Consent Form Template



INFORMED CONSENT AND RESEARCH AUTHORIZATION Aneurysmal Subarachnoid Hemorrhage Trial Randomizing Heparin (ASTROH) Sponsor/Principal Investigator: Robert F. James, MD, FAANS, FACS Associate Professor - Chief, Vascular Neurosurgery University of Louisville, Department of Neurological Surgery 220 Abraham Flexner Way, 15th Floor Louisville, KY 40202Site where study will be conducted: University of Louisville Hospital Jewish Hospital & St. Mary’s Healthcare Norton Healthcare, Inc. Primary Funding: Department of Neurological Surgery, University of Louisville (c/o University of Louisville Research Foundation) Brain Aneurysm FoundationAdditional Support:Investigator-Initiated Research Grants awarded by Microvention Inc, and Penumbra Inc.Telephone Contact for Study Questions: (502) 852-5251 - Ann Jerde or(502) 332-7611 - 24-Hour Neurosurgery On-Call Pager 24-Hour Emergency Phone Number: (502) 438-8707Introduction and Background InformationYou are invited to take part in a research study because you have been diagnosed with a special kind of brain hemorrhage known as a “subarachnoid hemorrhage” caused by a ruptured (burst) brain aneurysm. A brain aneurysm is an abnormal bulge or weak spot on an artery of the brain. The study is being conducted under the direction of Robert F. James, MD at the University of Louisville. About 11 local subjects will be invited to take part in this research. The total number of subjects across approximately 8 sites in the United States will be 88. PurposeThe purpose of this study is to determine if giving the medicine “heparin” intravenously (through the veins) continuously for up to 14 days to subjects after a brain aneurysm has burst will help improve the chances of subjects having a good recovery after the bleed compared to subjects who get routine brain aneurysm care (standard of care). Patients who get routine care would also get heparin, but they would typically get an overall lower dose and the heparin would be injected under the skin (heparin shot) instead of in the veins.ProceduresYour participation in this study will last for a total of about 12 months. If you are a candidate for this study and you consent to participate, you will have the following procedures done while you are in this study:If you join this study, it will be decided by chance (like the flip of a coin), whether you will receive the intravenous heparin medication or not. The chance of receiving this heparin medication is approximately 50:50 (or once out of two chances). If you are selected to receive the intravenous heparin medication, this medicine will be given to you through your IV (special tube in your vein) continuously for up to 14 days while you are in the hospital recovering from your brain aneurysm bleed. If you are discharged from the hospital before you complete the 14 days of IV heparin, you will not receive additional heparin to take after your release. If you are not selected to receive the intravenous heparin, then you will automatically receive the routine aneurysm care which includes a heparin shot twice per day (just as you would if you had not agreed to participate in this study). Heparin shots are a standard medication designed to help prevent blood clots in the deep veins of the legs of people who are in the hospital and spend most of their time in bed. Heparin shots come in two forms: 1) Regular Heparin and 2) Low-Weight Heparin (enoxaparin or Lovenox). If you receive heparin shots for this study, they will be the “Regular Heparin” type and you will receive those shots twice per day usually until discharge from the hospital as part of the standard of care. If you are chosen to receive the intravenous heparin medication then you will NOT receive any additional heparin shots while you are getting this medication. However, you will get the heparin shots AFTER the 14 days of intravenous heparin is finished usually until discharge from the hospital as part of the standard of care. To summarize, if you agree to participate in this study, you will be selected by chance to get one of the following heparin treatments:Intravenous heparin (continuous heparin through your IV for 14 days, after the 14 days you will get the normal heparin shots)ORHeparin shots (injections of heparin under your skin twice per day)You will have your blood drawn for blood tests specific to this study on the first day that you agree to participate in this study and then again on 4 additional days while you are in the hospital. A maximum total of 4 teaspoons (20 mL) of blood will be drawn at any one time for a maximum of 7 tablespoons (100 mL) of blood drawn total for this study. When possible we will obtain the blood from a vein in your arm or hand. Approximately 15 minutes of your time will be required for these blood draws. The blood in the tubes that we collect for the purpose of this study will be labeled with your Study ID number and the date and time that the blood was taken. They will not be labeled with your name. They will then be processed and stored in a freezer. At the end of the study, the blood samples that have been stored in the freezer will be sent to a laboratory at the University of Louisville to be analyzed to see if intravenous heparin changes the blood levels of certain substances in your blood. Any leftover blood will be kept in a freezer in this laboratory at the University of Louisville for up to 10 years after completion of the study for possible future analysis. Future testing would most likely include additional inflammatory biomarker analysis. DNA testing may be done on this blood to identify genetic biomarkers in subjects with this type of aneurysm.If you currently have, or eventually need a special brain catheter called an “external ventricular drain”, you will have some of the fluid removed from this catheter for testing. We will remove the fluid directly from the port on the tubing and this will not be painful. We will remove this fluid on the first day that you agree to participate (if the brain catheter is present) and then again on 4 additional days while you are in the hospital. A maximum total of 4 teaspoons (20 mL) of fluid will be removed at any one time for a maximum of 7 tablespoons (100 mL) of fluid total for this study. Your brain makes over 1? cups (400 mL) of this fluid per day and removal of 4 teaspoons (20 mL) of this fluid at one time is not considered dangerous. Whether or not you receive this special brain catheter is not related to whether you decide to participate in this research study. Your doctor will decide whether or not you need this special brain catheter. The fluid taken from this brain catheter will also be placed into tubes that will be labeled with your Study ID number and the date and time that the fluid sample was taken. They will not be labeled with your name. It will then be processed and stored in a freezer. At the end of the study, the fluid samples that have been stored in the freezer will be sent to a laboratory at the University of Louisville to be analyzed to see if intravenous heparin changes the levels of certain substances in your fluid. Any leftover fluid will be kept in a freezer in this laboratory at the University of Louisville for up to 10 years after completion of the study for possible future analysis. Future testing would most likely include additional inflammatory biomarker analysis. DNA testing may be done on this fluid to identify genetic biomarkers in subjects with this type of aneurism.While you are in the hospital, you will have various non-invasive tests performed that will assess the function of your brain and your memory. These usually involve asking you questions, having you draw pictures, having you remember words, or asking you to do certain things such as lift up your arms or say specific words or phrases. On some days you will have more tests than others depending on which day it is. You may refuse to answer any questions, which may make you feel uncomfortable. These tests will take approximately 30 – 45 minutes of your time to complete.On two separate occasions after you leave the hospital, we will need to do additional non-invasive tests. These non-invasive tests will assess the function of your brain, your memory, how you are coping after your bleed (quality of life), whether or not you have returned to work, and similar measurements of how well you have recovered from your aneurysm rupture. These visits would usually take place during one of your usual follow-up visits in your aneurysm doctor’s office. These visits will occur at approximately 3 months and 12 months after your aneurysm burst. Once the final visit is completed and all of the tests associated with the visit are finished, you will have completed the study. The person on the research team who is helping you do these tests will not know whether you got the intravenous heparin or the heparin shots. We will remind you on the day of your visit to not tell anyone which type of heparin you received while in the hospital. The type of heparin you received will be kept secret from the researchers who try to determine which type of heparin is better until all of the information is processed and calculated. This prevents any type of intentional or unintentional favoritism towards one type of heparin or the other by the researchers. These tests will take approximately 60 – 90 minutes of your time to complete.At your usual standard of care, one-year follow-up visit, you will have a cognitive test performed for this research study. This test is called the Montreal Cognitive Assessment (MoCA) and it will add about 15 to 20 minutes to your usual visit. While taking the MoCA test, you may refuse to answer any questions, which may make you feel uncomfortable. There will also be a few additional non-invasive tests similar to your 3-month visit but there will be less of these tests. Potential RisksThe following explains the known risks directly related to this research and approximately how often they may occur. This list of risks is not intended to list every possible risk. We will focus on the risks that commonly exist with heparin treatment or those risks that are uncommon but potentially serious.Heparin RisksLikely:BruisingLess Likely:Minor Liver Injury (Usually temporary when it occurs)Rarely:Blotchy skinKidney damageUpset stomachFever with chillsSwellingSweatingFast heartbeatBleedingDizzinessHigh blood pressureItchingFaintingHeadacheVery Rarely:Heparin Induced Thrombocytopenia – This is a type of heparin allergy that can cause a dangerous drop in platelets (the part of the blood that helps your body form blood clots). If you do have an allergic reaction between the heparin and the platelets, the number of platelets in your bloodstream could dangerously drop and the following may happen: Blood clots form in places they should not be and could cause:StrokeDifficulty breathingHeart attackCan kill parts of the body that aren’t getting blood which can lead to gangrene and amputation.Heparin is a medication that can cause an allergic reaction by reacting with the platelets in your bloodstream. Platelets are fragments (pieces) of a type of blood cell that help form a plug to stop bleeding. This allergic reaction is more common if you have had any heparin within the last 100 days prior to your admission. If you have had any heparin within 100 days prior to your hospital admission you should not participate in this study. It is important to note that the risk of this kind of allergic reaction to heparin is possible even if you are not part of this study. If you are NOT part of this study you will likely still receive heparin shots or a heparin like drug to prevent blood clots in your legs as part of your normal hospital care. BleedingIf you are chosen to receive the intravenous heparin medication, you will likely be getting more heparin overall than you would typically get with just heparin shots. Heparin is commonly used in medicine as a blood thinner (anticoagulant) and when your blood is too thin there is an increased risk of bleeding, OR if you start bleeding you might bleed more and it might be harder to stop the bleeding.The most common reason doctors give patients intravenous heparin is for the purpose of thinning the blood to treat blood clots in the legs or the lungs or to prevent blood clots from forming. The amount of intravenous heparin that you might get related to this study would be less than what doctors typically give to patients when they try to thin the blood. As a result, compared to patients who are getting heparin to treat blood clots, your risk of bleeding should be less overall. We will monitor your blood to see how thin it gets and we will adjust the amount of heparin you are getting and try to prevent it from getting too thin. Your risk of having a bleeding complication during this research study might be slightly higher if you are selected to receive the intravenous heparin compared to the heparin shots, although it is possible to have a bleeding complication even without any heparin medications in your system. We believe your risk of having a major bleeding complication would be less than 5% (less than one person out of 20 people). If you do have a bleeding complication, the blood thinning effects of heparin can be rapidly reversed with a special medication called protamine sulfate. This is a common medication that is available in all hospitals. If you do have a major bleeding event, you might require transfusions of blood or other blood products to prevent additional bleeding or to replace what has been lost from bleeding. If you have a major bleeding event, it is possible (but very unlikely) that you would need an additional surgery to fix the bleeding.Your brain aneurysm will already be “fixed” prior to you being involved in this study. Fixing the brain aneurysm will involve placing small flexible soft wires (coils) usually made of the metal platinum into your aneurysm to fill it up. Once the aneurysm is full of these coils, the blood in the arteries cannot get into the aneurysm anymore and the chance that the aneurysm might burst a second time is extremely low (almost zero). Because your aneurysm will already be “fixed” before you get any of the heparin related to this study, we do not expect to see any subjects have their aneurysm burst a second time because of the heparin. While it is extremely unlikely that the aneurysm will bleed again after it is coiled, in the very rare event that it did bleed again, it might bleed longer or more intensely if you have heparin in your system.We will monitor for any signs of bleeding and if we determine that you are having bleeding, we will immediately stop any heparin you are getting. If the bleeding is serious, we may give the reversal drug protamine sulfate. There may also be other procedures required as part of the study. The risks associated with these procedures are:Blood DrawsThe possible side effects for having your blood taken (drawn) include: Pain from the needle (likely)Bruising (sometimes)Fainting (rarely)Infection (rarely)Damage to blood vessels (rarely) Removing Fluid From the Brain or Spine It is possible that your doctor will determine that it is necessary for you to have a tube inserted into your brain or into your lower back to drain the clear fluid that your brain makes (cerebrospinal fluid) as part of the routine care for your aneurysm. Often this fluid will be pink or red after an aneurysm has burst because the blood has mixed in with the clear fluid. If you have one of these tubes draining this type of fluid, we will collect samples of this fluid as part of this research study. Those samples would typically be collected when you first start the study and four additional times. Removing this fluid is not painful and it does not involve being stuck by any needles. There are some minor risks associated with removing this fluid. The fluid will be removed with a clean sterile technique, but there is still a very small risk that removing the fluid could cause an infection of the tubing or the brain fluid (rarely). If this type of infection occurs, you will receive antibiotics to fight off the infection and you might have to have the tube draining the clear fluid removed or possibly removed and replaced with a new drain. An infection of the brain fluid that does not get better with antibiotics can (very rarely) become severe and could cause brain damage or death. All of these risks discussed are present just because you needed the tube inserted to drain the fluid and you would have these risks even if you were not part of this research study. However, the risk of infection of that fluid may be slightly higher because we are removing the fluid samples for this research study.Blood Clots After having any kind of surgery or procedure (such as having your aneurysm fixed), the risk for getting a blood clot is higher. You will be wearing special sleeves on your legs and/or special stockings to help prevent blood clots from forming in your legs. These sleeves (SCDs) on your legs will fill with air and gently squeeze your legs to keep the blood moving up your legs to help prevent the blood from clotting. Most patients in the hospital who have had an aneurysm burst will wear these SCDs as their routine care. If you participate in this research study, you could be selected to receive the intravenous heparin for up to 14 days. This amount of heparin is usually a little bit more than what you would typically get as a heparin shot to help prevent blood clots, so we think that the risk of you forming a blood clot would be similar to if you were not part of this research study. If you are not selected to receive the intravenous heparin but rather receive the heparin shots, then your risk of forming blood clots should be identical to your risk if you were not in this research study. Symptoms of a blood clot include: Pain in your arms, legs, chest, or other places (depending on where the clot is)Swelling, warmth, redness, leg pain that may get worse when you bend your footDifficulty breathingBlue or whitish colored skinIn extremely severe cases, death. The doctors, nurses, and others caring for you in the hospital will be watching closely for any side effects and will help you if you are having any of these problems. Let your nurses and doctors know if you feel you are getting worse or that you may be having a side effect. There is always a chance that a medicine can hurt you, and there may be side effects that we do not know about yet. Tell us right away if you think you are having a side effect or feel worse so you can get the care you need. In addition, you may suffer unexpected harms that we have not seen before or have not anticipated. Possible Pregnancy Risks If you are female, you should discuss pregnancy risks with your doctor before signing this consent form. Women who are pregnant or breast-feeding may not participate in this research study. If you are pregnant or become pregnant during the heparin treatment, your unborn child may suffer harms that we have not seen before. Heparin is not thought to increase the risk of complications with low-risk pregnancies but there is no guarantee that complications will not happen. If you become pregnant after you leave the hospital but before your 3-month or 12-month follow-up visits, we do not expect any additional risks and you may continue to participate in this research study. Any research related invasive procedures or research related medications have been completed by the time you are discharged from the hospital.Before starting this research study, females able to have children will have a pregnancy test. You should not have sexual intercourse while you are in the hospital recovering from your aneurysm rupture. You do not need to refrain from sexual intercourse after you are discharged from the hospital.The effects of heparin on an unborn baby are extremely low because it does not cross the placenta (the heparin would not get into your baby’s bloodstream). Because the intravenous heparin will be stopped after 14 days and will quickly clear from your system, we do not think there is any risk to you or your unborn baby if you become pregnant after you leave the hospital. Research Involving Genetic InformationA new Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways: Health insurance companies and group health plans may not request your genetic information that we get from this research or use your genetic information when making decisions regarding your eligibility or premiums. Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment. Employers with 15 or more employees, health insurance companies, and group health plans must follow this law. This new law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.BenefitsIf you agree to participate in this research, you may or may not directly benefit from your participation. However, other people who get brain aneurysms in the future may benefit from the information learned during this study. Intravenous heparin has been previously used to help treat patients with brain aneurysms that have ruptured. Intravenous heparin has most extensively been used at the University of Maryland Medical Center in Baltimore, Maryland and at Vidant Medical Center in Greenville, North Carolina. It may have also been used without our knowledge at other medical centers across the United States. In two separate studies, it appeared that human subjects who received the intravenous heparin did better than subjects who only received the heparin shots (which is the normal treatment). In the second study, there was evidence that patients who got the intravenous heparin did better on tests of thinking and memory (cognition) compared to those who only got the heparin shots. These two previous studies were not designed in a way that completely proves that intravenous heparin is better but they do suggest a potential benefit. We are performing this research study to help determine if giving intravenous heparin is safe and beneficial. AlternativesInstead of taking part in this study, you could choose to not participate in this study and you would receive the usual standard of care for your ruptured brain aneurysm. There would be no penalty for choosing not to participate in this study. Research Related Injury If you are injured by being in this research study, the study doctor will arrange for you to get medical treatment. The sponsor, the study site, or your study doctor has not set aside money to pay for treatment of any injury. You and your insurance will be billed for the treatment of these injuries. Before you agree to take part in this research study you should find out whether your insurance will cover an injury in this kind of research. You should talk to the study doctor or staff about this. If you are injured, there is no money set aside for lost wages, discomfort, disability, etc. You do not give up your legal rights by signing this form. If you think you have a research related injury, please call your study doctor (Dr. Robert James; 502-216-0483)CompensationYou will not be compensated for your time, inconvenience, or other expenses while you are in this study.CostsYou will not be billed for the extra office time, tests, medications and procedures that are done for this research study. The charges for these items will be paid for by the Sponsor. These include (intravenous heparin medication, research required blood tests that are not part of the normal standard of care, removal or testing of brain fluid, and the MoCA test and other question type tests at your standard of care, 12-month follow-up visit).You or your insurance company will be billed for all office visits, tests, medications and procedures that are part of your routine medical care outside of this research study. You will be responsible for paying your co-pay that is associated with any office visit, test, medication or procedure. Very rarely, some insurance companies will not pay for medical bills for people who participate in a research study. It is your responsibility to find out what costs, if any, your insurance company will cover before taking part in the study. If you need help finding out what your insurance company will cover, please ask your study doctor for assistance. If your insurance company does not pay for your bills associated with this study, you will be responsible for paying them.If you are injured, there will be additional costs to you for participating in this research study.HIPAA Research Authorization The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides federal safeguards for your protected health information (PHI). Examples of PHI are your name, address, and birth date together with your health information. PHI may also include your medical history, results of health exams and lab tests, drugs taken and results of this research study. Your PHI may not be used or shared without your agreement, unless it meets one of the HIPAA exceptions. State and federal privacy laws protect your health information. In most cases, health information that identifies you can be used or shared by the research team only if you give your permission by signing this form. If you sign this form your health information will be used and shared to answer the research questions described above and to make sure that the research was done correctly. The time period when information can be used or shared ends when all activities related to this study are completed. Your access to your health information will not be limited during this study. You do not have to sign this form. If you do not sign this form you may not participate in the study and health information that identifies you will not be shared with the research team. Site(s) where health information about you will be used or shared for this research:In our research, the research team will look at and may share information about you and your health. Federal law requires that health care providers and researchers protect the privacy and security of health information that identifies you. We may ask for your health information from the following:Affiliated Sites:University of LouisvilleJewish Hospital & St. Mary’s Healthcare Norton Healthcare, Inc., including Kosair Children’s HospitalUniversity of Louisville Hospital / J. Graham Brown Cancer CenterUnaffiliated Sites: Baptist Health SystemYour doctor and/or medical facility where you may have previously received treatment related to your condition and/or any doctor and/or medical facility where you may receive treatment while participating in this study.University of Louisville Research Foundation (ULRF) Clinical Sites:Clinical Trials Unit (CTU) outpatient clinicFaculty Practice Group Sites:University of Louisville Physicians (ULP)Protected health information (PHI) that will be used or shared for research Consultation reportsQuestionnairesDischarge summariesSpecimens (blood or cerebrospinal fluid)Healthcare provider ordersHistory and physical examsLaboratory, x-ray, and other testsRecords of your operation(s) or other procedure(s)Medical progress notesPhotos, videotapes, or digital or other imagesRecords about the study drug and other drugs you may be takingRevocation of Research AuthorizationYou may cancel the permission you have given to use and share your protected health information at any time. This means you can tell us to stop using and sharing your protected health information. If you cancel your permission:We will stop collecting information about you.You may not withdraw information that we had before you told us to stop.We may already have used it or shared it.We may need it to complete the research.Staff may ask your permission to follow-up with you if there is a medical reason to do so.To cancel your permission, you will be requested to complete a written “Revocation of Research Authorization” form located at the end of this document. You may also obtain a copy from your study doctor, designated personnel or from the Human Subjects Protections Program Office website (). Information Available on A description of this clinical trial will be available on , as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the overall results. You can search this website for the term “ASTROH” at any time to find the study on the website.ConfidentialityTotal privacy cannot be guaranteed. We will protect your privacy to the extent permitted by law. If the results from this study are published, your name will not be made public. Once your information leaves our institution, we cannot promise that others will keep it private. Your information may be shared with the following:The sponsor Robert F. James, MD, and others hired by the sponsor to oversee the researchThe University of Louisville Institutional Review Board, Human Subjects Protection Program Office, Privacy Office and others involved in research administration at the UniversityThe local research team (University of Louisville Clinical Trials Unit; Dr. Shesh Rai clinical trials biostatistician)Researchers at other sites participating in the study (Dr. David J. Fiorella at Stonybrook University Medical Center (Imaging core lab); OCULUS Imaging (Dr. Keith Woodward, Vista Radiology, Knoxville, TN and other OCULUS Imaging staff); Dr. Marc Simard at the University of Maryland School of Medicine; Bree Burks at Vanderbilt University who is consulting on this research study for REDCap database development and others.People who are responsible for research and HIPAA oversight at the institutions where the research is conductedYour protected health information will be shared through various means of communication of information including possibly via telephone, mail, email, facsimile, REDCap database access, OCULUS Imaging database access, or other meansPeople responsible for billing, sending and receiving payments related to your participation in the study Government agencies, such as: Office for Human Research Protections Office of Civil RightsFood and Drug Administration Data Safety Monitoring Board(s), the Clinical Events Committee, the Medical Safety Monitor, and the ASTROH steering committee related to the study Dr. Erik Everhart, neuropsychologist at East Carolina University, Greenville, North CarolinaOthers who may have responsibilities to this research studySecurity The majority of the data collected about you will be kept private and secure in a HIPAA compliant, encrypted, electronic data capture system known as REDCap. This system is encrypted and password protected. Only study personnel will be given user accounts and passwords that allow access to your protected health information related to this study. Any data collected in paper format will either be uploaded into REDCap and then the paper copy destroyed or certain paper copies of data may be stored in a locked filing cabinet within a locked office. Additional data will be kept in a HIPAA compliant, encrypted, imaging data capture system known as OCULUS and which again will have restricted access only to study personnel. Conflict of Interest This study involves a conflict of interest because the institution and investigator will be compensated for your participation. This compensation is used to pay for the costs of doing this study. If you want to know, please ask the investigator how the institution and investigator will benefit by your participation in the study. This compensation is provided by research grants and donations obtained by the sponsor, Robert James, MD. This compensation is only enough to cover costs. This study will not generate any financial profit for the institution or investigators. The sponsor and investigators will not have any increase in their salary or any financial bonuses related to any compensation for this study.Voluntary ParticipationTaking part in this study is completely voluntary. You may choose not to take part at all. If you decide not to be in this study, you won’t be penalized or lose any benefits for which you qualify. If you decide to be in this study, you may change your mind and stop taking part at any time. If you decide to stop taking part, you won’t be penalized or lose any benefits for which you qualify. You will be told about any new information learned during the study that could affect your decision to continue in the study. If you decide not take part in this study or stop taking part in this study you will still receive your usual medical care related to your brain aneurysm.TerminationYour study doctor or the study sponsor has the right to stop this study at any point. Your study doctor may take you out of this study with or without your okay. Reasons why this may occur include: The study treatment is found to be unsafeThe study treatment is found to be much better than normal care If you have a reaction to the study medication or a complication related to the study medicationIf you do not follow the directions of the study doctor or study staff If you stop taking part in this study, it could harm you. For your own safety, you may need additional blood tests to make sure the heparin has left your system. We think the risk of harm to you for stopping this study early is minimal.Participation in Other Research StudiesYou may take part in this study if you are currently in another research study as long as that other research study does not prescribe a specific treatment or medication and does not require invasive testing beyond the normal standard of care during the course of this study. It is important to let your doctor know if you are in another research study and he will determine if it is safe for you to also participate in this study.Contact PersonsIf you have any questions, concerns, or complaints about the research study, please contact please call your study doctor, Dr. Robert James at 502-216-0483 or Ann Jerde, RN, at (502) 852-5251.Research Subject’s RightsIf you have any questions about your rights as a research subject, you may call the Human Subjects Protection Program Office at (502) 852-5188. You may discuss any questions about your rights as a research subject, in private, with a member of the Institutional Review Board (IRB). You may also call this number if you have other questions about the research, and you cannot reach the study doctor, or want to talk to someone else. The IRB is an independent committee made up of people from the University community, staff of the institutions, as well as people from the community not connected with these institutions. The IRB has approved the participation of human subjects in this research study. Concerns and ComplaintsIf you have concerns or complaints about the research or research staff and you do not wish to give your name, you may call the toll free number 1-877-852-1167. This is a 24-hour hot line answered by people who do not work at the University of Louisville. Acknowledgment and SignaturesThis informed consent document is not a contract. This document tells you what will happen during the study if you choose to take part. Your signature indicates that this study has been explained to you, that your questions have been answered, and that you agree to take part in the study. You are not giving up any legal rights to which you are entitled by signing this informed consent document. You will be given a copy of this consent form to keep for your records. _________________________________________________________________________________Subject Name (Please Print)Signature of Subject Date Signed_________________________________________________________________________________________Printed Name of Legal Representative (if applicable)Signature of Legal Representative Date Signed ___________________________________________ Relationship of Legal Representative to Subject_______________________________________________________________________________________Printed Name of PersonExplaining Consent FormSignature of Person Explaining Date SignedConsent Form (if other than the Investigator) _________________________________________________________________________________________Printed Name of InvestigatorSignature of InvestigatorDate Signed______________________________________________________________________________________________List of Investigators:Phone Numbers:Robert F. James, MD502-587-2805Jerrad Businger, DO502-852-3763REVOCATION OF AUTHORIZATION FOR USE AND DISCLOSURE OF YOUR HEALTH INFORMATION FOR RESEARCH3873500-7620Institutional Review BoardMedCenter One, Suite 200501 E. BroadwayLouisville, KY 4020200Institutional Review BoardMedCenter One, Suite 200501 E. BroadwayLouisville, KY 40202Return To:1333532385PI Address:220 Abraham Flexner Way Louisville, KY 40202PI Phone: 502-587-280500PI Address:220 Abraham Flexner Way Louisville, KY 40202PI Phone: 502-587-280532137357620OR00OR13335252095Do not sign this letter unless you are withdrawing from this research. You will be sent confirmation that this notice was received.00Do not sign this letter unless you are withdrawing from this research. You will be sent confirmation that this notice was received.To Whom It May Concern:I would like to discontinue my participation in the research study noted above. I understand that health information already collected will continue to be used as discussed in the Authorization I signed when joining the study.Your options are (choose one):Withdraw from Study & Discontinue Authorization:Discontinue my authorization for the future use and disclosure of protected health information. In some instances, the research team may need to use your information even after you discontinue your authorization, for example, to notify you or government agencies of any health or safety concerns that were identified as part of your study participation. Withdraw from Study, but Continue AuthorizationAllow the research team to continue collecting information from me and my personal health information. This would be done only as needed to support the goals of the study and would not be used for purposes other than those already described in the research authorization._____________________________________________________________________________________Printed Name and Signature of SubjectDate Signed_____________________________________________________________________________________Signature of Subject’s Legal Representative (if subject is unable to sign)Date Signed_____________________________________________________________________________________Printed Name of Subject’s Legal Representative Birthdate of Subject_________________________________________________Relationship of Legal Representative to Subject_____________________________________________________________________________________Subject’s AddressSubject’s Phone NumberOptional:I am ending my participation in this study because: ________________________________________________________________________________________ ................
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