Blog

Fraudulent participation in social and behavioral research is becoming more sophisticated and more common. This blog explores how imposter participants threaten data integrity, the ethical challenges of screening methods, and how IRBs can help researchers strike the right balance between rigor and participant protection.

The Office for Human Research Protections (OHRP) has proposed updates to the Federalwide Assurance (FWA) form as part of its ongoing efforts to streamline regulatory processes for institutions conducting human subjects research. These changes aim to simplify the FWA application, reduce administrative burden, and modernize compliance requirements under the Common Rule.

This article explores the concept of Single IRB (sIRB) and how the SMART IRB platform has streamlined ethical and regulatory reviews for multi-site clinical trials. It highlights the efficiencies gained when institutions rely on a centralized IRB review, as required by NIH and HHS, and examines the recent halt in federal funding for the SMART IRB initiative. Despite the funding pause, the SMART IRB Agreement remains active and accessible — though support resources may soon dwindle. The piece offers timely guidance for research institutions navigating reliance agreements and underscores the urgency of acting while the platform is still operational.

The Chevron Deference standard was a 40-year-old Administrative Law benchmark that gave federal agencies the power to interpret ambiguous laws and issue regulation based on their subject-matter expertise. On June 28, 2024, in a 6-3 ruling in Loper Bright Enterprises...