Webinar: Responding to Noncompliance in Human Subjects Research

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Overview

Noncompliance can cause significant problems for study participants, institutions, sponsors, the IRB, and investigators. While definitions of “minor,” “serious,” and “continuing” noncompliance vary from institution to institution, noncompliance itself involves the failure to act in accordance with federal regulations, state and local laws, institutional policies, or IRB requirements in human subjects research. When it comes to noncompliant investigators, it is paramount for IRBs to understand and identify the underlying causes of the noncompliance to implement successful solutions. This webinar will examine empirical evidence on factors that contribute to investigator noncompliance and offer recommendations for addressing it.

Presented by a compliance manager and a social scientist whose own research focuses on noncompliance, this webinar will discuss:

  • Preventing noncompliance
  • Identifying potential root and systemic causes of noncompliance
  • Reporting and responding to findings of noncompliance, including strategies for addressing persistent noncompliance
  • Bridging communication and motivation gaps between investigators and IRBs
  • Training options for noncompliant investigators

What will I learn?

After attending this webinar, attendees will be able to:

  • Understand the potential root and systemic causes of noncompliance in human subjects research
  • Report findings of noncompliance appropriately
  • Identify potential corrective and preventative actions, and other possible responses to noncompliance, including disciplinary letters, increased oversight, online training, suspended human subjects research privileges, and remediation education
  • Communicate effectively with investigators to improve compliance

Who should attend?

This intermediate-level webinar will benefit human research protections program (HRPP), IRB, compliance, and research integrity professionals, as well as institutional officials, researchers, and research staff.

Faculty

James DuBoisJames DuBois, PhD, DSc, is the Steven J. Bander Professor of Medical Ethics and Professionalism, professor of psychology, and director of the Center for Clinical and Research Ethics at Washington University School of Medicine in the Division of General Medical Sciences. DuBois completed his PhD in philosophy at the International Academy of Philosophy in Liechtenstein and his DSc in psychology at the University of Vienna in Austria, where he focused on cross-cultural moral psychology. He directs the NIH-funded Professionalism and Integrity in Research Program (PI Program), which offers personalized assessments, a group workshop, and post-workshop coaching calls to help researchers operate professionally in today’s complex environments. He is the founding editor (with Ana Iltis) of Narrative Inquiry in Bioethics: A Journal of Qualitative Research, published by Johns Hopkins University Press. His research interests include: research ethics in mental health, understanding and preventing ethical lapses in healthcare and research, assessing moral development and education, and empirical research on ethical issues.

Jessica RandallJessica Randall, MA, CIP has been working in HRPP compliance for over ten years. She currently works at Yale University as HRPP compliance manager. She received her master’s degree from Teachers College, Columbia University in social-organizational psychology with a focus on research and reorganization. Jessica has led or assisted in the investigation of hundreds of compliance cases involving multiple disciplines across several IRBs during her tenure in research compliance, which includes two prominent New York City universities. In addition to her work, she has co-conducted two benchmarking surveys of human subject research regulatory compliance programs at universities to collect data on compliance program structures, responsibilities, processes, and determinations of serious/continuing noncompliance. She believes the data collected will be important to opening the dialogue toward standardization of compliance programs. Her knowledge, input and experience is frequently called upon when QA/QI programs are being initiated or enhanced. She prides herself on building strong relationships with investigators and departments and believes compliance can be achieved through effective communication, dynamic corrective action plans, and education.

Background Reading

"Misconduct: Lessons from researcher rehab" by James M. DuBois, John T. Chibnall, Raymond Tait and Jillon Vander Wal in Nature, June 2016.

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Certificates of Attendance

Certificates of attendance will be made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification

Webinar participants holding the CIP® credential who wish to apply credits from this webinar toward CIP® recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours. Additional information about recertification can be found here.

Contact Information

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