Frequently Asked Questions About Investigator-Initiated Trials (IITs)
Investigator-initiated trials (IITs) play a critical role in advancing clinical research by allowing investigators to pursue important scientific questions beyond
IRB
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
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
Why IRBs Ask for Certified Translations of Informed Consent Forms: Regulation, Guidance, and Practical Reality
Understanding the regulatory foundation behind translated informed consent documents and why many institutional review boards (IRBs) require certificates or attestations of translation.
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
Sponsor’s Guide to IRB Approval (Part VI): After IRB Approval: Compliance, Multi-Site Oversight, and Turning Review into a Strategic Advantage
IRB approval is a critical milestone in clinical research, but it isn’t the end of the oversight process. For sponsors, approval marks
Sponsor’s Guide to IRB Approval (Part V): How to Speed Up IRB Approvals
Institutional review board (IRB) approval is a critical milestone in clinical research, but it can also become a source of
Why Should Local IRBs and HRPPs Collaborate with External IRBs?
Multisite research and clinical trials increasingly rely on a single IRB (sIRB) for review. This increase reflects federal mandates, sponsor expectations, and the operational realities of modern multisite or cooperative research. For institutions with a local
Sponsor’s Guide to IRB Approval (Part IV): Preparing IRB Documents That Prevent Delays
A strong protocol and well-drafted consent form are essential, but they are not enough on their own to support a
Federal Public Policy Briefing: Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review
Federal Public Policy Briefing: Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review Research involving children that poses