INFORMED CONSENT TO PARTICIPATE IN A RESEARCH STUDY

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NOT TO BE USED FOR SUBJECT ENROLLMENT

Text highlighted in yellow are either instructions and/or prompts to enter protocol/sponsor-specific
details.

INFORMED CONSENT DOCUMENT
AGREEMENT TO BE IN A RESEARCH STUDY

NAME OF SPONSOR COMPANY: XXXX

PROTOCOL NUMBER AND TITLE OF STUDY: XXXX

NAME OF PERSON IN CHARGE OF
THE RESEARCH STUDY (STUDY DOCTOR): XXXX

ADDRESS OF STUDY SITE(S): XXXX

TELEPHONE NUMBER(S), DAYTIME &
AFTER HOURS: (XXX) XXX-XXXX

INTRODUCTION

You are being invited to take part in a research study to test an investigational drug(s) called XXXX.
"Investigational" means the drug(s) being tested have not been approved by the United States Food and
Drug Administration (FDA). You are being invited to take part in this research study because you have
advanced cancer and the standard drugs to treat your disease are no longer effective or no reliably effective
treatment is known for your type of cancer. We are doing this clinical research study to find a dose of
XXXX that would be the highest dose that can be given in humans without causing significant side effects.
We want to find out what effects, good and/or bad, it has on you and your cancer. Future studies (called
phase II studies) can then test whether or not this drug is useful against cancer.

Give additional drug information here if requested/provided by the sponsor.

You must read and sign this form before you agree to take part in this study. This form will give you more
information about this study. Please ask as many questions as you need to before you decide if you want to
be in the study. You should not sign this form if you have any questions that have not been answered.

The study doctor is being paid by the sponsor (the company paying for this study) to conduct this
research study.

You must be honest with the study doctor about your health history or it may not be safe for you to be in this
study.

Include this statement for first time in human studies:
THIS IS THE FIRST STUDY IN WHICH THE STUDY DRUG/FORMULATION IS BEING
GIVEN TO HUMANS.

PURPOSE OF THE STUDY

The purpose of this study is to find answers to the following research questions:

List the objectives as stated in the protocol in lay terms. Study objectives are usually standard for
Phase I studies but the language below will be modified as per protocol.

1. What is the highest dose of XXXX that can be given to subjects when given XXXX (give
schedule) without causing significant side effects?

2. What are the side effects of XXXX?

3. How much XXXX is in the blood at specific times after dosing and how does the body get rid of
the XXXX?

HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY

Your time in this research study will be followed in “cycles”. One cycle is XXXX days (XXXX weeks)
in duration. You will need to come to the study site XXXX times before you begin to receive the drug(s)
to see if you are eligible to be in the study. After you start the drug(s), you will visit the study site
XXXX times during Cycle 1, XXXX times during Cycle 2, and XXXX times for each following cycle.
The total number of cycles you go through in the study will depend on how you tolerate the drug, and if
your cancer gets worse. -- # of visits will vary between studies but most studies have different # of
visits for C1, C2 due to PK testing and then all other cycles are usually the same.

For studies that offer continued dosing after the standard study period:
You may be able to continue to take the drug as long as:

 your cancer does not get worse
 you do not have severe side effects
 both the study doctor and the sponsor agree

Approximately XX subjects (male and female), ages 18 and older, with advanced cancer will be enrolled
in this study. – If appropriate, a short description about the cohorts can be added here.

TO BE IN THIS STUDY

You cannot be in this study if you are in another research study or if you have been in any other research
study in which you received an investigational therapy in the last XXXX days. – look at eligibility
criteria to get maximum # of days but for phase I studies it is usually between 14(15) to 28(30) days
[revise as appropriate per the study protocol].

WHAT WILL HAPPEN DURING THE STUDY

Describe treatment design here. If there are different Parts or Arms, list them here briefly.
Explain dose escalation method such as (standard dose escalation in phase I):

In order to determine the highest dose of the drug(s) that can be given without causing significant side
effects, this study will start with a low dose of XXXX. Three to six subjects will be enrolled at the low
dose. If no severe or serious side effects are related to the XXXX dose in this first group of subjects,
another three to six subjects will be enrolled and started on a higher dose of XXXX. This will continue
until unacceptable side effects occur to subjects. Once the highest dose is found, an additional XXXX
subjects will be enrolled at that dose level. Therefore, the dose of XXXX you receive will depend on
when you enter the study. As a result, the dose you receive may not actually be the right dose to be
beneficial for you, but the information obtained may help benefit others in the future.

Please do not include any inclusion and exclusion criteria. These can be reviewed with the subjects
during the screening or consent process.

LIST PROCEDURES IN CHRONOLOGICAL ORDER, IN BULLET FORM AS LISTED IN
PROTOCOL STUDY SCHEDULE CHART OR TEXT INSIDE THE PROTOCOL.

Before the study starts, the study doctor will do some tests to find out if you can be in the study. As many
of these tests are a part of standard cancer care, you may have had them done recently and they may not
need to be repeated. Within XXXX days before the first dose of the drug(s), you will be asked to visit
the study site to have the following done:

 You will be asked to sign this consent form document
 Your medical history and demographic data (includes things like your sex, age, race/ethnicity) will
be recorded
 You will be asked about any medications you have taken and are currently taking
 Vital signs (temperature, pulse, breathing rate, blood pressure – edit as listed in protocol) will be
taken and your height and weight will be recorded
 Physical exam will be done
 A biopsy of your tumor proving that you have cancer
 You will be asked how well you are able to do your normal activities (bathing, driving, shopping,
working, etc.) – standard definition for performance status
 An electrocardiogram (ECG -- a recording of the electrical activity of the heart) will be done to check
your heart function. – standard definition for ECG
 If you are a woman capable of having children, you will have a pregnancy (blood or urine) test to
make sure you are not pregnant
 Blood samples will be taken for routine tests to check your blood counts (numbers of each type of
blood cell), chemistries (elements and minerals in your blood), blood clotting, and how well your
organs are functioning – standard definition for routine lab tests but can be revised to add any
additional tests such as thyroid, etc.
 A routine urine test will be done to check your kidney function – standard definition for routine urine
test
 An initial assessment of your tumor will be done by scans (PET/CT, MRI, etc.) to measure the extent
of your disease
 Etc.
 Etc.
 Etc.

Required wording when heart monitors are required per protocol (adjust wording as per
protocol):

At the screening visit, you will be given a small portable heart monitor to wear. This monitor will record
your heart rate for 24 hours. The monitor is connected by wires that are stuck to your chest, using tape or
stickers. To attach the monitor wires, a small section of your chest might have to be shaved. You must
return the monitor to the study staff.

Required wording for female subjects when a pelvic exam is required:

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The study exam and lab tests are not meant to take the place of your yearly women’s pelvic exam. You
will not be tested for sexually transmitted diseases. If you think that you might have a sexually
transmitted disease, you should see your private doctor.

Required wording when mammograms are required:

A mammogram is an x-ray of the breast used to help find small lumps in the breast before they become a
problem. The mammogram for this study will expose you to a small amount of radiation. The long-term
effects of low-level radiation are not known.

It is possible that after the results of these tests are reviewed, you will not qualify to be in the study. If
you are not eligible to receive the drug, the reasons why you cannot take part will be discussed with you
by the study doctor or the study staff.

Study Procedures:

If you are eligible and agree to receive the drug, you will need to come to the study site at various times
to have procedures done. These procedures are described below.

LIST PROCEDURES IN CHRONOLOGICAL ORDER, IN BULLET FORM AS LISTED IN
PROTOCOL STUDY SCHEDULE CHART OR TEXT INSIDE THE PROTOCOL.

Cycle 1, Day 1: (expected to take XX hours)
 You will be asked about any medications you are currently taking
 Etc.
 Etc.
 Etc.
 Etc.

Cycle 1, Day 2: (expected to take XX hours)
 You will be asked about any medications you are currently taking
 Etc.
 Etc.
 Etc.
 Etc.

End of Study/Final Visit (expected to take XX hours)
If you withdraw or are withdrawn from the study, for any reason, you will be scheduled for a final visit.
This visit will occur XXXX days after your last dosing. During this visit, the following procedures will
be done:

 You will be asked about any medications you are currently taking
 Etc.
 Etc.
 Etc.
 Etc.

Include this statement in studies requiring self-dosing:
You must keep the drug(s) out of the reach of children.

Required wording when endoscopy procedures will be performed:

Gastrointestinal endoscopy is a way to look at the inside of the digestive tract using a flexible tube that
has a light and camera on the end, called an “endoscope”. The instrument may also be used to take
samples (biopsies) or cultures or make repairs. A snake-like tube is usually passed through the mouth or
rectum, and the exam is usually performed while you are under a state of relaxation (sedation).

You may be given medications prior to the procedure for sedation. You should not drive or operate
machinery after this procedure until the next day. You will sign a separate consent document prior to
having this procedure.

Some of the possible risks of this procedure are:

 Pain, vomiting, and fluid in the lungs (aspiration)
 Bleeding
 Tearing of the wall of the stomach or intestines (perforation), which could cause infection
 Injury to other organs near the intestines
 Reactions to medications

Blood Samples:

Blood samples will be taken by single needle-sticks or by a tube that is left in your arm if multiple
samples need to be drawn the same day.

Blood samples may be drawn by either one of two ways depending on what is most convenient for you.
(1) A small flexible plastic catheter (tube) may be placed in your arm so that the blood can be drawn
for testing without additional “needle sticks”. The catheter will be placed in the arm by first
putting a tourniquet above the potential site of the catheter. The site will be cleaned, usually
with alcohol, and a needle with a flexible catheter will be inserted into the vein. The needle and
the tourniquet will then be removed, and the catheter will be secured in place with tape.

(2) Implanted ports may be used for obtaining blood specimens or infusion of medications. The skin
over your implanted venous access device or port will be cleaned with alcohol swabs and then
with betadine swabs. A needle designed specifically for use with implanted venous access
devices or ports will then be inserted into your port. This will allow us to obtain blood
specimens or infuse medications with less pain to you than repeatedly sticking a needle directly
into your vein.

There will be about XXXX blood draws. The total amount of blood drawn will be about XXXX (mL or
cups). For comparison, the standard blood donation is about 480 mL (two cups).
OR
Ensure the # of samples are broken down by cycle.

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Initials/master or site: date
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Blood loss may cause anemia (low red blood cell count). Anemia may make you feel tired. Some people
may need iron supplements to compensate for the blood loss resulting from the procedures done during
this study. Please make sure that you discuss this with the study doctor or your personal doctor.

POSSIBLE SIDE EFFECTS AND RISKS OF THE DRUG(S)

Do not use medical terminology to describe side effects - ONLY USE LAY LANGUAGE. LIST SIDE
EFFECTS IN BULLET FORM. Listing can be broken down by % or other notation (very common,
less common, and rare).

 Loss of appetite (instead of anorexia)
 Hair loss (instead of alopecia)
 Etc.
 Etc.
 Etc.

If you do not understand what any of these side effects mean, please ask the study doctor or study staff to
explain these terms to you.

Because this/these drug(s) is/are investigational, all of its/their side effects may not be known. There may
be rare and unknown side effects, some of which may be irreversible and/or life threatening.

You must tell the study doctor or study staff about all side effects that you have. If you are not honest about
your side effects, it may not be safe for you to stay in the study.

Required wording when using a combination of drugs:
When you take more than one drug at a time, the side effects can be worse or different than if you take
either drug by itself.

Required wording when drowsiness, dizziness, or blurred vision is a major side effect:
Because this drug can cause drowsiness, dizziness, or blurred vision (delete as appropriate), you should
use caution if you experience this side effect such as avoiding stairs, not driving a car or working with
machinery.

Required wording for drugs that can form antibodies:
You may form antibodies to the drug. An antibody is a type of protein that helps protect the body against
attack by bacteria and viruses. There is also a small chance that if you have these antibodies, this drug or
similar drugs will not work for you in the future.

Required wording for radio labeled studies:
This study involves exposure to radiation. The risk from radiation exposure in this study is small when
compared with other everyday risks. Female subjects must not be pregnant. Female subjects who have
not been surgically sterilized must have a negative pregnancy test to be in this study.

The risks of receiving the very low doses of radiation are thought to be low, but are unknown.

Required wording for radiation therapy studies:
Risks and side effects related to radiation therapy include those that are:

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Likely:
 Skin color change
 Skin redness
 Skin soreness
 Hair loss
 Possible short-term hearing loss
 Tiredness
 Sleepiness
 Skin dryness

Less likely:
 Nausea
 Vomiting
 Dry mouth
 Altered taste

Rare, but Serious:
 Development of other tumors
 Tissue damage

ADDITIONAL RISKS OR DISCOMFORTS

Include a description of any reasonably foreseeable risks or discomforts to the subject other than side
effects caused by the drug/device or procedures.

Blood Samples:

There may be side effects of having blood drawn such as:

 Fainting
 Redness
 Pain
 Bruising
 Bleeding
 Infection

If you feel faint tell the study staff right away.

BELOW IS INTEGREVIEW’S APPROVED LANGUAGE FOR OTHER STUDIES. USE
WHENEVER POSSIBLE UNLESS SPONSOR INSISTS ON OWN LANGUAGE.

 Infection
 Pain
 Redness
 Bruising
 Vein irritation from the fluids or medication being given
 Local swelling due to IV fluid accidentally entering the tissue rather than the vein
 Blood clots, which may cause inflammation, swelling and pain

Electrocardiogram (ECG):

The ECG test is a recording of the electrical activity of your heart and is harmless. The sticky pads used
may be cold when applied and sometimes cause some discomfort such as redness or itching. If the skin
under the patches needs to be shaved, irritation from shaving also could occur.

Magnetic Resonance Imaging (MRI):

An MRI is a way of looking at the soft tissues of the body. You will lie down on a large magnet. A
magnetic signal will be sent through your body and then received back. This process is safe for most
people. Subjects with metal near important organs may not receive an MRI. The metal may be drawn
away from the body and towards the large magnet, which could cause injury.

CT Scan:

A CT scan is a computerized series of detailed pictures of areas inside the body taken from different
angles. You may feel some discomfort or anxiety when lying inside of the CT scanner. The dye that is
injected into your body may cause you to get a metallic taste in your mouth, to feel warm, and rarely
cause nausea and vomiting. You will be exposed to a limited and medically acceptable dose of radiation
during the scan. There is always a slight risk of damage from being exposed to any radiation.
18
FDG-PET/CT Scan:

A PET Scan is a computerized image that looks at the activity of tumor cells in your entire body and that
requires injection of a special marker into your vein. You will be asked to fast (no food) for about 4 to 6
hours before the scan. A small amount of radioactive sugar (tracer) will be injected into your blood
about 1 hour before the scan. You may experience discomfort related to lying still in an enclosed space
for a long period. The camera will record the tracer’s signal as it travels through your body. You will be
exposed to a limited and medically acceptable dose of radiation during the scan. There is always a slight
risk of damage from being exposed to any radiation.

Bone scans:

A bone scan uses x-rays where a small amount of radioactive chemical is injected into your veins and
travels through the bloodstream. It collects in the bones and is picked up by the scanner. There is a
small risk of allergic reaction to the chemical used in the test. You could also have swelling, soreness, or
infection at the site where the tracer is injected into your vein. The radiation exposure of this test is very
low, and not likely to cause any damage to you.

During the echocardiogram, electrodes will be placed onto your chest to allow for an ECG to be
performed. Then a transducer (a device that looks like a computer mouse) will be applied. You may feel
slight pressure on your chest from the transducer. In addition, you may be asked to breathe in a certain
way or to rest on your side during the test.

Multiple Gated Acquisition (MUGA) scans:

This test measures how well your heart is pumping. A MUGA is a special type of x-ray machine used to
take a rapid series of pictures of the heart. This procedure involves getting radiation (like x-rays). A
radioactive substance called a tracer is given through an IV, which helps to create the pictures that are
taken. The amount of radiation involved is small, about the same amount as two regular chest x-rays.
There is a minimal amount of pain with this test. The tracer is passed out of the body through the urine
within 24 hours after the test is completed. This test takes about 2 to3 hours to complete.

Bone Marrow Biopsy or Bone Marrow Aspirate:

A small sample of bone marrow is taken usually from the hip (pelvis) bone. You are given a small
injection to numb the area. A needle is passed through the skin into the bone. A small sample of the
bone marrow is then drawn into a syringe. It may be painful, but this only lasts for a short time. You
may be offered medication to reduce any pain or discomfort during the test.

Though not common, there may be side effects of having a bone marrow aspiration and biopsy such as:

 Pressure and/or pain when the needle is inserted, as well as when the bone marrow is removed with a
syringe (aspiration)
 Bleeding where the needle is inserted into the skin and tissue over the bone
 Bruising where the needle is inserted into the skin and tissue over the bone
 Pain where the needle is inserted into the skin and tissue over the bone
 Infection where the needle is inserted into the skin and tissue over the bone

Rare side effects (that can be controlled) may include:

 Infection of the bone
 Extensive bleeding at the biopsy site

Risks of Using an Intramuscular (IM) Injection:

 Infection
 Pain
 Redness
 Bruising
 Irritation from the fluids or medication being given
 Local swelling
 Accidental intravenous (IV) injections
 Fainting

 Urinary tract or kidney infections
 Blood in the urine (hematuria)
 Blood infections (septicemia)
 Kidney damage (usually only with long-term, indwelling catheter use)
 Urethral injury
 Bladder stones
 Balloon rupture (the balloon is what holds the catheter in place in the bladder)

The risk of complications increases with prolonged use.

BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING

If you are a female, you must not get pregnant while in this study. The only certain way to not get
pregnant is to not have sex. If you are a female and choose to have sex, you must use a type of birth
control listed below while in this study (and for XXX days after last dose – refer to protocol for
specific requirements).

If you are a man, you must use birth control if you choose to have sex with women while in this study
(and for XXX days after last dose – refer to protocol for specific requirements).

(Refer to protocol for specific requirements)
Acceptable methods of birth control for this study include:

 Norplant
 Birth control pills plus another method (i.e. condom)
 Birth control patch
 IUD (intrauterine device)
 Depo-Provera
 Sterilization
 Abstinence
 Condoms with spermicide

Even if you use birth control during the study, there is a chance you could become pregnant.

You cannot be in the study if you are pregnant or breastfeeding. It is not known whether the drug(s)
is/are safe for breast fed babies. Therefore if you are breastfeeding a child then it may not be safe for you
to take part in the study. A pregnancy test can be wrong. If you become pregnant during the study, stop
taking the drug(s) and call the study doctor at once.

If you are pregnant or become pregnant during the study, the drug/device or procedure may involve risks
to the unborn baby, which are currently unforeseeable.

The main goal of this study is to test the safety of the drug(s). It is not to treat your cancer. The chances
that the drug(s) will shrink your cancer or help you live longer are very low. Your cancer might stay the
same or it may get worse. The drugs you receive may even be harmful. However, what we learn from
this study may benefit society and future patients with cancer.

OTHER OPTIONS TO BEING IN THE STUDY

Yes, there are other options. Other options may include:

 Participation in another research study with a different drug
 Chemotherapy with a drug which has already been approved (add or remove as appropriate per
the study)
 Radiation therapy may be an option depending on your tumor type (add or remove as appropriate
per the study)
 Supportive care without anti-cancer treatment
 No medical treatment at all

The study doctor can explain both the possible benefits and the risks of other options that are available to
you. Also talk with your doctor and oncologist about these and other options. If you decide that you do
not wish to take part in the study, you are free to leave the study center at any time.

CONFIDENTIALITY

IntegReview prefers HIPAA Authorization to be provided as a separate document, however if you require
HIPAA Authorization wording to be integrated into the informed consent, please place at the end of this
document (see last page for instructions).

Your records of being in this study will be kept private except when ordered by law. The following
people will have access to your study records:

 Study doctor
 Sponsor company or research institution
 The United States Food and Drug Administration (FDA) – remove/revise when applicable
 Other state or federal regulatory agencies
 IntegReview Ethical Review Board (IRB)

[Statement only applicable for treatment drug and device studies regulated by the FDA]
A description of this clinical study may be available on www.ClinicalTrials.gov, as required by U.S.
Law. This website will not include information that can identify you. At most, the website will include a
summary of the results. You can search this website at any time.

The Independent Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your
records, which may have your name on them. Therefore, your absolute confidentiality cannot be
guaranteed. If the study results are presented at meetings or printed in publications, your name will not
be used.

IN CASE OF STUDY RELATED INJURY

Use language provided by study sponsor since that is the legally approved language. However,
if the cost of medical treatment for a research-related injury will be the responsibility of the subject or
their insurance company, include the following statement:
Please be aware that some insurance plans may not pay for research-related injuries. You should contact
your insurance company for more information.

OR If no language is provided by sponsor, below is language previously approved by IntegReview for
other studies (please revise as appropriate).

If you are injured as a result of the research procedures, your injury will be treated. In the event of an
illness or injury that is determined to be directly related to the administration of the drug or the properly
performed study procedures, the sponsor, XXX, agrees to pay all reasonable and necessary medical
expenses to treat such illness or injury provided that you have followed the directions of the study doctor,
and that you cannot otherwise be reimbursed by your personal insurance, a government program, or other
third party coverage for such medical expenses. You or your insurance company will be billed for any
other charges. Please be aware that some insurance plans may not pay for research-related injuries. You
should contact your insurance company for more information. We have no plans to give you money if
you are injured. You do not waive any legal rights by signing this form. No other form of compensation
is offered.

If you are injured as a result of the research procedures, your injury will be treated. The sponsor has
insurance that covers the costs for treatment of any research related injury. The term “research-related
injury” means physical injury caused by the drug or the procedures required by the study which are
different from the medical treatment you would have received if you had not participated in the study.
You or your insurance company will be billed for any other charges. Please be aware that some insurance
plans may not pay for research-related injuries. You should contact your insurance company for more
information. We have no plans to give you money if you are injured. No other form of compensation is
offered.

LEGAL RIGHTS

You will not lose any of your legal rights by signing this consent form.

CONTACT INFORMATION

If you have questions, concerns, or complaints about this study or to report a study related injury,
contact:

PI
(XXX) XXX-XXXX daytime telephone number
(XXX) XXX-XXXX after hours number

If you are unable to reach anyone at the numbers listed above and you need medical attention,
please go to the nearest emergency room.

THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE
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Initials/master or site: date
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NOT TO BE USED FOR SUBJECT ENROLLMENT
If you do not want to talk to the study doctor or study staff, if you have concerns or complaints about the
research, or to ask questions about your rights as a study subject as provided in the Subject’s Bill of Rights
you may contact:

Chairperson
IntegReview
3001 S. Lamar Blvd., Suite 210
Austin, Texas 78704
512-326-3001 between 8 a.m. and 5 p.m.
Central Time (call collect)
integreview@integreview.com

IntegReview has approved the information in this consent form and has given approval for the study
doctor to do the study. This does not mean IntegReview has approved you being in the study. You must
consider the information in this consent form for yourself and decide if you want to be in this study.

PAYMENT FOR BEING IN THE STUDY

You will not be paid for being in this study.

VOLUNTEERING TO BE IN THE STUDY / RIGHT TO WITHDRAW

You are under no obligation to take part in this research study and your participation is strictly voluntary.
You are free to choose not to be in this study. You may leave the study at any time without penalty or
loss of benefits to which you are otherwise entitled. You can still get medical treatments without being
in the study. Tell your study doctor if you are thinking about stopping or decide to stop the study. He or
she will tell you how to stop safely. It is important to tell the study doctor about your decision to stop so
he or she can evaluate any risks of stopping as they relate to the drug or procedures. Another reason to
tell the study doctor why you are considering stopping the study is to discuss what follow-up care and
testing is most helpful for you.

The study doctor, the sponsor company, IntegReview, or the FDA may take you out of the study without
your permission, at any time, for the following reasons:

The list below can be revised as per protocol/sponsor requirements
 If you do not follow the study doctor’s instructions
 If we find out you should not be in the study
 If the study is stopped
 If it becomes harmful to your health

If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to
have some end of study evaluations or tests. In addition, the data collected on you to the point of
withdrawal remains part of the study database and may not be removed. If information generated from
this study is published or presented, your identity will not be revealed. If you leave the study, no more
information about you will be collected for this study. However, all of the information you gave us
before you left the study will still be used.

The first 2 sentences can be revised as per sponsor agreement.
The drug(s) XXX (and XX) will be provided free of charge while you are taking part in this study. In
addition, there are study procedures (i.e., ECGs, PET scans, lab work) that are directly due to your taking
part in this study and will be provided at no cost to you. You or your insurance company will be paying
for the costs of the clinic visits, XXXX (if approved drug being used in combination and sponsor not
providing), the routine blood tests, x-rays, scans, other lab tests and your routine medical care.
Insurance companies and Medicare may not pay for costs associated with some research studies like this
one. In cases where XXXX (approved drug) is not covered, and no other assistance is available, XXXX
will be paid for by the sponsor (include this statement if appropriate). If your insurance company does
not cover the cost of routine care, then you will have to pay these costs. You have the right to ask what it
will cost you to take part in this study or to have other treatments.

For more information on insurance coverage for clinical trials, 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.

Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and ask them to
send you a free copy.

NEW FINDINGS

If there is new information about the safety of the drug(s) or any significant new findings we will tell
you. You can then decide if you still want to be in the study.

THE FOLLOWING TWO SECTIONS ARE REQUIRED BY INTEGREVIEW AND MUST BE
INCLUDED IN THE INFORMED CONSENT DOCUMENT (DO NOT EDIT):

SUBJECT’S BILL OF RIGHTS

REQUIRED FOR CALIFORNIA SITES ONLY [NOTE: CA Bill of Rights are not required for
social/behavioral science research and do not need to be included.]:
You will be given a separate copy of the California Experimental Research Subject’s Bill of Rights. If
you have not received a copy of this document, please notify study staff.

FOR ALL NON-CALIFORNIA SITES, INCLUDE THE FOLLOWING:
As a subject in a research study, you should expect to:

1. Be told about the nature and purpose of the study.

2. Be told about the procedures used in the study and any drug or device to be used.

3. Be told about any side effects, discomforts or risks that we expect from being in this study.

4. Be told about any benefits that you can expect from this study.

6. Be told about any medical treatments available to you after the study if problems occur.

7. Be given a chance to ask any questions about the study or procedures.

8. Be told that your consent to be in the study can be withdrawn at any time. You may leave the study
at any time without being penalized.

9. Be given a copy of a signed and dated consent form when one is needed.

10. Be given the chance to decide to be in the study without force, fraud, or pressure.

THE REASON FOR INDEPENDENT REVIEW BOARDS AND INFORMED CONSENT

What is a consent form?
The informed consent document contains information required by federal regulations. The informed
consent document must be approved by an Independent Review Board (IRB).

What is an Independent Review Board (IRB)?
An Independent Review Board (IRB) is a group of people that reviews research studies. The main goal
of this review is to protect the rights and well being of the human subjects participating in research
studies.

IntegReview, the IRB for this study
IntegReview is an IRB whose board members provide IRB services across the nation.

To meet requirements of the law, the IntegReview Board currently includes:

 Doctors
 Pharmacists
 Nurses
 Toxicologists (people who study the harmful effects of chemicals)
 Other specialists
 Others who do not have a background in science/medicine

This consent form contains important information to help you decide if you want to be in the study. If
you have any questions that are not answered in this consent form, ask one of the study staff.

Please answer YES or NO to the following questions:

A. Is this document in a language you understand?

B. Do you understand the information in this consent form?

C. Have you been given enough time to ask questions and talk about the study?

D. Have all of your questions been answered to your satisfaction?

E. Do you think you received enough information about the study?

F. Do you agree that you were NOT pressured by the study doctor or study staff
to be in this study? If you feel that you have been pressured to be in this
study, do not answer “YES” to this question.

G. Do you know that you can leave the study at any time without giving
a reason and without affecting your health care?

H. Do you know that your health records from this study may be reviewed
by the sponsor company and by government authorities?

I. Do you know that you cannot be in another study while you are in this study?

IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS,
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS,
YOU SHOULD NOT SIGN THIS CONSENT FORM.

Printed Name of Adult Study Subject

Signature of Adult Study Subject Date
Do Not Sign After **********

Printed Name of Person Explaining Consent Form

Signature of Person Explaining Consent Form Date

Printed Name of Guardian or Legally Authorized Representative

Signature of Guardian or Legally Authorized Representative Date
Do Not Sign After **********

Description/Relationship of Guardian or Legally Authorized Representative

You will be given a signed and dated copy of this consent form to keep.

If HIPAA Authorization wording is integrated in this informed consent document, IntegReview will
review the content for confidentiality language and readability only. Because IRBs are not required to
ensure compliance with the Privacy Rule, IntegReview is not responsible for ensuring that the
appropriate HIPAA requirements are included.

THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE
VERSION CONTROL
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