UNIVERSITY OF PENNSYLVANIA
P.I. Name & Department
Telephone Number(s)
Co-P.I. Name(s)
Day Telephone Number(s):
24-Hour Emergency Number: (215) 662-6059
(Ask for Dept. Resident on Call)
CONSENT FORM
(Title of Study)
(REMOVE ALL BLUE PRINT BEFORE SUBMITTING APPLICATION)
INVITATION TO PARTICIPATE:
EXAMPLE:
You are being asked to participate in this study as a normal volunteer without any significant
medical or
history.
-orYou are being asked to participate in this study because you are a patient diagnosed with
____________.
PURPOSE: The purpose of the study should be expressed in lay language and should clearly state
the nature of the research project.
EXAMPLE:
The purpose of this research project is to test new methods for studying the brain using Magnetic
Resonance Imaging (MRI). MRI already provides detailed images of brain anatomy, and newer
methods will expand this capability by also providing images of brain function that can be used
to better understand how the normal brain processes information. Previous methods for
measuring these functions often required the injection or inhalation of radioactive substances
and/or exposure to X-rays. In contrast, the MRI methods will not require any injections or
exposure to radioactivity. This project will specifically develop MRI methods used for detecting
changes in blood flow to different parts of the brain (perfusion) that are known to occur during
activities such as thinking, touching, and movement.
The image data obtained from your study will be used to test and validate perfusion MRI for use
in brain mapping research.
-orIf successful, these new methods will expand the information which can be obtained from MRI
studies of the brain, while reducing the risk and discomfort of obtaining images of brain
function.
PROCEDURES: The subject must be informed exactly what his/her participation will involve in
chronological order. This may include the length and frequency of hospitalization, types of
medication, number and time of visits, placebo administration, types and number of tests, total
amount of blood to be drawn (in terms a lay person can understand such as cups, tablespoons,
teaspoons), randomization, questionnaires, video-taping, diets, withholding of standard treatment,
follow-up studies, etc. If a test article is involved, the consent form should explain that:
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CONSENT FORM
(Title of Study)
1. It is routinely used for the proposed purposes of the study.
2. It is experimental and not approved for general use in the United States but has been approved
for the use in this study.
EXAMPLE:
The study will be conducted at the Center for Advanced Magnetic Resonance Imaging and
Spectroscopy in the Department of Radiology, University of Pennsylvania Medical Center. The
study will be very similar to a routine clinical MRI scan of the brain. The study will be very
similar to a routine clinical MRI scan of the brain. The study will be performed using a 1.5 or a
3.0 Tesla magnet, which are both standard clinical MRI scanners.
Although the measurement is painless, it will be noisy inside the magnet due to beeping and
hammering sounds made when the magnetic field gradients are pulsed. Disposable earplugs will be
provided to diminish the noise. You will be asked to lie down on a platform which can be slid into
the middle of the magnet, which is shaped like a large tube. An MRI imaging coil will be placed
around your head. This coil is simply a number of wires covered in plastic. You will not come into
contact with the coil during the experiment. Foam pads will be placed around your head to limit
head movement during the study. You will then be slid into the magnet. You will be asked to lie still
for approximately one hour, during which time several images will be acquired.
[SPECIFY YOUR TASK HERE. e.g.: At different points during the experiment, you may be asked to
perform tasks, which activate specific brain functions. For example, you may be asked to wiggle
your fingers, watch flashing lights, compare shapes, or listen to lists of words while MRI scans are
being taken. None of these activation procedures are painful, and you may proceed with them at
your own pace.]
During the study a physician will be available for any medical questions or problems. The
technicians involved in the study will advise you on the progress of the study. If at any time you
feel uncomfortable, no matter what the reason, the study will immediately be stopped.
RISKS: Describe in lay language any potential side effects due to the procedures being performed
and/or due to any drugs or devices being utilized in this study.
EXAMPLE:
The levels of energy used to make magnetic resonance measurements are far less than are used
in a single X-ray, and many patients have been safely studied using magnetic resonance
techniques. However, some people become uncomfortable or claustrophobic while inside the
magnet. If you become uncomfortable inside the magnet, you may withdraw immediately from
the study.
During some of the MRI scans, subjects have occasionally reported “tingling” or “twitching”
sensations in their arms or legs, especially when their hands are clasped together.
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CONSENT FORM
(Title of Study)
Further, because of the strong magnetic field, people with pacemakers, certain metallic implants,
or metal in the eye cannot participate in this study. You will be given a checklist before entering
the MRI room, which will be reviewed and used to verify that you do not have anything harmful
in or on your body.
REQUIRED:
The known risks associated with this study are minimal. The greatest risk is a metallic
object flying through the air toward the magnet and hitting you. To reduce this risk we
require that all people involved with the study remove all metal from their clothing and all
metal objects from their pockets. No metal objects are allowed to be brought into the
magnet room at any time. In addition, once you are in the magnet, the door to the room
will be closed so that no one inadvertently walks into the magnet room.
Something similar to this is REQUIRED, if using custom head coils and experimental imaging
sequences:
This study may include the use of custom manufactured head coils and experimental
imaging sequences that are not FDA-approved, but are considered non-significant risks.
COSTS AND FINANCIAL RISKS: You are encouraged to discuss the possible effects of these
costs with the study doctor. If no costs, the consent should state that there would be no charge to the
subject for this research study:
EXAMPLE:
There will be no charge to you for this research study.
BENEFITS: Direct or to society. If there is no direct benefit to the subject, a statement reflecting
this fact must be recorded:
EXAMPLE:
There may be no direct benefit for you from participation in this study.
PREGNACY ISSUES: Gadolinium is not approved in pregnant women and pregnant women
should be excluded from trials using Gadolinium contrast. The following statement (as
appropriate) must be included in the informed consent:
REQUIRED:
Although there are no known risks of MRI on pregnant women or the fetus, there is a
possibility of yet undiscovered pregnancy related risks. If you are a woman of child-bearing
potential, a pregnancy test will be made available to you in order to help you make an
informed decision about your participation.
ALTERNATIVES: Describe in lay language how the patient would be treated if not otherwise in
a research study and any potential adverse effects from the alternatives. If there are no alternatives
other than not to participate in this study, this fact should be documented.
EXAMPLE:
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(Title of Study)
The alternative to participation is to decide not to enroll in this study.
COMPENSATION: Describe any fees (dollar amount) to be paid to the subject for participation,
describe partial payment or no payment for early termination or bonus for completion. If no
payment will be given, use the following statement:
There will be no financial compensation for participation.
EXAMPLE:
You will receive a $25 honorarium for participating in this study.
CONFIDENTIALITY:
REQUIRED:
Every attempt will be made by the investigators to maintain all information collected in this
study strictly confidential, except as may be required by court order or by law. Authorized
representatives of the University of Pennsylvania Institutional Review Board (IRB), a
committee charged with protecting the rights and welfare of research subjects, may be
provided access to medical or research records that identify you by name. If any publication
or presentations results from this research, you will not be identified by name.
ADDITIONAL INFORMATION: A statement that any significant new findings developed during
the course of the study that may relate to the subject's willingness to continue their participation
will be provided to the subject. (The investigator must provide the subject and the IRB with a
written statement concerning any significant finding(s) that may potentially influence a subject's
decision to continue participating in the study. In this circumstance the investigator must
renegotiate informed consent.
REQUIRED:
Any significant new findings that develop during the course of the study, which may affect
your willingness to participate, will be provided to you.
DISCLAIMER/WITHDRAWAL: There are two standard statements of disclaimer/withdrawal,
one of which needs to be included this section.
For non-medical studies:
REQUIRED:
Your participation in this study is completely voluntary and that you may withdraw at any
time without prejudicing your standing within the University of Pennsylvania or your class.
INJURY/COMPLICATIONS:
For Non-Industry Studies:
EXAMPLE:
These studies will be performed under the supervision of ________________, M.D., at the
Magnetic Resonance Imaging Center in the University of Pennsylvania Medical Center. These
studies are part of a research protocol, and are not intended to provide a comprehensive clinical
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CONSENT FORM
(Title of Study)
MRI examination of the brain. In the unlikely event that a significant brain abnormality is
observed while processing your brain images for the research study, you will be contacted and
we will arrange for your structural images to be sent to your physician.
REQUIRED:
In the event of any physical injury resulting from the research procedures, medical treatment
will be provided without cost to you, but financial compensation is not otherwise available
from the University of Pennsylvania. You or your third party payer, if any, may be billed for
medical expenses associated with this study if they are deemed medically necessary and such
expenses would have been incurred independent of the study, or if your third party payer
agrees in advance to pay for such expenses.
SUBJECT RIGHTS: If you wish further information regarding your rights as a research subject,
you may contact the Director of Regulatory Affairs at the University of Pennsylvania by
telephoning (215) 898-2614.
If you have any questions pertaining to your participation in this research study, you may contact
the physician by calling the telephone number(s) listed at the top of page one.
You have been given the opportunity to ask questions and have had them answered to your
satisfaction.
CONCLUSION: You have read and understand the consent form. You agree to participate in this
research study. Upon signing below, you will receive a copy of the consent form.
Name of Subject
Signature of Subject
Date
Name of Person Obtaining
Consent
Signature of Person Obtaining Consent
Date
If the protocol allows the entry of subject’s unable to provide informed consent, the following
signature line should also be placed under the area for the subject’s name and signature:
Name of Legally Effective
Representative
Signature of Legally Effective
Representative
Date
If the subject is unable to read or sign their name, the following signature line should also be placed
under the area for the subject’s name and signature:
Name of Witness to Subject
Mark or Consent
Signature of Witness to Subject Mark or
Consent
Date
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