Download wfusm informed consent template - Southeast Clinical Oncology

IRB Approval ______________
Version: Amendment #3 10/28/08
CCCWFU 98308
Southeast Cancer Control Consortium Consent Form
A Phase III Randomized, Double-Blind, Placebo Controlled Trial of North
American Ginseng Extract (CVT-E002 or COLD-fX®) to Prevent Respiratory
Infection and Reduce Antibiotic Use in Patients with Chronic Lymphocytic
Leukemia
What is a research study?
You are invited to be in a research study. Research studies are designed to gain
scientific knowledge that may help other people in the future. You are being asked to
take part in this study because you have been diagnosed with Chronic Lymphocytic
Leukemia (CLL). Your participation is voluntary. Please take your time to make your
decision, and ask your study doctor or the study staff to explain any words or
information that you do not understand. You may also discuss the study with your
friends and family.
Why is this study being done?
This study is being done because CLL results in a compromised immune system (the
body is unable to defend itself against viruses and bacteria) and an increased risk of
infection. CVT-E002 (a natural product, an extract from North American ginseng) is
being tested to determine if it will prevent respiratory infection and reduce antibiotic use
in patients with CLL. The purpose of this study is to determine the safety and
effectiveness of CVT-E002, compared to the placebo treatments (inactive powder and
pill). Knowledge gained from this study may be beneficial to prevent infection in
patients with CLL.
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How many people will take part in the study?
About 336 untreated CLL patients will be asked to participate in this study.
What will happen if I take part in this research study?
Before you enter the study you will have a screening visit so that your doctor can
determine that you are eligible to participate in the study. At this visit the procedures
that will be conducted will include:
 collection of your medical history
 a physical exam including height, weight, blood pressure, temperature and pulse
 blood samples for routine laboratory and immune function testing
 Acute Respiratory Infection (ARI) assessment diaries will be distributed and
collected at study visits
If you are eligible to participate in this study, you will be randomized to receive one of
two treatments throughout the study. Randomization means that you are put into a
group by chance. It is like flipping a coin. Neither you nor the doctor will know which
study drug you are receiving. This is done so that a fair evaluation of results can be
made. This information is available to your doctors or the researchers if needed in an
emergency.
1) Group 1: CVT-E002 (200 mg) taken by mouth twice a day. One taken in the
morning and one in the evening.
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Participant Initials _____
IRB Approval ______________
Version: Amendment #3 10/28/08
CCCWFU 98308
Southeast Cancer Control Consortium Consent Form
2) Group 2: matching placebo (an inactive substance) taken by mouth twice a day.
One taken in the morning and one in the evening. Placebos are used in research
studies to see if the drug being studied really does have an effect.
You have an equal chance of being assigned to Group 1 or Group 2.
You will be asked to return week 4, week 10, and at the end of study treatment to see
how you are doing. At each of these visits medications you have been taking will be
reviewed, blood samples for routine laboratory testing and immune function testing will
be collected, a physical examination will be performed, and your ARI assessment diary
will be collected.
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Immune function testing will include drawing approximately 2-3 teaspoons of blood
during visits at Baseline, 4 week, 10 week and the end of study. These blood samples
will be shipped to Wake Forest University for immune function testing.
You will be called on the phone 4 weeks after stopping treatment to see how you are
doing. During this phone call you will be asked if you have taken any antibiotics or had
any side effects.
How long will I be in the study?
You will be in the study approximately 6 months.
The researcher may decide to take you off the study if: 1) continued participation is
decided not to be in your best medical interest, 2) health conditions occur which would
make your participation possibly dangerous, 3) new information becomes available, 4) if
you do not follow study rules; or 5) the study is stopped.
Can I stop being in the study?
You can decide to stop being in the study at any time. This will not compromise or
affect the quality of your care that you receive.
If you decide to stop participating in the study we encourage you to talk to your study
doctor or study staff first to learn about any potential health or safety consequences.
What side effects or risks can I expect from being in the study?
Being in this study involves some risk to you. You should discuss the risk of being in
this study with the study staff. There also may be other side effects that we cannot
predict or are unforeseen or unexpected. You should tell the research staff about all
the medications, vitamins, and supplements you take and any medical conditions you
have. This may help avoid side effects, interactions and other risks.
CVT-E002 is generally well-tolerated. In three studies that included a total of 455
subjects comparing CVT-E002 to placebo, there was no difference between the active
treatment and placebo groups in the incidence of side effects. Side effects you may
experience include:
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Participant Initials _____
IRB Approval ______________
Version: Amendment #3 10/28/08
CCCWFU 98308
Southeast Cancer Control Consortium Consent Form
Most Common:
 Rashes
Less Frequent:
 Headaches
 Difficulty sleeping
 Confusion
 Dizziness
 Drowsiness
 Diarrhea
 Nausea
 Vomiting
 Hyperactivity
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Changes in blood pressure
Nosebleeds
Increased blood glucose levels
Nervousness
Diuresis(increased discharge of urine)
Joint Pain
Heartburn
Blood Drawing
Approximately 3 tablespoons of blood will be drawn at each blood draw (week 4 and 10
and at end of study treatment). You may experience discomfort, bruising and/or
bleeding where the needle is inserted. There may be bruising at the puncture site when
blood is drawn and occasionally some redness and swelling. Occasionally some
people become dizzy, lightheaded or feel faint. Infection may occur on rare occasions.
Reproductive Risks and other Issues to Participating in Research
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Women who can get pregnant
Due to unknown risks and potential harm to the unborn fetus, sexually active women of
childbearing potential must use a reliable method of birth control while participating in
this study. Reliable methods of birth control are: abstinence (not having sex), oral
contraceptives, intrauterine device (IUD), tubal ligation, 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 a cervical cap or sponge. We encourage you to discuss
this issue further with your physicians if you have any questions. Both male and female
patients should ask about counseling and more information about preventing
pregnancy.
Pregnant women are excluded from participation in this study. If you are a sexually
active woman of childbearing potential and have not been using a reliable method of
birth control, a negative serum pregnancy test within 10 days prior to registration is
required to check for possible early pregnancy prior to starting treatment.
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Participant Initials _____
IRB Approval ______________
Version: Amendment #3 10/28/08
CCCWFU 98308
Southeast Cancer Control Consortium Consent Form
Male Patients
Since the effects of CVT-E002 on conception and fetal development are not fully
known, it is important that you follow adequate birth control methods if you have not
been surgically sterilized, also called a vasectomy, (at least one month before
screening) and are having heterosexual intercourse from screening onwards until one
month after the last study drug administration.
These methods include using a condom, a condom combined with hormonal
contraceptives, intrauterine device, diaphragm, cervical cap or practicing heterosexual
abstinence. These restrictions are not applicable if your female sexual partner has had
a tubal ligation (had her “tubes tied”), a total hysterectomy (surgery of removal of the
womb) or if she is postmenopausal for at least two years.
Will I benefit from taking part in the study?
If you agree to take part in this study, there may or may not be direct benefit to you.
We hope the information learned from this study will benefit other patients in the future.
What other choices do I have if I do not want to take part in this study?
The alternative to participating in this trial is not to participate. There is currently no
standard treatment to reduce the risk of respiratory infections in patients with CLL.
Other options include enrolling in another study if one becomes available, or getting no
treatment. The purpose of this trial is research only.
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.
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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 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
Comprehensive Cancer Center of Wake Forest University (CCCWFU) CCOP
Research Base
National Cancer Institute (NCI) and its representatives
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at ____________ Hospital
A qualified representative of CV Technologies, supplier of study drug
Possible other federal or state government agencies
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Participant Initials _____
IRB Approval ______________
Version: Amendment #3 10/28/08
CCCWFU 98308
Southeast Cancer Control Consortium Consent Form
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.
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What are the costs of taking part in this study?
Taking part in this study may lead to added cost to you or your insurance company. You
or your insurance carrier will be responsible for the costs of clinic visits, any hospital
admissions, laboratory tests, and any other tests. Please ask your doctor about any
added costs or insurance problems.
You and/or your health plan/insurance provider (Medicare should be considered a
health insurance provider) will need to pay for regular medical care, which are not
related to this study.
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/
insurance-coverage. 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.
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Who is sponsoring this study?
This study is being sponsored by the National Cancer Institute and CV Technologies,
located in Edmonton, Alberta, Canada. The sponsors are providing money or other
support to Wake Forest University Health Sciences to help conduct this study. The
researchers do not, however, hold a direct financial interest in the sponsor or the
product being studied.
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
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Participant Initials _____
IRB Approval ______________
Version: Amendment #3 10/28/08
CCCWFU 98308
Southeast Cancer Control Consortium Consent Form
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.
You or your insurance company will be charged for continuing medical care and/or
hospitalization.
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
study drug. You can choose to withdraw one of two ways. In the first, you can stop
your study drug, but still allow the study doctor to follow your care. In the second, you
can stop your study drug 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
__________________________).
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
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Participant Initials _____
IRB Approval ______________
Version: Amendment #3 10/28/08
CCCWFU 98308
Southeast Cancer Control Consortium Consent Form
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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
For the NCI’s general information about cancer, go to:
http://cancer.gov/cancerinfo
Use of collected blood samples for future research
If there is any portion of the blood sample obtained that is left over after this study, it
may be of use in future research to learn more about cancer and the immune response.
Such additional research will only be done if you agree to it. The research that may be
done with your blood is not designed to help you specifically. It might help people who
have cancer and other diseases in the future. Reports about research done with your
blood will not be given to you or your doctor and they will not be put in your health
record. The research will not have an effect on your care.
The choice to let us keep the leftover blood for future research is up to you. No matter
what you decide to do, it will not affect your care. If you decide now that your blood 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 blood. Then any blood that remains will no
longer be used for research. In the future, people who do research may need to know
more about your health. While the researchers at Wake Forest University Health
Sciences may give them reports about your health, they will not give them your name,
address, phone number or any other information that will let the researchers know who
you are.
Sometimes blood is used for genetic research (about diseases that are passed on in
families). Even if your blood is used for this kind of research, the results will not be put
in your health records. Your blood will be used only for research and will not be sold.
The research done with your blood may help to develop new products in the future.
Benefits: The benefits of research using tissue include learning more about what
causes cancer and other diseases, how to prevent them, and how to treat them.
Risks: The greatest risk to you is the release of information from your health records.
The Wake Forest University Health Sciences 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.
Making Your Choice
Please read each sentence below and think about your choice. After reading each
sentence, check "Yes" or "No". If you have any questions, please talk to your doctor or
nurse, or call our research review board at # _____________________________
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Page 7 of 8
Participant Initials _____
IRB Approval ______________
Version: Amendment #3 10/28/08
CCCWFU 98308
Southeast Cancer Control Consortium Consent Form
I agree that my biological material (blood) and health records may be kept for use in
research for Chronic Lymphocytic Leukemia.
________ Yes
_______ No
I agree that my biological material (blood) and health records may also be kept for use
in future research to learn about, detect, prevent, treat or cure other health problems.
________ Yes
_______ No
I agree that my doctor or someone he chooses may contact me in the future to ask
about taking part in more research.
________ Yes
_______ No
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.
It may be necessary for my doctor to contact me at a future date regarding new
information about the study drug 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 8 pages of this consent. I have read it or it has been
read to me. 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)
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_________________________________
(Signature of Person Obtaining Consent)
Page 8 of 8
CCCWFU 98308
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 ___________
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CCCWFU 98308
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for participation on this
study. Even though I withdraw my consent for participation, 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 __________
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