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2026 DHHS Unified Agenda: Four Areas HRPP and IRB Leaders Should Watch
The U.S. Office of Information and Regulatory Affairs (OIRA), within the Office of Management and…
2026 DHHS Unified Agenda: What Clinical Operations and Study Startup Teams Should Watch
Planned changes outlined in the U.S. federal government’s 2026 Regulatory Plan and the Unified Agenda…
2026 DHHS Unified Agenda: What Clinical Research Leaders Need to Know
On July 3, 2026, the U.S. Office of Information and Regulatory Affairs (OIRA), within the…
The Belmont Report Still Shapes How IRBs Protect Human Research Subjects Today
With all the buzz recently on regulatory reform for institutional review boards (IRBs), it’s worth…
A Better SIV Model Starts by Separating the Common from the Unique
In fall 2026, the Advarra-facilitated Site-Sponsor Consortium will release a white paper on reducing redundant site training through competency-based, role-based, and reusable training models…
NHSR, Exempt, Expedited, or Full Board? A Plain-Language Guide to Potential Review Pathways
Researchers often want to know early whether a study will be considered Not Human Subjects…