Jerrold Ellner, M.D. Principal Investigator Boston Medical Center 650 Albany Street EBRC, Room 608 Boston, MA 02118 Phone: 1 (617) 414-3510 Email: Jerrold.ellner@bmc.org Hardy Kornfeld, M.D. Principal Investigator University of Massachusetts Medical School LRB-303 55 Lake Avenue North Worcester, MA 01655 Phone: 1 (508) 856-2646 Email: PROTOCOL TEAM COHORT RESEARCH UNIT INVESTIGATORS (CONTINUED) Amita Gupta, M.D., M.H.S. Principal Investigator Hopkins University 600 North Wolfe Street Phipps 540 Baltimore, MD 21287 1 (410) 502-7696 Email: Vidya Mave, M.D., M.P.H. & T.M. Co-Principal Investigator Byramjee Jeejeebhoy Medical College/ Hopkins University Clinical Trials Unit (BJMC-CTU) Clinical Research Site Leader and Director BJMC and Sassoon General Hospitals Pune, Maharashtra 411001 Phone: 91 (20) 26052419 vidyamave@gmail.com
Lalita Ramakrishnan, M.B.B.S., Ph.D. Principal Investigator University of Washington 1959 NE Pacific Street UW Box 357735 Seattle, WA Phone: 1 (206) 616-4286 Email: Gautam Roy, M.D. Principal Investigator JIPMER Dhanvantri Nagar Puducherry, Tamil Nadu 605006 Phone: 91 (93) 60263078 Email: Gautam@jipmer.net Thanjavur S. Ravikumar, M.D., F.A.C.S. Co-Principal Investigator JIPMER Dhanvantri Nagar Puducherry, Tamil Nadu 605006 Phone: 91 (413) 2272901 tsravi2008@gmail.com Padmini Salgame, Ph.D. Co-Principal Investigator UMDNJ Medical School Department of Medicine 185 South Orange Avenue Newark, NJ 07101 Phone: 1 (973) 972-8647 Email: Soumya Swaminathan, M.D. Principal Investigator National Institute for Research in TB No. 1 Sathyamoorthy Road Chetput, Chennai, Tamil Nadu 600031 Phone: 91 (944) 2174663 Email: Sonali Sarkar, M.D. Co-Principal Investigator JIPMER Dhanvantri Nagar Puducherry, Tamil Nadu 605006 91 (944) 2174663 PROTOCOL TEAM COHORT RESEARCH UNIT INVESTIGATORS (CONTINUED) John Szumowski, M.D., M.P.H. Co-Principal Investigator University of Washington & Clara Valley Medical Center 2400 Moorpark Drive, Suite 316B San Jose, CA 95128 Phone: 1 (206) 484-1778 Ramakrishna Vankayalapati, Ph.D. Principal Investigator University of Texas Health Center 11937 US Highway 271 Tyler, TX 75708 1 (903) 877-5190 Email:
A study outcome occurred: Active TB develops before the 24 Visit; the participant may enroll into Cohort A if all eligibility criteria are met; or Completion of the Month 24 Visit. Participants in Cohort A or Cohort B will be discontinued from the study for any of the following reasons: The participant/parent/legal guardian withdraws consent and/or assent; The participant is lost to follow-up or moves out of the area; The participant dies; The participant was inadvertently enrolled; The investigator determines that further participation would be detrimental to the health or well-being of the participant; The is stopped by a funding organization or other government agency; or The study has to stop for other administrative reasons. 7. Sample Size [this section will be modified based on host country sample size plans] The primary objective of the study is to provide specimens to biomarker researchers and their collaborators for investigations intending to lead to a better understanding of the prognosis of TB disease and the pathogenesis of progression from TB exposure to active disease. To address this primary objective, biospecimens will be “banked” over time from two prospective, observational cohorts, one with participants who have active pulmonary TB (Cohort A) and the second with participants who are HHCs of an active case of TB (Cohort B). A range of possible outcomes for use in research studies has already been described. In addition, general information will be collected on study participants, including demographic, medical history, clinical data, CBC and lymphocyte counts, HbA1c, HIV testing status, and for those that are determined to be HIV-positive at the time of specimen collection, their CD4 count will be
Urine Collection: This will be used for storage in the biobank. We will collect about 10 mLs (2 teaspoons) of urine. Chest X-Ray: At Month 2 and the End of Treatment Visits, results of your chest x-rays will be collected, if done as part of your regular medical care. You will not have a chest x-ray for this study at these visits. We will keep a copy of your chest x-ray as part of your study records and it may also be used in future studies. Treatment Failure/Relapse/Withdrawal Evaluation If you are not getting better, or after you finish your TB treatment you get sick again, or if you decide you want to come off the study for any reason, you will return for an extra visit as soon as possible. You will have most of the same evaluations you had at the Entry Visit. If you want to stop being in the study or we find out that the medicines are not working or your TB came back this will be your final visit. WHAT ARE THE POSSIBLE RISKS? The samples being taken for biobank storage may be taken during routine medical care and procedures. There is minimal risk to you if you decide to participate in this study. The following describes some of the possible risks: Drawing may cause some discomfort, bleeding, and/or bruising where the needle enters the skin. In rare cases, there may be fainting or infection. The IRB/IEC only allows a certain amount of blood to be drawn in 1 day for your safety. We will only take an amount that is allowed by the IRB/IEC. are no risks with coughing up sputum or breathing steam-like mist to help with deep coughing. A gastric aspiration (getting a stomach sample) is a simple procedure that involves putting a small flexible tube down your child’s nose. This may cause some discomfort and/or cause your child to gag. Chest x-rays are done as part of routine medical care. The amount of radiation emitted during a chest x-ray is small and poses no significant risks to you. If you are pregnant, you will not be required to have a chest x-ray.
your mind and withdraw your permission to store them at any time. WHAT ARE THE POSSIBLE BENEFITS? This study will not help you directly; however, you will receive clinical laboratory test results that may give you and your doctor more 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]. WHAT ARE MY OPTIONS? Taking part in this study is your choice. You can choose to take part or not to take part. If you choose to take part, you can change your mind at any time. WILL I BE TOLD IF THERE ARE NEW FINDINGS? You will be given clinical laboratory test results that are done for this study. These results may give you and your doctor information about your health, specifically about TB, anemia, diabetes, and HIV. You will not get test results from the samples that are collected for the biobank. These samples will be used by researchers in the future; and therefore, we will not have any test results to share with you. If you are interested in learning whether or not there are new findings in the future, you may contact [enter name of contact person] at [telephone number]. WHAT IF I CHANGE MY MIND? You can decide to withdraw your permission whenever you want. If you decide to withdraw your permission, contact the research There are two ways to withdraw your permission. You could allow researchers to remove all your personal identifiers linked to your stored samples, so that they are not linked to you anymore. These samples will then become anonymous. Or, you can ask researchers to destroy the samples. However, in either case, researchers will not be able to destroy samples or information from research that is already underway. If some tests have already been completed on your samples, any remaining samples will be destroyed. If you withdraw your permission, there will be no
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].