9. I have been assured that confidentiality will be preserved except that qualified 
monitors from the Food and Drug Administration, or National Cancer Institute 
may review my records where appropriate and necessary. Qualified monitors 
shall include assignees authorized by the Surveillance Committee of this 
institution provided that confidentiality is assured and preserved. My name will 
not be revealed in any reports or publications resulting from this study, without 
my expressed consent. 
10. I have been informed that, should I suffer any injury as a result of participation in 
this research activity, reasonable medical facilities are available for treatment at 
this institution. I understand, however, that I cannot expect to receive any credit 
or reimbursement for expenses from this institution or any financial compensation 
from this institution for any injury that is not caused by negligence. 
11. I have been informed that I should inquire of the attending physician whether or 
not there are any services, investigational agents or devices, and/or medications 
being offered by the sponsor of this clinical research project at a reduced cost or 
without cost. Should the investigational agent become commercially available 
during the course of the study, I understand that I may be required to cover the 
cost of subsequent doses. 
Costs related to my medical care that are not part of this research (including 
expensive tests or procedures such as bronchoscopy and biopsies) shall be my 
responsibility. I have been given the opportunity to discuss the expenses or costs 
associated with my participation in this research activity. 
12. It is possible that this research project will result in the development of beneficial 
treatments, new drugs, or possible patentable procedures, in which event I 
herein disclaim and hereby waive any right or claim to receive any compensation 
or benefits from the subsequent use of information acquired and developed 
through participation in this research project. 
13. I understand that practicing effective contraception is medically necessary and a 
prerequisite for my participation in this clinical research study. Should 
contraception be interrupted or if there is any suspicion of pregnancy, my 
participation in this clinical research study may be terminated at the sole 
discretion of the investigator. 
14. I may discuss any questions or problems during or after this study with Dr. Jack 
A. Roth at (713) 792-6932. In addition, I may discuss any problems I may have 
or any questions regarding my rights during or after this study with the Chairman 
or the Surveillance Committee at (713) 792-3220 and may in the event any 
problem arises during this clinical research contact the parties named above. 
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