Comprehensive Cancer Center Wake Forest University School of Medicine

PATIENT INFORMED CONSENT FOR CLINICAL RESEARCH

You are being asked to participate in a multicenter research study. In order to decide whether or not you should agree to be part of this research study, you should understand enough about its risks and benefits to make an informed judgment. This process is known as informed consent. This consent form gives detailed information about the research study that the investigator will discuss with you. Once you understand the study, you will be asked to sign this form if you wish to participate. You will have a copy to keep as a record. The research study being proposed to you is: Collection of Salivary Gland Acinic Cell Carcinoma Tissue for Research.

PURPOSE OF THE RESEARCH STUDY: You [have been diagnosed as having a salivary gland tumor] and/or [will have a procedure that may determine you have salivary gland acinic cell carcinoma]. The tissue retrieved by this procedure will be analyzed to better understand if the tissue is malignant, and generally help your doctor make decisions about your treatment.

DESCRIPTION OF THE RESEARCH PROCEDURES: You have been selected to participate in this study because you have a salivary gland tumor that may be diagnosed as acinic cell carcinoma. Information learned from study of this tumor tissue will be shared with the medical community to better understand the nature of acinic cell carcinoma and promote more effective management and treatment of this cancer. In order to do these analyses actual tissue samples from excess tumor that is removed is required. These tissue samples will be sent to the Tumor Tissue Core Laboratory of the Comprehensive Cancer Center of Wake Forest University for storage and distribution to research scientists. The samples taken will not affect your treatment being used to treat you. This tissue banking requires a small amount (less than 1 gram) of remnant tissue that would normally be discarded following pathologic examination. The use of this tissue will be restricted by an oversight research review board. This type of tumor tissue is needed for research to try to learn more about this uncommon cancer in hopes of understanding why it occurs in certain patients, how it may be prevented, and if it occurs, how it may be more effectively treated.

Comprehensive Cancer Center Wake Forest University School of Medicine Patient Consent DURATION OF PLANNED STUDY: This is an ongoing study to collect as many of these rare tumor types as possible for research purposes. There will be no change in the treatment ordinarily planned for you.

PRIVACY: Your research and hospital records are confidential. Your identity and all personal and confidential information about you will NOT be divulged to the Food and Drug Administration (FDA), or any participating scientist. A coded number will be given to the cancer tissue specimen, and used by the investigators for reference only. The only information needed to compare your cancer and similar cancers taken from other participants will be your age, sex, race, and whether you have any other diseases which might affect the interpretation of results. Participating scientists will not have access to your identity.

BENEFITS: You will not benefit directly from this study. This study will have no treatment effect on your case. No information obtained by this study will be made available to you. There is the potential to benefit other cancer patients in the future if this study leads to the development of effective methods for evaluation of acinic cell cancer and it's therapies.

RISKS: You will not be required to take any medication or undergo any treatment that is not usually indicated for your therapy. There will be no risk to your health or ability to receive appropriate therapy. By signing this consent form you give to Wake Forest University School of Medicine your cancer tissue for the advancement of science and will relinquish all rights and privileges obtained from analysis and experimental work on your cancer tissue or information obtained.

ALTERNATIVES: You do not need to participate in this study to be treated.

Comprehensive Cancer Center Wake Forest University School of Medicine Patient Consent FINANCIAL COST: There will be no additional charges to you for this study. You will receive a bill for doctor or clinic visits, hospitalization, tests and evaluations, therapy, and/or surgery that is part of the customary treatment of your disease. You or your insurance carrier will be responsible for these costs. Financial compensation for such things as lost wages, disability or discomfort due to an injury or directly resulting from your disease or from the treatment you receive is not available. You will not give up any of your legal rights by participating in this study as a patient at [North Carolina Baptist Hospital, Inc.] However, [North Carolina Baptist Hospital, Inc.] will not provide compensation. RIGHT TO REFUSE OR WITHDRAW: The choice to enter or not to enter this study is yours. You are in a position to make a decision if you understand what the doctor has explained and what you have read about the research study. If you decide not to participate, all usual and customary treatment will be made available without prejudice. Subjects have the right to withdraw at any time. As long as the Tumor Bank can identify their sample, the subject can ask to have it withdrawn. The only way a subject can not have a collected sample withdrawn is if once the sample is collected it is made absolutely anonymous. This means there can be no link any where to the subject's name, medical record number, social security number, etc. Following the procedure, you give up all rights to retract consent to use of the cancer tissue and information obtained. This study has been reviewed by the Institutional Review Board which is responsible for making sure that research with patients is appropriate and that the patient's rights and welfare are protected. If you have questions about your rights as a research subject you should call the Chair of the Institutional Review Board at [336-716-4542]. If you have any questions or need more information about the conduct of this study contact [Dr. Fred McGuirt 336-716-4161.] I have read this consent form and certify that the research described and in which I am to participate has been fully explained. Unless you have a mechanism to assess understanding you can't really expect someone to certify that they "understand" the information. This is best left as read and explained. You may want to say "I have read this consent form and the research study has been explained to my satisfaction. I also certify that I have received a copy of this consent form.

PERSON OBTAINING CONSENT

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