confidentiality will be maintained. The Food and Drug Administration 
(FDA) , the Department of Health and Human Services (DHHS) and/or their 
designate (s) , and representatives from Genetic Therapy, Inc. may inspect 
the records relating to your child's participation in the study. If the 
study plan or use of the information is to be changed, you will be so 
informed. 
VOLUNTARY PARTICIPATION 
This study program has been reviewed, and its consent form has been 
approved by the Institutional Biosafety Committee (IBC) , Committee on 
Clinical Investigations (IRB-Institutional Review Board) , the 
Recombinant Advisory Committee (RAC) at the National Institutes of 
Health, and the Food and Drug Administration (FDA) . The approval of 
these Committees does not alter the fact that the final decision to 
enter your child in the study program is yours. You have the right to 
remove your child from the study at any time. Dr. Corey Raff el and Dr. 
Stuart Siegel will answer any questions you may have regarding the 
study. Subsequent medical care of your child at the Childrens Hospital 
of Los Angeles is in no way contingent upon participation in this study 
program. 
HOW TO OBTAIN INFORMATION 
Daytime Monday through Friday, 8 a.m. to 5 p.m., you may call (213) 
669-2169. You may leave a message with a secretary, and a doctor will 
return your call. 
Evening, nighttime, and weekends or holidays: You may call the 
hospital number (213) 660-2450, and ask for the on-call doctor for the 
Neurosurgery Department. You may be asked to leave a message with the 
page operator, and the physician on-call will return your call as soon 
as possible. 
If your questions are not an emergency, you can obtain better 
information by calling Dr. Corey Raffel, or Dr. Stuart Siegel, Monday 
through Friday, 8:00 a.m. through 4:30 p.m., than by calling the 
Neurosurgery Department doctor on-call after hours. 
If you have questions regarding your rights or your child's rights 
as a patient/ subject with regard to this study program, you can contact 
Ms. Gwenn Oki, Administrator of the Committee on Clinical Investigations 
(IRB) at (213) 669-2265. 
I 
SIGNATURE 
Your signature below indicates that you have read this document, 
understand its meaning; have had a chance to ask questions; have these 
questions answered to your satisfaction; and consent to your child's 
participation in this study program. 
Recombinant DNA Research, Volume 18 
[83] 
