Attachment II - Page 17 
17 
involves pediatric or mentally handicapped patients, describe procedures 
for seeking the permission of parents or guardians and, where applicable, 
the assent of each patient. Areas of special ccncem highlighted 
below include potential adverse effects, financial costs, privacy, and 
long-term follow-up. 
1. How will the major points covered in Sections I -A through I-C of 
this document be disclosed to potential participants in this study 
and/or parents or guardians in language that is understandable to 
them? 
2. How will the innovative character and the theoretical ly-possible adverse 
effects of gene therapy be discussed with patients and/or parents or 
guardians? How will the potential adverse effects be ccrrpared with 
the consequences of the disease? What will be said to convey that 
some of these adverse effects, if they occur, could be irreversible? 
3. What explanation of the financial costs of gene therapy and any 
available alternative therapies will be pro/ided to patients and/or 
parents or guardians? 
4. How will patients and/or their parents or guardians be informed that 
the innovative character of gene therapy may lead to great interest 
by the media in the research and in treated patients? 
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