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
