0444 P07 
FEE-24- '94 THU 14:40 I D: HEnHTOLQGY-ONCOLOGY FAX NO: 602-626-2225 
Appr. Dace: 11/23/93 
Rev: 1/13/94 
SL^BJECTS' CONSEJsTT FORM 
TITLE' Phase I Srudy of Immunotherapy 
of Malignant Melanoma by 
Direct Gene Transfer 
Page _4_of_5^ 
Numben 
SWOG; 
HSC: 93-175 
padent names w-ill be used. In accord with the requirements of the Food and Drug 
Admirustration (FDA), occasionally medical records of patients may be re^iewed by 
medical monitors of sponsoring agencies whose duty it is to oversee diis research to 
verify- its accuracy. This may include the sponsoring company (VicaJ Inc. San Deigo. 
California), the NadonaJ Cancer Insdrute and the FDA. 
particlpattqv: costs 
The experimentaJ drug KLA-B7 gene in a plasmid liposome (faery substance) delivery 
system will be s'applied by the srjdy sponsor. I will be charged for the standard tests 
associated with the delivery of routine medical care for my disease. This includes 
routine blood tests, X-rays, scans, and physician's charges. The charges associated 
with the management of the side effects of treatment (medication, etc.) will also be 
billed to me or a third party carrier. Ail costs are standard for medical care 
involving these treatments. The drug and its administration and any addidonal 
testing will be covered by the sponsor. I can obtain further Information from Evan 
M. Hersh, M.D. (Principal Investigator) at (602) 626-2250 or page at 694-6000, (pager 
1240), Dr. Evan Unger (602) 69-^2515 (pager 2042), Dr. James Warneke (602) 626-7754 
(pager 2429) or Dr. Alison Stopeck (602) 626-2816 (pager 1231). 
IIABILTY 
I unde.'^cand that adverse reactions are possible in any research program despite the 
use 0 .^ high sta.ndards of care and could occur through no fault of mine or the 
investigator involved. Reactions which can be foreseen have been described in this 
consent form. However, unforeseeable harm may also occur and may require care. 
I unde."stand that money for research-related side effects or harm or for wages or 
tirne lest is not available. Necessary emergency medical care direedy related to this 
treatment will be provided from Evan M. Hersh, M.D. I can obtain further 
Information from Evan M. Kersh, M.D. (Principal Investigator) at (602) 626-2250). Dr. 
Evan Unger (602) 694-2515 (page.'- 2042), Dr. James Warneke (602) 626-7754 (pager 
2429) or Dr. Alison Stopeck (602) 626-2816 (pager 1231). If I have questions 
concerning my rights as a research subject, I may call the Human Subjects 
Commiriee office at (602) 626-6721. 
altthcriz.atton 
BEFORE GIVING MY CONSENT BY SIGNING THIS FORM. THE METHODS, INCONVENIENCES. 
RISKS .AND BENEFITS HA.VE BEEN EXPLAINED TO ME AND MY QUESTIONS HAVE BEEN 
answered. I UNDERSTAND THAT I MAY ASK QUESTIONS AT ANY TIME .AND THAT I AM 
FREE TO WITHDR-AW FROM THE PROJECT AT ANY TIME WITHOUT CAUSING BAD FEELINGS 
OR affecting my medical care my PARTICIPATION IN THIS PROJECT MAY BE ENDED 
BY THE INVESTIGATOR OR BY THE SPONSOR FOR REASONS THAT WOULD BE EXPLAINED. 
NEW INTORMATION DEVELOPED DLTING THE COURSE OF THIS STUDY .WHICH MAY 
AFFECT MY WILLINGNESS TO CONTINUH IN THIS RESEARCH PROJECT WHi BE GIV^ tb . 
ME AS IT BECOMES AVAILABLE.' I UNDERSTAND THAT THIS CONSENT FORM WHI BE 
FILED IN AN AREA DESIGNATED BY THE HUMAN SUBJECTS COMMITTEE WITH ACCESS 
RESTRICTED TO THE PRINCIPAL INVESTIGATORS. EVAN M. HERSH, MD, EVAN UNGER, 
MD. JANES WARNE<E,MD OR ALISON STOPEC.K,MD. AN AUTHORIZED REPRESENTATIVE 
Recombinant DNA Research, Volume 19 
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