IUPUI INFORMED CONSENT STATEMENT 
for 
PROJECT Retroviral-Mediated Gene Transfer o£ Bone Marrow Cells During 
TITLE ; Autoloftoug Bone Marrow Transplantation for Acute Leukemia 
Page 3 
theoretically possible that I could become infected with the virus, Since 
this has never happened, the consequences of such an infection are unknown. 
Also, the inserted gene produces a protein that inactivates the antibiotics 
neomycin and amikacin, These antibiotics are rarely used in bone marrow 
transplant patients. The antibiotics routinely used during bone marrow 
transplantation are not inactivated, and these will be used in treating 
any bacterial infections that might occur. 
5. I understand that I can proceed with the bone marrow transplantation 
without consenting to this extra research. I have been told that I have 
no obligation to participate and my care will not be affected in any way 
if I choose not to be a subject in this research study. I have been 
encouraged to ask questions that I may have and take as much time as I need 
to make my decision. 
6. Participation in this study is entirely voluntary. I may choose to 
participate or may withdraw at any time up to the time of infusion of the 
bone marrow, I understand that enough bone marrow has been harvested to 
be able to proceed with the transplantation even without the cells that 
are treated. If I withdraw my consent, the treated cells will simply not 
be infused. In the event that I do withdraw my consent after harvest, but 
do go ahead with transplantation, the course of my disease will be followed 
on a regular basis, either by chart review or by phone call to myself or 
my doctor. I will be asked to voluntarily contribute one bone marrow and 
blood sample 21 days after the bone marrow transplant. Whatever my 
decision, my doctors are committed to give me the best care they can, 
7. I have an illness which will be treated with the drugs and procedure 
described above. I am responsible for the cost of medical care which is 
related to the use of these drugs and procedures. NO compensation is 
availabe if I am injured in this research. If emergency medical treatment 
is required as a result of treatment with these drugs or procedure, I will 
be responsible for the cost of such treatment. In the event of such an 
injury or for more information, I should contact the investigator in 
charge, Dr. Ken Cornetta at (317)274-3589. A patient representative who 
is not associated with this research to whom I may address complaints about 
this study as well as questions about my rights as a research participant 
may be reached at (317)274-2126. 
8. The costs of hospitalization, treatment and laboratory procedures related 
to the bone marrow transplantation are my responsibility. Only the blood 
samples being analyzed for research purposes will be done at no cost. All 
Patient's Initials 
Recombinant DNA Research, Volume 15 
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