INFORMED CONSENT FORM FOR
TISSUE BANKING
You are being asked to donate blood,
tissue or body fluids (specimens) to a
Tissue Bank for research purposes. The
main goal of a Tissue Bank is to collect
biological specimens (tissue, hair, blood,
etc.) for use by researchers to gain
knowledge about human disease that
may help other people in the future.
If you agree to participate in this Tissue
Bank, you will be asked to sign this
informed consent document. Informed
consent is a written agreement that you,
or your authorized representative, sign
indicating willingness to participate in
this Tissue Bank. This informative
document will tell you about the purpose
as well as risks and benefits of the
Tissue Bank. You should consent only
after you have been given all the
necessary information and have had
enough time to decide whether you wish
to participate. Your signature on this
form is voluntary and does not waive
any of your legal rights or make any
institutions or persons involved in this
Tissue Bank any less responsible for
your well-being.
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TITLE: [INSERT TITLE HERE]
WHAT IS THE PURPOSE OF A TISSUE BANK?
Studies performed using blood, tissue or body fluids (specimens) can help researchers understand
how the human body works. Research performed using specimens can also be helpful for the
development of new tests to identify diseases or new ways to treat diseases. In the future, research
may help to develop new products, such as drugs. Some of the possible goals of the research
involving human specimens might include determining whether a particular gene (material that is
passed from parents to child that determines the makeup of the body) is associated with a certain
type of disease. Sometimes researchers collect and store many specimens together and use them
for different types of research or share them with other scientists; this is called a tissue bank.
We are requesting your permission to donate some of your blood, tissue or body fluids for future
research. The samples that will be stored in the tissue bank are left over from specimens that were
taken, or will be taken, as part of your routine medical care. […or as part of this study (if the tissue
banking request is an add-on study within a primary study.] [If additional procedures, such as blood
draws or biopsies, will be done to procure the specimen that will be stored, this must be explained.]
WHO IS RESPONSIBLE FOR COLLECTING SPECIMENS FOR THIS TISSUE BANK?
[Insert:
Principal Investigator’s Name
Institution and Department
Contact Phone Number]
HOW WILL YOUR SPECIMENS BE COLLECTED?
You are scheduled to have [a surgical procedure, a blood test, or insert other type of procedure].
During the procedure it may be necessary for your doctor to remove some [name the type of
specimen] to conduct tests to diagnose or treat your condition. It is common for there to be left over
tissue after the necessary tests are completed.
[If additional procedures, such as blood draws or biopsies, will be done to procure the specimen that
will be stored, this must be explained.]
The following information will be collected at the time of your procedure:
[List all information to be collected - Examples: age; gender; race; tissue site (for example breast or
lung); etc.]
[If follow-up is required] We may collect and save information from your medical records, such as
personal and family history of disease, lifestyle factors (activity level, smoking status, etc.), results of
physical examinations, diagnosis, diagnostic tests, treatments, hospitalizations, and follow-up
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information. We may access this information as long as your records are available at Southern Illinois
University School of Medicine, St. John’s Hospital and/or Memorial Medical Center.
WHAT WILL HAPPEN TO THE SPECIMENS?
Once your specimens are sent to the tissue banking facility, there are several possible ways in which
it may be stored. These include freezing it, growing it in laboratory animals, and immortalizing it in
culture (your sample is made up of cells, which are the building blocks of all living things. Some cells
can be cultured, grown in special nutrient enriched solution, indefinitely.).
[Briefly describe where the specimens will be kept and for how long.]
At this time, it is impossible to name all of the different types of studies that researchers may want to
perform using your specimens. Any research done with your donated specimens in the future must
be approved by the Springfield Committee for Research Involving Human Subjects, a review board
that is set up to determine that the research is done according to accepted standards.
WHAT ARE THE POSSIBLE BENEFITS TO YOU?
The research that may be conducted with your specimens is not designed to provide direct benefit to
you. You will not be notified of any results of the research conducted using your specimens. However,
others may be helped through the knowledge gained from these studies regarding diseases or
conditions and how to detect, prevent or treat them.
WILL THERE BE ANY COST TO YOU FOR STORAGE OF THE SPECIMENS?
There will be no cost to you for the storage and use of the specimens for research purposes.
WILL YOU RECEIVE PAYMENT FOR THE USE OF YOUR SPECIMENS?
All specimens will be considered a donation and no compensation is offered. You should be aware
that new products might be developed and commercially sold as a result of research done on your
specimens. You should understand that you will receive no economic benefit from this.
WHAT ARE THE POSSIBLE RISKS OR DISCOMFORTS INVOLVED WITH THE USE
OF YOUR SPECIMENS?
[If you are drawing blood for research purposes use the following language]: As part of this specimen
collection, you are agreeing to donate blood. Blood is collected by placing a needle in a vein and
withdrawing the blood. This may be associated with discomfort, bruising, and there is a small risk of
bleeding from the site and of infection.
Donation of your specimens does not involve any additional risks or discomfort beyond what is
already required for diagnosis or treatment. Your care, including any procedures, will not be affected
in any way by donating your specimens; nor will your care be affected if you decide NOT to donate.
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The greatest risk to you is the improper release or misuse of your private information and specimens.
The chance of this happening is very small. We have protections in place to lessen this risk.
If your specimens are used in genetic research there are unknown risks to you due to the
identification of genes that are known to cause a particular disease. Additional, potential risks may
include paternity determinations (who fathered a child), loss of social acceptance, employment or
insurance discrimination (for example: denial of insurance or difficulty finding employment). These
risks may also extend to your family members that share your genes (biological sibling or child). The
results of these tests will not be released to you. Your information will be treated as confidential and
practices to prevent the misuse of your information (identifiable or not) are in place.
WHO WILL USE AND SHARE INFORMATION ABOUT MY PARTICIPATION IN THE
STUDY?
[Please Note: Complete this section if the specimen collection consent is the only consent included
with your submission.]
This section explains who will use and share your study-related health information if you
agree to participate in this study.
A federal privacy law, the Health Insurance Portability & Accountability Act (HIPAA),
protects your individually identifiable health information (protected health information).
The privacy law requires that you agree to allow researchers to use and/or disclose your
protected health information for research purposes in this study. This agreement will be
documented by signing this consent.
During the study, the researchers will use, collect, and record health information about
you. This can include any information about you that the study doctor needs to conduct
this study.
The protected health information that may be used and/or disclosed includes:
[List all protected health information to be collected for this protocol/study from among the list
below. Choose only the elements that apply.]
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Names
All geographical subdivisions smaller than a State, including street address, city,
county, precinct, zip code, and their equivalent geocodes, except for the initial three
digits of the zip code if according to the current publicly available data from the
Bureau of the census: a) the geographic unit formed by combining all zip codes with
the same three initial digits contains more than 20,000 people; and b) the initial three
digits of a zip code for all such geographic units containing 20,000 or fewer people is
changed to 000.
All elements of dates (except year) for dates directly related to an individual,
including birth date, admission date, discharge date, death
date; and all ages
over 89 and all elements of dates (including year) indicative of such age, except that
such ages and elements may be aggregated into a single category of age 90 or
older.
Telephone numbers
Fax numbers
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Electronic mail addresses
Social security numbers
Medical record numbers
Health plan identification numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full-face photographic images and any comparable images
Any other unique identifying number, characteristic or codes
If you sign this consent, you agree to allow the study doctor and research team to use
and/or disclose your protected health information described above with:
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Southern Illinois University School of Medicine’s Institutional Review Board: The Springfield
Committee for Research Involving Human Subjects (SCRIHS)
Government representatives, when required by law
Hospitals [List Memorial Medical Center and/or St. John’s Hospital if study uses these
facilities]
SIU HealthCare
SIU School of Medicine
[List any collaborators, outside laboratories, etc.]
[If applicable – list the sponsor’s name]
[List any other groups with whom the information may be shared]
[If applicable - statement that primary physician will be contacted if researcher in the course
of the project learns of a medical condition that needs immediate attention]
U.S. Food and Drug Administration (If an FDA regulated clinical trial)
Office for Human Research Protections (OHRP)
There are national and state laws that require the study doctor to protect the privacy of
your records. However, you do not have a guarantee of absolute privacy. Some
information may be subject to re-disclosure. If this should occur, your information may
no longer be covered/protected by the federal privacy protections.
If you would like to know how the sponsor would protect the privacy of your records, ask
the study doctor how to get this information.
You have the right to see and copy your records. However, if you sign this consent form,
you may not be able to see or copy some records until all subjects complete the study.
Once the study has ended, you will be able to see and copy your records.
You can withdraw your consent to use and share your records at any time. If you choose
to withdraw your authorization, you must submit this request in writing to [name and
contact information of investigator] to inform him/her of your decision.
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If you decide to withdraw from this study, federal regulations may allow the data
collected about you to continue to be used for the purposes of the study. Please be sure
to ask the study doctor about your options for removing your data should you withdraw
from this study.
HOW WILL YOUR PRIVACY BE PROTECTED AND YOUR INFORMATION REMAIN
CONFIDENTIAL?
Information from your medical records may be stored along with your specimens. Any information
obtained for the Tissue Bank that may identify you will remain confidential within the limits of the law
or will be disclosed only with your permission and the approval of the Springfield Committee for
Research Involving Human Subjects. Should any publication or public presentation result from this
research, your identity will not be revealed.
The specimens may be shared with researchers at this or other institutions. We will not release any
information to a researcher (unless authorized by you) that could be linked to you or allow your
specimens to be identified.
[If a code number will be assigned to the specimen that would provide a link to identifying information,
then use the following statement.] We will assign a code number to your specimen and any data that
could identify you directly. The purpose of the code number is to protect your confidentiality. It is
necessary to maintain a link between your specimen and your identifying information because
[provide a brief reason for retaining this link]. Only approved research personnel will have access to
this information.
[Include if genetic analyses will be done] A federal law called the Genetic Information
Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health
plans, and employers with 15 or more employees to discriminate against you based on your genetic
information. GINA does not protect you against genetic discrimination by companies that sell life
insurance, disability insurance, or long-term care insurance. GINA also does not protect you against
discrimination based on an already-diagnosed genetic condition or disease.
[If applicable] The Tissue Bank has obtained a Certificate of Confidentiality from the U.S. Department
of Health and Human Services. The certificate protects against the forced release of personal
information from the tissue bank. What this means is that the Tissue Bank cannot be forced to
disclose your identity to any third party. It is possible that for some criminal proceedings, the
Certificate of Confidentiality could be over-ridden.
WHAT ARE YOUR RIGHTS AS A PARTICIPANT?
Taking part in this specimen collection for the Tissue Bank is voluntary. Your care, including any
procedures, will not be affected in any way by donating your specimens; nor will your care be affected
if you decide NOT to donate.
If at any time you decide you no longer want your specimens used for research purposes, you may
request to withdraw your specimens and data. However, you should understand that any research
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performed with your specimens cannot be withdrawn; only specimens and data which have not been
used can be removed.
CHOICE FOR FUTURE RESEARCH USE AND FUTURE CONTACT
Please indicate if you agree to participate by circling your response.
I agree to let researchers use some of the [insert specimen type] that was taken from me at the time
of my procedure to do research to learn about, prevent, or treat [insert medical condition].
YES
NO
I agree to let researchers use the [insert specimen type] that was taken from me at the time of my
procedure to do research about medical questions other than [insert medical condition].
YES
NO
I would be willing to have researchers contact me in the future to take part in more research.
Examples of this research may include, but are not exclusive to, information regarding my family
health history and information concerning me, the specimen donor.
YES
NO
If, as a result of a research study, the researcher believes that it is important to obtain information that
identifies me, I would allow release of my name and information to the researchers who have
obtained adequate approval through a separate Institution Review Board (IRB) protocol?
YES
NO
WHOM DO YOU CALL IF YOU HAVE QUESTIONS OR PROBLEMS?
You may contact the following person(s) to answer any inquiries you may have concerning the Tissue
Bank and your rights as a participant, or to find out where to inquire about withdrawing your
specimens from the Tissue Bank:
[INSERT CONTACT INFORMATION HERE]
For questions about your rights as a Tissue Bank participant, contact the Springfield Committee for
Research Involving Human Subjects at:
Southern Illinois University School of Medicine
801 North Rutledge
Springfield, IL 62702
Telephone number: (217) 545-7602
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DOCUMENTATION OF INFORMED CONSENT
AFTER SIGNATURES ARE OBTAINED FROM YOU AND AN AUTHORIZED
PERSON LISTED BELOW, A SIGNED COPY OF THIS CONSENT WILL BE GIVEN
TO YOU.
You are voluntarily making a decision regarding participating in the Tissue Bank. Your signature on
this form means that you have read and understood the information presented above and have made
the decision to participate. Your signature also means that the information on this consent form has
been fully explained to you and all your questions have been answered to your satisfaction. If you
think of any additional questions throughout the Tissue Banking process, you should contact the
Principal Investigator.
I agree to take part in the Tissue Bank.
Signature of Participant, Legal Guardian, or Power of Attorney
Date
Printed Name
I certify that all the elements of informed consent described on this consent form have been explained
fully to the participant. In my judgment, the participant has voluntarily and knowingly given informed
consent and possesses the legal capacity to give informed consent to participate in the Tissue Bank.
Signature of Authorized Personnel
Date
Printed Name
AUTHORIZED PERSONNEL CAPABLE OF OBTAINING INFORMED CONSENT FROM
PARTICIPANTS
Principal Investigator:
Telephone Number:
Co-Investigators:
Participating Physician(s) and Participating Health Care Personnel:
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