The Clinical Research Podcast Series at NYU Langone Health

The NYU Langone Health team is back with new topics, new guests, and a renewed vision.

Kicking off our Human Research Protections Podcast Series in this episode, we explore the dynamics between research teams and participants, particularly when unacceptable participant behavior—such as harassment and intimidation—arises in the field. Unacceptable participant behaviors can affect the conduct of research as well as the safety and well-being of others, including study team members.

Join experienced Principal Investigator and researcher safety advocate Amanda Bunting, PhD; Institutional Review Board (IRB) expert Robert Maril, MM, CIP; and Research Regulatory Compliance expert Ikoa Jeschke-Lopez, MD, CCRC, CIP, for an important conversation about navigating these challenging situations. Together, they discuss the PI's role in fostering and maintaining a safe research environment, planning proactively for safety, strategies for responding to and managing unexpected participant behavior in real time, reporting and documentation requirements, and available support and resources.

Host

Riley Littlefield, LMSW (he/they)Specialist, Human Research Protections Training and Resources

About Our Featured Guests

Amanda Bunting, PhD

Amanda Bunting, PhD, is an Assistant Professor in the Department of Population Health at NYU Grossman School of Medicine, a member of NYU Langone's Center for Opioid Epidemiology and Policy, and a leader of a collaborative initiative between NYU Langone's Human Research Protections and the Department of Population Health to increase awareness of the impact of unacceptable participant behaviors within research settings.

With expertise in polysubstance use, criminal legal system-involved populations, and carceral health systems, Dr. Bunting's research aims to improve health outcomes for vulnerable populations who use opioids and stimulants. The nature of her research often places her in nontraditional research settings and involves participant populations in which challenging or unacceptable behaviors may arise, potentially affecting both the conduct of research and the physical and psychological safety of study team members. Her experiences have shaped her approach to managing unacceptable participant behavior and have made her a leading voice on this topic.

Robert Maril, MM, CIP

Robert Maril, MM, CIP, Senior Scientific Manager with the NYU Langone Health Human Research Protections Institutional Review Board (IRB) Administrative team, also joins the discussion. With more than 12 years of dedicated regulatory experience, Robert provides context from the IRB perspective. He highlights the IRB's role in the management of unacceptable participant behaviors, explains when these occurrences may require reporting to the IRB through an RNI or Continuing Review submission, and discusses how the IRB can provide support when needed.

Ikoa Jeschke-Lopez, MD, CCRC, CIP

Ikoa Jeschke-Lopez, MD, CCRC, CIP, is Assistant Director of the NYU Langone Health Human Research Protections Quality Improvement and Assurance (QIA) team. Dr. Jeschke-Lopez and the QIA team provide the NYU Langone Health research community with regulatory compliance support and education. In this episode, she discusses the importance of appropriately documenting occurrences of unacceptable participant behavior and the role documentation plays in supporting regulatory compliance and research team safety.

Executive Producer - Royell Sullivan-Green, MA, CIP

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