Finally, because this procedure is relatively new it is possible that despite our extensive efforts, other 
unforeseen problems may occur including the possibility of death. 
You or your insurance will be responsible for any expense incurred during your treatment (clinic visit, 
labs, x-rays, or other medication). 
We will keep any information we learn from this study confidential and disclose it only with your 
permission. By signing these forms you allow us to make records available to the Food and Drug 
Administration and Genetic Therapy, Inc. If the information we learn from this study is published or 
reported at scientific or medical meetings, you will not be identified by name. 
Whether or not you take part in this study will not effect your future relations with your doctors or The 
University of Iowa Hospitals. 
You understand that you may or may not directly benefit from treatment with this study. 
Your participation in this study is voluntary. You may withdraw your consent and discontinue 
participation in this study at any time for whatever reason. 
If you have further questions, you may contact John C. VanGilder, M.D. (319) 356-2772. 
I have discussed the above points, including the information required by the Iowa Fair Information 
Practices Act, with the subject and his/her legally authorized representative, using a translator if 
necessary. It is my opinion that the subject understand the risks, benefits, and obligations involved in 
participation in this study. 
(Signature of Investigator) 
(date) 
(Signature of Witness) 
(date) 
(Signature of Subject) 
(date ) 
[184] 
Recombinant DNA Research, Volume 17 
