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Research Subject Information and Consent FormProtocol Title: DiabeteS AUtoimmuNity WithdRawn In New OnSEt and In Established Patients (SUNRISE):A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety of TOL-3021 in Patients with New Onset or Established Type 1 Diabetes MellitusProtocol Number: TOL-3021-231Sponsor: Tolerion, Inc.Sponsor Principal Investigator: Dr. Jay SkylerSite Principal Investigator: Dr. Darrell WilsonFor California participants: Before you read this consent form, please read and sign a copy of the California Experimental Subjects Bill of Rights. Ask the study staff for a copy of this document if you have not already received one.WHY AM I BEING ASKED TO TAKE PART IN A RESEARCH STUDY?You are asked to participate in this research study because you have Type 1 diabetes mellitus (T1D). We do research studies to try to answer questions to try to prevent, diagnose, and treat diseases like TID. This study (SUNRISE) currently only enrolls subjects 18-40 years old.WHO CAN I TALK TO?If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research team at Darrell M. Wilson, MD at 650-721-1811.This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may talk to them at 301-296-5943 or at primereviewboard@ if:Your questions, concerns, or complaints are not being answered by the research team.You cannot reach the research team.You want to talk to someone besides the research team.You have questions about your rights as a research participant.You want to get additional information or provide input about this research.WHY IS THIS RESEARCH STUDY BEING DONE?The primary purpose of this study is to evaluate the safety of the agent (TOL-3021) in people with Type 1 diabetes mellitus (T1D) -- in other words, to find out if the agent has any serious or harmful side effects. The study will also see if adding the study agent to standard care has any benefits for the treatment and management of T1D. Patients with T1D have an abnormal response in their immune system that results in damage to the cells that make insulin. Usually the body's immune system attacks only substances that are foreign to the body, but in people with type I diabetes, insulin itself appears to be involved in causing the immune system to attack the insulin secreting cells in the pancreas. This abnormal immunity causes the beta cells in the pancreas to stop producing insulin. TOL-3021 is an investigational therapy that may decrease this abnormal immunity to insulin and decrease damage to the insulin-producing cells in the pancreas. TOL-3021 is a circular strand of DNA, which is called a plasmid. The DNA in this plasmid has the gene code for instructing cells to make a larger version of insulin called proinsulin (hProIns). Though TOL-3021 contains the gene that codes for proinsulin, this strand of genetic material does not become a part of your genetic code. This gene in the plasmid is taken up by cells of the immune system and it tells these cells to make proinsulin. This proinsulin is not released from the cells, but the proinsulin stays in the immune cells for about a day. . The presence of proinsulin within the immune cells appears to cause the immune system to reduce its attack on the insulin-secreting beta cells. Because this therapy is made of the proinsulin gene, and this gene is transferred into the body, it is considered a form of gene therapy. Unlike gene therapies that are intended to modify a person’s genetic code permanently, the TOL-3021 genetic material does not stay in the body. It is designed to cause proinsulin to be made in the immune cells for a brief period so that the immune attack against beta cells might be reduced, and insulin secretion can be maintained.If you take part in this study, you will continue to receive the usual standard care that your doctor has prescribed for your T1D.You will also receive either TOL-3021 (the study agent) or a placebo (inactive agent) in addition to your regular care. This will be further explained in the next sections of this consent form.T1D develops in people when the immune system attacks the cells in the pancreas that make insulin. If this immune attack can be reduced, some ability to release insulin may be preserved. We are doing this study because we want to find out if there are any serious or harmful side effects or other unknown risks of the study agent (TOL-3021) in people with T1D. We also want to see if giving TOL-3021 can reduce the attack of immune cells that may damage the insulin-producing cells in patients with T1D. We want to know if this agent can preserve some natural insulin production which could have the benefits of more control of glucose (sugar) levels with injected insulin and reduced risk of hypoglycemia (low blood sugar). This study will help us to evaluate the safety and effectiveness (how well the agent works) of adding the study agent TOL-3021 to the usual care of insulin therapy. We are doing this study because we want to find out if this agent can be of help or have safety problems when added to the usual care of T1D.TOL-3021 is not approved by the US Food and Drug Administration (FDA) to treat T1D, though it has been tested extensively in animals and in one study of people with T1D. This study will help us to determine if TOL-3021 is safe. We hope the results of this research study will give us important information and greater understanding of how the study agent works. The study agent, TOL-3021, will be compared to a placebo (an inactive agent), which means there is a chance you will not receive the study agent if you choose to participate in this studyHOW MANY PEOPLE WILL TAKE PART IN THIS RESEARCH STUDY?Approximately 90 patients will be in this research study at about 15-20 study sites. Each study site will enroll about 5-6 patients.HOW LONG WILL THE RESEARCH LAST?There will be a screening period of up to 4 weeks to determine if you qualify to be in the study. If you are qualified and decide to participate, you will be in the study for 52 weeks of the study agent, and then follow-up visits 2 weeks after the end of receiving the study agent (week 54) and at 18 months (week 78), 24 months (week 104), and 36 months (week 156). The total length of the study will be approximately 3 years long. WHAT HAPPENS IF I SAY: YES, I WANT TO BE IN THE STUDY?ScreeningIf you agree to be in this study you will sign this consent form and you will have several medical tests to determine if you qualify for the study. These will include: Your medical history. A review of medications you are taking including your insulin use.A physical examination including your height and weight. Vital signs (heart rate and blood pressure), and a urine pregnancy test (if you can get pregnant). A urine sample will be collected.A urine collection at home over a 24-hour period that you will return to the study site may be collected depending on results of your urine sample analysis.Blood will be drawn (about 45 mL which is about 3 tablespoons) for laboratory tests, including tests for HIV and Hepatitis B and C, to determine your general health, your blood sugar control in the past few weeks, and some features of your immune system. A photograph of your retina will be taken if you have not had one in the last 3 months..Your medical charts from your regular doctor may also be reviewed.You will have blood drawn for an A1c level.You will have a Mixed Meal Tolerance Test (MMTT).You will begin Continuous Glucose Monitoring (CGM) that will last through the 52 week study, and possibly through week 54. A Dexcom G6 CGM and related supplies will be provided to you. This device provides minute-by-minute information about which way and how quickly your blood sugar levels are changingIf you agree to be in the study you will have 22 visits. The procedures to be done at study visits are listed below and are also in the tables at the end of this form. All study visits will be at the study site where you will be seen by the study doctor and/or other study staff members.HIV AND HEPATITIS TESTING As required by the study and if any person is exposed to your blood, you must have your blood tested for the hepatitis viruses and for HIV. HIV is the virus that causes AIDS. If you have a positive HIV or hepatitis test you cannot be in the study. If the HIV test is positive, a follow-up test will be done. If the follow-up test is also positive, you will be told in private and you will also be told about counseling. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Positive test results may be required to be reported to the State Department of Health. If you have any questions about what information is required to be reported please ask the investigator or study staff. Although this testing is supposed to be private, this cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.Mixed Meal Tolerance Test (MMTT)You will have a test called the Mixed Meal Tolerance Test (MMTT) at screening and during the study. This test is done to find out how much insulin someone with Type 1 diabetes mellitus (T1D) produces in their pancreas. This test will be done at screening and during visits at 12, 16, 24, and 52 weeks of the main study and at months 6, 12, and 24 of the two year follow-up phase. The two year follow-up phase is described later in this document. Approximately 88 mL of blood, (6 tablespoons) will be drawn during each of the MMTT tests. These are the important procedures for your MMTT visits:You will fast from 10:00 the night before the MMTT (no food or drink other than water)You must arrive at the study site between 7:00 AM and 10:00 AM.Your study doctor will advise you on what rapid-acting insulin dose to use on the morning of the test. You may need to take extra so that your blood glucose is in range at the time of arrival. If you use R insulin, you should not take a dose within 6 hours before the start of the test.Preparation will take 1-2 hours and the MMTT will last for 4 hours. You will have a catheter (a very small plastic tube just like those used to give intravenous fluids in the hospital) put into a vein in your arm to collect blood so that you do not have to be stuck with a needle each time. The catheter will stay in place until the end of the test. You will drink a liquid meal called Boost? and have 11 blood samples taken during the 4-hour test. During each MMTT, you will have about 88 mL (about 6 tablespoons) of blood drawn.RandomizationIf you are eligible to be in this study, you will be randomly assigned to get TOL-3021 (the study agent), or placebo (a solution that looks like TOL-3021 but does not contain the active ingredient). Randomly assigned means you or the study doctor cannot choose if you get the study agent or placebo. You will have 2 in 3 chances (67%) of getting TOL-3021 and 1 in 3 chances (33%) of getting placebo. You, your doctor and other study staff (including Tolerion) will not know if you are getting the study agent or the placebo during the study. TOL-3021 or placebo will be given as an injection into a large muscle in your upper arm, upper leg, or buttocks once a week for 52 weeks. You will be asked again about your medical history and the study team may re-review your medical chart. If you are able to become pregnant, you will have a urine pregnancy test. You will be asked to keep a personal diary and instructed on its use.The diagrams below shows the overall schedule for the study and the study randomization. Managing Blood SugarThe Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The Dexcom G6 system also aids in the detection of hyperglycemia (high blood sugars) and hypoglycemia (low blood sugars) and helps to guide you and your healthcare providers in adjusting your insulin doses, as needed. The Dexcom G6 also communicates the data digitally with other devices and will allow you and your study team to closely monitor your blood sugar levels. You will wear the device throughout the duration of this study, up to 54 weeks.You will receive extensive training on how to use the device and how to make treatmentdecisions based on the readings from this device.The User’s Guide is available for you to review and you are encouraged to ask the study doctor any questions you have prior to signing this consent form. A few important notes about this device include:Adults will insert the sensor in to the abdomen.The sensor is inserted by an applicator containing a needle holding the sensor. The applicator deploys the needle and inserts the sensor under the skin. The needle automatically retracts back into the applicator after insertion.The sensor can be worn up to 10 days. During your time in this study, you will replace the sensor every 10 days.The G6 components are NOT compatible with the previous Dexcom products. If you have used a previous Dexcom product, you cannot use any of those components (receiver, transmitter or sensor) with the G6 system.When traveling, you should request a hand-wand or full-body pat-down instead of going through the body scanner at an airport security checkpoint. You may wear the G6 for the walk-through metal detector. Additionally, you should not put the receiver or transmitter through the baggage x-ray machine.If you need to have an MRI, CAT scan or receive Diathermy treatment, YOU MUST REMOVE the G6 sensor from your body while having the procedure.The device will be provided to you at no cost. If you wish to continue use of the device after completion of the study, a member of the research team will help you to contact your insurance company to see if continued use of the device can be covered under your current insurance plan.Study Injections (TOL-3021 or Placebo)While you are in this study, injections of TOL-3021 or placebo are required every week for 52 weeks. The amount injected into your muscle is about 0.5 cc’s. The injection will be made into a muscle, in your upper arm, your thigh, or your buttocks. This type of injection is similar to a vaccination. It is different from your insulin injections that are given with a small needle that goes just under your skin. The TOL-3021 or placebo injection goes into a muscle. Injections will be given at the study site at Randomization and at Weeks 1, 2, 3 and 4. After that the injections will be done at home. You may give the injection to yourself or a caregiver at home may give the injections. You and any designated caregiver will be trained by the study staff during the previous visits so that you know how to give the injections and how to check for any reactions. You will be given detailed instructions about the injections to take home. The study staff will review these instructions with you to be sure you understand what you must do. You may be asked to take a picture of your injection site and send it to the study staff so they can check it. Visits During first 4 weeks and Monthly VisitsDuring the first 4 weeks of the study you will have a visit every week. After the first 4 weeks of the study, you will have visits at the study site every month. At every visit you will have evaluations to monitor how you are doing, what medications you have been taking in the past 3 months, and you will be asked about any side effects you might have had. Vital signs, including weight, will be recorded at every visit. The entries you made into your diary will be reviewed by study staff and may be discussed with you.At the Week 12, 24, 36, and 52 visits, you will also have a follow-up physical examination.At Week 24, you will have approximately 10mL (less than 1 tablespoon) of blood drawn for routine laboratory tests in addition to the blood being drawn for the MMTT. At Week 36, you will have approximately 20 mL (less than 2 tablespoon) of blood drawn. You will be asked to bring all used study vials with you to your appointments at weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48.If you are a female who is able to become pregnant, you will have a urine pregnancy test at weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48.Weeks 52 and 54 Visits At Week 52, you will have an additional 30 mL of blood (less than 3 tablespoons) drawn for routine laboratory and immune system tests. and 88 mL (approximately 6 tablespoons) of blood during the MMTT. Also, at Week 52, you will be asked to bring all used study vials with you to your appointment. In addition, if you are a female who is able to get pregnant, you will have a urine pregnancy test done at Week 52. You will have one follow-up safety visit at the study site at approximately 2 weeks after the last main study visit (Week 52), or after your last visit if you ended the study early for any reason. At this visit, you will have:A photograph of your retina.A physical examination, measurement of vital signs and weight.Collection of a urine sample for routine analysis, and a urine pregnancy test (if you can get pregnant). If you had to collect a 24-hour urine during screening, you will do a urine collection done at home over a 24-hour period that you will return to the study site.Blood will be drawn (about 10 mL which is less than 1 tablespoon) for routine laboratory tests. You will be asked if you had any side effects since your last visit. Two Year Follow-up VisitsAs part of this study, you will also be in a 2-year follow-up phase to evaluate long-term safety. You will not receive any study injections (TOL-3021 or placebo) during this period, but you will have visits to the study site at week 54 and 6, 12, and 24 months after the Week 52 visit in the main study. During those visits you will have a physical examination including weight, assessment of vital signs (heart rate and blood pressure), blood and urine sample tests to evaluate your general health, an MMTT, and a review of any adverse events and other medications you have used. At each of these visits you will have about 98 mL (approximately 7 tablespoons) of blood drawn. In addition, at Month 12 and Month 24 after the Week 52 visit in the main study, you will also have a dilated eye exam.DiaryYou will be asked to complete a diary to record certain events during the study for 52 weeks. The diary, which will be provided to you, will ask questions about administration of your study injection (TOL-3021 or placebo), and any events of hypoglycemia. The diary will be put on your smartphone or other electronic device and the information will be sent directly to the study site. You will use the diary during the 52 week main study. After that the diary access will be deleted from your device. If you do not have an electronic device to use, you will be given a paper diary to collect the information. Additional InformationBefore you complete the study, you may also be offered the opportunity to be in an extension study. The extension study would allow for continuation of the study agent (TOL-3021), if you were in the group receiving the study TOL-3021), or to start the TOL-3021 if you were in the placebo group. There might be benefits to continuing TOL-3021 agent if you were in that group and to starting TOL-3021 agent if you were in the placebo group. The extension study would last for at least 1 year. You do not have to go in the extension study. We are not sure if this extension study will take place. If the extension study does go ahead, you will be told about it before you finish this first study, and you will be get more information to help you to decide whether to be in the extension study. Your visits to the study site will take approximately the following amount of time:Screening: 2-3 hoursMMTT Visit during Screening period: 6 hoursRandomization: 1 hourMMTT at Weeks 12, 16, 24, and 52: 6 hoursOther visits: 1 hourFollow-up visit at Week 54: 1 hour Follow-up visits at Months 6, 12, and 24 after the Week 54 visit, including MMTT: 6 hours WHAT ARE MY RESPONSIBILITIES IF I TAKE PART IN THIS RESEARCH?If you volunteer to be in this study, you will be expected to keep your appointments, receive or administer injections each week, and have the tests and procedures described in this consent form. You will also be expected to complete your diary each day and report any side effects you may experience. You should contact your study doctor at any time if you feel unwell or experience any side effects that you think are from the study injections (TOL-3021 or placebo).You will be asked if the study doctor can receive some records from your regular doctor. These will help the study doctor to see if you are eligible for the study. Your regular doctor might also share information that he or she thinks is important for your study doctor to know as part of good medical care. If you agree, this information will be handled confidentially, just like your individual data and information from the study. If you are sexually active and you or your partner are able to get pregnant, you are expected to use a medically acceptable form of birth control. This is described in greater detail under the risk section of this consent form. Initials: ________ Before receiving any routine vaccinations (e.g. influenza vaccination), you should contact your study doctor and the treating physician.WHAT HAPPENS IF I DO NOT WANT TO BE IN THIS RESEARCH?Being in this research is completely voluntary. You can decide if you want to be in the study or not. You will not be penalized if you decide you do not want to be in the study. Your choice will not affect any treatments or benefits that you would otherwise receive as part of your medical care at this site. WHAT HAPPENS IF I SAY YES BUT CHANGE MY MIND LATER?If you choose to participate, you can change your mind at any time without penalty. If you decide to quit the study after you have had at least one dose of study injection (TOL-3021 or placebo) you will be asked by your study doctor to complete a final safety evaluation. If you withdraw from the research study, data already collected will not be removed from the study database. You must return any unused study injections (TOL-3021 or placebo) and any other study related materials that were given to you. Even if you decide to stop receiving the study agent, you will be asked to stay in the study if you are willing to go to the study visits and have the scheduled tests so safety data can still be collected. You do not have to do this. It will be up to you to decide.IS THERE ANY WAY BEING IN THIS STUDY COULD BE BAD FOR ME?The agent in this study could make you feel sick or itchy, have pain, or have a hard time running, eating, or doing other things. These could be small problems that go away quickly, or they could be more serious problems that require you to go to the hospital. This is why you would have a lot of check-ups and medical tests. The doctor wants to make sure that you are okay and to take care of problems right away. The study agent and procedures involved in this study may have unexpected risks that are impossible to predict. These unforeseen risks may affect you during your participation in the study and/or at some point in the future. Getting TOL-3021 may have other risks or discomforts that are not known or expected at this time.Study Agent or ProcedurePossible RisksStudy agent TOL-3021Feeling itchyFeeling sick, throwing upFeeling tiredFever, chills IndigestionHeadacheAbdominal discomfortInjection site painNauseaDiarrheaAcneAllergic reaction including anaphylaxisStudy injection reactionsPain at the injection siteTingling and numbnessRedness, itchinessSwellingWarmth at the injection siteDrainage at the injection siteBleedingGetting blood drawnPain, bruising, or infectionFaintingMMTTPain, bruising, bleeding, infectionNausea, fainting HyperglycemiaVomitingCGM devicePain, bleeding, or infectionSensor coming loose from exercise or bumping into things. If this happens, you will be asked to repeat the CGM test.The sensor membrane will stay in your skin each time the CGM is removed. There are no known long-term health effects of this, though there may be some for you.Eye PhotographBrief discomfort from a bright flashOther RisksUnknown risk to a fetusHarder time controlling your blood sugarNeed for more insulin to control your diabetes Abnormal blood testsAlso, important to know is that the risks of receiving vaccinations, such as flu shots, while also receiving TOL-3021 are not known. At this time we do not have reasons to believe that TOL-3021 will interfere with vaccines or that vaccines could interfere with the effects of TOL-3021, but either is possible. If you are advised to receive a vaccination or know that you are due for a vaccine such as for influenza or pneumococcal pneumonia, you should first discuss this with your doctor and the study physician. You should report any vaccinations received during the study to one of the study site personnel. You should avoid receiving vaccinations in the same muscle as your study injections.Reproductive RisksThe risks of TOL-3021 on the fetus and your ability to have or to father children are not known. Because of this you must agree to use birth control throughout the study if you or your partner are able to get pregnant. If you are sexually active and can get pregnant or can impregnate someone, you should use a medically effective form of birth control (such as hormonal contraceptives (e.g., birth control pills, transdermal patch, progestin implant or injection, vaginal ring), intrauterine devices (IUD), condoms, spermicidal foam, abstinence or surgical sterilization) while you are on the study. You should continue to use birth control until three months after you receive the last study injection. If you become pregnant while participating in this study, you must inform the study team. You will no longer receive any additional study medication. We will ask you if we can follow up with you for information about your pregnancy for ongoing health and safety information through the conclusion of your pregnancy. If your partner becomes pregnant while on this study, we will ask her to participate in a survey about her pregnancy. Once you have the baby, please inform the site. You may be asked about the health of your baby. You can refuse to provide this information. Upon your completion in the study, whether by early termination or finalization of all study procedures, you should discuss with your study doctor the estimated days for recovery from study interventions and/or study procedures. If you experienced adverse events related to your study participation, your recovery may be longer.WILL BEING IN THIS STUDY HELP ME IN ANY WAY?We cannot promise any benefits to you or others from your taking part in this research. If this agent is effective for diabetes, your condition may improve, but this is not known for sure. Your participation in this study may add to the medical knowledge about the treatment of diabetes. You may receive no benefit from your participation in this study. You have a 33% chance of receiving placebo and, therefore, any benefits from study agent would not be available.WHAT HAPPENS TO THE INFORMATION COLLECTED FOR THE RESEARCH?You will be given a unique number to identify you in all study records. Only your study doctor and the research staff will have access to records that link your identity to the research records. In certain circumstances, the study sponsor or its agents may review those records; however, these study-related parties are required by law to maintain the confidentiality of the information they view there. All data that we collect will be stored in a study database located on a secure server to keep this information safe and, with respect to CGM data, on a secure server owned and managed by a vendor of the sponsor. In these databases, you will not be identified by name, social security number, address, or telephone number. You will just be identified by a unique code number. The database will include your date of birth, gender, and date of each study visit and data automatically collected by the CGM device. The list that includes the code number and your name and/or other personal identification is confidential and will be kept secure by the study team. When the study is over, your name and other identifying information will be removed from the data you provided. That data, without any information that could identify you, may be used for future studies.Efforts will be made to limit the use and release of your personal information, including research study and medical records, to people who need to review this information. Representatives of the study sponsor or its agents, the US Food and Drug Administration (FDA), other regulatory authorities, and this medical center may inspect your study site, hospital, and research records to review the data collected for this study. The results of this research study may also be published in scientific journals and/or be presented at scientific meetings without further permission from you, but your identity will not be revealed. Every attempt will be made to keep your participation in this research study and your records confidential, but we cannot guarantee absolute confidentiality. There is a potential risk of loss of confidentiality. Information from which you may be personally identified will be maintained in a confidential, secure location at this site. Such information will be accessible only to authorized members of the research study team and will not be disclosed to third parties except as described in this consent form, with your permission, or as may be required by law. If you participate in the study and later withdraw your consent for any further participation, your study doctor will not collect any more information about you for this research study. Researchers will use the information collected for this research study before you withdrew your consent. As mentioned previously, you may withdraw your permission to receive the study agent in the study, but you may continue to participate in some or all other aspects of the study if you wish. A description of this research study will be available on , as required by U.S. Law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.Authorization To Use Your Health Information For Research Purposes?Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it. What is the purpose of this research study and how will my health information be utilized in the study?We are doing this study because we want to find out if there are any serious or harmful side effects or other unknown risks of the study agent (TOL-3021) in people with T1D. We also want to see if TOL-3021 can reduce the attack of immune cells that may damage the insulin-producing cells in patients with T1D. We want to know if this agent can preserve some natural insulin production which could have the benefits of more control of glucose (sugar) levels with injected insulin and reduced risk of hypoglycemia (low blood sugar). This study will help us to evaluate the safety and efficacy (how well the agent works) of adding the study agent TOL-3021 to the usual care of insulin therapy. We are doing this study because we want to find out if this agent can be of help or have safety problems when added to the usual care of T1D. The data will be submitted to the FDA.Do I have to sign this authorization form?You do not have to sign this authorization form. But if you do not, you will not be able to participate in this research study including receiving any research-related procedures. Signing the form is not a condition for receiving any medical care outside the study.If I sign, can I revoke it or withdraw from the research later?If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to: Dr Darrell Wilson, MD, G313 Medical Center, Stanford CA 94305.What Personal Information Will Be Obtained, Used or Disclosed?Information about you related to this study may be used or disclosed, including, but not limited to, personal health information and other information that could identify you. This includes your name, address, telephone number, date of birth, and information about medical tests and procedures. Medical records made before the start of the study and made during the study can contain personal health information.Who May Use or Disclose the Information?The following parties are authorized to use and/or disclose your health information in connection with this research study:The Protocol Director Darrell M. Wilson, MDThe Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessaryResearch StaffWho May Receive or Use the Information?The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study: The Office for Human Research Protections in the U.S. Department of Health and Human ServicesAuthorized personnel from Tolerion, Inc., the company sponsoring this study, and parties acting on behalf of Tolerion, Inc., including its agents and vendors who are helping to carry out the study,Health authorities (e.g., the U.S. FDA),Prime Review Board, LLC, Other government, regulatory, or oversight organizations.Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.When will my authorization expire?Your authorization for the use and/or disclosure of your health information will end on 14 June 2051 or when the research project ends, whichever is earlier. Will access to my medical record be limited during the study?To maintain the integrity of this research study, you may not have access to any health information developed as part of this study until it is completed. At that point, you would have access to such health information if it was used to make a medical or billing decision about you (e.g., if included in your official medical record). ________________________________? ______________Signature of Adult Participant Date________________________________? Print Name of Adult Participant WHAT WILL HAPPEN WITH MY BLOOD SAMPLES?Some of the blood you give will be used to monitor your immune response as a key part of the testing to be completed in this study. After these tests are done, any remaining samples will be stored (without your personally-identifiable information) for future research by the study sponsor. This research may include other tests that could assist the study sponsor in its efforts to develop new diabetes therapy options. This may include new tests of immunity, prognosis of T1D, and quality assurance. The samples will not be used for genetic testing. The choice to keep left-over samples for future research use is up to you. If you want your samples destroyed after this study is complete, you should inform your doctor. If you decide now that your samples can be kept for research, you can change your mind at any time; contact your study doctor and let him/her know that you do not want Tolerion, Inc., to use your samples, and they will be destroyed after this study is completed.I consent that my blood samples can be stored for future use. 9126915206800165407113572900 YESNO (please initial appropriate box)WHAT ARE THE COSTS OF BEING IN THIS STUDY?If you participate in this study, the study will pay for those services, supplies, procedures, and care associated with the study that are not a part of your routine medical care. However, there may be additional costs to you. These include basic expenses like transportation and the personal time it will take to come to the study visits. You and/or your health insurance must pay for services, supplies, procedures, and care that are required during this study for routine medical care. You will also be responsible for any co-payments and/or deductibles as required by your insurance. Participation in this study is not a substitute for health PENSATION FOR BEING IN THE STUDYYou will be paid for being in this study. You will be asked to complete twenty-two in-clinic visits throughout the study and you will be paid with a gift card valued at $100.00 for your time at the end of each of these in-clinic visits. If you completed all scheduled visits, you will have received gift cards totaling $2,200.00 for the entire study. COMPENSATION FOR INJURYAll forms of medical diagnosis and treatment – whether routine or experimental – involve some risk of injury. In spite of all precautions, you might develop medical complications from participating in this study. If such complications arise, the Protocol Director and the research study staff will assist you in obtaining appropriate medical treatment. In the event that you have an injury or illness that is directly caused by your participation in this study, care will be provided to you. You will not be responsible for any of these costs. If you receive Medicare benefits, and if the sponsor of this study pays for any study-related treatment, complications or injuries, personal information about you, your treatment, and your participation in this study will be provided to the sponsor, who is required by law to provide it to Medicare. You do not waive any liability rights for personal injury by signing this form.If you experience any side effect during the study, you should immediately contact Dr Darrell M Wilson at 650 721 1811 or one of the study team members at your site.CAN I BE REMOVED FROM THE RESEARCH WITHOUT MY OK?The person in charge of the research study or the sponsor can remove you from the research study without your approval. Possible reasons for being removed include: new information suggests it may no longer be safe for you to continue; your condition has become worse; you become pregnant; the sponsor ends the study earlier than planned; or you are no longer able to perform the study procedures. WILL I BE NOTIFIED OF NEW FINDINGS?If you decide to participate in this research study, your study doctor will keep you informed of any new findings discovered during the course of the study that may affect your continued willingness to participate in this study. You may discontinue participation in the study at any time.WHAT OTHER OPTIONS ARE THERE?If you decide not to participate in this research study, your decision will not affect the care to which you are entitled and will not influence your doctor in any way. If you decide not to participate, your doctor will discuss alternative treatment options with you. These may include other experimental treatments. USE IN COMMERCIAL DEVELOPMENT OF PRODUCTSThis study and any information gathered from your participation used in research may result in new products, tests, or discoveries. In some instances, these may have potential commercial value. However, you do not retain any property rights to the materials. Therefore, you would not share in any financial benefits from these products, tests, or discoveries.IS THERE A CONFLICT OF INTEREST?Tolerion, Inc., the sponsor, is funding this research. Your study doctor and the participating site are being compensated by the study sponsor for their time and expenses to conduct the study.Dr. Darrell M. Wilson, MD, is a paid advisor to Tolerion, the company sponsoring this study.Stanford University has a financial interest in the company supplying materials for this study. Any equity or royalties will be held in an account managed by an independent third party, which will not know about the results of the human subjects research until publicly available.Study Visit Schedule and Procedures Through Week 54ScreeningRandomizationWeek 1Week 2Week 3Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 50Week 52Week 54ProcedureInformed consentxMedical history xPhysical examxxxxxxVital signs, weightxxxxxxxxxxxxxxxxxxxHeightxEye examxxBlood sample takenxxxxGive urine samplexxPregnancy testxxxxxxxxxxxxxxxCollect 24-hour urine if requiredxx4-hour MMTTxxxxxContinuous glucose monitoring (CGM) started. Will continue through Week 52 and possibly Week 54xInjection administration and trainingxxxxxInjection site evaluationxxxxxxxxxxxxxxxxxReview diary information with staffxxxxxxxxxxxxxxxxxReport medications usedxxxxxxxxxxxxxxxxxxReport side effectsxxxxxxxxxxxxxxxxxxVisit Schedule and Procedures in Follow-up PhaseMonth 18Month 24Month 36ProcedurePhysical examxxxVital signs and weightxxxEye ExamxxBlood sample takenxxxGive urine samplexxxReport side effectsxxxReport medications usedxxx4-hour MMTTxxxAmount of Blood to be Taken at Each VisitVisitBlood Draw AmountScreening133 mL (about 9 tbs)Randomization5 mL (about ? tbs)Week 1295 mL (about 7 tbs)Week 1695 mL (about 7 tbs)Week 2498 mL (about 7 tbs)Week 3620 mL (about 2 tbs)Week 52118 mL (about 9 tbs)Week 5410 mL (about 1 tbs)Total in main study554 mL (about 19 ounces)Month 1898 mL (about 7 tbs)Month 2498 mL (about 7 tbs)Month 3698 mL (about 7 tbs)Total in 2-year follow-up294 mL (about 10 Ounces)EXPERIMENTAL SUBJECT’S BILL OF RIGHTSAs a research participant you have the following rights. These rights include but are not limited to the participant's right to:be informed of the nature and purpose of the experiment; be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized; be given a description of any attendant discomforts and risks reasonably to be expected; be given an explanation of any benefits to the subject reasonably to be expected, if applicable; be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits;be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise; be given an opportunity to ask questions concerning the experiment or the procedures involved; be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.Signature Block for Capable AdultYour signature documents your permission to take part in this research.Signature of participantDatePrinted name of participantSignature of person obtaining consentDate8/1/2019Printed name of person obtaining consentIRB Approval Date ................
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