UNIVERSITY OF PENNSYLVANIA
Consent Form for Use of Tissue For Research
Protocol Title:
Principal
Investigator:
Insert Title of Research Study or Acronym
Insert Name of the Principal Investigator
Address
Insert Phone Numbers
About Using Tissue for Research
You are going to have a biopsy (or surgery) to see if you have cancer. Your doctor will
remove some body tissue to do some tests. The results of these tests will be given to you
by your doctor and will be used to plan your care.
We would like to keep some of the tissue that is left over from your biopsy for future
research studies. If you agree, this tissue will be kept and may be used in research to learn
more about cancer and other diseases. Please read the question and answer sheet called
"How is Tissue Used for Research" to learn more about tissue research.
Use of your left over tissue for future research studies will not require any additional time
commitment on your part.
Your tissue may be helpful for research whether you do or do not have cancer. The
research that may be done with your tissue probably will not help you. It might help
people who have cancer and other diseases in the future.
Reports about research done with your tissue will not be given to you or your doctor.
These reports will not be put in your health record. The research will not have an effect
on your care.
[If your study involves the use of clinical procedures or practices, for example clinical lab
results or an MRI, include the following language] Results of laboratory tests and clinical
procedures will be placed in your medical record and may be accessible to employees of
the health system that are not part of the research team. This information may also be
viewed by your insurance company during routine audits.
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Things to Think About
The choice to let us keep the left over tissue for future research is up to you. No matter
what you decide to do, it will not affect your care.
If you decide now that your tissue can be kept for research, you can change your mind at
any time. Just contact us and let us know that you do not want us to use your tissue. Then
the tissue will no longer be used for research.
In the future, people who do research may need to know more about your health. Reports
about your health will not include your name, address, or phone number.
Sometimes tissue is used for genetic research (about diseases that are passed on in
families). Even if your tissue is used for this kind of research, the results will not be put
in your health records.
Your tissue will be used only for research and will not be sold. The research done with
your tissue may help to develop new products in the future.
Benefits
The benefits of research using tissue include learning more about what causes cancer and
other diseases, how to prevent them, how to treat them, and how to cure them.
Risks
There are very few risks to you. The greatest risk is the release of information from your
health records. The University of Pennsylvania will protect your records so that your
name, address, and phone number will be kept private. The chance that this information
will be given to someone else is very small.
In the event that you are hurt or injured as a result of participation in this research study,
please contact the investigator at listed on page one of this form.
Making Your Choice
Please read each sentence below and think about your choice. After reading each
sentence, check "Yes" or "No." No matter what you decide to do, it will not affect
your care. If you have any questions, please talk to your doctor or nurse.
1. My tissue may be kept for use in research to learn about, prevent, treat, or cure
cancer.
Yes
No
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2. My tissue may be kept for research about other health problems (for example:
causes of diabetes, Alzheimer's disease, and heart disease).
Yes
No
3. Someone from the University of Pennsylvania may contact me in the future to ask
me to take part in more research.
Yes
No
If you decide to participate, you are free to leave the study at anytime. Withdrawal will
not interfere with your current or future care.
If you have questions, concerns or complaints regarding your participation in this
research study or if you have any questions about your rights as a research subject, you
should speak with the Principal Investigator listed on page one of this form. If a
member of the research team cannot be reached or you want to talk to someone other
than those working on the study, you may contact the Office of Regulatory Affairs with
any question, concerns or complaints at the University of Pennsylvania by calling
(215) 898-2614.
Please sign your name here after you check your answers.
Your Signature: __________________________________________
Printed Name: ___________________________________________
Date:
Signature of Person Obtaining Consent: _______________________
Printed Name: ___________________________________________
Date:
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IRB Informed Consent Template Version: 13 December 2010
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