Blog

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...

Informed consent is the foundation of ethical research; ensuring participants are fully aware of what they’re agreeing to before participating in a study. After reviewing consent forms for the past decade, here are the 5 most common errors that we (an IRB) encounter....

Full board meetings occur Monday afternoons at 4:30 PM Eastern.  Complete study submissions received by the EOB Monday will be reviewed at the Monday meeting of the following week.  To ensure a timely review of your study, please refer to the Example Timeline for Full...