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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:
PROTOCOL NUMBER AND TITLE OF STUDY:
NAME OF PERSON IN CHARGE OF THE RESEARCH
STUDY (INVESTIGATOR/STUDY DOCTOR):
TELEPHONE NUMBER(S), DAYTIME:
AFTER HOURS:
INTRODUCTION
You (“you” refers to you or your child throughout this consent form) – include parenthetical statement if
study involves adults and minors 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 research study to find
a dose of XXXX that would be safe in humans. Future studies (called phase II studies) can then test
whether or not this drug is useful against cancer.
In this document, you may see the terms “medication”, “treatment”, and “treatment period”; these are
terms used in research studies as mentioned above, this does not mean that you will be receiving medical
treatment for any condition. These terms apply to the investigational study drug and parts of the study
where you will be receiving this investigational product.
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.
OR
FOR INVESTIGATOR-SPONSOR STUDIES ONLY:
The investigator is the sponsor, and is paying for this 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:
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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)?
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?
Include this statement when placebo is part of the study design. All subjects will receive placebo
sometime during the study. Placebo contains no active ingredient.
Include this statement if appropriate to the study design. This is a double-blind study, which means that
neither you nor the investigator will know which drug you are taking. The study staff can get this
information if needed.
Include this statement if appropriate to the study design. The drug you receive will be assigned by
chance, like the flip of a coin.
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:
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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.
WHEN ARE YOU ELIGIBLE TO PARTICIPATE IN ANOTHER DRUG STUDY? (Use as
appropriate)
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The decision for when you can participate in another study is determined by the drug safety information
gathered from the previous study. Typically, you can participate in another study as soon as 30 days after
the last dose of drug received in the study you are enrolled in. This information is true for most drugs;
however, some drugs may be present in your body longer and that may mean you may have to wait longer
before entering into another study. These results are usually only known after the last blood sample
taken from you is analyzed to look for left over drug levels. We will always make this information
available to you as soon as we know. Our goal is to keep you from doing anything that may be
potentially harmful to you. Your safety while participating in these studies is our primary concern.
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].
Subject Responsibilities:
While participating in this research study, you will need to:
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Be willing and able to follow the study directions and procedures
Tell the study staff about any side effects or problems
Ask questions as you think of them
Tell the study doctor or the study staff if you change your mind about staying in the study.
[State other applicable subject responsibilities]
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 safely, 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
in 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.
Screening:
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.
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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:
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You will be asked to sign this consent form document
Your medical history and demographic data (includes your sex, age, race/ethnicity, etc.) 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:
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.
*If the study design requires a washout period, describe, in lay terms, the meaning of washout.
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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 study 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 study 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:
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You will be asked about any medications you are currently taking
Etc.
Etc.
Etc.
Etc.
Include this statement in studies requiring self-dosing:
Do not give the study drug to other people and keep it out of the reach of children.
Required wording when endoscopy procedures will be performed:
A 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 sedation (which will make you relaxed,
or sleep).
Blood Samples:
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If multiple blood draws are required, identify the number of blood draws and the total amount of blood
(e.g., approximately 1 cup).
If multiple samples are drawn on the same day, they may be drawn by either one of two ways. Which
method is used will depend 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.
OR
(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 multiple blood draws during the study as follows:
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Screening – about XX blood draws for a total of about XX mL
Cycle 1 – about XX blood draws for a total of about XX mL
Cycle 2 – about XX blood draws for a total of about XX mL
All subsequent cycles – about XX blood draws for a total of about XX mL
End of study visit – about XX blood draws for a total of about XX mL
For comparison, the standard blood donation is about 480 mL (two cups).
Required wording if blood volume is greater than 450 mL in 30 days. This should follow the
paragraph which describes the total amount of blood to be drawn:
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.
HIV AND HEPATITIS TESTING
Provide language as per your State Department of Health and/or state law or include the
following:
If addressed in the protocol, begin paragraph with, “As required by the study and…”
If any person is exposed to your blood, you must have your blood tested for the hepatitis viruses and for
HIV. HIV is the virus that causes AIDS. If you have a positive HIV or hepatitis test you cannot be in the
study.
If the HIV test is positive, a follow-up test will be done. If the follow-up test is also positive, you will be
told in private and you will also be told about counseling.
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It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not
always right.
Positive test results may be required to be reported to the State Department of Health. If you have any
questions about what information is required to be reported please ask the investigator or study staff.
Although this testing is supposed to be private, this cannot be guaranteed. For example, it is possible for
a court of law to get health or study records without your permission.
POSSIBLE SIDE EFFECTS AND RISKS
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, you may harm yourself by staying in the study.
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 drug/formulation/device/procedure is investigational, all of its/the/their side effects may not
be known. There may be rare and unknown side effects. Some of these may be life threatening.
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 (the most
common, less common, and rare).
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Loss of appetite (instead of anorexia)
Hair loss (instead of alopecia)
Etc.
Etc.
Etc.
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 drugs are involved:
Until you know how the drug(s) will affect you, you should use caution by 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 study
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.
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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:
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
Required wording for confinement of 2 weeks or more:
The long time you have to spend at the study site may make you uncomfortable.
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 (taken by single needle-sticks or by a tube that is left in your arm):
There may be side effects of having blood drawn such as:
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Fainting
Redness
Pain
Bruising
Bleeding
Infection
Nerve damage
Blood clots, which may cause inflammation, swelling and pain
If you feel faint tell the study staff right away.
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BELOW IS INTEGREVIEW’S APPROVED LANGUAGE FOR OTHER STUDIES. USE
WHENEVER POSSIBLE UNLESS SPONSOR INSISTS ON OWN LANGUAGE.
Risks of Using an Intravenous (IV) Catheter:
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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. The sticky pads used may be cold
when applied and sometimes cause some discomfort such as redness or itching. If the hair under the
patches needs to be shaved, irritation from shaving also could occur.
Endoscopy:
Some of the possible risks of this procedure are:
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Pain, vomiting, and fluid in the lungs (aspiration)
Infection
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
You may be given medications before the procedure for sedation. You should not drive or operate
machinery after this procedure until the next day.
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. 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 risk of damage from being exposed to any radiation.
18
FDG-PET/CT Scan:
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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 radioactive marker (tracer) 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. The injection of the radioactive tracer may cause
some discomfort. Allergic reactions to the tracer are rare, but may occur. 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 risk of damage from being exposed to any radiation.
Bone scans:
A bone scan uses x-rays where a small amount of radioactive chemical (tracer) 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
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. The injection of the radiotracer may cause some
discomfort. Allergic reactions to the radiotracer are rare.
X-rays:
The x-ray will provide information about the status of your lungs, heart and chest wall. There is always a
chance of excessive exposure of radiation with x-rays; however, the effective radiation dose from this
procedure is about the same as the average person receives from background radiation in 10 days.
Echocardiogram:
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
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.
There may be side effects of having a bone marrow aspiration and biopsy such as:
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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 may include:
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Infection of the bone
Extensive bleeding at the biopsy site
Tumor Biopsy:
There are several procedures your study doctor may use to get the tumor biopsy. Your study doctor will
discuss with you the risks of anesthesia and the procedure involved with getting a biopsy of your specific
type of cancer.
The risks of having a biopsy done may include:
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Pain and discomfort. The amount of pain and discomfort will vary, depending on the location of the
biopsy site. These risks can be discussed with the study doctor.
Bleeding
Tenderness
Scarring
Infection
Increased risk of cancer spreading
Uncommonly, complications from biopsies can be life threatening. Potentially serious complications
from bleeding or organ damage may occur. These might require additional surgical intervention.
Required wording for radiation therapy studies:
Risks and side effects related to radiation therapy include those that are:
Likely:
 Skin color change
 Skin redness
 Skin soreness
 Hair loss
 Possible short-term hearing loss
 Tiredness
 Sleepiness
 Skin dryness
Less likely:
 Nausea
 Vomiting
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Dry mouth
Altered taste
Rare, but serious:
 Development of other tumors
 Tissue damage
Risks of Using an Intramuscular (IM) Injection:
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Infection
Pain
Redness
Bruising
Irritation from the fluids or medication being given
Local swelling
Accidental intravenous (IV) injections
Fainting
Risks associated with the use of a urinary catheter are:
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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.
Risk associated with the use of opioids and opiates list other drugs in the study that may cause a positive
drug test:
For a short time following the study you may test positive for drugs of abuse.
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). You must also not
donate sperm during the study and for at least (insert number of weeks/months) after completion of the
study.- refer to protocol for specific requirements)
(Refer to protocol for specific requirements)
Acceptable methods of birth control for this study include:
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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. 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.
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.
You cannot be in the study if you are pregnant or breastfeeding. It is not known whether the drug(s) can
be given to breast fed babies. Therefore if you are pregnant or breastfeeding a child, you should not take
part in the study.
POSSIBLE BENEFITS OF THE STUDY
The primary purpose of this study is to learn more about anti-cancer agents that may benefit others in the
future. The purpose of this study is not to treat your cancer and it is not known what effect it will have
on your condition. It might stay the same or it may get worse. The drugs you receive may even be
harmful.
OTHER OPTIONS TO BEING IN THE STUDY
Yes, there are other options. Other options may include:
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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).
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Your records of being in this study will be kept private except when ordered by law.
people will have access to your study records:
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The following
Study doctor
Sponsor company or research institution [including monitor(s) and auditor(s)]
The United States Food and Drug Administration (FDA) – remove/revise when applicable
Other country (include if outside of the US), state or federal regulatory agencies
IntegReview Ethical Review Board (IRB/REB)
[Any study that is considered an “applicable clinical trial” (e.g., Trials of Drugs and Biologics:
Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA
regulation; Trials of Devices: Controlled trials with health outcomes of a product subject to FDA
regulation (other than small feasibility studies) and pediatric postmarket surveillance studies) by
the FDA and required to be registered in the Clinicaltrials.gov database must also include the
following paragraph in the informed consent:]
A description of this clinical study will be available on www.ClinicalTrials.gov, as required by U.S. Law.
This Web site will not include information that can identify you. At most, the Web site will include a
summary of the results. You can search this Web site at any time.
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your
records, which may have your name on them. Therefore, total confidentiality cannot be guaranteed. If
the study results are presented at meetings or printed in publications, your name will not be used.
Future Research of Biomarker Samples:
Loss of confidentiality is the primary risk of testing, collecting and storing tissue/blood samples. It may
be possible for DNA to be extracted (through various testing methods) from the donated tissues/blood,
which would allow knowledge about you, that you may not want known, be gained. Your test results are
confidential. The sponsor will make every effort to protect any information about you generated from
their testing and analysis of your samples except those people or companies you read about in this form.
We believe that the benefits of learning more about human genetic variation and how it relates to health
and disease outweigh the current and potential future risks, but this is something that you must judge for
yourself.
There are also current limited protections afforded to you by a U.S. Federal law, the Genetic Information
Non-discrimination Act (GINA), which generally makes it illegal for health insurance companies, group
health plans, and most employers to discriminate against you based on your genetic information. All
health insurance companies and group health plans provided by employers with 15 or more employees
must follow this law.
Be aware that this Federal law does not protect you against genetic discrimination by companies that sell
life insurance, disability insurance, or long term-care insurance, nor does it prohibit discrimination on the
basis of a genetic disease or disorder that you already know about.
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IN CASE OF STUDY RELATED INJURY
Complete this section by providing the following information. If you have a contract/agreement with the
sponsor that addresses provisions to pay for research-related injury, this wording must agree with the
wording in the contract/agreement.
If compensation for injury is available, give an explanation as to what it consists of, or where further
information might be obtained. If no compensation is offered aside from medical treatment, you may
include a statement such as, “No other form of compensation is offered.”
Give an explanation as to whether any medical treatment is available if injury occurs and, if so, what it
consists of, or where further information might be obtained.
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. You do not waive any legal rights by
signing this form. No other form of compensation is offered.
OR
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. 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:
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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 require immediate (life
threatening) medical attention, please go to the nearest emergency room.
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 you may contact IntegReview.
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a
convened IRB meeting to:
Mailing Address:
OR
Chairperson
IntegReview IRB
3815 S. Capital of Texas Highway
Suite 320
Austin, Texas 78704
Email Address:
[email protected]
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation
regarding subject safety, contact our office at:
512-326-3001 or
toll free at 1-877-562-1589
between 8 a.m. and 5 p.m. Central Time
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 your 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
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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. 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.
COSTS FOR BEING IN THE STUDY
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. 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 or any significant new findings that could relate to your willingness to
continue participation 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):
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.]:
SUBJECT’S BILL OF RIGHTS
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.
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THE REASON FOR INSTITUTIONAL 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 Institutional Review Board (IRB).
What is an Institutional Review Board (IRB)?
An Institutional 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 United States, Latin
America and Japan.
To meet requirements of the law, the IntegReview Board currently includes:
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Doctors
Pharmacists
Nurses
Toxicologists (people who study the harmful effects of chemicals)
Other specialists
Others who do not have a background in science/medicine
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AGREEMENT TO BE IN THE STUDY
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 volunteer to be in this study of your own free will and without being
pressured by the investigator or study staff?
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
Printed Name of Person Explaining Consent Form
Signature of Person Explaining Consent Form
Date
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The signature lines below are required when adult subjects are not able to legally give consent.
Printed Name of Guardian or Legally Authorized Representative
Signature of Guardian or Legally Authorized Representative
Date
Description/Relationship of Guardian or Legally Authorized Representative
You (and/or your legally acceptable representative) will be given a signed and dated copy of this consent
form to keep.
CONSENT FOR SUBJECTS WHO CANNOT READ
The study subject has indicated that he/she is unable to read. The consent document has been read to the
subject by a member of the study staff, discussed with the subject by a member of the study staff, and the
subject has been given an opportunity to ask questions of the study staff.
______________________________
Printed Name of Impartial Witness
Signature of Impartial Witness*
Date
*Impartial Witness: A person, who is independent of the study, who cannot be unfairly influenced by
people involved with the study, who attends the informed consent process if the subject cannot read, and
who reads the informed consent and any other written information provided to the subject.
The signature lines below are required for subjects that are visually impaired.
The study subject has indicated that he/she is visually impaired. The consent document has been read to
the subject by a member of the study staff, discussed with the subject by a member of the study staff, and
the subject has been given an opportunity to ask questions of the study staff.
__________________________________________________________
Printed Name of Impartial Witness
____________________________________________________________________________________
Signature of Impartial Witness*
Date
*The impartial witness attests that the information in the consent form and any other written information
was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable
representative, and that informed consent was freely given by the subject or the subject’s legally
acceptable representative.
You (and/or your legally acceptable representative) will receive a signed and dated copy of this consent
form to keep.
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HIPAA AUTHORIZATION
If HIPAA Authorization wording is integrated in this informed consent document, please insure the
following are included:
 A specific and meaningful description of the PHI to be used or disclosed
 The identification of the persons or class of persons authorized to make the use or disclosure of PHI
(who do you want to get information from including your own hospital, practice group, etc.?)
 The identification of the persons or class of persons to whom the covered entity is authorized to
make the disclosure (what internal or external persons or entities will be getting the information?)
 Description of each purpose for which the specific PHI identified earlier is to be used or disclosed
 An expiration date or, an authorization for a research purpose, may state that the authorization does
not expire; that there is no expiration date or event; or that the authorization continues until the “end
of the research study”.
 The individual’s signature and date, and if signed by a personal representative, a description of his or
her authority to act for the individual
 A statement that the individual may revoke the authorization in writing, and instructions on how to
exercise such right (who does the individual need to write, name and address?)
 A statement about the potential for the PHI to be re-disclosed by the recipient and no longer
protected by the Privacy Rule
Signature of Study Subject or Legally Authorized Representative
Date
Description/Relationship of Legally Authorized Representative
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