BOILERPLATE LANGUAGE FOR MEDICAL CONSENT FORMS
Consent forms must be written in laymen terms and at least sixth grade language.
RISKS AND DISCOMFORTS
No Risks
There are no additional risks to you from participating in this study.
Pregnancy
 This clinical research may involve unknown risks to unborn children; therefore, you must
practice medically accepted methods of birth control while you are on this study and sexually
active. Acceptable methods of birth control include; birth control pills, depo-progesterone
injections, a vaginal hormonal contraceptive ring, a barrier contraceptive such as a condom
with spermicide cream or gel, diaphragms or cervical cap with spermicide cream or gel, or an
intrauterine device (IUD).

We do not know the effect of the study drug on babies before they are born, or on nursing
children. Many drugs can get into the mother's milk. You should not breast feed your child
while taking the study drug.

Pregnancy tests will be done on all women who might be able to get pregnant at the start of
the study. Be sure to indicate who will pay for the pregnancy tests.

Men should not father children while in the study and should use a suitable contraceptive,
either a condom with spermicidal cream or gel OR female contraceptive agreeable to partner.

If you or your partner becomes pregnant during the study you should notify the researcher
right away.

If you are a woman and you are planning to get pregnant, you should not be in the study.
Birth Control and Pregnancy (Minors)
The risks of the research drug to the human embryo, fetus or nursing infant are unknown. Your
child cannot take part in this study if she is pregnant or nursing an infant. If she is a female who
is able to have children, she must agree not to become pregnant during her participation in this
study. She must use birth control throughout the study. Acceptable methods of birth control
include: hormonal contraceptives, intrauterine device, spermicide and barrier. If sexually
abstinent and capable of pregnancy, she must agree to continue abstinence or to use an
acceptable method of birth control (as listed above) should sexual activity commence. If your
child becomes pregnant during the study, you or your child must tell the study doctor
immediately and your child will be removed from the study. The study doctor will advise you
regarding your child’s medical care.
Anaphylaxis Reaction
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As with any drug, it is possible that you could experience an allergic reaction to________. Such
allergic reactions include: itching, skin rash, an acute or sudden drop in blood pressure to shock
levels with loss of consciousness and/or associated with seizures, including the possibility of
death.
Blood Drawing
The risks of blood drawing include: fainting, the occurrence of temporary discomfort and/or
bruise at the site of puncture; rarely, infection or the formation of a small clot or swelling to the
vein and surrounding area may occur.
Venous Catheter
There may be slight discomfort in your arm or hand during the inserting of the catheters into the
vein. Occasionally, a small accumulation of blood (hematoma) may form at the point of insertion
of the catheter. This may result in a small lump that will disappear. Occasionally, a small amount
of bleeding may occur around the catheter site. On rare occasions, a local infection may occur
around the catheter site.
Arterial Catheter
There may be slight discomfort in your arm or hand during the inserting of the catheters into the
vein or artery. Occasionally, a small accumulation of blood (hematoma) may form at the point of
insertion of the catheter, particularly over the radial or brachial artery. This may result in a small
lump that will disappear. Occasionally, a small amount of bleeding may occur around the
catheter site. On rare occasions, a local infection may occur around the catheter site. Other
complications of the arterial catheter occur very rarely and are usually seen only when the
catheter remains in the artery for extended periods of time. These complications may include
obstruction of the artery with critical reduction in the circulation of the hand, requiring
immediate surgery to re-open the artery.”
Bone Marrow Aspirate
The risks of a bone marrow aspirate include the following: temporary discomfort and or bruise at
the site of puncture, fainting, and rarely infection or a small clot or swelling in the area of the
puncture.
Drugs causing drowsiness
Because the study medication may produce drowsiness in some patients, you should not operate
heavy machinery, including driving a car.
Potential to harm or hurt yourself or others
All information will remain confidential to the extent permitted by law, except that if any
information collected indicates the immediate potential for harm to you, your child, or others, the
investigators and or their staff or associates may be required to disclose such information.
Hypoglycemia
This medication could lower your blood sugar too much (hypoglycemia). This could make you
feel tired, dizzy, sweaty, and/or nauseated. Also, it could cause your heart to feel as if it is racing.
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There may also be other effects. Untreated hypoglycemia could cause convulsions, loss of
consciousness and can lead to death.
PET scan
If you take part in this research, you will have one or more medical imaging studies which use
radiation. The tests or treatments you will have include a PET FDG scan. To give you an idea
about how much radiation you will get, we will make a comparison with an every-day situation.
Everyone receives a small amount of unavoidable radiation each year. Some of this radiation
comes from space and some from naturally-occurring radioactive forms of water and minerals.
This research gives your body the equivalent of about 6 extra years' worth of this natural
radiation. The radiation dose we have discussed is what you will receive from this study only and
does not include any exposure you may have received or will receive from other tests.
MUGA scan
If you take part in this research, you will have one or more medical imaging studies which use
radiation. The tests or treatments you will have include a MUGA scan. To give you an idea about
how much radiation you will get, we will make a comparison with an every-day situation.
Everyone receives a small amount of unavoidable radiation each year. Some of this radiation
comes from space and some from naturally-occurring radioactive forms of water and minerals.
This research gives your body the equivalent of about 2 extra years' worth of this natural
radiation. The radiation dose we have discussed is what you will receive from this study only and
does not include any exposure you may have received or will receive from other tests.
CT scan
If you take part in this research, you will have one or more medical imaging studies which use
radiation. The tests or treatments you will have include a whole body CT scan. To give you an
idea about how much radiation you will get, we will make a comparison with an every-day
situation. Everyone receives a small amount of unavoidable radiation each year. Some of this
radiation comes from space and some from naturally-occurring radioactive forms of water and
minerals. This research gives your body the equivalent of about 3 extra years' worth of this
natural radiation. The radiation dose we have discussed is what you will receive from this study
only and does not include any exposure you may have received or will receive from other tests.
Psychological stress in completing a questionnaire
You will be asked to complete questionnaires that ask questions about your feelings and
behaviors. Some of the questions may discuss issues that might make you feel uncomfortable or
cause you stress.
UM students needing counseling
If you become distressed during the course of the study, the University of Miami Counseling
Center offers counseling to students.
VOLUNTARY PARTICIPATION / WITHDRAWAL FROM STUDY
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Student Rights
If you are a student, your desire not to participate, or your request to withdraw from the study,
will not affect your grades or other academic standings within the University.
Employee Rights
If you are an employee of the University, your decision to participate in or to withdraw from the
study will not affect your employment within the University.
LEGAL RIGHTS
Replacement language for Sponsor’s statement: “By participating in this study/signing
this consent form you do not give up any of your legal rights”.
By participating in this study, you do not give up any rights to which you would otherwise be
entitled.
This replacement language is only used if a sponsor’s consent form already includes similar
language. Otherwise, this section is not included in the consent form.
BENEFITS
Choose or modify ONE of the following groups of sentences as appropriate to the specific
study:
Research is designed to benefit society by gaining new knowledge. You (your child) will not
benefit personally from being in this research study.
Research is designed to benefit society by gaining new knowledge. There is little chance you
(your child) will benefit from being in this research study.
Research is designed to benefit society by gaining new knowledge. The benefits to you (your
child) from being in this study may be
Hematology Oncology/Radiation Oncology/ Pediatric Oncology Protocols
It is hoped that this treatment will cause you to achieve an increase in the disease-free time frame
compared to the standard therapy alone.
COST
For Category B devices, include the following:
You or your insurance company will be billed only what the University will pay to obtain the
device from the manufacturer.
COMPENSATION FOR INJURY
Non-Sponsored studies that involve greater than minimal risks:
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You may be exposed to risk of injury from participation in this study. If injury occurs, treatment
will in most cases be available. If you have insurance, your insurance company may or may not
pay for these costs. If you do not have insurance, or if your insurance company refuses to pay,
you will be expected to pay. Funds to compensate for pain, expenses, lost wages and other
damages caused by injury are not routinely available.
Sponsored studies that involve greater than minimal risks:
You may be exposed to risk of injury from participation in this study. If injury occurs, treatment
will in most cases be available. If you experience an injury as a result of the study drug or
procedures, the Sponsor will cover the cost of treatment of these injuries. Funds to compensate
for pain, expenses, lost wages and other damages caused by injury are not routinely available.
Studies that involve minimal to no risks:
Although risks are unlikely, if injury should occur, treatment will in most cases be available. If
you have insurance, your insurance company may or may not pay for these costs. If you do not
have insurance, or if your insurance company refuses to pay, you will be expected to pay. Funds
to compensate for pain, expenses, lost wages and other damages caused by injury are not
routinely available.
Standard language for studies that involve risk: All medications can have side effects or other
reactions. While you are taking part in this clinical study, your doctor will check your health very
carefully.
Hematology Oncology/Radiation Oncology/ Pediatric Oncology Protocols
It is possible in the course of the study that new adverse effects of treatment may be
discovered that result in physical injury. If you experience an injury due to your
participation in this study, medical treatment will be offered to you. If you have
insurance, your insurance company may or may not pay for these costs. If you do not
have insurance, or if your insurance company refuses to pay, you will be expected to pay.
No financial compensation is available for your participation in this study.
PAYMENT FOR PARTICIPATION
You will be paid $__ for your participation in this study. You must complete a W-9 form in
order to receive payment for participation. This information will not be linked to any of the study
data and will only be used for payment purposes.
CONFIDENTIALITY
Child Abuse
If information is revealed concerning child abuse, it is required by law that this be reported to the
appropriate authorities.
Other Abuse
The only exception is if information is revealed concerning harm to yourself or others, child
abuse, neglect, or other forms of abuse that is required by law to be reported to the appropriate
authorities.
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Include for clinical trials – Per FDA regulations, the exact wording is mandatory and
cannot be altered
A description of this clinical trial will be available on http://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.
COMMERCIAL ISSUES
Use of Specimens for Commercialization
Any blood, urine or tissue specimens obtained for the purposes of this study become the
exclusive property of the University of Miami. The University of Miami may retain, preserve or
dispose of these specimens and may use these specimens for research which may result in
commercial applications. You will not receive money for donating blood, urine or tissue samples
nor will you receive money from any future proceeds as a result of this research project.
Institutional/Investigator Conflict of Interest
The University of Miami has patented the technology of the [Name of drug/device/biologic] and
licensed the patent to [Name of Company], a biotechnology company. The University of Miami
has a financial interest in the commercialization of this [drug/device/biologic] and owns stock in
[Name of Company]. The inventor of the [drug/device/biologic] also owns stock in [[Name of
Company] and is a faculty member at the University of Miami. The [drug/device/biologic] will
be manufactured at the University of Miami, one of the study sites.
ADDITIONAL ISSUES
Studies having a federal Certificate of Confidentiality
Insert language provided by the federal agency that issued the certificate.
Studies that involve video or audio recording
 Describe what will be done with tapes.
 Include plans for storage during use and what will be done after transcription, e.g., how long
the tapes will be kept.
 Advise subjects that audio and video recordings may be requested to be turned off, if that is
true for the study.
Studies that involve group interviews or focus groups
 Advise subjects that they do not need to reveal their name, or that they may use a fictitious
name.
 Advise subjects that they must agree not to reveal anything they learn from group discussions
or other activities.
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