IRB review of human subjects research consistently presents a wide variety of ethical and regulatory challenges in even the simplest of research protocols. In this session, we will explore several of a wide variety of biomedical and social and behavioral science studies, and parse out the often thorny ethical and regulatory issues that are part and parcel of an IRB’s everyday reviews.

Potential topics include ethical justification for randomized clinical trials; use of placebo; fCOI; inclusion (and exclusion) of vulnerable subjects; phase 1 trials and risk-benefit analysis; compensation (and coercion) of subjects; optimizing informed consent; secondary research findings; data and safety monitoring; and assessment and minimization of risk.

This case study-based Zoom meeting offers attendees the opportunity to interact with the speakers and other participants on screen. Through a combination of active audience participation and very brief didactic episodes, the speakers will highlight the challenges, how those challenges fit within the regulatory criteria for approval, and best practices for review. Attendees will leave with a framework for IRB members and administrators to use in effectively reviewing protocols involving these thorny components.

What will I learn to do?

• Describe how to use the ethical and regulatory framework in the Common Rule to address challenging components of everyday IRB deliberations

Who should attend?
This program is geared toward HRPP/IRB personnel and those working in research programs more broadly including HRPP/IRB directors, members, chairs; researchers and research staff; and more.

Access Interval
Access to live content will be available for 90 days after the recording is made available. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. To earn a certificate, one must complete all required sections and complete the certificate section within the 90-day access period. After access has expired, users can purchase an additional 90 days of access.