MEDICAL RECORD 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER; CONTINUATION: page^£l of pages. 
bacterial infection. 
We must emphasize that the technique of retroviral-mediated gene transfer has not been used 
extensively in humans and has never been used in children or teenagers. The procedure may have 
unknown risks for patients with ADA deficiency. Because this will be the first gene therapy experiment 
in humans, it is possible that despite all of our efforts, other unforeseen, perhaps serious, problems 
may occur. 
Your Obligation to the Study 
Your participation in this study is voluntary. Once your child has received an infusion of the ADA- 
corrected cells, we urge that your child continue to be followed throughout the rest of his/her life. This 
would involve at least one blood sample each year to monitor the long term effects of the gene- 
containing cells. If you choose to withdraw, you will not be penalizing your child’s care and there will 
be no loss of benefits. If your child develops a study related injury, appropriate medical treatment 
will be provided by the National Institutes of Health (NIH). If a medical emergency related to the study 
develops following discharge from the Clinical Center, emergency treatment will be provided here if 
your child is in the immediate area of the NIH. For patients’ rights questions, contact Ms. Betty 
Schwering at (301)-496-2626. A copy of this consent form will be given to you. 
There will be no cost to you for any of the evaluations or treatments your child receives at NIH. All 
round trip travel costs for you and your child to participate in this protocol will be arranged and paid 
for by NIH. 
Every effort will be made to ensure the confidentiality of your child’s medical record. The NIH ADA gene 
therapy research team, and qualified representatives of the FDA and NCI are the only authorized 
personnel with access to your child’s medical record. This clinical procedure has attracted a great deal 
of attention from the lay media. We will make every effort to protect the privacy of your and your 
family. However, because of this media interest there is a greater risk than usual that information 
concerning you and your treatment will appear publicly without your consent. 
Research Questions 
For research related questions or in the event of an injury, you should contact Dr. R. Michael Blaese or 
Dr. Kenneth W. Culver at (301 )-496-5396 or (301)-496-4703. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-251A-1 (1CW4) 
NIH-2514-2 (1(>64) 
P.A : 09-25-0099 
Recombinant DNA Research, Volume 14 
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