Immunity and Infection Research Centre



BLOOD DONOR CONSENT FORMTitle of Study: Blood collection for the molecular analysis of Mycobacterium tuberculosis signalingPrincipal Investigator:Yossef Av-Gay, PhDProfessor – Division of Infectious Diseases, University of British Columbia604-875-4329Sponsors:Canadian Institutes of Health ResearchImmunity and Infection Research CentreVGH & UBC Hospital Foundation Research Nurse:Connie Feschuk RN, MSHSClinical Research Unit Manager604-875-5886Research Coordinator:Jeffrey Helm604-875-4111 x68576Emergency Number:604-875-5000 *Ask for Infectious Disease Clinician on Service*You are being invited to take part in this research study because you are interested in providing a sample of your blood for research on infection and immunological processes (body’s protection against disease). Your participation is entirely voluntary, so it is up to you to decide whether or not to take part in this study. Before you decide, it is important for you to understand why the research is being done and what it will involve. If you wish to participate, you will be asked to sign this form. You do not have to provide any reason should you decide not to participate. Should you refuse to participate or withdraw, it would not in any way jeopardize your future medical care at this institution. You can withdraw from the study at any time without providing any reasons for your decision. You can declare your intention to withdraw by informing a research nurse involved in the study, or calling one of the contact numbers provided at the bottom of this document. If you decide to withdraw after already donating blood and before the blood is processed, your blood donation will be destroyed. You will not be able to withdraw your participation after the blood is processed because at that point components of the blood cells have already been incorporated into experiments involving tuberculosis. This study is being conducted by Dr. Yossef Av-Gay a member of the Infection and Immunity Research Centre at the Vancouver Coastal Health Research Institute and the University of British Columbia. The study is sponsored by the Canadian Institutes of Health Research.The purpose of this study is to develop new ways to improve treatments for a variety of infectious diseases by studying the interactions between white blood cells and pathogens (organisms that cause diseases or illness). The overall goal is to identify common pathways in the body’s immune response to infections in order to develop new treatments to combat infectious diseases.Specifically the Molecular analysis of Mycobacterium tuberculosis signaling research project needs blood from healthy donors with the blood group AB+, who have not been exposed to tuberculosis, or vaccinated with the Bacillus Calmette–Guérin vaccine (BCG), in order to support research studying the pathogenesis of tuberculosis, and mechanisms the pathogen uses to infect and reside in mononuclear phagocytes in the blood. The goal of this research is to develop novel diagnostics and therapeutics to treat tuberculosis and other diseases that compromise the normal functions of blood monocytes. This study requires blood from healthy subjects, and could not be performed with any other type of material. Approximately 4 subject per year will be needed, over a period of 3 years, to complete this research.You are eligible to participate in this study because you are between 19 and 60 years of age, are in good health and weigh at least 50 kg (110 lbs). In addition, you are AB positive and are tuberculin skin test negative, or have no history of exposure to TB and are a Canadian born Caucasian, or Canadian born with no travel history outside North America.You cannot participate in this study if have donated blood within the last 56 days; have been diagnosed with HIV, hepatitis, or other infectious diseases; have engaged in high risk activities that facilitate infectious disease transmission (including intravenous drug use); have had heart problems or heart surgery; have diabetes and are on insulin; or you are pregnant.The Procedures, if you agree to take part in this study, will include the following:A brief physical exam to measure your weight, blood pressure, and temperature A questionnaire about your health and any high-risk activitiesBlood withdrawal from a vein in your arm through a sterile needle by a trained member of the Vancouver Costal Health Research Institute Clinical Research Unit. You may experience momentary discomfort associated with insertion of the needle, and a small bruise occasionally occurs at the puncture site.50ml of blood will be collected (~1/4 cup, 10x less than the amount of a standard donation at Canadian Blood Services). Although the amount of blood to be removed will not exceed 10% of your total blood volume, some people have a reaction to the discomfort from the needle. About 1% of people will experience mild pain and swelling at the needle site, sweating, dizziness, gastrointestinal disorders, decreased blood pressure, slow pulse. More severe adverse reactions of nausea and fainting occur only 0.2% of the time. If you have any of these symptoms during the blood withdrawal, the procedure will be stopped. These symptoms usually subside after a few minutes of rest. The visit will take approximately 50 minutes, which includes time for consenting to the study, the physical examination, questionnaire, blood collection, and time for small snack. You will be observed by the Clinical Research Unit staff during your donation and up to the time you leave the unit.The blood that was removed will be regenerated by the bone marrow within 4 weeks, and there are no long-term side effects associated with the procedure. The cells from your blood may be used immediately, or frozen for use at a later date. However, regardless of whether they are used immediately or stored in liquid nitrogen, your cells will be used strictly for research as describe above. No other investigators will have access to the material, and it will not be stored as part of the inventory of a blood bank. Once your donation has been used for its intended purpose, any remnants will be destroyed.ConfidentialityYour confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, research records and medical records identifying you may be inspected, in the presence of the Investigator or his or her designate, by representatives of the UBC Research Ethics Board for the purpose of monitoring the research. You will be assigned a unique study number as a subject in this study.? Only this number will be used on any research-related information collected about you during the course of this study, so that your identity [i.e. your name or any other information that could identify you] as a subject in this study will be kept confidential.?? Information that contains your identity will remain only with the Principal Investigator and/or designate.? The list that matches your name to the unique study number that is used on your research-related information will not be removed or released without your consent unless required by law. In rare instances it will not be possible to ensure confidentiality because of mandatory reporting laws. This legal obligation includes a number of circumstances, such as suspected child abuse and infectious disease, expression of suicidal ideas, where research documents are ordered to be produced by a court of law and where researchers are legally obliged to report to the appropriate authorities.The investigators and/or their partners/immediate family members will not receive any personal benefits connected to this research study.You should understand that Canadian legislation prohibits the sale of human tissues, including blood. You will however receive $20 to compensate your for your time and travel expenses.If you have any questions or desire further information about this study before, during or after participation, you can contact Connie Feschuk, the Manager of the Clinical Research Unit at 604.875.5886. You may also contact Jeffrey Helm, Research Coordinator for this project, at 604-875-4111, extension 68576, should you wish to be informed of the progress in this project, and/or of how the data collected from the blood you donate has contributed to improving the success of treating infectious diseases.If you have any concerns or complaints about your rights as a research subject and/or your experiences while participating in this study, contact the Research Subject Information Line in the University of British Columbia Office of Research Services by e-mail at RSIL@ors.ubc.ca or by phone at 604-822-8598 (Toll free: 1-877-822-8598). Blood collection for The Immunity and Infection Research Centre; Molecular analysis of Mycobacterium tuberculosis signalingMy signature on this consent form means:I have read and understood the subject information and consent form. I have had sufficient time to consider the information provided and to ask for advice if necessary. I have had the opportunity to ask questions and have had satisfactory responses to my questions. I understand that all of the information collected will be kept confidential and that the results will only be used for scientific objectives. I understand that my participation in this study is voluntary and that I am completely free to refuse to participate or to withdraw from this study at any time without jeopardizing my future medical care at this institution. I understand that I am not waiving any of my legal rights as a result of signing this consent form. I have read this form and I freely consent to participate in this study. I have been told that I will receive a dated and signed copy of this form. Printed name of subjectSignatureDate4677410952500229997095250013970952500Printed name of person Signature Dateobtaining consent4751705180340001968518034000230568518034000654051270000I would like to be contacted for future donations ________________________________ subject signature65405508000 I do not want to be contacted for further donations ________________________________ subject signature ................
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