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 Budget (OMB), released the federal
IBC
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 of Federal Regulatory and Deregulatory
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 Office of Management and Budget
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 looking back to the foundation
Advarra AI Council Members Participate in a Panel at Northwestern University to Discuss the Impacts of AI on Biosecurity
What impact will advancements in artificial intelligence (AI) have on national security and global public health issues, particularly when it
How Integrated IRB and IBC Administration Facilitate a New Era of Interventional Genetic Therapeutics
Gene therapies and gene-based therapeutics are giving way to a new era of interventional genetics. Integrated ethics review and biosafety review have developed into an operational advantage to facilitate this
The Heart’s Broken Blueprint: Rewriting the Cardiovascular Playbook with Gene Therapy
Cardiovascular disease remains a worldwide challenge, causing undue strain on the health system and contributing substantial patient burden. For decades, our medical response has been
The Executive Order that Brings Private Bioresearch Under Federal Oversight
The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.
Central Oncology Review
Advarra meets the growing needs of oncology by offering robust human subject protections that cancer research institutions expect.
IBC Registration Form
Join the Gene Therapy Network to accelerate study activation, gain IBC support, and position your site as a preferred choice for sponsors.
IBC Review and Consulting Services
Advarra’s biosafety experts streamline startup for gene therapy trials with comprehensive IBC reviews and proven rapid turnaround times.
Materials Required for Submitting a Study to the IBC
Comprehensive IBC submissions require detailed materials, including investigator CVs, safety protocols, and site-specific SOPs for study agent handling.