The Clinical Research Podcast Series at NYU Langone Health

The Clinical Research Podcast Series at NYU Langone Health offers insights into resources pertaining to the conduct of research involving human subjects. Through this series, audience members can learn more about the tools and support that are available for clinical study teams at NYU Langone Health.

A Synergistic Partnership - Dr. Chau Trinh-Shevrin Shares the Benefits of her Dual Role as IRB Chair and Researcher 06/01/2023

A Synergistic Partnership - Dr. Chau Trinh-Shevrin Shares the Benefits of her Dual Role as IRB Chair and Researcher For this episode we have Dr. Chau Trinh-Shevrin here. Dr. Trinh-Shevrin is a professor for the NYU Langone Health Depts of Population Health and Medicine, Section for Health Equity, Vice Chair for Research in the Department of Population Health, and serves as chair for the NYU Langone Health Institutional Review Board. She joins our host, Robert Maril, MM, CIP, for a discussion about the her experience as an IRB member, advice for researchers and more. Host: Robert Maril, MM, CIP, Senior Scientific Manager, NYU Langone Human Subjects Protections Producer: Royell Sullivan-Green, MA, CIP, Education Manager, NYU Langone Human Subjects Protections 0:32 Tell us a bit about your research? (Area of focus, risk level, estimated number of studies) 1:33 How long ago did you come to NYU? 1:51 How did you become an institutional review board member? 3:01 How do you feel your role as a researcher impacts the way you approach IRB review or acting as an IRB chair? 4:11 How has your role as a board member impacted the way you develop and conduct your research? 5:37 What about your experience as a board member has surprised you? 8:13 What are some common misconceptions you think researchers have about the IRB? 10:05 What are some common misconceptions you think researchers have about human subjects research? 11:48 What advice would you give new researchers? 14:03 Are there any resources you would recommend researcher take advantage of for study development, conduct, regulatory compliance etc. /episode/index/show/clinicalresearchpodcast/id/27015681

Understanding the Role of a Data and Safety Monitoring Board: How DSMBs Support Human Subjects Research 09/07/2022

Understanding the Role of a Data and Safety Monitoring Board: How DSMBs Support Human Subjects Research Clinical trials often require the use of a data and safety monitoring board (DSMB) but understanding the role of DSMB in human subjects research can be confusing for some. Dr. Erinn Hade highlights NYU Langone Health’s Clinical and Translational Science Institute (CTSI) Data and Safety Monitoring Board (DSMB). In a recent discussion with Dr. Hade, HRP’s Robert Maril helped get some clarity on DSMBs. Dr. Hade shared her insights regarding the role of a DSMB in human subjects research including the services CTSI provides in support of DSMBs, the review process, submission requirements and reporting responsibilities of investigators. Dr. Erinn Hade is an Associate Professor of Biostatistics in the Department of Population Health at NYU Grossman School of Medicine. She is also a researcher, a trial statistician, and a member of the NYU Langone Health CTSI DSMB. Discussion Breakdown: 0:44 - When the NYU Langone Health CTSI Data and Safety Monitoring Board (DSMB) started? 1:00 - NYU Langone Health created its own DSMB 1:53 - The difference between and IRB and a DSMB 4:23 - DSMB Composition 6:14 - When researchers should connect with the DSMB regarding their human subjects’ research 8:59 - When use of the CTSI DSMB is required 10:27 - The DSMB review process and submission requirements for new studies 12:29 - Interim safety data reporting requirements 15:15 - How the DSMB member experience has impacted Erin’s own research 17:09 - Advice on developing data and safety monitoring plan (DSMP) 18:51 - Resources for DSMP development 20:30 - What the CTSI DSMB has in store for the future Helpful Links: /episode/index/show/clinicalresearchpodcast/id/24299838

The Nuts and Bolts of Single IRB and External IRB Review 09/02/2021

The Nuts and Bolts of Single IRB and External IRB Review With a growing number of multisite human research studies requiring the use of the NYU Langone Health IRB as the single IRB (sIRB) of record, in addition to studies that require institutional clearance when using an External IRB, a new unit, the External Review Unit has emerged into the Human Research Protection area to manage the work related to these 2 work flows. /episode/index/show/clinicalresearchpodcast/id/20231567

IRB Education Requirements and Resources 10/16/2019

IRB Education Requirements and Resources Listen to hear about about required certification and all available resources to help you prepare High quality submissions and maintain regulatory compliance. /episode/index/show/clinicalresearchpodcast/id/11670545

Meet the IRB Members 05/31/2019

Meet the IRB Members The inner workings of the Institutional Review Board (IRB) at times may seem like a mystery. In this episode, you will hear directly from IRB chairs, Frederick More, DDS, MS, and Alexes Hazen, MD, FACS and member Samuel Bliss, PharmD. Together, they discuss their experiences serving on the IRB, their role in the overall review process, and their advice for human subjects researchers. /episode/index/show/clinicalresearchpodcast/id/9987548

Association of Clinical Coordination & Research Management (ACCRM) 05/31/2019

Association of Clinical Coordination & Research Management (ACCRM) This episode covers the Association of Clinical Coordination & Research Management (ACCRM), an internal NYU organization created by study team members to improve research processes across the health system. /episode/index/show/clinicalresearchpodcast/id/9995816

Clinical Research Coordinator (CRC) Foundational Program 05/30/2019

Clinical Research Coordinator (CRC) Foundational Program This episode focuses on the creation and implementation of the Clinical Research Coordinator (CRC) Foundational Program, a two day, instructor-led course that covers essential topics for research study team success. /episode/index/show/clinicalresearchpodcast/id/9987446

The Clinical Research Podcast Series at NYU Langone Health

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