The Latest Federal Funding Cuts and Their Impact on Ethical Clinical Research Oversight

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.

Harmonization of FDA Regulations with the Common Rule

The 21st Century Cures Act mandated that the Department of Health and Human Services (“DHHS”) “revise the DHHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules to reduce regulatory duplication and unnecessary delays;...