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Patient Information Sheet
TISSUE BANKING
(This form is not protocol-specific and should not require much modification, if any)
What is Human Tissue?
Human tissue includes parts of the human body such as: liver, breast, reproductive tissues,
kidneys, lungs, bone, teeth, blood, skin and more. It does not include hair, nails, or secretions or
excretions of the body, such as saliva or urine.
Where Does Human Tissue For Research Come From?
You might be scheduled to have a biopsy (a small piece of tissue that can be obtained in various
ways) or surgery (where generally a larger piece of tissue is removed) or some other procedure
such as a pap smear, or some blood drawn from a vein in your arm.
Whenever a biopsy (or surgery) is performed, the tissue that is removed from the patient is
usually examined by a trained doctor who makes a diagnosis using a microscope and looking at
the results of various lab tests. This is part of your regular medical care.
Your doctor will only take enough tissue that is needed for your care. No additional samples will
be taken. After all tests have been done on your tissue, there will usually be some tissue leftover. Often this tissue would not be kept because it is not needed for your care. However, you
can choose to have this tissue kept for future research. If you agree, your left-over tissue will be
saved for research.
Researchers can also use blood or even scrapings from the inside of the mouth in studies. You
may be asked to provide these sorts of samples for a certain study. Generally, you will provide
an additional sample(s) for these studies beyond those needed for your regular medical care.
These types of tissues are easily procured and you may be asked to donate these sorts of samples
as a healthy volunteer.
Why Do People Do Research With Tissue?
Research with tissue can help to find out more about what causes cancer, how to prevent it, and
how to treat it. Research using tissue can also answer other health questions. Some of these
include finding causes of diabetes and heart disease, or finding genetic links to diseases, such as
Alzheimer’s disease or diabetes, or finding the best way to treat various diseases.
What Is A Tissue Bank?
A human tissue bank is usually a special freezer that is located in a researcher's lab at the
university or at a national research center. Usually, the tissue bank contains lots of similar types
of human tissues. Some tissue banks are used for transplantation (to help gather healthy tissues,
such as a heart or parts of an eye, from one person that can be put into a sick person) in medical
treatment. However, most tissue banks, like the one that you are contributing to, are used to
collect human tissues for medical research.
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How Long Will My Tissue Be Stored?
Tissues placed in tissue banks are usually kept at very cold temperatures and can be stored this
way for a very long time. Your tissue will be stored indefinitely or until it is used up. If you want
to withdraw from the study you may be able to request that it be removed from the tissue bank
and destroyed. However, in some cases, this may not be possible, since in some studies, tissue
samples may be stored anonymously without any labels that link them to specific subjects.
What Type Of Research Will Be Done With My Tissue?
Many different types of research rely on the use of human tissues. They can be used to develop
new tests to help diagnose diseases, or can be used to help develop new ways to treat or even
cure diseases. Some of the research may lead to new medical products, such as diagnostic tests
and drugs, or new procedures.
Some types of research that use human tissues can be considered controversial by some people.
This includes genetic research. This can involve looking at the way that diseases might be
inherited in families or how certain genes might cause disease or how a person’s genes influence
the way that they respond to treatment. Some research might involve the development of drugs
for certain uses, such as for birth control, that can be considered wrong by some people. Please
talk to the consenting staff if you have concerns about this. It may not be a concern for this
study.
Who Gets to Use Tissue In The Tissue Bank?
Access to your tissue and any personal data that may be associated with your tissue, is strictly
controlled. Various researchers from this university and elsewhere may use your tissue in
research studies. However, they must make a formal request to use these samples and their
research must be approved by a group of people who are responsible for the protection of human
rights in human research. Once the study is approved, the researcher receives your tissue and
when appropriate, information about you from your hospital record. The researcher will not
receive your name, address, phone number, social security number, or any other personal
identifying information. This is done to protect your confidential information.
Why Do You Need Information From My Health Records?
In order to do research with your tissue, researchers may need to know some things about you.
For example: Are you male or female? What is your race or ethnic group? How old are you?
Have you ever smoked? What medications are you taking? Do you have other medical
problems? Is there a family history of disease? This helps the researcher answer questions about
diseases.
The information that may be given to the researcher includes but is not restricted to: your age,
sex, race, medical history, diagnosis, treatments, and possibly some family history. This
information will be collected from your health record by the study staff. They may also look at
your medical record in the future in order to up-date your personal health information. Neither
your name nor other identifying information will be shared with researchers.
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Could The Information Obtained From My Health Records Be Used In Ways That Might
Be Harmful To Me?
Sometimes, health records have been used against patients and their families. For example,
insurance companies may deny a patient insurance or employers may not hire someone with a
certain illness (such as AIDS or cancer). The results of any genetic research that is done on your
tissue, may not only apply to you, but also to your family members, since diseases are often
inherited through families. For diseases caused by genetic changes, the information in a person’s
health record could be used against family members.
How Will You Protect My Personal Information?
The people involved in conducting these studies are all trained in ways to protect your rights as a
study participant. The University of Oklahoma Health Sciences Center is dedicated to ensuring
that the highest standards are followed in all human research conducted at this campus.
The Principal Investigator and sponsor of this study are responsible for safeguarding your
personal information. Your name, address, phone number and other identifying information will
be taken off of anything, including paperwork, associated with your tissue before it is given to
other researchers. This would make it very difficult for any specimen or research results to be
linked directly to you or your family. The research done on your tissue may be reported in
scientific journals and meetings but you will not be identified in these reports.
Will I Find Out The Results Of Research Done Using My Tissue?
No, you will not receive the results of research done with your tissue. There are many reasons
for this:
 Research can take a long time because many people have to be tested and there can be
many tests to do.
 The exact meaning of some of the research may be unknown at this time.
 Legally, we may not be allowed to use these research results for your medical care.
 If your tissue did not have any kind of identifier or code put on it at the time that it was
collected, it would be impossible to know which tissue in the tissue bank came from you.
Will Anything Go Into My Health Record Relating To This Research?
Sometimes a note may be placed into your record that says that you took part in this research
study. But no research results will ever be placed in your medical record. Research results will
not be shared with your doctor, you or your family members or used for your medical care.
Will I Benefit From The Research Using My Tissue?
There will be no direct benefit to you because your tissue will not be used for your immediate
medical care. However, it is hoped that the results of research on your tissue and tissues from
other patients will provide information that will help other patients in the future.
IRB Office Use Only:
Reviewed: 08/31/2014
Last Revised: 04/21/2006
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