10.0 INFORMED CONSENT AND IRB APPROVAL 
The Investigator at each site will be responsible for and shall prepare a written 
Informed Consent Document. The Protocol and the Informed Consent Document must 
be provided to his IRB. The IRB must approve the Protocol and Informed Consent 
Document and agree to monitor the conduct of the study and periodically review its 
progress at no less than one year intervals. Before the study begins, the Investigator 
will provide the Sponsor with documented evidence, i.e., a letter from the IRB or a 
copy of the IRB minutes, of: 
o Protocol and Informed Consent approval. 
o The IRB agreement to monitor the conduct of the study and review it 
periodically. 
( 
10.1 Updates To The Informed Consent Documents 
The Sponsor will notify the Investigator should significant new findings develop 
during the course of the study that may relate to the patient's wtilingness to continue 
pcirticipation. It is the Investigator's responsibility to: 
o Notify the local IRB. 
o Update the Informed Consent Document, 
o Notify each patient accordingly. 
o Each patient's record must contain a signed copy of the updated Informed 
Consent Document. 
o Send the Sponsor a copy of each patient's signed updated Informed Consent 
Document. 
11.0 STATISTIC CONSIDERATIONS 
Descriptive statistics will be performed due to the small number of patients. 
12.0 REFERENCES 
1 B. Zbar, ID. Bernstein, H.J. Rapp (1971) J. Nat. Cancer Inst. 46, 831. 
2 S.A. Rosenberg, J.J. Mule, P.J. Spiess (1985) J. Exp. Med. 161, 1169. 
3 S. Shu, S.A. Rosenberg (1985) Cancer Res. 45, 1657. 
4. P.J. Spiess, J.C. Yang, S.A. Rosenberg (1987) J. Nat. Cancer Inst. 79, 1067. 
5 T. Chou, A.E. Chang, S. Shu (1988) J. Immunol. 140, 2453. 
6 H. Yoshizawa, A.E. Chang, S. Shu (1991) J. Immunol. 147, 729. 
7 D.L. Morton, F.R. Eilber, E.C. Holmes (1974) Ann. Surgery 180, 635. 
8 S.A. Rosenberg, M.T. Lotze, J.C. Yang, P.M. Aebersold, W.M. Linehan, et al 
(1989) Ann. Surgery 210, 474. 
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