits to which the 
subject is otherwise entitled, and the subject may discontinue 
participation at any time without penalty or loss of benefits 
to which the subject is otherwise entitled." 
Specific points regarding gene therapy that follcw frcm or relate to 
these general requirements are: 
(1) The adequacy of a particular consent form in explaining in a 
clear and coherent manner the design and procedures of the 
gene therapy protocol 
(2) The mode of explaining the protocol and consent form to parents, 
if the prospective subject is a child 
(3) The mode of securing the consent of a child, if the child is 
considered to be capable of understanding the study 
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