possibility. 
f. Radiation Safety: I will receive 12 pairs of chest x-rays during the 4'/2 months that 
I will be participating in this study. Each pair of x-rays, a front and a side view, 
give me a dose of 25mrem, so the total dose will be 300mrem. I will also receive 
some radiation exposure from the lung scans. The chances of developing cancer 
from this amount of radiation are very small. This dose of x-rays is within the 
official radiation exposure limits for the public, so long as my exposure to x-rays is 
infrequent. 
Although the above potential risks are rarely of clinical significance, my condition will be 
monitored throughout the study, and every precaution consistent with the best medical 
care will be taken. 
I have been informed that patients who participate in Phase I trials are sometimes 
excluded from future experimental therapies, although this is not the intention of my 
doctors. I understand that participation in this study could exclude me from later (Phase 
II and Phase III) trials until gene therapy is commercially available. 
I understand that if I believe that I has been injured as a result of participation in 
biomedical or behavioral research I am to contact Dr. Robert Wilmott or the Director of 
Social Services to discuss my concerns. Children's Hospital Medical Center follows a 
policy of making all decisions concerning compensation and/or medical treatment for 
physical injuries occurring during or caused by participation in biomedical or behavioral 
research on an individual basis. 
ALTERNATIVES 
An alternative treatment for me is standard cystic fibrosis care (chest physiotherapy, 
antibiotics, nutritional support, pancreatic enzymes, and vitamins) without gene therapy. 
CONFIDENTIALITY OF RECORDS 
All information gathered in this study will be kept confidential to the extent provided by 
federal, state, and local law. Records relating to my participation in this study will be 
protected against release to unauthorized people. In addition to the members of the 
health care staff who usually have access to my file, the records may be reviewed by 
Food and Drug Administration and Genetic Therapy, Inc. 
AVAILABILITY OF INFORMATION 
If I have any questions regarding this study, my rights as a research subject, or I think 
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