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 
/ iH 
STUDY NUMBER CONTINUATION: page of pages. 
A small proportion of people develop short-lived reactions during the gadolinium 
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 MRI scan suite. 
Risks from Open and Stereotaxic Procedures 
The surgical risks depend on the preoperative condition of the patient, the nature of the 
operation, and the location and size of the tumor. Known risks associated with stereotaxic brain 
surgery include hemorrhage, deterioration of neurological functions (such as motor - weakness in 
the arm and/or leg, sensory - loss of sensation over parts of your body, and cognitive functions - 
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 
risks will be discussed with you in accordance with your condition, specific findings and planned 
surgical procedures. 
Risks of the TK Gene Transfer 
Even though the disabled mouse viral vectors cannot grow and are considered 
harmless in humans, it is possible that events could occur within the cells that would permit the virus 
to grow and/or make the cells cancerous. Gene transfer using disabled mouse viruses has been 
used in adult and child patients with cancer. None of the more than 15 humans that have received 
genes transferred by vectors into their cells, and followed since these experiments started in 1 989, 
has developed any problems related to the gene transfer method. We believe these vectors are 
• safe and are not a threat to other people or to society. 
This is the first experiment in humans that will involve the implantation of the mouse producer 
PATIENT 
IDENTIFICATION 
CONTINUATION SHEET for either 
NIH-2514-1 (10-84) 
Recombinant DNA Research, Volume 15 
[ 843 ] 
1 
