Detection of Recurrent or Metastatic Head and Neck Cancer
Using Proteomics as a Novel Technique
UPCC 14303
PATIENT INFORMED CONSENT FORM
ABRAMSON CANCER CENTER
UNIVERSITY OF PENNSYLVANIA
3400 Spruce Street, Penn Tower Building, Philadelphia, PA 19104
Principal Investigators: Marcia Brose, M.D., Ph.D.
Sub-Investigators: Bert O'Malley, MD, Gregory Weinstein, MD,
Ara Chalian, MD, Harry Quon, MD, Robert Lustig, MD
(215) 614-1858 or (215) 662-6059 (24 hrs.) and ask for the oncologist on call
Invitation to Participate:
You are being invited to participate in this research project because your doctors would like to include
samples of some of your blood in a research study. You have the right to know that consent is purely
voluntary, that your permission to participate in research may be withdrawn at any time, and that you
may discontinue participation in all or part of the research without affecting your present or future medical
care. This document contains important information that you should know before allowing your blood to
be studied. Please take your time to review this form. Feel free to discuss it with your family, friends, or
family doctor before you make your decision.
Why is This Study Being Done?
The purpose of this research is to find better ways to detect and treat head and neck cancers. Research
using blood is an important way to try to understand human diseases. Doctors and other medical
scientists want to (1) find better ways to detect cancer early, (2) determine how cancer spreads and
resists current types of treatment, and (3) treat patients who have cancer by understanding the above
processes. To do these things, they need more information about the causes and behavior of cancer.
Medical doctors therefore want to compare the study samples of cancer patients to study samples from
people who have not been diagnosed with cancer.
How Many People Will Take Part in the Study?
About 80 patients are expected to take part in this study. All are expected to be enrolled at the University
of Pennsylvania. Patients with cancer and patients without cancer will be invited to participate in the
study.
What are the Procedures Involved in This Study?
If you agree to participate in this study, you will be asked to sign this consent form. A small sample of
the blood obtained from you will be collected, frozen, and kept in the Head, Neck and Oral Tissue, Serum
and Saliva Bank at the Hospital of the University of Pennsylvania under the direction of Dr. Michael
Feldman. The blood placed in this area will not be needed for the diagnosis or management of your
health. In terms of blood collection, we may ask for no more than 10 ml of blood which is equal to two
teaspoons.
Samples obtained for this research study may be tested immediately or may be frozen and examined
later. The frozen samples of your blood cells will be kept in the above designed Head, Neck and Oral
Tissue, Serum and Saliva Bank. Samples to be used right away will be given to the researchers at the
University of Pennsylvania. Samples may be tested for blood markers for your cancer so that we may
find better ways to detect, treat, and understand head and neck cancers. The study of such markers is
important for developing cancer detection tests, cancer treatment strategies and new cancer therapies.
Your sample may be kept until notice is given by you to the doctors to discard the samples. Some cells
obtained from your body may be used to establish a cell line that may be shared in the future with other
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Detection of Recurrent or Metastatic Head and Neck Cancer
Using Proteomics as a Novel Technique
UPCC 14303
PATIENT INFORMED CONSENT FORM
researchers. A cell line is a group of cells that will grow continuously in the laboratory. Cell lines may be
useful because of the special actions of the cells and/or the products they may produce.
If you prefer not to allow storage of your blood cells for research tests, you may refuse at any time. Your
frozen samples will then be destroyed. To withdraw from the study please contact (in writing) any of the
individuals listed on the first page of this document.
Blood stored in the tissue bank will be linked with disease information including patient identification
known only to the Principal Investigator. This is necessary to allow for linking patient disease and
disease outcome. While your blood is being studied, the tissue specimen will be coded so that personal
information will not be available to the investigators.
Your personal contact information is important for the University of Pennsylvania Health System and
School of Medicine research team to contact you during the study. Your health information and results of
tests and procedures are being collected as part of this research study and for the advancement of
medicine and clinical care. The Principal Investigator may also use the results of these tests and
procedures to treat you.
In addition to blood, any information that is felt to be disease related will be collected. This will include,
but not be limited to, history on smoking and alcohol use, location and extent of your disease, and any
previous treatment. Information on the outcome of therapy will also be maintained.
At times it may be necessary to contact you or your primary/referring physician who could be outside the
Hospital of the University of Pennsylvania Health System to obtain additional information. All of this
information will be stored in a computer database and used for research purposes only. Your research
information will be coded with a code number in order to protect your confidentiality. Your name will not
be used at any time in association with the research materials and the data will be maintained under
password protection and lock and key.
What Are the Risks of the Study?
Donating blood for these research purposes will not add any additional risks to that of any surgery or
procedures you have had or will have.
When blood is requested, a trained technician, nurse or doctor will obtain the blood samples. You will be
checked closely to see if complications due to blood drawing occur. Complications that may arise as a
result of blood collection are typically minimal and may include bruising, swelling, fainting, and infection.
Medical care will be available if the need arises.
The greatest risk is the release of medical information from your medical records. The investigators will
protect your records so that your name will be kept private. The chance that this information will be given
to someone else is very small. There is a chance that an authorized person may review your private
information. Under certain circumstances, research study records like hospital records can be requested
by a court order. In such rare cases, your complete privacy cannot be guaranteed.
Things to Think About:
The choice to let us keep blood for research is up to you. No matter what you decide to do, it will not
affect your care. The research being done with your blood will probably not help you. It might help
others who have cancer and other diseases in the future. Reports about research done with your blood
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Detection of Recurrent or Metastatic Head and Neck Cancer
Using Proteomics as a Novel Technique
UPCC 14303
PATIENT INFORMED CONSENT FORM
will not be given to you or your doctor. These reports will not be put in your medical record. The
research will not have an effect on your care.
If you decide now that your blood can be kept for research, you can change your mind at any time. Just
contact your doctor and let him/her know that you do not want your blood to be used. Then the blood will
no longer be used for research.
In the future, people who do research may need to know more about your health. If this is done, the
investigators will not give them your name. Sometimes blood is used for genetic research (about
diseases that are passed on in families). Even if your blood is eventually used for this kind of research,
the results will not be put in your medical record.
Your blood will be used only for research and will not be sold. You will not be paid for allowing your
blood to be used in research even though the research done with your blood may help to develop new
products in the future. Similarly, there will be no cost to you for any blood that is collected and stored.
Are There Benefits to Taking Part in the Study?
Your contribution to this study will be for research purposes only. You will not receive personal medical
information from this study. You will not be paid for participating in this study.
You should not expect your condition to improve as a result of participating in this research study.
However, new information learned from this study about cancer could help doctors identify new methods
for early detection, new treatments, and possibly new cures. This study may provide information leading
to the discovery of genes involved in causing cancer. You will not receive any personal benefit from
being in this study.
Use of Specimens:
Any blood obtained for the purposes of this study becomes the property of the University of
Pennsylvania. The University may retain, preserve, or dispose of these specimens and may use these
specimens in research which could result in grant applications or commercial applications. You will not
receive money for donating blood nor will you receive money for any future commercial ventures. Your
blood will be used for research only.
Are There Alternatives to the Study?
You have the alternative of not participating in this study. Your participation is completely voluntary and
will not affect your medical treatment now or in the future.
Is There Compensation for the Study?
There will be no financial compensation for participation in this study.
What about Confidentiality?
All information collected in this study will be kept strictly confidential, except as may be required by law.
Your blood samples used in this research study will be stored with a confidential code and your name will
not be included with any data shared with other investigators. The key connecting your name to your
code number will be held in a separate, secure location. The medical information produced as a part of
this study will not become part of your medical record or that of any of your relatives.
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Detection of Recurrent or Metastatic Head and Neck Cancer
Using Proteomics as a Novel Technique
UPCC 14303
PATIENT INFORMED CONSENT FORM
What are the Costs?
Blood samples will be drawn in conjunction with routine blood work and thus no additional charges
should be incurred. In the case of injury resulting from this study, emergency medical treatment is
available but will be provided at the usual charge. No funds have been set aside to compensate you in
the event of injury.
If you agree to participate in this study, your blood samples will be stored at no cost to you. Any
research tests involving your blood samples will be performed at no cost to you.
What Are My Rights As A Participant?
Taking part in this study is voluntary. You may choose not to take part or may leave the study at any
time. Leaving the study or choosing not to take part will not result in any penalty or loss of benefits to
which you are entitled.
Disclaimer/Withdraw
Your participation in this research study is completely voluntary. If you choose not to participate, that will
not affect your present or future care at the University of Pennsylvania. If you decide to participate, you
are free to withdraw your consent and discontinue participation at any time without prejudice to your
present or future care. If you choose to withdraw from the study, the blood samples could be destroyed
so that they are unavailable for future research. The investigators may retain the identified samples as
part of your routine clinical care but not for additional research. Alternatively any information linking your
identity to the blood can be permanently removed so that the blood may still be used for other research
that does not require clinical data.
Whom Do I Call If I Have Questions or Problems?
For questions about the study or a research-related injury, contact your study doctor at the telephone
numbers on page one of this form. For questions about your rights as a research participant, contact the
Director of the Office of Regulatory Affairs (a group of people who review the research to protect your
rights) at 215-898-2614.
Signature
Your signature below indicates that you have been given the opportunity to read this consent form and to
ask questions. Your questions have been answered to your satisfaction. You voluntarily agree to
participate in this research study. Upon signing below, you will receive a copy of the consent form.
_________________________ _______________________________ ________________________
Name of Participant
Signature of Participant
Date
_________________________ _______________________________ ________________________
Name of Person Obtaining
Signature of Person Obtaining
Date
Consent
Consent
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