University of Pittsburgh Department of Critical Care Medicine Consent to Participate in a Research Study of a Monitor Study Name: Research Directors: Augmented multimodal neurologic monitoring in high risk survivors of cardiac arrest Lori Shutter, MD Departments of Neurology, Neurosurgery and Critical Care Medicine University of Pittsburgh Medical Center shutterla@upmc.edu office: 412-647- 8410 Jonathan Elmer, MD Department of Critical Care Medicine University of Pittsburgh Medical Center elmerjp@upmc.edu cell: 646-696- 0454 Coinvestigators Study Sponsor Clifton Callaway MD/PhD Ankur Doshi MD Frank Guyette MD Jon C Rittenberger MD/MS Lilian Emlet MD Cameron Dezfulian, MD David Okonkwo, MD/PhD Department of Critical Care Medicine Department of Emergency Medicine University of Pittsburgh Medical Center Purpose of the study The person you are representing has suffered a cardiac arrest, a life threatening medical condition. During a cardiac arrest, the heart does not beat and so oxygen and nutrients are not delivered to the body. This causes injury to the whole body, but the brain is the most sensitive to this kind of injury and can become severely damaged. The person you are representing is eligible for this study because he or she is going to receive neurological monitoring that includes placement of monitors into the brain itself as part of his Page 1 of 7
or her regular clinical care. The Departments of Critical Care and Emergency Medicine are conducting a research study to evaluate an additional monitor that can be added to what will be used already in the person you represent. This monitor is designed to detect seizures or abnormal brain electrical activity, both of which can worsen brain damage. This is a research study This monitor has been shown to be effective in other patients with other brain problems like severe seizures or epilepsy. However, they have not been regularly used in the past in people who have had a cardiac arrest. The reason we are doing this study is because we do not know whether or not using the information these monitors provides will improve the care we can provide, if it will have no effect, or if it will worsen the care we can provide. These are the goals of this study: To look for abnormal electrical activity in the brain such as seizures. If seizures or inadequate blood flow is detected, they will be treated by the intensive care unit doctors caring for the person you represent During the study, this is what will happen: 1) Regular clinical care (not research) The person you represent will have a metal bolt placed in the bone skull that holds the individual monitors that are used. This is placed as part of the regular care we provide to patients who have had a cardiac arrest and severe brain damage. Each individual monitor is small, about 1 millimeter wide (about as wide as a guitar string), and passes through a hole in the metal bolt into the surface of the brain itself. As part of regular care, we place monitors that measure things like the pressure, oxygen level and temperature in the brain. 2) Research study In this study, we will pass an additional monitor through the metal bolt to look for seizures. The information that these monitors give us will be used by the doctors taking care of the person you represent. If seizures are detected, they will be treated by the intensive care unit doctors. We will also use the information from these monitors to help us learn more about the brain injury that happens after a cardiac arrest. When the person you represent is ready to have the bolt with the monitors removed, all of the monitors will be removed together. The person you represent will participate in the study from the time the monitors are placed in the brain until it is removed, and we will continue to collect information until Page 2 of 7
he or she leaves the hospital. We will keep a computer record of the information we record. Some of the information will be kept as part of the medical record, and some will be kept separately for research uses. The risks of placing these monitors are as follows: It may cause bleeding in or around the brain. This happens in less than 1% of patients An infection may develop in or around the brain The monitor may stop working properly If we detect more seizures by monitoring inside the brain, the person you represent may receive more medications to treat these seizures. Like all medications, these may cause side effects. If we learn of any new information about study risks that could cause you to change your mind about continuing to participate, we will notify you promptly. Confidentiality We make every effort to keep the information about the person you represent confidential. Some of the information that we collect will be part of the medical record. For the information that is not part of the medical record, we will assign the person you represent a code number. A key linking the person you represent to the code number is kept locked in a secure location and will be available only to the investigators. All patient identifiers (medical record number) will be removed from data within a year of the completion of the study. Data from this study, without identifying information, may be reported in scientific meetings, articles or other appropriate communications. Although we will make every effort to keep all information confidential, no system for protecting the confidentiality of the person you represent can be completely secure. It is possible that unauthorized persons might discover that the person you represent is in this study, or might obtain information about him or her. The person you represent will not be at greater risk than he or she is by being a patient in this hospital, as we will use similar safeguards. University of Pittsburgh sometimes reviews studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, the records of the person you represent may be examined. The reviewers will protect his or her privacy. The study records will not be used to put the person you represent at legal risk of harm. In addition to the investigators listed on the front page of this consent form and their research staff, the following individuals may have access to identifiable information related to the participation of the person you represent in this research study: Authorized representatives of Page 3 of 7
federal and local agencies providing oversight, including University of Pittsburgh Research Conduct and Compliance Office, who may review identifiable research information (which may include identifiable medical record information for the person you represent) for the purpose of monitoring the appropriate conduct of this research study. In unusual cases, the investigators may be required to release identifiable information (which may include identifiable medical information) related to the participation of the person you represent in this research study in response to an order from a court of law. If the investigators learn that the person you represent or someone with whom he or she is involved is in serious danger or potential harm, they will need to inform, as required by Pennsylvania law, the appropriate agencies. Alternatives to taking part in this study We look for seizures in all patients who have had a cardiac arrest by using a seizure monitor that is attached to the skin of the scalp. We also measure blood pressure and sometime the amount of blood the heart is pumping using monitors placed in inside arteries (blood vessels). Regardless of whether the person you represent participates in this research study, we will provide this regular care, like we do for all patients who have had a cardiac arrest. We will also measure the pressure and oxygen levels inside the brain using the monitors that are part of regular (not research) care. Benefits of the study It is possible that the monitors that we are using for this study may provide the doctors caring for the person you represent with important information that can be used to improve the quality of the care they receive. However, this is not certain. It may also be that they do not provide useful information. Costs and Payments There are no costs for study participation. The person you represent or his or her insurer or third party payer will not be billed for services related solely to the research all study specific procedures will be paid for by the research grant. However, the person you represent or his or her insurer, will be billed for all other usual care services, and/or services not connected with the study, just as he or she would if not in the study. No additional costs will be accrued due to participation in this study. Neither you nor the person you are representing will be paid for agreeing to participate in this study. What compensation is available in case of injury? If you or the person you represent believes that the research procedures have resulted in an injury, immediately contact the Principal Investigator who is listed on the first page of this form. Emergency medical treatment for injuries solely and directly related to the participation of the person you represent in this research study will be provided by the hospitals of UPMC. His or her insurance provider may be billed for the costs of this emergency treatment, but none of those costs will be charged directly to you or the person you represent. If research- related injury requires medical care beyond this emergency treatment, he or she will be responsible for the costs of this follow- up care. At this time, there is no plan for any additional Page 4 of 7
financial compensation. Right to Withdraw If you decide to withdraw the person you represent from this study, this decision will not affect either his or her current or future medical care at the University of Pittsburgh Medical Center. If you agree to allow the person you represent to participate and later change your mind or decide to withdraw him or her from the study, a written and dated notice of this decision needs to be sent to the investigator. All information and samples collected prior to this withdrawal will continue to be used. The investigators may continue to use and disclose, for the purposes described above, identifiable information (which may include identifiable medical information) related to participation in this research study indefinitely. Please note that it is University policy that all research records must be maintained for at least 7 years following final reporting or publication of a project. You or the person you represent have the right to request that all information collected to date and/or the blood samples be destroyed. Voluntary Participation Being in this study is voluntary. The person you represent does not have to be in this study if you don t want him or her to be. He or she can stop being in this study at any time. Whether you choose to allow him or her to be in this study, or choose not to allow him or her to be in this study, will not affect the health care the person you represent will receive here at UPMC. The doctors caring for the person you represent may be involved as an investigator in this research study. As both a doctor and a research investigator, he is interested both the medical care that the person you represent receives and the conduct of this research study. Before agreeing to allow the person you represent to participate in this research study, or at any time during study participation, you may discuss the care provided to the person you represent with another doctor who is not associated with this research study. You are not under any obligation to allow the person you represent to participate in any research study offered by his or her doctor. Voluntary Consent The above information has been explained to me and all of my current questions have been answered. I understand that I am encouraged to ask questions, voice concerns or complaints about any aspect of this research study during the course of this study, and that such future questions, concerns or complaints will be answered by a qualified member of the research team or by Dr. Lori Shutter, at 412-647- 8410. I understand that I may always request that my questions, concerns or complaints be addressed to Dr Shutter. At any time I may also contact the Human Subjects Protection Advocate of the IRB Office, University of Pittsburgh (1.866.212.2668) to discuss problems, concerns, and questions; obtain information; offer input; or discuss situations in the event that the research team is unavailable. By signing this form I agree to allow the person I represent to participate in this research study, and allow the use and disclosure of his or her medical record information for the purposes described above. A copy of this consent form will be given to me. Page 5 of 7
Surrogate Consent is unable to provide direct consent for study participation because: Participant s Name (Print) Therefore, by signing this form, I consent to his/her participation in this research study and provide my authorization to share his/her medical records with the research team. Representative s Name (Print) Representative s Signature Witness Signature if faxing or Electronic transfer Relationship to Participant Date/Time Date /Time CERTIFICATION of INFORMED CONSENT I certify that I have explained the nature and purpose of this research study to the above- named individual, and I have discussed the potential benefits and possible risks of study participation. Any questions the person has about this study have been answered, and we will always be available to address future questions as they arise. I further certify that no research component of this protocol was begun until after this consent form was signed. Printed Name of Person Obtaining Consent Signature of Person Obtaining Consent Role in Research Study Date Page 6 of 7
Consent for continued research participation: I understand that I am currently participating in a research study. Permission for my participation in this study was obtained from my authorized representative (surrogate) because I was unable to provide consent when initially. I have now recovered to the point where I feel that I can provide consent for my continued participation in this research study. The study has been described to me and all of my questions have been answered. I understand that I have the right to request that all information collected to date and /or my blood samples be destroyed. Any additional questions or concerns about any aspect of this study will be answered by the researchers. Questions I might have about my rights as a research participant will be answered by the Human Subject Protection Advocate at 1-866-212-2668. By signing this form I consent to participate in this research study and provide my authorization to share my medical records with the research team. A copy of this consent form will be given to me. Participant s Signature Participant s Name (Print) Date/Time Investigator s Certification I certify that the nature and purpose, the potential benefits and possible risks associated with participation in this research study have been explained to the subject or their family member and any questions about this information have been answered. Investigator s Name (Print) Investigator s Signature Date/Time Page 7 of 7