Appendix 21 – BRANY IRB Standard Operating Procedures
INFORMED CONSENT TEMPLATE GENETIC FOR GENETIC RESEARCH/TISSUE BANKING
Sample language to be used in developing consent forms for genetic research and tissue banking.
An Introduction of Genetic Testing and Voluntary Participation
(1) Introduction: a general description of the test, explaining genetic testing and voluntary participation.
For example:
“You are being asked to provide one [additional, if applicable] blood sample (about __ teaspoonfuls)
for the study described below. [You do not have to agree to be in this additional study in order to be in
the main study of [name of study drug], if applicable].
DNA is the material in your body’s cells (genes) that pass on characteristics that are inherited from one
generation to the next (like hair and eye color).
DNA will be extracted from your blood sample in a laboratory so that your genetic information can be
used to study [fill in]”
(2) Statement of Purpose: what information is expected to result from the research.
(3) Scope of the Project:
“This study is being conducted at approximately ___ research centers [in the US, or in ____ and
______, or worldwide] and is expected to involve about ____ subjects.”
(4) Statement Regarding Identification of Samples:
For identified samples:
“In order to protect your privacy, your sample will be identified by your subject number, not your name.
Only the study doctor and the sponsor of the study, [name of sponsor], will be able to link your subject
number with your name. Neither you nor your doctor will be given the results of the testing [where
applicable].”
For non-identified samples:
“Your sample will be given a number that cannot be linked with you. Your sample will be stored with
thousands [or hundreds or many] of other non-identified samples from [name of institution]. Neither
you nor your doctor will be given the results of the testing.”
(5) Physical/Non-Physical Risks and Benefits:
a. Physical Risks:
 For blood draws:
“Although the taking of the blood sample causes no serious problems for most people, it can
cause some bleeding, bruising, tiredness, dizziness, and/or discomfort at the injection site”
 For skin biopsies:
Describe the procedure and the risk of pain and possible infection. Also address whether or
not any topical or other anesthetic will be used and any attendant risks associated with the
anesthesia.
 For other collection procedures:
Describe procedure(s) and attendant risks.
b. Non-Physical Risks:
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“There is a chance of future discrimination if the results of the testing show a genetic disorder. You
might be denied a job or promotion, or denied health or life insurance if employers or insurance
companies find out. You may experience other forms of discrimination. We will not release any
information to anyone without your written permission. However, it is possible that genetic
information may be gotten through legal means and then affects your ability to get insurance or a
job. In cases where parents and children are both tested, tests may reveal the possibility that the
father is not the biological parent.”
c. Potential Benefits of Genetic Testing:
“This study may improve our understanding of the role of genes in [genetic condition]. Information
learned about the gene may increase general knowledge, provide scientists with information about
disease and/or eventually lead to improved treatment. There will [or “may” if results will be
available and may allow for informed healthcare decisions] be no direct benefit to you or your
family from participating in this study.”
(6) Statements Regarding Subject’s Authorized Disclosure:
All consents must include confidentiality and authorized disclosure statement to the effect of:
“Your test results may be disclosed to [name of organizations, persons, or categories of persons] [use your
institution’s standard consent form confidentiality and disclosure language here].”
(7) Statement regarding contact:
“If you have questions about the research at any time, you may contact [Investigator name and phone
number]. If you have questions about your rights as a study subject, please call [IRB name and phone
number].
(8) Statement regarding subject injury:
“If you believe you have been injured as a result of your participation in this research, please call
[Investigator name and phone number]. [“Medical care will be provided at [name of Institution]”OR [“Dr.
__________ will assist you in obtaining appropriate medical care.”]
“[The costs of this medical care will be paid for by ________” OR “You will be expected to pay for this
medical care.” ]
“No other compensation will be offered by [Institution]. However, you are not waiving any legal right to
seek additional compensation through the courts by signing this form”
(9) Statement regarding copy of consent:
“You will receive a copy of this consent form.”
(10) Statement regarding withdrawal:
“You are free to withdraw from this study at any time without giving up anything you might otherwise be
entitled to. Withdrawal will not have any negative effect on your medical care or anything else. The
Investigator may also decide to end your participation in the study at any time. You may request that
your sample and data relating to it be destroyed at any time, but this will only be possible if the sample
and data can be identified.”
(11) Statement Regarding Use and Storage of Samples
“No tests other than those described in this form will be performed on your sample without your
permission. Your sample will be destroyed at the end of the testing process, which is estimated to take
approximately [or specify longer period]
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OR
(12) For Storage of Samples for Other Research Purposes:
“We would like to store a sample of your blood or tissue that will be obtained from you during this
current research study. We need to ask your permission to store this sample, and we would like to
know how we might use it in future approved research studies.
1. Do you give permission for the samples to be used by the study doctor in future research studies
that are directly related to the current research?
Please initial your choice:
Yes ____
No____
3. 2.
Do you give permission for the samples to be used by the study doctor in future
research studies that are unrelated to the purpose(s) of the current research?
Please initial your choice:
Yes ____
No____
3. Do you give permission for the samples to be given to other investigators at this Institution or
other institutions for use in research that is either related or unrelated to the purpose of this
study?
Please initial your choice:
Yes ____
No____
4. If you agree to have the samples stored for future research do you consent to have your sample
stored and labeled in a way that it will be possible to identify you as the donor of the sample?
Please initial your choice:
Yes ____
No____
Please note: If you agree then because the blood/tissue will be linked to you, if you change your
mind and ask in writing, we will destroy the sample. If we have already shared the blood/tissue
with other researchers we will ask that they destroy the sample.
[If the answer is no, please skip down to Question 5, as the text between questions 4 and 5
will not apply.]
a. If the future research can be done without having to know who you are or any information
about you then we will remove all identifying information from the sample before doing any of
the types of research you agreed to above.
b. If the future research requires that we know who the sample came from and information about
the donor of the sample then we will do one of the following:
i. If you allow us to contact you in the future, we will be able to explain to you why we wish
to use your blood/tissue and your associated information in future research, and we will
tell you what we will do with the sample and the information about you. We will then ask
your permission to use your blood or tissue in that research project.
May we have your permission to contact you in the future?
Please initial your choice:
Yes ____
No____
ii. If you do not give us permission to contact you in the future, or if we find that contacting
you is not practical, for example because you have moved, we may still use your blood
and tissue. Either we will use it after we have removed all links to you and your
identifiable health information, or will ask the Institutional Review Board for permission to
use the sample. The IRB can give permission to the researcher to use and share your
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health information and the associated blood/tissue, but only if it determines that doing
this will be more than a minimal risk to you or your privacy.
5.
Do you consent to have your sample stored and labeled in a way that will make it impossible to
identify you as the donor of the sample?
Please initial your choice:
Yes ____ No____
Note: If you agree to have the sample and information stored without any way of identifying you,
then you will not be able to change your mind and ask for the blood/tissue to be destroyed at a
future date.
(13) For cell lines, where applicable:
“ The Investigator may want to use your sample to make a cell line, which means that the cells from my
sample would be treated in such a way that they may live and divide outside the body, be frozen for
storage indefinitely, and be thawed in the future and used for future genetic research. There are no
plans to share with you any financial profits that may result from this research.
Please tell us (by initialing the applicable line) whether you authorize the Investigator to use your
sample to make a cell line:
________ I consent to using my sample to make a cell line
________ I do not consent to my sample being used for a cell line.”
(14) Statement of Consent:
“I have read this consent form and all of my questions have been answered to my satisfaction.
I voluntarily consent to be a subject in this research study and to the procedures described in
this form. I have been told that there are no plans to share with me any financial profits
resulting from the use of my sample. I am not waiving any legal rights by signing this form.”
______________________
Printed Name of Subject
_______________________________
Subject Signature
_____________
Date
_______________________________
Signature of Person Obtaining Consent
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