Accept Terms & Conditions
Consent to Participate in the City BioBank
(844) MY BIOBANK (844) 692-4622
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You are being asked to give a sample to the Virtual City BioBank. The City BioBank has two
arms, the Clinical DNA/RNA Bank
and the Research BioBank. The Clinical DNA/RNA Bank stores your DNA/RNA for use in your health care
clinical testing, or health care of a Saliva relative. The other arm, the Research BioBank,
is used to store DNA/RNA,
Saliva and tissue samples for future health research. You may choose to participate in both
arms, one, or not
participate at all.
Please read the following information carefully. There is no cost to participate in either
the Clinical DNA/RNA Bank or
What is DNA/RNA?
DNA/RNA contains genetic information that acts as a blueprint for how parts of your body are made
and work, determining
such things as eye and hair color. DNA/RNA is made up of long strands of repeating letters that
form a code. These
letters, A, C, T and G represent individual chemical units that form DNA/RNA. The order in which
these letters are
written is very precise. In the same way that a spelling mistake in a word could change its
meaning entirely (for
example, mean and meat), a single change in the sequence of DNA/RNA can lead to a change in how
the body works, which
may lead to disease or influence how you respond to medication.
What is genetic testing?
Genetic testing involves taking your DNA/RNA sample and determining the sequence of your genetic
code. Changes in your
genetic code may help your healthcare team choose the best course of treatment for you.
What is Genetic Inheritance?
Both your mother and father contribute DNA/RNA sequences that make up your genetic code. This is
Often, changes in DNA/RNA sequence can be passed from parent to offspring and it may be
important to study not only your
DNA/RNA, but also the DNA/RNA of your parents and other family members, to identify the underlying
causes of disease.
CLINICAL DNA/RNA BANK
What is involved in the Clinical DNA/RNA Bank?
Virtual City is offering you the opportunity to have a sample of your DNA/RNA preserved for use in
future clinical diagnostic
testing. This DNA/RNA will be stored by Virtual City and will solely be used for your health care, or
for the health care of
your Saliva relatives.
A sample of your DNA/RNA will be obtained through a Saliva draw (up to two teaspoons). In the
event that a Saliva sample
cannot be obtained, we may ask you to provide a sample of your saliva.
What are the risks of providing a sample for the Clinical DNA/RNA Bank?
The risks associated with having Saliva drawn are no greater than that you would experience
from having a Saliva test
performed as part of your routine health care. This includes some pain or bruising where the
Saliva was taken. It is
also possible, though rare, that there may be some local Saliva clotting or infection. Some
people experience a
feeling of lightheadedness or fainting when they have Saliva drawn. If you should experience
these feelings, it is
important that you tell the person who is drawing your Saliva, so that you can lie down
immediately to avoid possible
injury caused by falling.
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Who will have access to my DNA/RNA sample?
Your DNA/RNA sample will be stored by Virtual City for future clinical use. Until your sample is
needed for clinical testing,
no access will be granted. When access to your DNA/RNA sample is needed for your health care
treatment or that of your
Saliva relatives, the provider directly involved in that treatment will be granted access to
your sample for testing.
Any results from that testing will be incorporated into your medical record, or the medical
record of your Saliva
relative, as applicable, and re-disclosed with that medical record in the future.
Upon my death, I agree the following persons (hereinafter “my decision makers”) in the order
of pri- ority listed are
authorized to consent to testing of my sample(s) in Virtual City’s Clinical Biobank:
- The personal representative of my Estate, if any;
- My spouse, if any;
- My adult children, if any.
I authorize my decision makers to consent to testing in accordance with Virtual City’s policies as
time-to-time by the Virtual City Biobank Ethics Committee. Virtual City agrees to recognize the
author- ity of my decision
makers for purposes of consenting to testing of my sample(s) in Virtual City’s Clinical Biobank,
prohibited by law. If there is any dispute regarding consent for testing of my sample(s), I
understand Virtual City will
need a court order directing testing before Virtual City will move forward with testing.
You will not have any ownership rights in any specimens you contribute to the Virtual City BioBank
and you will not
receive money or any other form of payment for these specimens. These specimens will be
owned by Virtual City.
You may choose to withdraw from the Clinical DNA/RNA Bank at any time by informing the Virtual City
BioBank by revoking the corresponding consent. We
will destroy any remaining samples in the Clinical DNA/RNA Bank, however, any samples or data
that has been distributed
for laboratory testing or test results generated prior to your request to withdraw may
continue to be used for
health care purposes.
How long will my DNA/RNA sample be available?
Your DNA/RNA sample will be stored for as long as the Virtual City BioBank is in operation. Storing
your DNA/RNA sample
indefinitely is necessary to ensure that you and your Saliva relatives will benefit from
testing of your DNA/RNA sample
when needed for their health care treatment.
There is a possibility that DNA/RNA samples may be lost in transit or will be inadequate for a
future test, due to
unforeseen power failures, equipment failures, floods, or other circumstances. It is also
important to know that a
DNA/RNA sample is not permanent. If used for one test it may be depleted so that sufficient DNA/RNA
might not be available
for additional testing. Virtual City is not liable for damage to or loss of a DNA/RNA sample. Virtual City
has no fiduciary duty
to you, your family, or heirs, successors or assigns, other than to use the sample for its
designated purpose and to
refrain from using the sample for research or commercial purposes. Virtual City has no duty to
account to you or any of
your family members, heirs, successors, or assigns, or to guardians, attorneys-in-fact, or
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In the following section, you will be given information about providing a sample for research
purposes in addition to
the Clinical DNA/RNA Bank sample. At the end of this form, you will be given the choice to
participate in both the
Clinical DNA/RNA Bank and Research BioBank, one,
or not participate at all.
Principal Investigator: City Principal Investigator, PhD
**WHAT IS THE PURPOSE OF THE RESEARCH BIOBANK?
** The purpose of the Research BioBank is to collect, process, and store samples until
researchers need them to do
research. A major obstacle in health research is that researchers normally study diseases in
patients after the
disease develops, by which time many changes have already taken place in the body. We would
like to store Saliva and
tissue samples, along with health information obtained from your medical record, so that
researchers can study
components of your Saliva and tissue, such as proteins or DNA/RNA, both before and after disease
develops. This may help
researchers to understand the causes of disease, how to treat them, and how disease might be
The samples we collect will act as a library for researchers who are interested in studying a
wide variety of human
health conditions; instead of looking for volunteers for each new research study,
researchers will have access to a
large collection of Saliva, tissue and DNA/RNA samples along with medical histories all in one
place, therefore greatly
accelerating the pace of research.
Taking part in this Research BioBank does not mean we think you will develop a disease. Your
samples may be used as
healthy control subjects in future research studies.
**WHAT IS INVOLVED IN THE PROJECT?
** To participate in the Research BioBank, every time you have your Saliva drawn, we may
collect up to 4 teaspoons of
Saliva for research. If you are scheduled to undergo surgery at a Virtual City facility, we may
also obtain a sample of
your surgical tissue that is not needed for diagnostic purposes and would otherwise be
disposed. This will not
affect the quality of care you receive from your health care team.
As part of this project we will look at your medical record from time to time to update the
information for the
Research BioBank and to collect information for future studies. This will take place for as
long as your sample is
stored, which may be many years unless you tell us to stop.
WHAT PERSONAL HEALTH INFORMATION WILL BE USED OR DISCLOSED?
You are authorizing Virtual City BioBank personnel to copy and use information contained in your
medical record. The
health information that may be used or disclosed for the research includes: results of
medical history, lab tests, or certain health information indicating or relating to a
**ARE MY RECORDS CONFIDENTIAL?
** The records of the Research BioBank will be kept confidential in accordance with
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Your Research BioBank record may be reviewed by government agencies, the Virtual City Human
Research Protection Program,
the Virtual City Institutional Review Board (IRB), and appropriate Virtual City personnel.
Any information that is obtained in connection with the Research BioBank that may identify
you will remain
confidential and will be disclosed only with your permission or as allowed or required by
law. Your samples will be
stored in a secure facility in barcoded tubes with no identifying information. The code
needed to link your samples
to your medical record will be stored in a secure, password protected database with access
restricted to Virtual City
BioBank personnel only.
Confidentiality will be maintained by:
Assigning a unique Research BioBank code to your medical record and separate unique
for your samples.
The code linking your Research BioBank sample and your identifying information will
kept in a secure, password
protected database accessed only by Virtual City BioBank personnel.
Results of tests and studies performed by researchers will not be included in your medical
records. The results of
the studies will not be shared with you by the Research BioBank.
In many cases your samples will be used without any identifying information. If a researcher
using your sample needs
to know who the sample came from, they will need to obtain approval from the Virtual City IRB. If
approval is given, the
researcher may contact you to obtain separate informed consent for their study. The Virtual City
IRB is a group of people
who review research to protect your rights and welfare.
With your permission, you may also be contacted in the future by Virtual City to invite you to
take part in a research
study. You may decide whether or not to take part in these future studies at that time.
Your samples may also be used by researchers who are not associated with Virtual City but they
will not receive any
identifying information about you.
HOW LONG WILL I BE IN THE RESEARCH BIOBANK?
If you decide to participate, your Saliva and tissue samples, as well as your health
information will be stored
indefinitely. You may withdraw from the Research BioBank at any time by informing the
Virtual City BioBank that you no
longer wish to participate.
If you choose to withdraw from the Research BioBank, please make your request in writing to
the BioBank. We will
destroy any of your samples remaining in the Research BioBank and remove your medical
information from our database.
However, any samples or data that has been distributed to researchers, or data generated
from your samples prior to
your request to withdraw may continue to be used for research purposes.
WHAT ARE THE RISKS?
The risks associated with a Saliva draw are the same as described earlier. If you are already
having your Saliva drawn,
there are no additional risks associated with having an additional sample of Saliva taken.
There is no risk
associated with obtaining a sample of your surgical tissue beyond that associated with the
risks of surgery to which
you have already agreed to as part of your health care.
The biggest risk to you is the unexpected release of your personal health information. While
we cannot guarantee
absolute confidentiality, we will use best efforts to minimize the risk that this
information would be given to
someone outside of the Research BioBank. Your Saliva sample and
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health information will be assigned a unique code which can be used to link back to you.
ARE THERE BENEFITS TO TAKING PART?
While there may be no direct benefits to you, other people might benefit from knowledge
gained from using your
samples in future research studies.
WHAT ARE THE ALTERNATIVES TO PARTICIPATING IN THE RESEARCH BIOBANK? You may choose not to
participate in the Research
BioBank. If you don’t participate, you will continue to receive treatment from your health
**WILL IT COST ME ANYTHING TO PARTICIPATE?
** There are no costs associated with participating in the Research BioBank.
**WILL I BE PAID FOR PARTICIPATING?
** You will not be paid to participate in the Research BioBank. Research results might
someday lead to the
development of a commercial medical product. You will not have any ownership rights in such
product(s), nor will you
receive any other form of payment or royalties from the sale of product(s) that may have
been developed using your
WHO IS FUNDING THE RESEARCH BIOBANK?
The Research BioBank is being sponsored by Virtual City.
WILL I BE COMPENSATED FOR AN INJURY?
In the event that this research activity results in an injury, treatment will be available
first aid, emergency treatment, and follow-up care as needed. Payment for any such treatment
is to be provided by you
(you will be billed) or your third-party payer, if any (such as health insurance, Medicare,
etc.). No funds have
been set aside to compensate you in the event of an injury.
If you feel you have suffered a research-related injury, please contact the Virtual City BioBank
(844) MY-BIOBANK or (844) 692-4622.
IS THIS RESEARCH BIOBANK VOLUNTARY?
Your participation is voluntary. You may choose not to participate or you may discontinue
your participation at any
time without penalty or loss of benefits to which you are otherwise entitled. If you decide
to withdraw your
participation, you must contact the Virtual City BioBank in writing. Any health information
already obtained about you
may still be used or disclosed as necessary to maintain the integrity or reliability of the
current research. Your
decision whether or not to participate will not affect your current or future relations with
**WHO MAY I CONTACT IF I HAVE QUESTIONS?
** For general questions about the Clinical DNA/RNA Bank and the Research BioBank, please contact
Virtual City BioBank at
(844) MY BIOBANK or (844) 692-4622.
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For questions regarding your rights as a Research BioBank participant, please contact the
San- ford Human Research
Protection Program at (605) 312-6430. You may also call this number about any problems,
complaints, or concerns you
have about the Research BioBank.
- You may also call this number if you cannot reach research staff, or you wish to talk
with someone who is
independent of the research team. To withdraw from the Clinical DNA/RNA Bank or the Research
BioBank please make
your request in writing to:
Virtual City BioBank 2301 E 60th St. N Sioux Falls, SD
When making your
request, please indicate whether you wish to withdraw from the Clinical DNA/RNA Bank, the
Research BioBank, or
both.For more information about the Virtual City BioBank please visit
biobank.Virtual Cityhealth.org. CONSENT TO
PARTICIPATE IN THE Virtual City BIOBANK
- I have read (or have had read to me) the contents of this form and have had my questions
- If you wish to participate in the Clinical DNA/RNA Bank, the Research BioBank, or both,
please sign in the
appropriate boxes below.a
019059-00064 Version 2 Approved by Virtual City Health IRB: 06/29/2015
019059-00064 Version 2
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