login

PRIM&R Flash Learn

Data Safety Monitoring Boards: Essentials for Risk-Based Oversight

April 7, 2026 | 1:00 - 1:30 PM ET

Register Here

Overview

Data Safety Monitoring Boards (DSMBs) are a key component of risk-based oversight and ongoing safety monitoring within clinical trials. This 30-minute Flash Learn provides a concise introduction to DSMB purpose, structure, and function, and situates DSMBs within the broader Human Research Protection Program (HRPP) responsibilities. Participants will learn when DSMBs are required or recommended, how their recommendations support continuing review and risk assessment, and what IRBs and institutions should expect to receive as part of their oversight obligations. This session offers a focused, practical foundation for understanding DSMBs as part of effective participant protection systems.

What Will I Learn?

  • Explain the role of DSMBs in ongoing risk assessment and participant safety monitoring, and describe how DSMB oversight aligns with HRPP and IRB responsibilities for protecting research participants
  • Identify study types and risk profiles that warrant DSMB involvement, reflecting principles of proportionate review and risk-based oversight
  • Describe the essential components of DSMB operations—including composition, charters, confidentiality, and reporting—and articulate what IRBs and institutions should expect in DSMB communications to support continuing review and institutional accountability

Presenter

John Baumann, PhD Assistant Vice Chancellor for Research Compliance and Integrity University of California San Diego. Dr. Baumann earned his Ph.D. in Sociology from the Graduate Center of the City University of New York. Dr. Baumann has over 30 years of experience in research, research administration, responsible conduct of research and research compliance. In these positions, he has had direct line responsibility for research development, coordination and submission of grant and contract applications, management of funded research as well as compliance with regulations and ethical standards for human subjects research, research with animals, conflict of interest, and radiation and biological safety. He has, therefore, been directly involved in the administration of research at all levels. In addition to his position at UCSD, he provides consulting services on research compliance program development and assessment to universities, hospitals, and research institutes, serves as a site visitor – and former member of Council of Accreditation -- for AAHRPP, and chairs the social-behavioral IRBs of National Development and Research Institutes and American Academy of Family Physicians. Prior to joining UCSD, Dr. Baumann was Associate Vice President for Research Compliance at Indiana University (covering 7 campuses and affiliated hospitals), Vice Provost for Research at University of Missouri – Kansas City and, before that, Deputy Executive Director of National Development and Research Institutes (NDRI), a private not-for-profit behavioral science research institute in New York City with a primary focus on substance abuse, HIV/AIDS, and related social problems.

CE Credit

Participants will receive a certificate of attendance that documents up to 0.5 continuing education credit hour for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.

Cost

Members: $45 Nonmembers: $95

CIP® Credit

Participants holding the Certified IRB Professional (CIP®) credential may apply 0.5 continuing education credits towards CIP recertification. Please refer to the CIP® recertification guidelines for additional information.