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12 HS# University of California Permission to Use Personal Health Information for Research Study Title (or IRB Approval Number if study title may breach subject s privacy): Echocardiogram Screening of Young Athletes for Cardiac Abnormalities in a Community Setting Lead Researcher Name: Dr. JOHN FOX Sponsor/Funding Agency (if funded): A. What is the purpose of this form? State and federal privacy laws protect the use and release of your health information. Under these laws, the University of California or your health care provider cannot release your health information to the research team unless you give your permission. The research team includes the researchers and people hired by the University or the sponsor to do the research. If you decide to give your permission and to participate in the study, you must sign this form as well as the Consent Form. This form describes the different ways that the researcher, research team and research sponsor may use your health information for the research study. The research team will use and protect your information as described in the attached Consent Form. However, once your health information is released it may not be protected by the privacy laws and might be shared with others. If you have questions, ask a member of the research team. B. What Personal Health Information will be released? If you give your permission and sign this form, you are allowing: to release the following medical records containing your Personal Health Information. Your Personal Health Information includes health information in your medical records and information that can identify you. For example, Personal Health Information may include your name, address, phone number or social security number. Entire Medical Record Laboratory Reports Emergency Medicine Center Reports Outpatient Clinic Records Dental Records Health Care Billing Statements Pathology Reports Operative Reports Diagnostic Imaging Reports EKG Radiology Reports History & Physical Exams Progress Notes Radiologic & MR Scans Consultations Discharge Summary Psychological Tests Other (describe): HIPAA Authorization

13 HS# C. Do I have to give my permission for certain specific uses? Yes. The following information will only be released if you give your specific permission by putting your initials on the line(s). I agree to the release of information pertaining to drug and alcohol abuse, diagnosis or treatment. I agree to the release of HIV/AIDS testing information. I agree to the release of genetic testing information. I agree to the release of information pertaining to mental health diagnosis or treatment as follows: D. How will my Personal Health Information be used? Your Personal Health Information may be released to these people for the following purposes: 1. To the research team for the research described in the attached Consent Form; 2. To others at UC who are required by law to review the research; 3. To others who are required by law to review the quality and safety of the research, including: U.S. government agencies, such as the Food and Drug Administration, the research sponsor or the sponsor s representatives, or government agencies in other countries. These organizations and their representatives may see your Personal Health Information. They may not copy or take it from your medical records unless permitted or required by law. E. How will my Personal Health Information be used in a research report? If you agree to be in this study, the research team may fill out a research report. (This is sometimes called a case report.) The research report will not include your name, address, or telephone or social security number. The research report may include your date of birth, initials, dates you received medical care, and a tracking code. The research report will also include information the research team collects for the study. The research team and the research sponsor may use the research report and share it with others in the following ways: 1. To perform more research; 2. Share it with researchers in the U.S. or other countries; 3. Place it into research databases; 4. Use it to improve the design of future studies; 5. Use it to publish articles or for presentations to other researchers; 6. Share it with business partners of the sponsor; or 7. File applications with U.S. or foreign government agencies to get approval for new drugs or health care products. F. Does my permission expire? This permission to release your Personal Health Information expires when the research ends and all required study monitoring is over. Research reports can be used forever HIPAA Authorization

14 HS# G. Can I cancel my permission? You can cancel your permission at any time. You can do this in two ways. You can write to the researcher or you can ask someone on the research team to give you a form to fill out to cancel your permission. If you cancel your permission, you may no longer be in the research study. You may want to ask someone on the research team if canceling will affect your medical treatment. If you cancel, information that was already collected and disclosed about you may continue to be used. Also, if the law requires it, the sponsor and government agencies may continue to look at your medical records to review the quality or safety of the study. H. Signatures Subject If you agree to the use and release of your Personal Health Information, please print your name and sign below. You will be given a signed copy of this form. Subject s Name (print)--required Subject s Signature Date Parent or Legally Authorized Representative (where IRB approved) If you agree to the use and release of the above named subject s Personal Health Information, please print your name and sign below. Parent or Legally Authorized Representative s Name (print) Parent or Legally Authorized Representative s Signature Relationship to the Subject Date Witness If this form is being read to the subject because s/he cannot read the form, a witness must be present and is required to print his/her name and sign here: Witness Name (print) Witness Signature Date HIPAA Authorization

15 University of California Irvine Demographics and Heart Health History Form Echocardiogram Screening of Young Athletes for Cardiac Abnormalities in a Community Setting Please complete the following questions regarding the individual being screened: CONTACT INFORMATION Student Name: Date of Birth: Street Address: City: State: Zip: Home Phone: Mobile Phone: Parent/Guardian Name: Address: DEMOGRAPHICS Age: Gender: Male Female Height: Weight: Race/ethnicity: (check all that apply) African-American/Black Caucasian/White Hispanic/Latino Asian/Pacific Islander Native American Other: Please Specify:

16 SPORTS & PHYSICAL ACTIVITY 1) Do you play on an organized sports team or compete in an individual sport? Yes No If yes, what level: Club/Select Recreational/Intramural High School College Professional If yes, what sport(s) do you play competitively or on an organized team? (check all that apply) Baseball Golf Skiing Basketball Gymnastics Squash Cheer Hockey Swimming/Diving Cross Country Lacrosse Tennis Cycling Martial Arts Track Football Rowing Volleyball Field Hockey Rugby Wrestling Fencing Soccer Other: Frisbee Softball 2) Exercise and physical activity per week. On average I get (check one) More than 10 hours of exercise or physical activity per week hours of exercise or physical activity per week. 2-5 hours of physical activity per week. Less than 2 hours of exercise or physical activity per week. PAST MEDICAL HISTORY Do you have any ongoing medical illnesses? Yes No What illness? Asthma ADHD Diabetes High Blood Pressure Pre-existing heart condition:

17 Other: Are you taking any medication? Yes No If yes, what medication? HEART HEALTH QUESTIONS Yes No 1. Have you ever passed out during exercise? 2. Have you ever had a seizure that is unexplained? 3. Has a family member suffered cardiac arrest or died from a heart problem before the age of 40? 4. Do you get chest pain/discomfort with exertion? 5. Have you had unexplained syncope (passing out) or near-syncope (nearly passing out)? 6. Do you get excessive/unexplained exertional shortness of breath or fatigue associated with exercise? 7. Have you been told you have a heart murmur? 8. Have you been told you have elevated blood pressure? 9. Has a family member had premature death (sudden and unexpected, or otherwise) before age 50 years due to heart disease? 10. Has a family member had disability from heart disease at <50 years of age? 11. Does a family member have any of these heart conditions: Hypertrophic or dilated cardiomyopathy, Long-QT syndrome or other ion channelopathies, Marfan syndrome, or clinically significant arrhythmias.

18 UNIVERSITY OF CALIFORNIA IRVINE MINOR ASSENT / PARENTAL PERMISSION / ADULT CONSENT TO ACT AS A HUMAN RESEARCH SUBJECT TO BE IN A STUDY Echocardiogram Screening of Young Athletes for Cardiac Abnormalities in a Community Setting RESEARCH TEAM Lead Researcher J. Christian Fox, MD, RDMS Department of Emergency Medicine jfox@uci.edu In the instance of parental permission, you means your child. What is the study about? The doctors and researchers are asking you to take part in a research study about whether having an ultrasound test before participating in sports at school will find any hidden problems with your heart. Why are they doing this study? They want to find out if there are any hidden problems with your heart that could begin to cause problems once you start playing sports. What will happen to me? You will be asked to fill out a form about you and your family s medical history. The doctors are performing an echocardiogram as part of the screening. Echocardiogram means that they will place some gel on your chest and then put a small sensor called a probe on top of the gel to get a virtual image of your heart. The doctors will write down the results of the procedure. Doctors may store the virtual images of your heart in a secure electronic database. If they see anything unusual, they will recommend that you see your usual doctor for a checkup. Is it harmful for me to be in this study? No, it is not dangerous to be in this study. The ultrasound test is painless and will only take a few minutes. The research part involves gathering data about your test. What if I have any questions? I can ask questions any time. I can talk to the doctors or I can talk to my parent(s). The phone number I can call is Do I have to be in the study? I do not have to be in the study if I do not want to be. I can say Yes now and change my mind later. Also, I understand that I can talk this over with my parent(s)/guardian(s). My mom or dad will also be asked to give their permission for me to take part in this study. But even if my parent(s) say Yes I can still decide not to participate in this study and say No. UCI IRB Approved: MOD# HS# of 6

19 Purpose of study: Young people with cardiac abnormalities such as Hypertrophic Cardiomyopathy (HCM) will often show no symptoms and are therefore often undiagnosed. The exertion on the heart caused by exercising can lead to sudden cardiac death in these athletes. Previous studies have shown that routine screening can lead to detection of some of these abnormalities and intervention or withdrawal from sport can reduce mortality. The purpose of this study is to screen for and determine the prevalence of abnormalities of the heart in a population of young athletes using echocardiogram (echo, which is an ultrasound of the heart) as well as perform a cost-effectiveness analysis of the screening. Subjects will be screened by trained echo technicians on their campuses and their results will be interpreted by board-certified pediatric cardiologists. Subjects: To be eligible for this study, you must be an athlete of high school or college age and be participating in your school athletics pre-participation physical examination. Procedures: If you elect to participate in the study, the time commitment will be approximately 5-10 minutes. We will collect data from you about your medical and family medical history on the health history form, and we will retain the form. This will not be added to your medical record. An echocardiogram will be performed on you as part of the screening. The interpretation by a cardiologist of your echo as performed is part of the screening. The research activity in this protocol will be the echo procedure, data collection of demographics, and echo results. If you have abnormal echo results, we will contact you by phone or mail recommending that you see your primary care physician. We will ask you to sign a HIPAA (Health Insurance Portability and Accountability Act) form giving permission for us to access your medical record for the purpose of following up on the results of the formal evaluation as well as the interventions taken such as medicinal, surgical, or withdrawal from exercise. All results of this study will be kept confidential from school personnel. The investigator can remove me from the study without my consent for, but not limited to, the following reasons: 1. If it is judged to be in my best interest in an effort to protect my safety and welfare 2. If I experience an injury or illness that warrants ending my participation 3. If the study is stopped unexpectedly Risks: As this study involves the use of your identifiable information, the primary risk of the research is the potential breach of confidentiality. All efforts to ensure that this does not happen will be made including the following: once data is taken from the medical record and entered into a database, a special code will be assigned to my data set. This data will be locked in the office of the lead investigator who holds the only key. The link for the special code will be kept locked separate from the data set. There is also a very minimal risk of mild skin irritation from the echocardiogram gel used. There is risk of discomfort from disclosure of any abnormality. There are no additional risks associated with my participation in this study. UCI IRB Approved: MOD# HS# of 6

20 Benefits: The screening may potentially find an abnormality in your heart that was previously undetected. Your participation in the study may demonstrate that screening young athletes using echo can be cost effective and can reduce mortality if the appropriate interventions are taken. Alternative Treatments: If you choose not to participate in this study you will still receive the routine and standard pre-participation physical exam as required by your school. Compensation and Costs You will not be compensated for your participation in the study. The screening is being provided free of charge and you will not be billed for your participation in the study. If you seek further medical care following the screening, you will be responsible for all further costs. Confidentiality: Subject Identifiable Data and Data Storage Dr. Fox will manage the study database and access to the database. There is a potential risk of breach of confidentiality. In order to minimize this risk, all identifiable information that will be collected about you will be removed and replaced with a study code. A list linking the study code and your identifiable information (decoding key) will be kept separate from the coded research data. This decoding key is the only way to link the data to the identifiers. The repository will contain only coded data and will not contain any identifiable information. The decoding key will be locked in the office of Dr. Fox. Only study investigators will be given access to the study data and decoding key. All of the data collected will be stored in coded form, and will be kept in a locked computer in a locked cabinet in a locked facility at the UCI Medical Center Emergency Department that only the study investigators have access. The data collected from this study may be made available to other researchers for further or separate studies. Any information derived from this research project that personally identifies you will not be voluntarily released or disclosed without your separate consent, except as specifically required by law. Your identity will remain anonymous if the study results are published or presented. Stored imaging will only include the virtual ultrasound-generated images of your heart and will not contain any imaging of your leg, neck, or face. Data Access The research team, authorized UCI personnel, and regulatory entities such as the Office of Human Research Protections (OHRP) may have access to your study records to protect your safety and welfare. Any information derived from this research project that personally identifies you will not be voluntarily released or disclosed by these entities without your separate consent, except as specifically required by law. Research records provided to authorized, non-uci entities will not contain identifiable information about you. Publications and/or presentations that result from this study will not include identifiable information about you. UCI IRB Approved: MOD# HS# of 6

21 Data Retention The investigators intend to keep the research data for at least 6 years because the study involves Personal Health Information. Financial Interests: No one on the study team has a disclosable financial interest related to this research project. New Findings: If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the researcher team listed at the top of the form. If You Have A Question: If you are unable to reach a member of the research team listed at the top of the form and have general questions, or you have concerns or complaints about the research study, research team, or questions about your rights as a research subject, please contact UCI s Office of Research by phone, (949) or (949) , by at IRB@rgs.uci.edu or in person at 141 Innovation Drive, Suite 250, Irvine, CA Voluntary Participation: You should not sign this form unless you have read it and understand its contents. You may request a copy from school personnel or any research team member. Participation in this study is voluntary. You may refuse to answer any question or discontinue your involvement at any time without penalty or loss of benefits to which you might otherwise be entitled. The results of your screening will not be released to your school or athletics department. Your decision will not affect your future relationship with UCI or your quality of care at the UCI Medical Center. Your signature below indicates that you have read the information in this consent form and have had a chance to ask any questions that you have about the study. If you have any questions you can contact the research team at UCI IRB Approved: MOD# HS# of 6

22 PLEASE SIGN BELOW IF YOU AGREE TO PARTICIPATE IN THIS STUDY School Name Student Age Printed Student name Student Signature Date (Required) (Required) Printed Parent/Guardian name Parent/Guardian Signature Date (Required only if student under 18 years of age) Printed Researcher name Researcher Signature Date UCI IRB Approved: MOD# HS# of 6

23 UNIVERSITY OF CALIFORNIA, IRVINE Experimental Subject's Bill of Rights The rights listed below are the right of every individual asked to participate in a research study. You have the right: 1. To be told about the nature and purpose of the study. 2. To be told about the procedures to be followed in the research study, and whether any of the drugs, devices, or procedures is different from what would be used in standard practice. 3. To receive a description of any side effects, discomforts, or risks that you can reasonably expect to occur during the study. 4. To be told of any benefits that you may reasonably expect from the participation in the study, if applicable. 5. To receive a description of any alternative procedures, drugs, or devices that might be helpful, and their risks and benefits compared to the proposed procedures, drugs or devices. 6. To be told of what sort of medical treatment, if any, will be available if any complications should arise. 7. To be given a chance to ask any questions concerning the research study both before agreeing to participate and at any time during the course of the study. 8. To refuse to participate in the research study. Participation is voluntary. You may refuse to answer any question or discontinue your involvement at any time without penalty or loss of benefits to which you might otherwise be entitled. Your decision will not affect your right to receive the care you would receive if you were not in the experiment. 9. To receive a copy of the signed and dated written consent form and a copy of this form. 10. To be given the opportunity to freely decide whether or not to consent to the research study without any force, coercion, or undue influence If you have any concerns or questions regarding the research study you should contact the research team listed at the top of the consent form. If you are unable to reach a member of the research team and have general questions, or you have concerns or complaints about the research study, research team, or questions about your rights as a research subject, please contact the UCI s Human Research Protections unit in the Office of Research by calling (949) or (949) Monday Friday, 8 am 5 pm; or by at IRB@rgs.uci.edu; or by writing us at 141 Innovation Drive, Suite 250, Irvine, CA UCI IRB Approved: MOD# HS# of 6