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Phase I Oncology Sample Informed Consent

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  • 1. NOT TO BE USED FOR SUBJECT ENROLLMENT Text highlighted in yellow are either instructions and/or prompts to enter protocol/sponsor- specific details. INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY NAME OF SPONSOR COMPANY: XXXX NUMBER AND NAME OF STUDY: XXXX NAME OF PERSON IN CHARGE OF THE RESEARCH STUDY (STUDY DOCTOR): XXXX ADDRESS OF STUDY SITE(S): XXXX TELEPHONE NUMBER(S), DAYTIME & AFTER HOURS: (XXX) XXX-XXXX INTRODUCTION You are being asked to take part in a research study to test an investigational drug(s) called XXXX. "Investigational" means the study drug(s) being tested have not been approved by the United States Food and Drug Administration (FDA). You are being asked to take part in this research study because you have advanced cancer and the standard drugs to treat your disease are no longer effective or no reliably effective treatment is known for your type of cancer. We are doing this clinical research study to find a dose of XXXX that would be the highest dose that can be given in humans without causing significant side effects. Future studies (called phase II studies) can then test whether or not this drug is useful against cancer. Give additional drug information here if requested/provided by the sponsor. You must read and sign this form before you agree to take part in this study. This form will give you more information about this study. Please ask as many questions as you need to before you decide if you want to be in the study. You should not sign this form if you have any questions that have not been answered. The study doctor is being paid by the sponsor (the company paying for this study) to conduct this research study. You must be honest with the study doctor about your health history or it may not be safe for you to be in this study. Include this statement for first time in human studies: THIS RESEARCH STUDY WILL BE THE FIRST TIME THE STUDY DRUG(S)/DRUG COMBINATION WILL BE GIVEN TO HUMANS. THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 2. Protocol number ****** Investigator name and Title Informed Consent Page 1 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT PURPOSE OF THE STUDY The purpose of this study is to find answers to the following research questions: List the objectives as stated in the protocol in lay terms. Study objectives are usually standard for Phase I studies but the language below will be modified as per protocol. 1. What is the highest dose of XXXX that can be given to subjects when given XXXX (give schedule) without causing significant side effects? 2. What are the side effects of XXXX? 3. How much XXXX is in the blood at specific times after dosing and how does the body get rid of the XXXX? HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY Your time in this research study will be followed in “cycles”. One cycle is XXXX days (XXXX weeks) in duration. You will need to come to the study site XXXX times before you begin to receive the study drug(s) to see if you are eligible to be in the study. After you start the study drug(s), you will visit the study site XXXX times during Cycle 1, XXXX times during Cycle 2, and XXXX times for each following cycle. The total number of cycles you go through in the study will depend on how you tolerate the study drug, and if your cancer gets worse. -- # of visits will vary between studies but most studies have different # of visits for C1, C2 due to PK testing and then all other cycles are usually the same. For studies that offer continued dosing after the standard study period: You may be able to continue to take the study drug as long as: • your cancer does not get worse • you do not have severe side effects • both the study doctor and the sponsor agree Approximately XX subjects (male and female), ages 18 and older, with advanced cancer will be enrolled in this study. TO BE IN THIS STUDY You cannot be in this study if you are in another research study or if you have been in any other research study in which you received an investigational therapy in the last XXXX days. – look at eligibility criteria to get maximum # of days but for phase I studies it is usually between 14(15) to 28(30) days [revise as appropriate per the study protocol]. WHAT WILL HAPPEN DURING THE STUDY Describe treatment design here. If there are different Parts or Arms, list them here briefly. Explain dose escalation method such as (standard dose escalation in phase I): In order to determine the highest dose of the drug(s) that can be given without causing significant side effects, this study will start with a low dose of XXXX. Three to six subjects will be enrolled at the low dose. If no severe or serious side effects are related to the XXXX dose in this first group of subjects, another three to six subjects will be enrolled and started on a higher dose of XXXX. This will continue THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 3. Protocol number ****** Investigator name and Title Informed Consent Page 2 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT until unacceptable side effects occur to subjects. Once the highest dose is found, an additional XXXX subjects will be enrolled at that dose level. Therefore, the dose of XXXX you receive will depend on when you enter the study. As a result, the dose you receive may not actually be the right dose to be beneficial for you, but the information obtained may help benefit others in the future. Screening: Please do not include any inclusion and exclusion criteria. These can be reviewed with the subjects during the screening or consent process. LIST PROCEDURES IN CHRONOLOGICAL ORDER, IN BULLET FORM AS LISTED IN PROTOCOL STUDY SCHEDULE CHART OR TEXT INSIDE THE PROTOCOL. Before the study starts, the study doctor will do some tests to find out if you can be in the study. Within XXXX days before the first dose of the study drug(s), you will be asked to visit the study site to have the following done: • You will be asked to sign this consent form document • Your medical history and demographic data (includes things like your sex, age, race/ethnicity) will be recorded • You will be asked about any medications you have taken and are currently taking • Vital signs (temperature, pulse, breathing rate, blood pressure – edit as listed in protocol) will be taken and your height and weight will be recorded • Physical exam will be done • You will be asked how well you are able to do your normal activities (bathing, driving, shopping, working, etc.) – standard definition for performance status • An electrocardiogram (ECG -- a recording of the electrical activity of the heart) will be done to check your heart function. – standard definition for ECG • If you are a woman capable of having children, you will have a pregnancy (blood or urine) test to make sure you are not pregnant • Blood samples will be taken for routine tests to check your blood counts (numbers of each type of blood cell), chemistries (elements and minerals in your blood), blood clotting, and how well your organs are functioning – standard definition for routine lab tests but can be revised to add any additional tests such as thyroid, etc. • A routine urine test will be done to check your kidney function – standard definition for routine urine test • An initial assessment of your tumor will be done by scans (PET/CT, MRI, etc.) to measure the extent of your disease • Etc. • Etc. • Etc. Required wording when heart monitors are required per protocol (adjust wording as per protocol): At the screening visit, you will be given a small portable heart monitor to wear. This monitor will record the beat of your heart rate for 24 hours. The monitor is connected by wires that are stuck to your chest, using tape or stickers. You must return the monitor to the study staff. To attach the monitor, a small section of your chest might have to be shaved. Required wording for female subjects when a pelvic exam is required: THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 4. Protocol number ****** Investigator name and Title Informed Consent Page 3 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT The study exam and lab tests are not meant to take the place of your yearly women’s pelvic exam. You will not be tested for sexually transmitted diseases. If you think that you might have a sexually transmitted disease, you should see your private doctor. Required wording when mammograms are required: A mammogram is an x-ray of the breast used to help find small lumps in the breast before they become a problem. The mammogram for this study will expose you to a small amount of radiation. The long-term effects of low-level radiation are not known. It is possible that after the results of these tests are reviewed, you will not qualify to be in the study. If you are not eligible to receive the study drug, the reasons why you cannot take part will be discussed with you by the study doctor or the study staff. Study Procedures: If you are eligible and agree to receive the study drug, you will need to come to the study site at various times to have procedures done. These procedures are described below. LIST PROCEDURES IN CHRONOLOGICAL ORDER, IN BULLET FORM AS LISTED IN PROTOCOL STUDY SCHEDULE CHART OR TEXT INSIDE THE PROTOCOL. Cycle 1, Day 1: • You will be asked about any medications you are currently taking • Etc. • Etc. • Etc. • Etc. Cycle 1, Day 2: • You will be asked about any medications you are currently taking • Etc. • Etc. • Etc. • Etc. End of Study/Final Visit If you withdraw or are withdrawn from the study, for any reason, you will be scheduled for a final visit. This visit will occur XXXX days after your last dosing. During this visit, the following procedures will be done: • You will be asked about any medications you are currently taking • Etc. • Etc. • Etc. • Etc. Include this statement in studies requiring self-dosing: You must keep the study drug(s) out of the reach of children. Required wording when endoscopy procedures will be performed: THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 5. Protocol number ****** Investigator name and Title Informed Consent Page 4 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT Gastrointestinal endoscopy is a way to look at the inside of the digestive tract using a flexible tube that has a light and camera on the end, called an “endoscope”. The instrument may also be used to take samples (biopsies), cultures or make repairs. A snake-like tube is usually passed through the mouth or rectum, and the exam is usually performed while you are under a state of relaxation (sedation). You may be given medications prior to the procedure for sedation. You should not drive or operate machinery after this procedure until the next day. You will sign a separate consent document prior to having this procedure. Some of the possible risks of this procedure are: • Pain, vomiting, and fluid in the lungs (aspiration) • Bleeding • Tearing of the wall of the stomach or intestines (perforation) which could cause infection • Injury to other organs near the intestines • Reactions to medications Blood Samples: If multiple blood draws are required, identify the number of blood draws and the total amount of blood (e.g., approximately 1 cup). Blood samples will be taken by single needle-sticks or by a tube that is left in your arm if multiple samples need to be drawn the same day. Blood samples may be drawn by either one of two ways depending on what is most convenient for you. (1) A small flexible plastic catheter (tube) may be placed in your arm so that the blood can be drawn for testing without additional “needle sticks”. The catheter will be placed in the arm by first putting a tourniquet above the potential site of the catheter. The site will be cleaned, usually with alcohol, and a needle with a flexible catheter will be inserted into the vein. The needle and the tourniquet will then be removed, and the catheter will be secured in place with tape. OR (2) Implanted ports may be used for obtaining blood specimens or infusion of medications. The skin over your implanted venous access device or port will be cleaned with alcohol swabs and then with betadine swabs. A needle designed specifically for use with implanted venous access devices or ports will then be inserted into your port. This will allow us to obtain blood specimens or infuse medications with less pain to you than repeatedly sticking a needle directly into your vein. There will be about XXXX blood draws. The # of samples can be broken down by cycle if necessary to give more detail. The total amount of blood drawn will be about XXXX (mL or cups). For comparison, the standard blood donation is about 480 ml (two cups). Required wording if blood volume is greater than 450 cc in 30 days. This should follow the paragraph which describes the total amount of blood to be drawn: A blood loss in this amount may cause anemia (low red blood cell count). Anemia may make you feel tired. Once you finish the study, you may want to take an over-the-counter iron pill or vitamins with iron to help you build up your blood. Also, you should not donate blood for several months. POSSIBLE SIDE EFFECTS AND RISKS OF THE STUDY DRUG(S) THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 6. Protocol number ****** Investigator name and Title Informed Consent Page 5 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT Do not use medical terminology to describe side effects - ONLY USE LAY LANGUAGE. LIST SIDE EFFECTS IN BULLET FORM. Listing can be broken down by % or other notation (very common, less common, and rare). • Loss of appetite (instead of anorexia) • Hair loss (instead of alopecia) • Etc. • Etc. • Etc. If you do not understand what any of these side effects mean, please ask the study doctor or study staff to explain these terms to you. Because this/these drug(s) is/are investigational, all of its/their side effects may not be known. There may be rare and unknown side effects, some of which may be irreversible and/or life threatening. You must tell the study doctor or study staff about all side effects that you have. If you are not honest about your side effects, it may not be safe for you to stay in the study. Required wording when using a combination of drugs: When you take more than one drug at a time, the side effects can be worse or different than if you take either drug by itself. Required wording when drowsiness, dizziness, or blurred vision is a major side effect: Because this drug can cause drowsiness, dizziness, or blurred vision (delete as appropriate), you should use caution if you experience this side effect such as avoiding stairs, not driving a car or working with machinery. Required wording for drugs that can form antibodies: You may form antibodies to the study drug. An antibody is a type of protein that helps protect the body against attack by bacteria and viruses. There is also a small chance that if you have these antibodies, this drug or similar drugs will not work for you in the future. Required wording for radio labeled studies: This study involves exposure to radiation. The risk from radiation exposure in this study is small when compared with other everyday risks. Female subjects must not be pregnant. Female subjects who have not been surgically sterilized must have a negative pregnancy test to be in this study. The risks of receiving the very low doses of radiation are thought to be low, but are unknown. ADDITIONAL RISKS OR DISCOMFORTS Include a description of any reasonably foreseeable risks or discomforts to the subject other than side effects caused by the study drug/device or procedures. Blood Samples: There may be side effects of having blood drawn such as: • Fainting • Redness THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 7. Protocol number ****** Investigator name and Title Informed Consent Page 6 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT • Pain • Bruising • Bleeding • Infection If you feel faint tell the study staff right away. BELOW IS INTEGREVIEW’S APPROVED LANGUAGE FOR OTHER STUDIES. USE WHENEVER POSSIBLE UNLESS SPONSOR INSISTS ON OWN LANGUAGE. Risks of Using an Intravenous (IV) Catheter: • Infection • Pain • Redness • Bruising • Vein irritation from the fluids or medication being given • Local swelling due to IV fluid accidentally entering the tissue rather than the vein • Blood clots, which may cause inflammation, swelling and pain Electrocardiogram (ECG): The ECG test is a recording of the electrical activity of your heart and is harmless. The sticky pads used may sometimes cause some discomfort such as redness or itching. If the skin under the patches needs to be shaved, irritation from shaving also could occur. Magnetic Resonance Imaging (MRI): An MRI is a way of looking at the soft tissues of the body. You will lie down on a large magnet. A magnetic signal will be sent through your body and then received back. This process is safe for most people. Subjects with metal near important organs may not receive an MRI. The metal may be drawn away from the body and towards the large magnet, which could cause injury. THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 8. Protocol number ****** Investigator name and Title Informed Consent Page 7 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT CT Scan: A CT scan is a computerized series of detailed pictures of areas inside the body taken from different angles. You may feel some discomfort or anxiety when lying inside of the CT scanner. The dye that is injected into your body may cause you to get a metallic taste in your mouth, to feel warm, and rarely cause nausea and vomiting. You will be exposed to a limited and medically acceptable dose of radiation during the scan. There is always a slight risk of damage from being exposed to any radiation. 18 FDG-PET/CT Scan: You will be asked to fast (no food) for about 4 to 6 hours before the scan. A small amount of radioactive sugar will be injected into your blood about 1 hour before the scan. You may experience discomfort related to lying still in an enclosed space for a long period. You will be exposed to a limited and medically acceptable dose of radiation during the scan. There is always a slight risk of damage from being exposed to any radiation. Bone scans: There is a small risk of allergic reaction to the chemical used in the test. You could also have swelling, soreness, or infection at the site where the tracer is injected into your vein. The radiation exposure of this test is very low, and not likely to cause any damage to you. Echocardiogram: During the echocardiogram, electrodes will be placed onto your chest to allow for an ECG to be performed. Then a transducer (a device that looks like a computer mouse) will be applied. You may feel slight pressure on your chest from the transducer. In addition, you may be asked to breathe in a certain way or to rest on your side during the test. Multiple Gated Acquisition (MUGA) scans: This test measures how well your heart is pumping. A MUGA is a special type of x-ray machine used to take a rapid series of pictures of the heart. This procedure involves getting radiation (like x-rays). A radioactive substance called a tracer is given through an IV, which helps to create the pictures that are taken. The amount of radiation involved is small, about the same amount as two regular chest x-rays. There is a minimal amount of pain with this test. The tracer is passed out of the body through the urine within 24 hours after the test is completed. This test takes about 2-3 hours to complete. Bone Marrow Biopsy or Bone Marrow Aspirate: A small sample of bone marrow is taken usually from the hip (pelvis) bone. You are given a small injection to numb the area. A needle is passed through the skin into the bone. A small sample of the bone marrow is then drawn into a syringe. It may be painful, but this only lasts for a short time. You may be offered medication to reduce any pain or discomfort during the test. Though not common, there may be side effects of having a bone marrow aspiration and biopsy such as: • Pressure and/or pain when the needle is inserted, as well as when the bone marrow is removed with a syringe (aspiration) • Bleeding where the needle is inserted into the skin and tissue over the bone • Bruising where the needle is inserted into the skin and tissue over the bone • Pain where the needle is inserted into the skin and tissue over the bone • Infection where the needle is inserted into the skin and tissue over the bone THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 9. Protocol number ****** Investigator name and Title Informed Consent Page 8 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT Rare side effects (that can be controlled) may include: • Infection of the bone • Extensive bleeding at the biopsy site BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING If you are a female, you must not get pregnant while in this study. The only certain way to not get pregnant is to not have sex. If you are a female and choose to have sex, you must use a type of birth control listed below while in this study (and for XXX days after last dose – refer to protocol for specific requirements). If you are a man, you must use birth control if you choose to have sex with women while in this study (and for XXX days after last dose – refer to protocol for specific requirements). (Refer to protocol for specific requirements) Acceptable methods of birth control for this study include: • Norplant • Birth control pills plus another method (i.e. condom) • Birth control patch • IUD (intrauterine device) • Depo-Provera • Sterilization • Abstinence • Condoms with spermicide Even if you use birth control during the study, there is a chance you could become pregnant. You cannot be in the study if you are pregnant or breastfeeding. It is not known whether the study drug(s) is/are safe for breast fed babies. Therefore if you are breastfeeding a child then it may not be safe for you to take part in the study. A pregnancy test can be wrong. If you become pregnant during the study, stop taking the study drug(s) and call the study doctor at once. If you are pregnant or become pregnant during the study, the study drug/device or procedure may involve risks to the unborn baby, which are currently unforeseeable. POSSIBLE BENEFITS OF THE STUDY The main goal of this study is to test the safety of the study drug(s). It is not to treat your cancer. The chances that the study drug(s) will shrink your cancer or help you live longer are very low. Your cancer might stay the same or it may get worse. The drugs you receive may even be harmful. However, what we learn from this study may benefit society and future patients with cancer. OTHER OPTIONS TO BEING IN THE STUDY You are under no obligation to take part in this research study, and other options may be available. These may include: • Participation in another research study with a different study drug THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 10. Protocol number ****** Investigator name and Title Informed Consent Page 9 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT • Chemotherapy with a drug which has already been approved (add or remove as appropriate per the study) • Radiation therapy may be an option depending on your tumor type (add or remove as appropriate per the study) • Supportive care without anti-cancer treatment The study doctor can explain both the possible benefits and the risks of other options that are available to you. Also talk with your doctor and oncologist about these and other options. If you decide that you do not wish to take part in the study, you are free to leave the study center at any time. RELEASE OF YOUR MEDICAL RECORDS AND CONFIDENTIALITY If HIPAA Authorization wording is integrated in this informed consent document, IntegReview will review the content for confidentiality language and readability only. Because IRBs are not required to ensure compliance with the Privacy Rule, IntegReview is not responsible for ensuring that the appropriate HIPAA requirements are included. Your records of being in this study will be kept private except when ordered by law. The following people will have access to your study records: • Study Doctor • Sponsor company or research institution • The United States Food and Drug Administration (FDA) – remove when not applicable [refer to submission form] • Other state or federal regulatory agencies • IntegReview Ethical Review Board (IRB) The Independent Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your records, which may have your name on them. Therefore, your total privacy cannot be guaranteed. If the study results are presented at meetings or printed in publications, your name will not be used. IN CASE OF STUDY RELATED INJURY Use language provided by study sponsor since that is the legally approved language. However, if the cost of medical treatment for a research-related injury will be the responsibility of the subject or their insurance company, include the following statement: Please be aware that some insurance plans may not pay for research-related injuries. You should contact your insurance company for more information. OR If no language is provided by sponsor, below is language previously approved by IntegReview for other studies (please revise as appropriate). If you are injured as a result of the research procedures, your injury will be treated. In the event of an illness or injury that is determined to be directly related to the administration of the study drug or the properly performed study procedures, the sponsor, XXX, agrees to pay all reasonable and necessary medical expenses to treat such illness or injury provided that you have followed the directions of the study doctor, and that you cannot otherwise be reimbursed by your personal insurance, a government program, or other third party coverage for such medical expenses. You or your insurance company will be billed for any other charges. Please be aware that some insurance plans may not pay for research- related injuries. You should contact your insurance company for more information. We have no plans to give you money if you are injured. You do not waive any legal rights by signing this form. No other form of compensation is offered. THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 11. Protocol number ****** Investigator name and Title Informed Consent Page 10 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT OR If you are injured as a result of the research procedures, your injury will be treated. The sponsor has insurance that covers the costs for treatment of any research related injury. The term “research-related injury” means physical injury caused by the study drug or the procedures required by the study which are different from the medical treatment you would have received if you had not participated in the study. You or your insurance company will be billed for any other charges. Please be aware that some insurance plans may not pay for research-related injuries. You should contact your insurance company for more information. We have no plans to give you money if you are injured. No other form of compensation is offered. LEGAL RIGHTS You will not lose any of your legal rights by signing this consent form. CONTACT INFORMATION If you have questions, concerns, or complaints about this study or to report a study related injury, contact: PI (XXX) XXX-XXXX daytime telephone number (XXX) XXX-XXXX after hours number If you are unable to reach anyone at the numbers listed above, and you need medical attention please go to the nearest emergency room. If you do not want to talk to the study doctor or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject as provided in the Subject’s Bill of Rights you may contact: Chairperson IntegReview 3001 S. Lamar Blvd., Suite 210 Austin, Texas 78704 512-326-3001 between 8 a.m. and 5 p.m. Central Time (call collect) integreview@integreview.com IntegReview has approved the information in this consent form and has given approval for the study doctor to do the study. This does not mean IntegReview has approved you being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study. PAYMENT FOR BEING IN THE STUDY You will not be paid for being in this study. VOLUNTEERING TO BE IN THE STUDY / RIGHT TO WITHDRAW It is your choice if you want to be in the study. No one can force you to be in the study. You are free to choose not to be in this study or to stop being in this study at any time. You may leave the study at any THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 12. Protocol number ****** Investigator name and Title Informed Consent Page 11 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT time without penalty or loss of benefits to which you are otherwise entitled. You can still get medical treatments without being in the study. The study doctor, the sponsor company, IntegReview, or the FDA may take you out of the study without your permission, at any time, for the following reasons: The list below can be revised as per protocol/sponsor requirements • If you do not follow the study doctor’s instructions • If we find out you should not be in the study • If the study is stopped • If it becomes harmful to your health If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to have some end of study evaluations or tests. In addition, the data collected on you to the point of withdrawal remains part of the study database and may not be removed. COSTS FOR BEING IN THE STUDY The first 2 sentences can be revised as per sponsor agreement. The study drug(s) XXX (and XX) will be provided free of charge while you are taking part in this study. In addition, there are study procedures (i.e., ECGs, PET scans, lab work) that are directly due to your taking part in this study and will be provided at no cost to you. You or your insurance company will be paying for the costs of the clinic visits, XXXX (if approved drug being used in combination and sponsor not providing), the routine blood tests, x-rays, scans, other lab tests and your routine medical care. Insurance companies and Medicare may not pay for costs associated with some research studies like this one. In cases where XXXX (approved drug) is not covered, and no other assistance is available, XXXX will be paid for by the sponsor (include this statement if appropriate). If your insurance company does not cover the cost of routine care, then you will have to pay these costs. You have the right to ask what it will cost you to take part in this study or to have other treatments. For more information on insurance coverage for clinical trials, you can visit the National Cancer Institute’s Web site at http://cancer.gov/clinicaltrials/understanding/insurance-coverage . You can print a copy of the “Clinical Trials and Insurance Coverage” information from this Web site. Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and ask them to send you a free copy. NEW FINDINGS If there is new information about the safety of the study drug(s) or any significant new findings we will tell you. You can then decide if you want to still be in the study. THE FOLLOWING TWO SECTIONS ARE REQUIRED BY INTEGREVIEW AND MUST BE INCLUDED IN THE INFORMED CONSENT DOCUMENT (DO NOT EDIT): SUBJECT’S BILL OF RIGHTS REQUIRED FOR CALIFORNIA SITES ONLY [NOTE: CA Bill of Rights are not required for social/behavioral science research and does not need to be included.]: You will be given a separate copy of the California Experimental Research Subject’s Bill of Rights. If you have not received a copy of this document, please notify study staff. THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 13. Protocol number ****** Investigator name and Title Informed Consent Page 12 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT OR FOR ALL NON-CALIFORNIA SITES, INCLUDE THE FOLLOWING: As a subject in a research study, you should expect to: 1. Be told about the nature and purpose of the study. 2. Be told about the procedures used in the study and any drug or device to be used. 3. Be told about any side effects, discomforts or risks that we expect from being in this study. 4. Be told about any benefits that you can expect from this study. 5. Be told about any other procedures, drugs, or devices that might be helpful to you, and their risks and benefits. 6. Be told about any medical treatments available to you after the study if problems occur. 7. Be given a chance to ask any questions about the study or procedures. 8. Be told that your consent to be in the study can be withdrawn at any time. You may leave the study at any time without being penalized. 9. Be given a copy of a signed and dated consent form when one is needed. 10. Be given the chance to decide to be in the study without force, fraud, or pressure. THE REASON FOR INDEPENDENT REVIEW BOARDS AND INFORMED CONSENT What is a consent form? The informed consent document contains information required by federal regulations. The informed consent document must be approved by an Independent Review Board (IRB). What is an Independent Review Board (IRB)? An Independent Review Board (IRB) is a group of people that reviews research studies. The main goal of this review is to protect the rights and well being of the human subjects participating in research studies. IntegReview, the IRB for this study IntegReview is an independent IRB whose board members provide IRB services across the nation. To meet requirements of the law, the IntegReview Board currently includes: • doctors • pharmacists • nurses • toxicologists (studies the harmful effects of chemicals) • other specialists • others who do not have a background in science/medicine THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 14. Protocol number ****** Investigator name and Title Informed Consent Page 13 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT AGREEMENT TO BE IN THE STUDY This consent form contains important information to help you decide if you want to be in the study. If you have any questions that are not answered in this consent form, ask one of the study staff. Please answer YES or NO to the following questions: A. Is this document in a language you understand? B. Do you understand the information in this consent form? C. Have you been given enough time to ask questions and talk about the study? D. Have all of your questions been answered to your satisfaction? E. Do you think you received enough information about the study? F. Do you agree that you were not pressured by the study doctor or study staff to be in this study? G. Do you know that you can leave the study at any time without giving a reason and without affecting your health care? H. Do you know that your health records from this study may be reviewed by the sponsor company and by government authorities? I. Do you know that you cannot be in another study while you are in this study? IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, YOU SHOULD NOT SIGN THIS CONSENT FORM. Printed Name of Adult Study Subject Signature of Adult Study Subject Date Do Not Sign After ********** Printed Name of Person Explaining Consent Form Signature of Person Explaining Consent Form Date THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc
  • 15. Protocol number ****** Investigator name and Title Informed Consent Page 14 of 16 NOT TO BE USED FOR SUBJECT ENROLLMENT The signature lines below are required when adult subjects are not able to legally give consent. Printed Name of Guardian or Legally Authorized Representative Signature of Guardian or Legally Authorized Representative Date Do Not Sign After ********** Description/Relationship of Guardian or Legally Authorized Representative You will be given a copy of this consent form to keep. THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL Initials/master or site: date /home/pptfactory/temp/20101029110401/phase-i-oncology-sample-informed-consent4099.doc