The Clinical Research Podcast Series at NYU Langone Health

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.

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:

• NYU Langone's Clinical and Translational Science Institute (CTSI) Data and Safety Monitoring Board (DSMB) Webpage
• Data and Safety Monitoring Guidance (NYU Langone Health- IRB)
• Data and Safety Monitoring Plan Guidance (NIH)
• Data and Safety Monitoring Plan (Independent Monitor) Example

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. Ms. Nadia Johnson, MS, CIP, Assistant Director of the External Review Unit, explains study eligibility, process and institutional requirements for both single IRB and external IRB submissions.

Discussion Questions:

Use of an External IRB

1:04 - When can an investigator use an IRB other than the NYU Langone Health IRB?

1:44 - Is use of an external IRB a matter of preference?

2:13 - What should the study team do once they receive confirmation of eligibility?

2:43 - What does institutional clearance entail?

3:39 - How long should the investigators expect reliance agreement execution and institutional clearance to take?

Single IRB

4:11 - What does "single IRB" mean? How is it different from external IRB?

4:49 - How can investigators request use of the NYU Langone Health IRB for single IRB review?

5:39 - What happens once the study team receives a "Just In Time" communication or "Notice of Grant Award?"

6:00 - What does the sirb/xirb unit do to facilitate SIRB review? Are the study teams responsible for reliance agreement set up or does this unit handle that?

6:43 - How long should the investigators expect reliance agreement execution and site approval to take?

General

7:12 - Can you go over how the sIRB and xIRB unit has changed over your time here?

8:01 - What is the future of the unit? What big projects are you working on?

9:10 - Final Thoughts

Listen to hear about required certification and all available resources to help you prepare high quality submissions and maintain regulatory compliance

Host: Robert Maril, MM, CIP, IRB Specialist Produced by Royell Sullivan-Green, MA, CIP Sr. IRB Education Specialist

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.

Host: Robert Maril, MM, CIP, IRB Specialist Produced by Royell Sullivan-Green, MA, CIP Sr. IRB Education Specialist

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.

Host: M'lis Kendrick, MA, Senior Education Specialist

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.

Host: M'lis Kendrick, MA, Senior Education Specialist