IRB Approval Date _______
Version: Revision #7 11/15/03
SWOG S9910
Southeast Cancer Control Consortium Consent Form
Leukemia Centralized Reference Laboratories And Tissue Repositories - Consent To Perform
Cellular And Molecular Studies In Leukemia Patients
What Is A Research Study?
This is a clinical trial (a type of research study). Clinical trials include only patients who choose to
take part. Please take your time to make your decision. Discuss it with your family and friends.
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You are being asked to take part in this research because you have leukemia or myelodysplasia, and
are eligible to participate in the treatment study #S9918 and/or S0010.
Why Is This Study Being Done?
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The main purpose of this research is to gather biologic information from patients who have
leukemia and myelodysplasia. We want to set up a system of storing bone marrow and/or
peripheral blood from leukemia and myelodysplasia patients to use in current and future scientific
research studies. We hope that the knowledge gained from such research will increase the
understanding of the biologic basis of leukemia and myelodysplasia, will improve the survival of
patients with this disease, and will help doctors choose the best for patients in the future.
The treatment for your leukemia or myelodysplasia, which you will receive as part of study #S9918
and/or S0010, will be discussed separately. No guarantees or promises have been made as to the
result of research on your samples. New knowledge gained from research on your individual tissue
specimens will not be provided to you or your doctor. However, the knowledge gained from studies
using your samples and those of other patients who take part in this study (who will remain
anonymous) will be published in medical journals.
How Many People Will Take Part In The Study?
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A maximum of 2,000 leukemia and myelodysplasia patients will take part in this study.
What Is Involved In The Study?
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Samples of blood and/or bone marrow will be collected from patients with leukemia or myelodysplasia.
Research that is part of treatment study #S9918 and/or S0010
Samples of blood (25 - 30 cc, less than 6 teaspoonfuls) and/or bone marrow (8 - 10 cc, less than 2
teaspoonfuls) will be collected in syringes, and sent to a special laboratory for storage and scientific testing.
These samples will be in addition to the blood and bone marrow samples that will be obtained as part of
your standard care. These additional samples will be collected at the following times:
1. At least 14 days prior to entry of this study
2. At remission of your leukemia
3. At time of relapse of your leukemia
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Participant Initials ____
IRB Approval Date _______
Version: Revision #7 11/15/03
SWOG S9910
Southeast Cancer Control Consortium Consent Form
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You are free at any time in the future to decide not to provide samples or to withdraw your samples from
further research.
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Other research
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As part of the ongoing scientific and biotechnological activities of the Southwest Oncology Group, samples
of your blood and bone marrow that are stored as part of this study may be used for research and
development purposes which are not directly related to study #S9918 and/or S0010. Although the principal
reason for research using these samples is to learn more about leukemia, it is possible that as a result of
these activities, an economic benefit may be derived directly or indirectly by the Southwest Oncology
Group, individual researchers, and others engaged in these activities. On the Consent Form for use of Bone
Marrow and/or Peripheral Blood for Research for Study #S9918 and/or S0010, you may indicate your
choices regarding the use of specimens for these kinds of activities. You are free, at any time in the future,
to change your mind about these choices, and to stop providing specimens for these kinds of activities or to
withdraw your samples from further research. Such a decision will have no impact on your
treatment or your participation in study #S9918 and/or S0010.
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How Long Will I Be Involved In This Research?
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Your active involvement is limited to the time it takes to draw the blood and marrow samples. The blood
and bone marrow will be stored at the storage facility for up to 25 years.
What Are the Risks Of The Study?
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Both the diagnostic bone marrow sample and the research bone sample can be drawn most of the
time through the same needle and that an extra needle puncture is usually not necessary. The bone
marrow aspiration may or may not be associated with discomfort or pain, and if pain does occur
with the first bone marrow aspiration, the same pain will probably occur with the second aspiration
for the research sample.
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For more information about risks, ask the researcher or contact your local doctor.
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Another risk is the unintentional release of information about your samples of blood and/or bone marrow or
from your health records. As explained below ("What about Confidentiality?") your samples of blood
and/or bone marrow will be identified only by a code number before being given to any researcher. This
will make it very difficult for any research results to be linked to you or your family. However, there is
always a remote risk that information about your samples or from your health records would adversely
affect applications for insurance or employment of you or members of your family. The Southwest
Oncology Group is in charge of making sure that this will not occur as a result of any research using your
blood and/or bone marrow samples.
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Participant Initials ____
IRB Approval Date _______
Version: Revision #7 11/15/03
SWOG S9910
Southeast Cancer Control Consortium Consent Form
Will I Benefit From The Study?
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The additional research studies will not provide direct benefit to you other than the satisfaction of
participating in this research for the possible benefit of future generations. However, your participation in
these additional research studies may help answer questions related to the health and longevity of persons
in your age group and may help establish a scientific understanding of the factors which influence the
development and progression of cancer.
What About Confidentiality?
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All information related to your participation in this study will be kept confidential and used only for
scientific purposes, in accordance with applicable state and federal laws. Since genetic research may
discover genetic information about you, this information will be kept confidential to the full extent
permitted by law.
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To protect your confidentiality, your blood and/or bone marrow samples will be labeled with a code
number. The researchers doing studies of your samples will be told only this code number, not your name
or any other information that can be used to identify you. A file linking the code number to your name will
be kept separately in a specially protected location, and will not be available to the researchers who analyze
your samples. If a researcher needs clinical information about you, that information will be identified only
by the code number, not by your name or other identifying information.
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A record of your progress will be kept in a confidential form at your hospital or doctor's office
where you receive treatment. Organizations that may inspect and/or copy your research records
(blood samples and pathology slides) for quality assurance and data analysis include groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
Southwest Oncology Group (SWOG)
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
Office for Human Research Protection (OHRP)
Institutional Review Board (IRB) at your hospital
Possible other federal or state government agencies
If your record is used or given out for governmental purposes, it will be done under conditions that
will protect your privacy to the fullest extent possible consistent with laws relating to public
disclosure of information and law-enforcement responsibilities of the agency.
You authorize the use of clinical information, contained in your records, but any publication which
includes such information or data shall not reveal your name, show your picture, or contain any
other personally identifying information, except as otherwise required by law.
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Participant Initials ____
IRB Approval Date _______
Version: Revision #7 11/15/03
SWOG S9910
Southeast Cancer Control Consortium Consent Form
What Are The Costs?
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The cost of keeping research records will be paid by those organizing and conducting the research.
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You will not be charged for storage of your blood and/or bone marrow samples or for any of the tests that
will be conducted using these samples.
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The additional blood and bone marrow samples are for medical research only and the research results will
not be used to make decisions about your medical care. The results of these research studies will not be
available to you. The blood and bone marrow samples will only be used for research and will not be sold.
The blood draws and bone marrow procedures will be charged in the usual way. Please ask about any
expected added costs or insurance problems.
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In the case of injury or illness resulting from this study, emergency medical treatment is available
but will be provided at the usual charge. No funds or monies have been set aside to compensate you
in the event of injury.
You or your insurance company will be charged for continuing medical care and/or hospitalization.
What Are My Rights As A Participant?
Taking part in this study is voluntary. You may choose not to take part or you may leave the study
at any time but we encourage you to talk to your doctor first. Leaving the study will not result in
any penalty or loss of benefits to which you are entitled.
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You may continue to participate in the treatment study #S9918 and/or S0010, even if you decline to have
additional samples of blood and/or bone marrow collected and stored for research.
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If you initially decide to have your samples of blood and/or bone marrow stored for research, but later
change your mind, you may notify your doctor in writing at the hospital where you received treatment, and
your remaining samples will then be destroyed. Such a decision will have no effect on your medical care
or participation in treatment study #S9918 and/or S0010.
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We will tell you about new information that may affect your health, welfare or willingness to stay in
this study.
Whom Do I Call If I Have Questions Or Problems?
For questions about the study or a research-related injury, contact your doctor, ______________, at
# __________________. You may ask your doctor for further information on the risks or benefits.
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Participant Initials ____
IRB Approval Date _______
Version: Revision #7 11/15/03
SWOG S9910
Southeast Cancer Control Consortium Consent Form
For questions about your rights as a research participant, contact the ______________________
Institutional Review Board (which is a group of people at the hospital in the community where you
receive treatment who review the research to protect your rights) at # __________________ (the
office of ______________________).
Where Can I Get More Information?
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You may call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) or
TTY: 1-800-332-8615 or you may visit the Cancer Information Service Website:
http://www.cancer.gov/cis
You may visit the NCI’s Web site:
http://www.cancer.gov
This website contains comprehensive clinical trials information and accurate cancer information.
Participant Contract
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I have been offered the opportunity to ask questions about this study and all questions have been
answered to my satisfaction. The contents of this form have been explained to me and I understand
them. By signing this consent form, you authorize the collection, storage and use of your blood
and/or bone marrow samples although you are free, at any time in the future, to decide not to
provide specimens or to withdraw your samples from further research. Such a decision will have no
impact on your treatment or your participation in the treatment study #S9918 and/or S0010.
I agree to allow the research personnel specified above the access to my medical records.
It may be necessary for my doctor to contact me at a future date regarding new information about
the study, therefore I agree to notify my doctor of any change of address and/or telephone number.
My signature below means that I have voluntarily agreed to participate in this research study. A
copy of this consent form has been given to me.
_______________________
(Date)
_____________________________________________
(Participant Signature)
I certify that I have explained to the above individual the nature and purpose, the potential benefits,
and possible risks associated with participation in the research study and have answered any
questions that have been raised.
__________________
(Date)
2/11/00
______________________________________
(Signature of Person Obtaining Consent)
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Participant Initials ____
SWOG S9910
Southeast Cancer Control Consortium Withdrawal of Consent
I, __________________________ , withdraw my consent to participate in SWOG S9910 and refuse
to be followed and have clinical data collected from my medical records.
Participant Name __________________________ SWOG Pt. Number ___________________
(Please Print Name)
Participant Signature _________________________________
2/11/00
Date _______________
SWOG S9910
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for treatment on SWOG S9910. Even
though I withdraw my consent for treatment, I will continue to be followed and clinical data will be
collected from my medical records.
Participant Name _______________________
(Please Print Name)
SWOG Pt. Number ___________________
Participant Signature _________________________________
2/11/00
Date _______________