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. . . Print Subject Name . . . . 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. . . Print Name of Person Obtaining Consent . . . . 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.