IRB Approval Period: 03/21/2017 Medical College of Wisconsin and Froedtert Hospital CONSENT TO PARTICIPATE IN RESEARCH Name of Study Subject: Comprehensive study of acute effects and recovery after concussion: An integrated investigation of head impact sensor technology, blood biomarkers, advanced neuroimaging, genetic testing and clinical outcome metrics Michael McCrea, PhD, ABPP-CN Department of Neurosurgery 414-955-7300 Medical College of Wisconsin 8701 Watertown Plank Road Milwaukee WI 53226 You are invited to take part in this research study. This form tells you why this research study is being done, what will happen in the research study, and possible risks and benefits to you. If there is anything you do not understand, please ask questions. Then you can decide if you want to join this study or not. A1. INTRODUCTION WHY ARE WE ASKING YOU ABOUT THIS STUDY? You are invited to participate in this research study because participate in a sport at a Milwaukee area high school or college. A total of about 1200 people are expected to participate in this study all at high schools and colleges in Southeastern Wisconsin. The Director of the study is Dr. Michael McCrea in the Department of Neurosurgery. A study team works with Dr. Michael McCrea. You can ask who these people are. The Department of Defense, a government agency, is funding the study. A2. DO I HAVE TO BE IN THIS STUDY? You can decide whether to take part in this study or not. You are free to say yes or no. Even if you join this study, you do not have to stay in it. You may stop at any time. A3. WHY IS THIS RESEARCH STUDY BEING DONE? The purpose of this study is to investigate the effects of concussion associated with sport participation on an athlete s health. The specific goal of this study is to look at several tools available for concussion at the same time to better understand how a concussion affects a person (neurologic, biologic, psychological, and social). Page 1 of 7
IRB Approval Period: 03/21/2017 B1. WHAT WILL HAPPEN IF I TAKE PART IN THE STUDY? Screening procedures If you participate in a non-contact sport (basketball, track, etc) and if you decide to join the study, you will first be given a questionnaire asking about basic demographic information to see if you are eligible. This visit will take about 5 minutes. If you are eligible, we will contact you at a later date if you are selected to participate further. If you participate in a contact sport (football, soccer, etc), you will not have to complete this screening form. Baseline Testing You will undergo testing before the sports season to establish your baseline performance and we will collect a sample of your blood (including some blood for genetic testing). These tests include a computer test, balance test, questionnaires, and others that are often used to assess concussion. The testing session will take place at your school and will last about 2.5 hours. You will be paid $60 for your time for completing the baseline testing. You may also be asked to conduct a preseason MRI (see below) that will take place at Froedtert Hospital. If you are selected for this, it will take an additional hour and you will be paid $100. Head Impact Sensors We may ask you to wear a helmet with head impact sensors (HITS) in it throughout your season. These sensors will automatically record all impacts to your head while you are participating in your sport. The helmet based sensor will not take any additional time to put on compared to your normal equipment. Your coach and athletic trainer will not use these sensors for diagnostic purposes. Practice and game film collected by your school may be shared and reviewed by the study team at a later date to analyze head impact data. Follow-Up Testing If you sustain a sport-related concussion during your season, you will undergo a short series of tests (blood sample, symptom checklist) within 6 hours of your injury (at your school) and will be paid $30 for your time. You will then take more tests (neurocognitive, MRI, blood sample) at 48hrs and 8, 15 and 45 days after the injury. The testing sessions will usually take place at Froedtert Hospital and will last about 2.5 hours. You will be paid $180 for your time for each testing session you complete. If you are not injured, we may ask you undergo the same follow-up procedures to compare your results on the tests to other injured athletes. You will be paid the same amount as listed above. Procedure Details MRI (Magnetic Resonance Imaging) is a way for us to see inside your body. MRI uses a powerful magnet, radio waves and a computer to produce detailed pictures of organs, bones and other internal body structures. For the MRI, you will lie on a table inside a scanner tube for about 1 hour, while the scanner moves the reading unit over the areas of your body to be scanned. Genetic testing will occur at the baseline assessment. Genetic testing is done on blood and other specimens. In this study, we will do genetic testing on your blood. This will be collected by a blood draw (see below). Genetic testing will be done because it is unknown if genetic factors play a role in concussion. This genetic study is for research only. The purpose is not to discover information that could be used to change your medical care, make or change your diagnosis, or advise you on your risk of diseases. Information that can Page 2 of 7
IRB Approval Period: 03/21/2017 identify you will not be attached to your blood or genetic samples. You will not be given your genetic test results. Blood Draw: For this procedure, you will be seated and blood will be drawn by putting a needle into a vein in your arm. You will have about 20-30 ml (1-2 tablespoons) of blood taken for each assessment you complete (30 ml at baseline, 20 ml at 6 hr, 48 hr, 8 day, 15 day, 45 day). Release of Results: The athletic trainer at your school or your healthcare providers may request access to results from the clinical assessments (computer, paper and pencil, and balance tests, and symptom checklist) to aid in clinical management. These will only be released to your athletic trainer or healthcare provider. Blood and genetic test results will not be released to anyone. MRI results will only be released to you (or parent if you re a minor) upon referral for clinical follow up of incidental findings. Data Sharing: We plan to share de-identified data from this study with Federal Interagency Traumatic Brain Injury Research (FITBIR) and The Database of Genotypes and Phenotypes (dbgap). All links with your identity will be removed from the data before they are shared. Only de-identified data which do not include anything that might directly identify you will be shared with these entities and the general scientific community for research purposes. B2. HOW LONG WILL I BE IN THE STUDY? You will be in this research study until you stop participating in sports at your school. If you sustain a concussion, we want to keep in touch with you to see how you are doing over time. We may also contact you to tell you about other research opportunities in the future. B3. CAN I STOP BEING IN THE STUDY? You may stop at any time. If you decide to leave the study, please let the study team know. The study investigator may stop your participation in the study at any time for any reason without your consent. He will tell you if this happens. C1. WHAT RISKS OR PROBLEMS CAN I EXPECT FROM THE STUDY? We watch everyone in the study for unexpected problems. You need to tell the study director or a member of the study team immediately if you experience any problems or become too upset. A study team member will be available during the entire testing session and testing may be stopped at any time. Cognitive/Balance/Questionnaire Testing: There are no known risks associated with these tests. Head Impact Sensors: There is no known risk with the helmet based head impact sensor. They look and function identical to other helmets and meet National Operating Committee on Standards for Athletic Equipment (NOCSAE) safety standards. Page 3 of 7
IRB Approval Period: 03/21/2017 MRI Scan: There is no exposure to x-rays or radioactivity during a MRI (Magnetic Resonance Imaging) scan, and the risk of injury is very low. However, MRI is not safe for everyone. Serious injury or death can result if you go into the scanner with certain metal objects in or attached to your body. For example, it is not safe to have an MRI scan if you have a cardiac pacemaker, defibrillator, certain metal or implants in your body or have metal in or near your eye. The MRI scanner makes loud banging sounds that can cause hearing damage, but with earplugs properly worn, there is no known risk of permanent hearing damage. Rarely, your hearing may be less sensitive for several days after an MRI scan, but if this happens your hearing should return to normal within a few days. You may feel some discomfort because you are lying still for a long time, or because of the padding used to keep your head from moving. Some people feel anxious being in closed or narrow spaces. The scanner operator will be in constant contact with you, and if you choose, you can be taken out of the scanner quickly. The safety of an MRI during pregnancy is unknown. If you are pregnant or of childbearing age and not on a reliable form of birth control, you will not be allowed to participate in the study. If you are female, birth control use will be documented at all visits. The MRIs used in this project are approved by the U.S. Food and Drug Administration. However, the FDA considers the software used to collect the images to be experimental. Blood Draw/Genetic Testing: The side effects that you might experience as a consequence of donating a blood sample for this study include possible discomfort and bruising at the needle entry site. Rare complications of any venipuncture (drawing blood from a vein) include fainting, arterial puncture, peripheral nerve injury, local infection, and local blood clot. There may be other unanticipated risks, but every precaution will be taken to assure your personal safety and to minimize discomfort. The person drawing your blood will observe you for side effects, but please inform him or her if you experience any discomfort or feel faint. The study team will make every effort to protect the information and keep it confidential, but it is possible that an unauthorized person might see it. Depending on the kind of information being collected, it might be used in a way that could embarrass you. If some records include genetic information, it is against federal law (GINA) for health insurance companies to deny health insurance, or large employers to deny jobs, based on your genetic information. But the same law does not protect your ability to get disability, life, or long term care insurance. If you have questions, you can talk to the study doctor about whether this could apply to you. The tests used in this study are conducted for research purposes only and are not the type used for diagnostic purposes. Most tests will not be systematically reviewed for abnormalities or irregularities. However, occasionally an incidental finding will show what could be an abnormal or unexpected finding. Such findings do not mean that there is necessarily anything wrong, only that it would be a reasonable response to have a qualified professional examine you further. Should this occur and we feel you need another type of testing that is diagnostic, or an exam to be used as a basis for diagnosis and treatment, we will tell you. These examinations and tests would be your responsibility to schedule and pay for. We can provide names of qualified professionals experienced in performing such exams or you can choose your own medical professional. If you have any questions about what might be considered an abnormal finding, please feel free to discuss this with the study staff. Page 4 of 7
IRB Approval Period: 03/21/2017 C2. ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY? This study will not help you, but we hope the information from this study will help us develop a better model of concussion to help assess and treat this injury. D1. ARE THERE ANY COSTS TO BEING IN THE STUDY? There are no costs to you for any activities in this study. D2. WILL I BE PAID FOR BEING IN THE STUDY? You will be paid $60 for completing the baseline testing procedures and an additional $100 if you are chosen to complete a baseline MRI. If you are injured or chosen as a control, you will be paid $30 for the 6 hour visit, $180 for the 48 hour visit, $180 for the 8 day visit, $180 for the 15 day visit, and $180 for the 45 day visit. If you are unable to transport yourself to Froedtert for post injury testing, we will provide transportation services (taxi, car service, etc). This will be over and above the $180 stipend paid for your participation. To pay you, we need your social security number. Any payment may be reportable as income on your taxes. D3. WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THE STUDY? If you have been following directions, the injury is directly related to the research, and not the result of an underlying condition, then MCW will compensate you for the injury. If you think you have been injured because of this study, let the study doctors know right away by calling 414-955-7300. D4. WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY? If you have more questions about this study at any time, you can call Dr. Michael McCrea, PhD, ABPP at 414-955-7300. If you have questions about your rights as a study participant, want to report any problems or complaints, obtain information about the study, or offer input you can call the Medical College of Wisconsin/Froedtert Hospital Research Subject Advocate at 414-955-8844. E. PERMISSION TO COLLECT, USE AND SHARE HEALTH INFORMATION E1. What health information will be collected and used for this study? To do this research study, we need your permission to collect and share some of your health information, or you cannot be in the study. This information may come from questions we ask, forms we ask you to fill out, as described below. We will only collect information needed for the study. Page 5 of 7
IRB Approval Period: 03/21/2017 The health information we will collect and use for this study is: Questionnaires and assessments, blood samples (including genetic samples from blood), MRI scans, and head impact sensor data E2. Who will see the health information collected for this study? The only MCW/Froedtert Hospital employees allowed to handle your health information are those on the study team, those on the Institutional Review Board (IRB) and those who check on the research activities to make sure the hospital s rules are followed. The study team may share your information with people who don t work at MCW/Froedtert Hospital because they planned, pay for, or work with us on this study. The federal Privacy Rule may no longer protect your health information once it leaves MCW/Froedtert Hospital. For this study, we plan to share information with those doctors, researchers or government representatives working with us on this study at the institutions or companies listed here: Department of Defense (DoD), Washington, DC. L-3 Applied Technologies, San Diego, CA Simbex, Lebanon, NH Riddell, Rosemont, IL Banyan Biomarkers, Alachua, FL Indiana University, Indianapolis, IN Federal Interagency Traumatic Brain Injury Research (FITBIR), Bethesda, MD National Institute of Health (NIH), Bethesda, MD The Database of Genotypes and Phenotypes (dbgap), Bethesda, MD We will not use your health information for a different study without your permission, or the permission of a hospital research review board (IRB). Once all personal identification is removed, the information might be used or released for other purposes without asking you. Results of the study may be presented in public talks or written articles, but no information will be presented that identifies you. E3. What are the risks of sharing this health information? One risk of taking part in a research study is that more people will handle your personal health information collected for this study. The study team will make every effort to protect the information and keep it confidential, but it is possible that an unauthorized person might see it. Depending on the kind of information being collected, it might be used in a way that could embarrass you or affect your ability to get insurance. If you have questions, you can talk to the study director about whether this could apply to you. E4. How long will you keep the health information for this study? If you sign this form, we plan to keep your information for 10 years after the research study ends in case we need to check it again for this study. Page 6 of 7
IRB Approval Period: 03/21/2017 E5. Can I cancel my permission to share this health information? If you change your mind later and do not want us to collect or share your health information, you need to send a letter to Dr. Michael McCrea, PhD at Department of Neurosurgery, 8701 W Watertown Plank Rd. Milwaukee, WI 53226. The letter must say that you have changed your mind and do not want the researcher to collect and share your health information. At that time, we may decide that you cannot continue to be part of the study. We may still use the information we have already collected. CONSENT TO PARTICIPATE IN THE STUDY By signing my name below, I confirm the following: I have read (or had read to me) this entire consent document. All of my questions have been answered to my satisfaction. The study s purpose, procedures, risks and possible benefits have been explained to me. I agree to let the study team use and share the health information and other information gathered for this study. I voluntarily agree to participate in this research study. I agree to follow the study procedures as directed. I have been told that I can stop at any time. IMPORTANT: You will receive a signed and dated copy of this consent form. Please keep it where you can find it easily. It will help you remember what we discussed today. Consent of Adult Subject (18 years or older) Subject's Name please print Subject's Signature Date Assent of Minor Subject (younger than 18) Name of Minor please print Signature of Minor Consent of Parent/Guardian of Minor Subject Date Name of Parent/Guardian please print Signature of Parent/Guardian Date Page 7 of 7