Medical Record . Continuation Sheet for Consent to Participate in a Clinical Research Study 
Number Continuation: page 4 o f 8 pages 
sample of blood per year for the remainder of your life to monitor the safety of this gene transfer 
methodology. 
RISK ASSOCIATED WITH EVALUATION AND TREATMENT 
Risk of MRI and CT scans: 
MRI and CT brain scans are painless procedures that are very safe for most patients. During 
the scan you will lay flat in a long metal cylinder, which people who fear closed spaces sometimes 
find a little frightening. Patients can be observed at all times by the operators and can be assisted if 
necessary. You will be moved out of the machine if requested. The MRI machine makes a thumping 
sound while operating. 
A small proportion of people develops short-lived reactions during the dye administration 
including nausea, headache, hot flashes, and heart palpitations. These symptoms usually resolve 
spontaneously within minutes. A smaller group of patients are actually allergic to the dye and may 
develop a rash, hives, respiratory difficulty, and in extreme cases pulmonary and cardiac arrest and 
death. You will be closely monitored and if an allergic reaction develops, you will be promptly 
treated with epinephrine and breathing assistance if necessary. Both therapies are immediately 
available in the room where the brain scan will be performed. 
Patients at risk for injury from MRI are those with pacemakers, aneurysm clips (metal clips on 
the wall of a large artery), or shrapnel fragments. Welders and metal workers are also at risk for 
injury because of possible metallic foreign bodies in the eye. If you are at risk for injury by MRI 
scanning, you will undergo CT scanning instead. 
Risk of Surgery: 
The surgical risk depend on the preoperative condition of the patient, the nature of the 
operation, and the location and size of the tumor. Known risk associated with brain surgery include: 
hemorrhage, deterioration of neurological functions (such as weakness in the arm and/or leg, loss of 
sensation over parts of your body, and partial or complete loss of functions related to communication 
such as speech and comprehension, and other functions related to intellectual capacity, memory, etc.), 
infection and death. The relative risk will be discussed with you in accordance with your condition, 
specific findings and planned surgical procedures. 
Risk of the Ommaya reservoir: 
The Ommaya reservoir is a commonly used device in neurosurgery. The Ommaya reservoir is 
inserted under the skin with an attached tube that extends into the area of tumor. To use the Ommaya 
reservoir, the overlying skin is cleansed and a needle is inserted through the skin into the chamber. 
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