Form 
M-03 
DUKE UNIVERSITY MEDICAL CENTER 
A PHASE 1 TRIAL OF HUMAN GAMMA 
INTERFERON TRANSDUCED AUTOLOGOUS 
TUMOR CELLS in PATIENTS with 
DISSEMINATED MALIGNANT MELANOMA 
(Page 4 of 5 ) 
IRB# 1456 92-12 
COSTS: The treatment and all experimental costs will be supplied 
free of charge by the study sponsor. Any other cost including 
costs of needed medical care will be the responsibility of you 
and/or your insurance carrier. You may contact our Business Office 
for further information at (919) 684-2395. 
Taking part in this study is entirely voluntary. You may decline 
to participate or you may withdraw your consent and discontinue 
participation in the project at any time without affecting your 
needed medical care or your relationship with your physician. If 
your physician determines it is not in your best interests to 
continue participation in this study, your physician may 
discontinue this treatment. You will be given a copy of this 
informed consent. Any questions or concerns you may have about 
this study will be answered by the Principal Investigator, Dr. 
Hilliard Seigler, (919)684-3942. 
During your treatments, you will also be notified of any additional 
information that becomes available and which might influence your 
decision to continue in the study. 
Immediate necessary care is available if an individual is injured 
because of participation in a research project. However, there is 
no provision for free medical care or for monetary compensation for 
such injury. Further information concerning this and your rights 
as a research subject can be obtained from the Hospital Risk 
Management Office (919)684-3277. 
The confidentiality of this study's records identifying you will 
be maintained within Duke University Medical Center. Your identity 
will remain confidential if material from the record is used for 
publication or for educational purposes. However, you should be 
aware that the sponsor, Viagene, the Food and Drug Administration, 
and/or the National Cancer Institute may inspect the records. 
Patient's Initials 
[652] 
Recombinant DNA Research, Volume 17 
