Presentations

DBT No Objection Certificate

TIMELINE 4-5 Weeks from s ubmission to approval GUIDELINES DBT NOC is required for RePORT studies only. DBT approval is in lieu of ICMR/HMSC approval. It must be requested by an Indian investigator. Projects may be submitted for DBT NOC in tandem with seeking local EC approvals. As a nodal agency of the VAP, the DBT is authorized to review projects for alignment with VAP program priorities and to provide approval. To request DBT NOC for RePORT India-related studies, the Indian PI for the proposed project must email Dr. Jyoti Logani ( jyoti.logani@nic.in ), Scientist-E, DBT a summary of the...

Importation of Test Kits & Reagents

Documents linked below are the latest versions on file, and should be tailored for specific research protocol needs Questions? Contact the Research Team Timeline: 4-6 Months from Submission to Approval Research studies requiring medical devices (test kits and reagents) are generally approved by the U.S Food & Drug Administration (FDA) when used for an IND study. When the required test kit or reagent is not available in India, and the vendor does not possess the license to import it, complete an online application via the Central Drugs Standard Control Organization (CDSCO) Online System...

Importation of Test Kits & Reagents

Questions? Contact the Research Team TIMELINE 4-6 Months from Submission to Approval GUIDELINES Research studies requiring medical devices (test kits and reagents) are generally approved by the U.S Food & Drug Administration (FDA) when used for an IND study. When the required test kit or reagent is not available in India, and the vendor does not possess the license to import it, complete an online application via the Central Drugs Standard Control Organization (CDSCO) Online System for Regulation of Medical Devices Contact Vandana Kulkarni with questions. Return to Regulatory Main Page

Johns Hopkins IRB Approval

Questions? Contact the Regulatory Team TIMELINE 1-2 Months from Submission to Approval GUIDELINES IRB approvals are required from Johns Hopkins and the institution with which you are affiliated. Check with the Regulatory Team if you have questions. Submission to the Hopkins IRB requires BJGMC EC approval and any other partnerhing institutions. Hopkins IRB submissions are prepared by JHU members of the regulatory team, with input from investigators Refer to the Johns Hopkins School of Medicine IRB Submission Checklist for International Research for a detailed list of requirements. SUBMISSION...

IRB Process: Workflow

Questions? Contact the Research Team Investigators work with PI to plan study, write protocol, consents, assents and any additional documents India & JHU Regulatory staff/or India Study Coordinator review final protocol, consents/assents, & other documents prior to submission India Regulatory staff and/or India study coordinator and JHM Regulatory staff review final protocol and relevant documents prior to IRB submission India Regulatory staff and/or India study coordinator prepare and submit to India Ethics Committee (EC) Two to three weeks later, the EC will provide an approval...

Clinical Trial

Questions? Contact the Research Team DEFINITION According to the revised common rule, §46.102(b), "a clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” TIMELINE 7.5–25.5 Months to Approval Following Protocol Development PLANNING PHASE 2-4 weeks Some projects that will eventually involve human participants include an initial planning phase without participant involvement. This...

Observational Study

Questions? Contact the Research Team DEFINITION Studies involving analysis of patient data that was collected for other reasons or during previous research. Such data include, but are not limited to, diagnostic test results, clinical notes, admission and discharge information, lab reports. TIMELINE 3–5 Months to Approval Following Protocol Development PLANNING PHASE 2-4 weeks Some projects that will eventually involve human participants include an initial planning phase without participant involvement. This phase may, for example, focus on the development of research instruments, performance...

Retrospective Chart Review

Questions? Contact the Research Team DEFINITION Studies involving analysis of patient data that was collected for other reasons or during previous research. Such data include, but are not limited to, diagnostic test results, clinical notes, admission and discharge information, lab reports. TIMELINE 3–5 Months to Approval Following Protocol Development APPROVAL STEPS STEP 1: Develop Retrospective Chart Review Protocol Package Timeline: Determined by Investigator For Studies with 2 or More U.S. Sites: If a study includes 2 or more U.S.-based, NIH-funded sites, NIH requires a single IRB review,...

Use of Stored Samples

Questions? Contact the Research Team DEFINITION Studies involving Stored Samples involve biological samples in storage that were collected from patients during a past approved research study, or during clinical care. Such data include, but are not limited to, diagnostic test results, clinical notes, admission and discharge information, lab reports. TIMELINE 12–19 Months to Approval Following Protocol Development APPROVAL STEPS STEP 1: Develop Use of Stored Samples Protocol Package Timeline: Determined by Investigator For Studies with 2 or More U.S. Sites: If a study includes 2 or more U.S.-...

RePORT Consortium

Questions? Contact the Research Team DEFINITION RePORT Consortium Studies are tuberculosis studies conducted under the multinational consortium: Regional Prospective Observational Research on Tuberculosis (RePORT). The Indo-US Clinical Research Partnership oversees India’s countrywide efforts, and conducts research as a member of two research consortia. More information about RePORT India can be found on the RePORT International Website TIMELINE 14.5–21.5 Months to Approval Following Protocol Development PLANNING PHASE 2-4 weeks Some projects that will eventually involve human participants...

Annual Review: Ongoing Clinical Trial

Questions? Contact the Research Team DEFINITION Research regulations in both India and the U.S. require that clinical trials be reviewed by IRBs and obtain re-approval annually to determine degree of risk. TIMELINE 3–5 Months from Submission to Approval APPROVAL STEPS STEP 1: Develop Progress Report Timeline: Determined by Investigator STEP 2: Submit Annual Review for Ongoing Clinical Trial Package to Indo-JHU Regulatory Team Timeline: 3 Weeks Prior to India Ethics Committee Meeting STEP 3: Obtain India Ethics Committee Approval Timeline: 1–2 Months from EC Meeting to Approval *Local IRB...

Informed Consent Requirements

GUIDELINES Per US regulation CFR 46.116, the elements below must be included in all consent forms. Please note, there have been some changes to the Common Rule for studies that were initially approved after January 21, 2019, including the addition of Requirement #9 below. For more information regarding Common Rule changes on Consent Forms, please refer to the Revised Common Rule and Implementation Memorandum . An IRB may require that other elements be incorporated into the consent documents(s) beyond those stated below. More information regarding consent form requirements can be found in CFR...

Annual Review: Ongoing Retrospective Chart Reviews, Stored Samples, and Observational Studies

Questions? Contact the Research Team DEFINITION Research regulations in both India and the U.S. require that studies be reviewed by IRBs and obtain re-approval annually to determine degree of risk. TIMELINE 3–5 Months from Submission to Approval APPROVAL STEPS STEP 1: Develop Progress Report and Assemble Review Package Timeline: Determined by Investigator Cover letter (signed by site PI) Progress report Protocol Informed consent form Package inserts/Investigator brochures (for drug studies only or “if applicable”) Other documents, as needed STEP 2: Obtain India Ethics Committee Approval...

Acknowledging Funders

Questions? Contact the Abstracts & Publications Team ACTIVE GRANTS | COMPLETED GRANTS (In aphabetical order by commonly-used name) BWI-CTU | Award dates: 12/10/13–11/30/20 | PI: Amita Gupta Official Grant Title: The Johns Hopkins Baltimore-Washington-India Clinical Trials Unit Required Acknowledgement: Research reported in this publication was supported by NIAID of the National Institutes of Health under award number UM1AI069465. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. CFAR | Award...

Qualitative Study, Implementation Science, Psychosocial Assessment Review

DEFINITION Qualitative Research studies examine social phenomena—such as personal experiences, people's beliefs, attitudes, individual and group behaviors, interactions, organizational dynamics, and relationships—in order to determine what events happen, why, and the effect they have on people. Qualitative research generates non-numerical data. Implementation Science studies develop, pilot test, and promote evidence-based approaches, practices, and health interventions that improve health outcomes. TIMELINE 9–14 Months to Approval Following Protocol Development PLANNING PHASE 2-4 weeks Some...

Bob Bollinger, MD, MPH

Raj and Kamla Gupta Professor of Infectious Diseases, Professor of Medicine, Public Health, and Nursing
Dr. Bollinger is the Raj and Kamla Gupta Professor of Infectious Diseases at the Johns Hopkins University (JHU) School of Medicine, and he holds joint appointments in International Health at the Johns Hopkins (JH) Bloomberg School of Public Health, and in Community Public Health at the JH School of Nursing. He is Founding Director of the Center for Clinical Global Health Education (CCGHE), Director of the JHU Fogarty India Program, and Associate Director for Medicine of the JH Center for Global Health. He is board certified by the American Board of Internal Medicine in internal medicine and...

Larry Chang, MD, MPH

Associate Professor of Infectious Diseases, JHSOM; Associate Professor of International Health, Social and Behavioral Interventions Program, JHBSPH; Associate Professor of Epidemiology, JHBSPH; Associate Director, JHU Global mHealth Initiative
Baltimore, Maryland
Dr. Larry Chang is Associate Professor of Medicine, Epidemiology, and International Health at Johns Hopkins University. He is a physician trained in internal medicine, infectious diseases, and epidemiology with an interest in interdisciplinary, innovative, and pragmatic approaches to impacting the HIV pandemic. Dr. Chang has experience in HIV treatment and prevention, implementation science, cohort, community-based trials, and mixed methods research. He is currently Co-PI of the Rakai Health Sciences Program (RHSP) in Uganda and is an active infectious diseases and HIV clinician. For the past...

Joel E. Gallant

Joel E. Gallant, MD, MPH, is Associate Professor of Medicine in the Division of Infectious Diseases at the Johns Hopkins University School of Medicine in Baltimore and Associate Professor of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. He is the Associate Director of the Johns Hopkins AIDS Service. He is Director of the Garey Lambert Research Center, through which he has conducted dozens of clinical trials on the treatment of HIV infection. He is also an investigator in the HIV Prevention Trials Network (HPTN), the Acute Infection Early Disease Research Program (AIEDRP...

Amita Gupta, MD, MHS

Professor of Medicine and Public Health
Amita Gupta, MD, MHS
Dr. Gupta is Deputy Director of the Johns Hopkins (JH) Center for Clinical Global Health Education (CCGHE), and Professor of Infectious Diseases at the JH School of Medicine, with a joint appointment in International Health at the JH Bloomberg School of Public Health. Board certified by the American Board of Internal Medicine in infectious diseases, Dr. Gupta specializes in international public health, clinical research, and education in infectious diseases, HIV/AIDS, and tuberculosis (TB). Since 2002, her work has been focused primarily on India, where she leads several Indo-JHU research...

Kathleen Page, MD

Associate Professor
Dr. Kathleen Page, MD, is an Associate Professor in the Division of Infectious Diseases at Johns Hopkins University School of Medicine. Her work focuses on improving access and quality of care to underserved communities in Baltimore. She provides HIV, HCV and substance use disorder care at the Bartlett Clinic at Johns Hopkins Hospital and the Baltimore City Health Department STD clinics. She co-founded Centro SOL (Center for Salud/Health and Opportunities for Latinos), which is developing novel strategies to meet the health needs of Latino migrants through research, education, community...

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