HOW WILL INFORMATION ABOUT ME BE KEPT PRIVATE? Your privacy is very important to us and we will make every effort to protect it. Here are just a few of the steps we will take: Only study code numbers will be used on your samples and study information. Your identity will not be known by the researchers who study your samples and health information. Published results will not include your private information. We will keep the list that links the code number to your name separate from the samples and information. Only certain study staff can access this list. We will keep the samples in locked freezers in locked buildings. We will keep health information and research information on secure computers. These computers have many levels of protection. An IRB/IEC will review and approve the research done on the samples collected for storage at the biobank. WHO WILL SEE MY PRIVATE INFORMATION? Apart from the research staff, representatives from the IRBs/IECs, funding organizations of this research study ([enter funding organization(s), as applicable]), and regulatory agencies may request to see your private information. In addition, your private information may be provided to national authorities as required by law [enter examples, if applicable]. HOW LONG WILL RESEARCHERS STORE MY SAMPLES? Researchers will store your samples for up to 15 years after study completion. However, you can change your mind and withdraw your permission to store them at any time. WHAT ARE THE POSSIBLE BENEFITS? This study will not help you directly; but, if you become ill with TB, you will receive clinical laboratory test results that may give you and your doctor information about your health (for example, complete blood count). The main reason you may want to take part is to help researchers make discoveries that might help you and other people now and in the future. ARE THERE ANY COSTS OR PAYMENTS? There are no costs to you. You [cru to modify: will/will not] be paid [cru to include compensation that will be provided, if applicable]. If any of the research leads to new tests, drugs, or other commercial products, you will not share in any profits. If you experience injury as part of this research study, [crus to add what care is to be provided, per irb/iec requirements].
HOW WILL INFORMATION ABOUT ME BE KEPT PRIVATE? Your privacy is very important to us and we will make every effort to protect it. Here are just a few of the steps we will take: Only study code numbers will be used on your samples and study information. Your identity will not be known by the researchers who study your samples and health information. Published results will not include your private information. We will keep the list that links the code number to your name separate from the samples and information. Only certain study staff can access this list. We will keep the samples in locked freezers in locked buildings. We will keep health information and research information on secure computers. These computers have many levels of protection. An IRB/IEC will review and approve the research done on the samples collected for storage at the biobank. WHO WILL SEE MY PRIVATE INFORMATION? Apart from the research staff, representatives from the IRBs/IECs, funding organizations of this research study ([enter funding organization(s), as applicable]), and regulatory agencies may request to see your private information. In addition, your private information may be provided to national authorities as required by law [enter examples, if applicable]. HOW LONG WILL RESEARCHERS STORE MY SAMPLES? Researchers will store your samples for up to 15 years after study completion. However, you can change your mind and withdraw your permission to store them at any time. WHAT ARE THE POSSIBLE BENEFITS? This study will not help you directly; but, if you become ill with TB, you will receive clinical laboratory test results that may give you and your doctor information about your health (for example, complete blood count). The main reason you may want to take part is to help researchers make discoveries that might help you and other people now and in the future. ARE THERE ANY COSTS OR PAYMENTS? There are no costs to you. You [cru to modify: will/will not] be paid [cru to include compensation that will be provided, if applicable]. If any of the research leads to new tests, drugs, or other commercial products, you will not share in any profits. If you experience injury as part of this research study, [crus to add what care is to be provided, per irb/iec requirements].
RePORT-International-Common-Protocol-V1.1-12Jan16-Template.docx