12. SAMPLE CONSENT 
Informed Consent 
University of California - San Diego 
Consent to Act as a Research Subject 
Drs. Flossie Wong-Staal and her colleagues are conducting a study to find out more about 
gene therapy for the treatment of HIV and AIDS (Acquired Immunodeficiency Syndrome). 
The study is entitled "Ribozyme Gene Therapy for HIV." You have been asked to 
participate because you have infection with the Human Immunodeficiency Virus (HIV). 
The purpose of this study is to test the safety and effects of an experimental treatment 
for HIV. The treatment is called "ribozyme gene therapy". 
This therapy is called "gene therapy" because the object of it is to give your cells a new 
gene, the gene for the ribozyme. Ribozymes are pieces (molecules) of genetic material 
("genes") that have been popularly called "molecular scissors". Like a scissors, their 
function is to cut. Ribozymes cut other pieces of genetic material. The ribozyme that will 
be used to treat your cells cuts the genetic material of HIV. In this way, we hope the 
treated cells will become protected against HIV when they are back in your body because 
the ribozyme can cut the virus's genetic material inside the cells. 
Tests we have done with cells in the laboratory has shown that the ribozyme does help to 
protect cells growing in laboratory dishes from HIV. In this study, we will study what 
happens to you and to your cells when they are put back into your body after being given 
the ribozyme. That way we can find out whether what works in cells in laboratory dishes 
will work in cells when they are in your body. We will find out if this can be done safely 
and whether or not there are any side effects. 
If you agree to participate in this study, the following will happen to you: 
1 . Dr. David Looney or Dr. Eric Poeschla will take your complete medical history and 
perform a complete physical examination. 
2. You will have blood tests and x-rays to determine if you will be able to complete the 
study. 
3. If you are eligible for the study, you will come into the clinic and have about 12-18 
ounces (a typical can of soda is 12 ounces) of blood drawn from a vein in your arm. 
The exact amount will depend on your weight (roughly 6 ounces for each 50 lbs. of 
your weight). We will watch you for an hour or so to make sure you tolerate the blood 
drawing without any problems and, if so, you will then be able to go home on the same 
day. 
4. In the laboratory some of your white blood cells (your T cells) will be separated 
from the rest of your blood and placed in laboratory dishes. There they will be treated 
in various ways to make them grow and to keep any HIV in them from spreading in the 
dishes. After the cells have multiplied in number, they will be treated with the 
ribozyme. 
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