11.0. REPORTING OF ADVERSE DATA 
Report by phone to the FDA (301-295-8416) within 24 hours; (recorder 
after working hours). 
a) All life-threatening events (Grade 4 toxicities) must be reported. 
b) All fatal events while on study. 
Written reports to follow within 10 working days to: 
Dr. Curt Gunter, or new desigate, 
Center for Biologies Evaluation and Research 
Office of Therapeut ics , Research and Review 
Food & Drug Administration 
8800 Rockville Pike 
Bethesda, Maryland 20892 
Copies of written reports will also be sent to the NIH Office of 
Recombinant DNA Activities : 
ORDA, National Institutes of Health 
Building 31,Room 4B11 
Bethesda, Maryland 20892 
12.0 INFORMED CONSENT 
The informed consent form for this trial is attached as Appendix 14. G. 
Signed informed consent for participation in this clinical trial will be 
obtained in conformance with all guidelines of the Joint Committee on Clinical 
Investigation of the Johns Hopkins Medical Institutions. A patient and family 
information packet edited by current Johns Hopkins Oncology Center patients 
and family members has been prepared to help interested patients raise 
questions and better understand the nature of the trial prior to deciding on 
whether or not to give consent. (^Appendix 14. H) 
13.0 FEDERAL SAFETY STANDARDS AND^ BIOSAFETY REVIEW PROCESS 
V 
This phase I trial involves human recombinant DNA therapy. Two levels 
of federal review must be satisfied prior to commencement of the trial at the 
Johns Hopkins Oncology Center. 
13.1. FDA 
The Food and Drug Administration will review and must approve 
experimental use of the Somatix Therapy Corporation retroviral vector 
containing the human GM-CSF gene (Appendix 14. B). Production, storage, and 
use of this replication defective retrovirus in the creation of gene 
transduced lethally-irradiated renal cell tumor vaccine will conform strictly 
to FDA regulations for gene therapy studies. The principal investigator will 
be granted an IND Number. Full documentation of FDA approval and guidelines 
for use at the Johns Hopkins Oncology Center will be filed with the Joint 
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