Attachment VI - Page 13 
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men t silly handicapped patients, describe procedures for seeking the 
permission of parents or guardians and , vhere applicable, the assent 
of each patient. Areas of special concern highlighted below include 
potential adverse effects, financial costs, privacy, and the right 
to withdraw f rom further participation in the study. 
1. 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? ( Include a copy of the patient consent form as part of the 
documentation requested in Part III below.) 
2. Will the innovative character and the theoretically-poes lble adverse 
effects of gene therapy be discussed with patients and/or parents or 
guardians? Will the potential adverse effects be compared with 
the consequences of the disease? What will be said to convey that 
same of these adverse effects, if they occur, could be irreversible? 
3. Will the financial costs of gene therapy and any available alterna- 
tive therapies be explained to patients and/or parents or guardians? 
4. 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? Vhat special 
procedures, if any, will be followed to protect the privacy of 
patients and their families? 
[ 77 ] 
