Download SPECIFIC AIM 3: to determine if secondary prophylaxis can cause

IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
9/4/07
A Phase II Trial of BAY 43-9006 (Sorafenib) in Patients
With Relapsing or Resistant Multiple Myeloma
What is a research study?
This is a clinical trial, a type of research study. Your study doctor will explain the clinical
trial to you. Clinical trials include only people who choose to take part. Please take
your time to make your decision about taking part. You may discuss your decision with
your friends and family. You can also discuss it with your health care team. If you have
any questions, you can ask your study doctor for more explanation.
You are being asked to take part in this study because you have multiple myeloma that
has either not responded to past treatment (resistant), or did respond to past treatment
and has now come back (relapsed).
Who is doing this study?
The Southwest Oncology Group (SWOG) is sponsoring this clinical trial. SWOG is an
adult cancer clinical trials organization. SWOG is funded through the National Cancer
Institute, and its network consists of almost four thousand doctors at almost three
hundred institutions throughout the United States. Your study doctor has met all
requirements to be a member of SWOG and to perform National Cancer Institutefunded research through this group.
Why is this study being done?
BAY 43-9006 has shown some activity against tumor models in the laboratory and in
some patients with cancers that have a certain mutation of a gene called "Ras".
Several studies have shown the Ras mutation in patients with multiple myeloma, which
is why we want to study BAY 43-9006 in myeloma.
The purpose of this study is to find out what the effects (good and bad) of treatment with
BAY 43-9006 will be in research participants like you that have resistant or relapsed
multiple myeloma. BAY 43-9006 is a research drug not yet approved by the Food and
Drug Administration.
How many people will take part in the study?
About 20 - 40 people will take part in this study at several hospitals around the country.
What will happen if I take part in this research study?
Before you begin the study …
You will need to have the following exams, tests or procedures to find out if you can be
in the study. These exams, tests or procedures are part of regular cancer care and may
be done even if you do not join the study. If you have had some of them recently, they
may not need to be repeated. This will be up to your study doctor. Before you are
registered on the study your doctor will review your medical history and you will have
the following tests:
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Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
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Southeast Cancer Control Consortium Consent Form
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Blood tests to measure your blood cell counts and blood chemistries
Blood tests to measure the amount of myeloma
Urine tests to measure the amount of myeloma
A bone marrow aspirate and biopsy
Imaging scans to measure myeloma in your bones and bone marrow (this
could include an MRI and X-rays of your skeleton)
Some of these tests will be done to make sure you meet all the requirements to take
part in the study. Others will measure how much myeloma is present before treatment is
given.
During the study …
If the exams, tests, and procedures show that you can be in the study, and you choose
to take part, then you will need the following tests and procedures. They are part of
regular cancer care:
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Blood and urine tests to measure the amount of myeloma will be done before
each cycle of treatment (about every 4 weeks)
● Bone marrow aspirate and biopsy will be done before you begin treatment and if
your myeloma comes back after or during treatment (relapses) if you consent to
this specimen submission.
● Bone marrow aspirate and biopsy will be done if your myeloma disappears while
on study.
 Imaging scans of your bones will be done when your doctor decides they are
needed
 Blood tests to measure your blood cell counts and blood chemistries.
If you take part in this study, you will take the research drug, BAY 43-9006. You will
swallow the drug whole with a full cup of water, twice every day by mouth, for 4 straight
weeks. This four week period is called a “cycle” of treatment. During the first four
weeks of the study, you will have your blood pressure monitored weekly to be sure you
are tolerating the drug well.
BAY 43-9006 may be taken without regard to meals. However, if taken with meals,
you should take BAY 43-9006 with a moderate-fat to low-fat meal. A high fat meal may
decrease the amount of BAY 43-9006 that gets into your blood.
You will record the number of pills you take each day and any side effects you
experience on a calendar. You should bring your calendar with you each time you have
an appointment. During your visits with your doctor, your pills will be counted and your
calendar reviewed. You will also be asked if you would like to take part in research by
providing bone marrow and blood samples before starting treatment, and at the time of
relapse or progression of your myeloma. You will be asked to sign an additional
consent for research samples if you would like to participate in this part of the study.
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Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
You will continue repeating your cycles of treatment with BAY 43-9006 until your
disease comes back, spreads, gets worse, or if you and your doctor decide that you
should stop taking the drug for other reasons.
When I am finished taking treatment on this study…
You will have all the blood and urine tests repeated, as well as the bone marrow
aspirate and biopsy and imaging scans. You will have follow-up exams and tests to
monitor you for possible side effects and your myeloma every 6 months for two years
and then annually after that for 3 years from when you began the study. After that, you
will not have any other treatment or tests/procedures on this study.
How long will I be in the study?
You will be asked to take BAY 43-9006 for as long as your myeloma is not getting
worse and you are not having serious side effects. After you are finished taking
treatment on this study, the study doctor will ask you to visit the office for follow-up
exams and tests as described earlier in the consent. We would like to keep track of
your medical condition for a maximum of three years. Keeping in touch with you and
checking on your condition helps us look at the long-term effects of the study.
Can I stop being in the study?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about
stopping or decide to stop. He or she will tell you how to stop safely.
It is important to tell the study doctor if you are thinking about stopping so any risks from
the treatment can be evaluated by your doctor. Another reason to tell your doctor that
you are thinking about stopping is to discuss what follow-up care and testing could be
most helpful for you.
The study doctor may stop you from taking part in this study at any time if he/she
believes it is in your best interest; if you do not follow the study rules; or if the study is
stopped.
What side effects or risks can I expect from being in the study?
While on the study, you are at risk for these side effects. You should discuss these with
the researcher and/or your regular doctor. There also may be other side effects that we
cannot predict or are unforeseen or unexpected. Other drugs will be given to make side
effects less serious and uncomfortable. Many side effects go away shortly after the BAY
43-9006 is stopped, but in some cases side effects can be serious, long-lasting or
permanent.
Risks and side effects related to the BAY 43-9006 include those which are:
Likely:
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Fatigue
Skin rash, itchy skin, dry skin, and skin peeling
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IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
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Less Likely:
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Diarrhea
Allergic reactions
Hair loss
Fluid build-up in the abdomen and lungs
Constipation
Pain with swallowing solids and liquids
Gas
Heartburn
Low white blood cell count which may cause you to get an infection
Nerve pain and numbness
Low oxygen in your blood
Inflammation of your lungs
Low levels of phosphates in your blood
A non life-threatening type of skin cancer
High blood pressure
Fever
Chills
Weight loss
Sores in your mouth
Skin condition which shows up as smooth white spots on various parts
of your body
Nail changes
Redness, dryness, and sometimes pain of the palms and soles
Loss of appetite
Dehydration
Infection
Increase in the enzymes that breakdown starch and fats
High blood sugars
Abdominal (stomach) pain or cramping
Joint pain and muscle pain
Flu-like syndrome
Decreased hemoglobin
Decreased platelets
Flushing
Liver damage
Inflammation of the pancreas causing abdominal pain
Bleeding in your urinary tract or bowels
Collapse of your lungs
Kidney failure
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Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
7/19/06
9/4/07
Rare, but Serious:
 Tear in stomach or intestines that may be painful and possibly fatal
Risks related to fertility and pregnancy: The drugs in this study may affect the way a
woman’s ovaries work and her ability to get pregnant. The drugs in this study can affect
an unborn baby. Therefore, women should not become pregnant and men should not
father a baby while on this study. Both men and women must use a reliable method of
birth control while participating in this study. Check with your study doctor about what
kind of birth control methods to use and how long to use them. Some methods might
not be approved for use in this study. Reliable methods of birth control are considered
to be: abstinence (not having sex), oral contraceptives, Intrauterine Device (IUD),
Norplant, tubal ligation, hysterectomy or vasectomy of the partner (with confirmed
negative sperm counts) in a monogamous relationship (same partner). An acceptable,
although less reliable method involves the careful use of condoms and spermicidal foam
or gel and/or cervical cap or sponge. Both male and female patients should ask about
counseling and more information about preventing pregnancy. Female patients who
feel they might be pregnant, even though they practiced birth control, must notify the
study doctor immediately. A pregnancy test may be performed.
Male patients should also inform the study doctor immediately if their sexual partners
become pregnant while the patient is receiving treatment. Women should not
breastfeed a baby while on this study. Pregnant women and nursing mothers are
excluded from participation in this study. If a woman becomes pregnant, she will be
withdrawn from the study. If a man fathers a child, there may be potential risk to the
unborn baby; therefore, female sexual partners of men on treatment should use an
adequate form of birth control.
Since most methods of birth control are not 100% reliable, if you are a sexually active
woman of childbearing potential, a pregnancy test (at least 10 days from your last
normal menstrual period) is required.
For more information about risks and side effects, ask your study doctor.
Will I benefit from taking part in the study?
Taking part in this study may or may not make your health better. While doctors hope
that treatment on this study will be more useful against multiple myeloma compared to
the usual treatment, there is no proof of this yet. We do know that the information from
this study will help doctors learn more about this treatment as a treatment for multiple
myeloma. This information could help future cancer patients.
What other choices do I have if I do not take part in this study?
Your other choices may include:
 Getting treatment or care for your myeloma without being in a study
 Taking part in another study
 Getting no treatment
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Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
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Getting comfort care, also called palliative care. This type of care helps reduce
pain, tiredness, appetite problems, and other problems caused by the cancer. It
does not treat the cancer directly, but instead tries to improve how you feel.
Comfort care tries to keep you as active and comfortable as possible.
Talk to your doctor about your choices before you decide if you will take part in this
study.
Will my medical information be kept private?
We will do our best to make sure that the personal information in your medical record
will be kept private. However, we cannot guarantee total privacy. Your personal
information may be given out if required by law. If information from this study is
published or presented at scientific meetings, your name and other personal information
will not be used.
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 and medical records (blood samples, x-rays, scans, pathology slides, etc.) for
quality assurance, research, and data analysis include groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
Southwest Oncology Group (SWOG)
National Cancer Institute (NCI) and its representatives
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
A qualified representative of Bayer Pharmaceuticals and Onyx Pharmaceuticals,
the makers of BAY 43-9006
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. These agencies may review the research to see that it is being done safely
and correctly.
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.
What are the costs of taking part in this study?
You and/or your health plan/insurance provider (Medicare should be considered a
health insurance provider) will need to pay for some or all of the costs of treating your
cancer in this study. Some health plans will not pay these costs for people taking part in
studies. Check with your health plan or insurance company to find out what they will
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Page 6 of 14
Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
pay for. Taking part in this study may or may not cost your insurance company more
than the cost of getting regular cancer treatment. You or your insurance carrier will be
responsible for the costs of clinic visits, any hospital admissions, laboratory tests,
x-rays, scans, chemotherapy treatments, radiation treatments, and any other tests.
Please ask your doctor about any added costs or insurance problems.
Administration of the drug will be charged in the usual way. The parts of the research
consisting of keeping research records will be paid by those organizing and conducting
the research. The research requires that you receive certain standard medical tests
and examinations. These standard tests and examinations will be charged in the usual
way.
The Division of Cancer Treatment and Diagnosis with the National Cancer Institute and
Bayer Pharmaceuticals Corporation will provide you with the research drug, BAY 439006, at no cost to you. The study drug, BAY 43-9006, will be provided free of charge
while you are participating in this study. However, if you should need to take the study
drug much longer than is usual, it is possible that the free supply of study drug given to
the NCI could run out. If this happens, your study doctor will discuss with you how to
obtain additional drug from the manufacturer and you may be asked to pay for it.
For more information on clinical trials and insurance coverage, you can visit the National
Cancer Institute’s Web site at http://cancer.gov/clinicaltrials/understanding/insurancecoverage. You can print a copy of the “Clinical Trials and Insurance Coverage”
information from this Web site.
You will not be paid to participate in this study.
What happens if I am injured because I took part in this study?
It is important that you tell your study doctor, _________________________ if you feel
that you have been injured because of taking part in this study. You can tell the doctor
in person or call him/her at #____________________________.
You will get medical treatment if you are injured as a result of taking part in this study.
You and/or your health plan will be charged for this treatment. The study will not pay for
medical treatment. Although no funds or monies have been set aside to compensate
you in the event of injury or illness related to the study treatment or procedures, you do
not waive any of your legal rights for compensation by signing this form.
In the case of injury resulting from this study, you do not lose any of your legal rights to
seek payment by signing this form.
You or your insurance company will be charged for continuing medical care and/or
hospitalization.
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Page 7 of 14
Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
7/19/06
What are my rights if I take part in this study?
Taking part in this study is voluntary. You may choose to take part, not to take part, or
may leave the study at any time. No matter what decision you make, there will be no
penalty to you and you will not lose any of your regular benefits. Leaving the study will
not affect your medical care or result in any penalty or loss of benefits to which you are
entitled.
Even after you agree to take part in this study, you may withdraw at any time. Before
you withdraw, you should talk to one of the researchers or nurses involved. This will
allow them to inform you of any medical problems that could result from stopping your
treatment. You can choose to withdraw one of two ways. In the first, you can stop your
study treatment, but still allow the study doctor to follow your care. In the second, you
can stop your study treatment and not have any further contact with the study staff.
Either way, there will be no penalty to you. Your decision will not affect your medical
treatment or your relationship with those treating you or with this institution. If you
withdraw from the study, you will still be offered all available care that suits your needs
and medical condition. You are free to seek care from a doctor of your choice at any
time.
We will tell you about new information that may affect your health, welfare or willingness
to stay in this study. You may be asked to sign another consent form in response to
new information.
Who can answer my questions about the study?
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, benefits or alternative treatments.
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 ___________________).
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Please note: This section of the informed consent form is about additional
research studies that are being done with people who are taking part in the main
study. You may take part in these additional studies if you want to. You can still
be a part of the main study even if you say ‘no’ to taking part in any of these
additional studies.
You can say "yes" or "no" to each of the following studies. Please mark your choice for
each study. NOTE: If the patient consents to submission of specimens, they must be
registered separately to S0309.
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Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
1.
Future Contact
I agree to allow my study doctor, or someone approved by my study doctor, to
contact me regarding future research involving my participation in this study.
Yes
2.
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No
Specimen Submission
I agree to submit specimens for research as part of this study before I begin
treatment and if my myeloma comes back (relapses) after or during treatment.
Yes
No
9/4/07
3.
Future Use of Specimens (only if answer to Question #2 above is Yes).
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Consent Form for Use of Specimens For Research (S0309)
Where will my specimens be kept?
3/11/08
Lymphoma/Myeloma Specimens Repository
AHSC (Arizona Health Sciences Center)
Room 5211, Department of Pathology
Box 245043
1501 N. Campbell Avenue
Tucson, AZ 85724
Phone: 520/626-7477
Attn: Yvette Frutiger or Betty Glinsmann-Gibson (Technical), Lisa Rimsza, M.D. (Medical)
3/11/08
About Using Specimens for Research
If you participate in this study, your doctor will remove some blood and bone marrow to
do some tests. The results of these tests will be given to you by your doctor and will be
used to plan your care.
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We would like to keep some of the specimens that are left over for future research.
Less than one teaspoon of marrow will be submitted to a special laboratory for testing.
Additionally, we are asking for submission of less than 6 teaspoons of blood and less
than two additional teaspoons of bone marrow for research purposes. If you agree,
these specimens will be kept and may be used in research to learn more about cancer
and other diseases. Please read the question and answer sheet (attached) called "How
are Specimens Used for Research?" to learn more about specimen research.
The research that may be done with your specimens probably will not help you. It might
help people who have cancer and other diseases in the future.
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Page 9 of 14
Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
3/11/08
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Reports about research done with your specimens will not be given to you or your
doctor. These reports will not be put in your health record. The research will not have
an effect on your care.
Things to Think About
The choice to let us keep the leftover specimens for future research is up to you. No
matter what you decide to do, it will not affect your care. You may choose to not donate
specimens for future research, while still participating in the main study.
If you decide now that your specimens can be kept for research, you can change your
mind at any time. Just contact us and let us know that you do not want us to use your
specimens. Then the specimens will no longer be used for research.
In the future, people who do research may need to know more about your health. When
the Southwest Oncology Group gives them reports about your health, it will not give
them your name, address or phone number.
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Sometimes specimens are used for genetic research (about diseases that are passed
on in families). Even if your specimens are used for this kind of research, the results will
not be put in your health records.
Your specimens will be used only for research and will not be sold. The research done
with your specimens may help to develop new products in the future.
Benefits
The benefits of research using specimens include learning more about what causes
cancer and other diseases, how to prevent them, how to treat them, and how to cure
them.
Risks
There are very few risks to you. The greatest risk is the release of information from your
health records. The Southwest Oncology Group will protect your records so that your
name, address, and phone number will be kept private. The chance that this information
will be given to someone else is very small.
Please read each sentence below and think about your choice. After reading each
sentence, check "Yes" or "No." No matter what you decide to do, it will not affect
your care. If you have any questions, please talk to your doctor or nurse. For
questions about your rights as a research participant, contact the _______________
Institutional Review Board (which is a group of people who review the research to
protect your rights) at # _____________________.
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Page 10 of 14
Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
Please note: the questions below regarding banking apply only to patients who agreed
to submit specimens.
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-----------------------------------------------------------------------1.
My specimens may be kept for use in research to learn about, prevent, treat or
cure cancer.
Yes ____________
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My specimens may be kept for research about other health problems (for
example: causes of diabetes, Alzheimer's disease, and heart disease).
Yes ____________
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No ____________
No ____________
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Someone may contact me in the future to ask me to allow other uses of my
specimens.
Yes ____________ No ____________
-----------------------------------------------------------------------If you decide to withdraw your specimens from a Southwest Oncology Group Specimen
Repository, in the future, a written withdrawal of consent should be submitted through
your treating doctor to the Southwest Oncology Group Operations Office. Please
designate in the written withdrawal whether you would prefer to have the specimens
destroyed or returned to the treating doctor.
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Where can I get more information?
 You may call the National Cancer Institute’s (NCI’s) Cancer Information Service
at:
1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615
 You may also visit the NCI Web site at http://cancer.gov
 For the NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials

9/4/07
For the NCI’s general information about cancer, go to: http://cancer.gov/cancerinfo
Participant Agreement
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. I agree to allow the research personnel specified above
the access to my medical records.
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Page 11 of 14
Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Consent Form
It may be necessary for my doctor to contact me at a future date regarding new
information about the treatment I received; 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. I will be given a copy of all 14 pages of this consent. I may also request a copy of
the study (complete study plan).
______________
(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)
3/15/06
_________________________________
(Signature of Person Obtaining Consent)
Page 12 of 14
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Information Sheet
Specimen Consent Supplemental Sheets
How are Specimens Used for Research?
Where do specimens come from?
A specimen may be from a blood sample or from bone marrow, skin, toenails or other
body materials. People who are trained to handle specimens and protect donors' rights
make sure that the highest standards of quality control are followed by the Southwest
Oncology Group. Your doctor does not work for the Southwest Oncology Group, but
has agreed to help collect specimens from many patients. Many doctors across the
country are helping in the same way.
Why do people do research with specimens?
Research with specimens can help to find out more about what causes cancer, how to
prevent it, how to treat it, and how to cure it. Research using specimens can also
answer other health questions. Some of these include finding the causes of diabetes
and heart disease or finding genetic links to Alzheimer's disease.
What type of research will be done with my specimen?
Many different kinds of studies use specimens. Some researchers may develop new
tests to find diseases. Others may develop new ways to treat or even cure diseases. In
the future, some of the research may help to develop new products, such as tests and
drugs. Some research looks at diseases that are passed on in families (called genetic
research). Research done with your specimen may look for genetic causes and signs
of disease.
How do researchers get the specimen?
Researchers from universities, hospitals, and other health organizations conduct
research using specimens. They contact the Southwest Oncology Group and request
samples for their studies. The Southwest Oncology Group reviews the way that these
studies will be done, and decides if any of the samples can be used. The Southwest
Oncology Group gets the specimen and information about you from your hospital, and
sends the specimen samples and some information about you to the researcher. The
Southwest Oncology Group will not send your name, address, phone number, social
security number or any other identifying information to the researcher.
Will I find out the results of the research using my specimen?
You will not receive the results of research done with your specimen. This is because
research can take a long time and must use specimen samples from many people
before results are known. Results from research using your specimen may not be
ready for many years and will not affect your care right now, but they may be helpful to
people like you in the future.
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Page 13 of 14
Participant Initials ____
IRB Approval ______________
Version: Revision #3 3/11/08
SWOG S0434
Southeast Cancer Control Consortium Information Sheet
Why do you need information from my health records?
In order to do research with your specimen, 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?) This helps researchers answer questions
about diseases. The information that will be given to the researcher may include your
age, sex, race, diagnosis, treatments, and family history. This information is collected
by your hospital from your health record and sent to the Southwest Oncology Group. If
more information is needed, the Southwest Oncology Group will send it to the
researcher.
Will my name be attached to the records that are given to the researcher?
No. Your name, address, phone number, and anything else that could identify you will
be removed before they go the researcher. The researcher will not know who you are.
How could the 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 genetic
research may not apply only to you, but to your family members too. For disease
caused by gene changes, the information in one person's health record could be used
against family members.
How am I protected?
The Southwest Oncology Group is in charge of making sure that information about you
is kept private. The Southwest Oncology Group will take careful steps to prevent
misuse of records. Your name, address, phone number, and any other identifying
information will be taken off anything associated with your specimen before it is given to
the researcher. This would make it very difficult for any research results to be linked to
you or your family. Also, people outside the research process will not have access to
results about any one person which will help to protect your privacy.
What if I have more questions?
If you have any questions, please talk to your doctor or nurse, or call our research
review board at # _______________________.
3/15/06
Page 14 of 14
Participant Initials ____
SWOG S0434
Southeast Cancer Control Consortium Withdrawal of Consent
I, _____________________________, withdraw my consent to participate in this study
and refuse to be followed and have clinical data collected from my medical records.
Participant Name ___________________________________ Study/ID #___________
(Please Print Name)
Participant Signature ____________________________________ Date ___________
Witness Signature ______________________________________ Date ___________
3/15/06
SWOG S0434
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for treatment on this study.
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 ___________________________________Study/ID #____________
(Please Print Name)
Participant Signature ____________________________________
Date __________
Witness Signature ______________________________________
Date __________
3/15/06