and/or parents or guardians in language that is understandable to 
them? 
2. How will the innovative character and the theoretically-possible adverse 
effects of gene therapy be discussed with patients and/or parents or 
guardians? How will the potential adverse effects be compared 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 provided 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? 
5. Hew will patients and/or their parents or guardians be informed: 
a. That some of the procedures performed in the study may 
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? 
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