NATHAN S

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					                                                                           Participant’s Initials: ______
                                                                                          ID#: ________

    NATHAN S. KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH (NKI)

                   INFORMED CONSENT TO PARTICIPATE IN RESEARCH
                    INVOLVING MAGNETIC RESONANCE IMAGING (MRI)
                           USING THE 3.0 TESLA MRI SYSTEM

You are being asked to volunteer to be a subject in a research study. This form is designed to provide
information about this study which you should know and understand, as well as to answer any questions.

Participant Name: ________________________________________                   Participant ID: ____________

Project Director: Craig A. Branch, Ph.D.                                     Phone: 845-398-5471


TITLE OF RESEARCH STUDY: Applications Development: 3.0 Tesla MRI System

Your participation will involve this many visits:     1

Each of these visits will take the following amount of time: less than 90 minutes

The total duration of your participation will be this amount of time: less than 90 minutes

THE PURPOSE OF THIS RESEARCH IS: to develop and test new MRI methods.

THE FOLLOWING PROCEDURES WILL BE INVOLVED:

MRI scanning makes pictures of your brain. During the scanning session, you will lie down quietly on a
platform, and the platform will slide into the scanner. Once you are inside the scanner, it will start to take
the pictures. For some experiments, pictures of the brain are not actually taken, but other infor mation about
the brain’s structure and/or function are measured by the scanner.

While the scanner is working, you may hear noises, like knocking or beeping sounds. We will give you ear -
plugs or earphones to reduce the noise to a more comfortable level. While you are in the scanner, you can
talk to the person who is running the scanner, and if you ask, they can stop the scan.

THE POTENTIAL RISKS OR DISCOMFORTS TO YOU ARE:

This MRI scanner is an investigational device. However, this scanner operates wit hin safe limits for MRI
scanning that have been determined by the FDA for all MRI scanners. The safety of this scanner has been
reviewed and its use in this study has been judged not to be associated with significant risk. There are no
known long term risks associated with this kind of MRI scanning.

The magnet of an MRI scanner, including this one, can cause electronic devices like pacemakers, beepers,
and watches to malfunction, and some metal objects can be pulled into the magnet. If you have an
electronic device (like a pacemaker) on your body, or implanted in your body, there is a risk that it may stop
working. Certain medical devices or objects that you have on or in your body may make it unsafe for you to
be scanned. We will ask you a series of questions before the scan to make sure you do not have any
unsafe device or object on or in your body, and we will ask you to take off metallic objects you may be
wearing (such as a watch or jewelry). If we determine that you have an unsafe device or object o n or in
your body that cannot be removed, you cannot have the scan.

The long-term effects of being placed in a magnet of this strength are unknown, but you should be aware
that there have been no reports of any ill long-term effects caused by magnets of the same and even higher
strength here or elsewhere. Also, although there are no known risks associated with MRI during pregnancy
and MRI is commonly performed in pregnant women, we will not scan someone who is pregnant; so you

                NKI/RPC CONSENT TO PARTICIPATE IN RESEARCH
Applications Development, 3T   page 1 of 3   Investigator: Craig Branch, Ph.D.
                                                                                   Participant’s Initials: ______
                                                                                                  ID#: ________

should understand that if you are a woman in her child-bearing years, your consent to participate indicates
that you believe you are not pregnant. This study is designed only for adults, so if you are not at least 18
years old, you cannot participate.

Some people have reported sensations during the MRI scan, such as “tingling” or “twitching”, which are
caused by changes in the magnetic field that can stimulate nerves in your body. If you experience
sensations and feel that these are uncomfortable, you can tell the operator and sto p the scan. Rarely
some people have experienced painful sensations, and if you do we will stop the scan immediately.
Despite these experiences, no one has ever had sensations from the scan that did not stop as soon as the
scanning stopped. After you finish the session and leave the scanner, the operator will ask you questions
about whether you had any sensations or other experiences.

In some experiments, you may be asked to perform tasks while you are in the scanner. These tasks
involve different activities, such as examining pictures, making decisions, and/or pressing buttons or
moving one of your limbs. Sometimes these tasks can be tiring or frustrating.

THERAPEUTIC OBJECTIVES: This research study will give you no direct benefits. While sometimes MRI
scans are done for clinical purposes, the scans you will receive are being done for research purposes.
Since these scans are not designed for clinical reading, your scans will not receive a clinical interpretation.
It is hoped, however, that the knowledge gained will be of benefit to others in the future.

THE POTENTIAL BENEFITS TO YOU OR TO OTHERS ARE: By participating in this research, new
methods for gaining information about the brain can be obtained. These methods may be used in research
studies of mental illnesses to enhance our understanding of the causes and treatments for these disorders.

IF YOU DO NOT PARTICIPATE IN THIS RESEARCH, YOU MAY RECEIVE THE FOLLOWING
ALTERNATIVE TREATMENT(S): Since this is not a treatment research study, there are no alternative
treatments.

CONFIDENTIALITY: Should you consent to participate in this research, your identity will be kept confidential within
the following limits. If investigational drugs and/or devices subject to U.S. Food and Drug Administration (FDA)
regulations are involved, it may be necessary for this consent form and other medical records to be reviewed by
representatives of the FDA and the agency providing the test substance and/or the Sponsor of the study. In
addition, if your participation in this research is for treatment or diagnostic purposes, a copy of this informed consent
will be included in your medical record maintained by your treating physician or hospital, as applicable, and will be
subject to New York State and federal regulations concerning confidentiality of medical records. A copy of this
informed consent may also be sent to the Director of Quality Assurance at Rockland Psychiatric Center for
monitoring purposes. Under state law, certain legal advocacy organizations (groups that support patients’ rights)
have authority to obtain confidential patient records. We could be required to give copies of your study records to
one of these organizations if they request these. However, they would not be allowed to reveal your identifying
information to anyone else without your permission. All research information obtained from you will not be identified
with your name; we will use only a coded number and/or your initials. All data will be kept in locked cabinets, and
any publications resulting from this study will not identify you.

TERMINATION OF YOUR PARTICIPATION: Your decision to take part in this study is voluntary. You have
the right to decide not to participate. Should you agree to participate in this research, you may change your
mind at any time and withdraw from the study. If you choose not to participate, there will be no penalty or
loss of benefit to which you would otherwise be entitled. A decision not to participate will not harm your
relationship with the doctors and/or staff. The Project Director may withdraw you from the study without
your consent at any time if: he believes it is in your best interest; you significantly fail to follow study
directions and procedures; there are unexpected or serious side effects.

MEDICAL COMPENSATION FOR RESEARCH-RELATED INJURIES: Federal and New York State
regulations require that we inform you about our institution’s policy with regard to compensation and
payment for treatment of research-related injuries. All forms of medical diagnosis and treatment, whether
routine or experimental, involve some risk of injury. In the event that you experience an injury at Nathan


                NKI/RPC CONSENT TO PARTICIPATE IN RESEARCH
Applications Development, 3T  page 2 of 3  Investigator: Craig Branch, Ph.D.
                                                                             Participant’s Initials: ______
                                                                                            ID#: ________

Kline Institute as a direct result of participating in this research the facility will provide emergency medical
care within its capabilities, arrange such other emergency medical care as may be necessary and assist
you in arranging follow up care. Neither the facility nor the Research Foundation for Mental Hygiene makes
any commitment to pay for medical care, nor do they have programs to provide you with financial
compensation for such injury. By agreeing to participate in this research and signing this consent form, you
do not waive any legal rights nor do you release the research staff, the Nathan Kline Institute, The
Research Foundation for Mental Hygiene, Inc. from liability for negligence.

PAYMENT FOR YOUR PARTICIPATION: You may be paid up to $20 per hour for your participation, and
we may pay minimal expenses associated with travel to our center.

GENERAL CONDITIONS AND OTHER INFORMATION:
     1. You will be told of any new findings that may influence your willingness to continue to participate
        in this research. Your participation is this study may be terminated by the Project Director if in
        his/her judgment it is inadvisable for you to continue.
      If you would like to discuss your rights as a research subject and/or your participation in
        this study with an institutional representative who is not part of this study, you may contact
        Erna Ostrom, NKI/RPC IRB Coordinator at (845) 398-5493 or Carole Roth, JD, IRB Director
        at (845) 398-5492.
      If you have any questions about this research during the study, or if you experience a
        research-related injury at any time during this study, you may call Dr. Branch at 845-398-5471.
     2. A copy of this consent form will be given to you, and a copy will be kept at in a locked file in the
        office of the researchers.

I voluntarily consent to participate in the research study described above.


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Print Subject Name


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Subject Signature                                                             Date


I believe that this consent is freely given, by a subject with sufficient capacity to consent, who has been
given all information deemed necessary by the Institutional Review Board or requested by the subject.


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Print Name of Person Obtaining Consent


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Signature of Person Obtaining Consent                                             Date




                NKI/RPC CONSENT TO PARTICIPATE IN RESEARCH
Applications Development, 3T  page 3 of 3  Investigator: Craig Branch, Ph.D.

				
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