HeyJaredDarri L. Scalzo
- Indexed articles, last 90 days
- 4
- Latest publication
- Aug 27, 2026
- Outlet visibility, for Mondaq
- Top 500K sites
- Earliest in this view
- Jul 24, 2026
Latest articles
The Research Integrity Challenge Behind ORI's New AI Guidance (opens the original)
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The Office of Research Integrity (ORI) released its “Guidance on Generative Artificial Intelligence” on August 14, 2026.1 The guidance does not create a new category of artificial intelligence (AI) misconduct, nor does it alter the legal standard for research misconduct under 42 CFR Part 93.2 Instead, it applies the existing framework to a rapidly evolving technological environment and, in doing so, highlights a new readiness challenge for research institutions. Institutions may increasingly nee
Research Integrity Could Become The New Funding Edge (opens the original)
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A proposed Office of Management and Budget (OMB) rule could materially change how federal agencies evaluate research integrity in funding decisions. If finalized, the rule would make research integrity a visible indicator of institutional funding readiness, not merely a post-award compliance expectation. The practical question for research institutions is no longer whether they have policies on paper, but whether they can demonstrate at the funding application stage that those policies operate e
More Questions About Operation TrialBlazer: Can The U.S. Design A Clinical Research System That Is Faster And More Trusted? (opens the original)
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While Operation TrialBlazer appears aimed at addressing that challenge by reducing unnecessary friction, improving early Food and Drug Administration (FDA) engagement, modernizing trial design, expanding use of real-world data and AI-enabled tools, and making it easier to match patients to studies, there is more to consider. The conversation around Operation TrialBlazer is ultimately about more than speed. A few questions seem especially important: 1. What does success look like beyond speed? Sh
Operation TrialBlazer: Is This The Spark America’s Clinical Research Needs? (opens the original)
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The U.S. Department of Health and Human Services (HHS) has launched a department-wide clinical trials reform initiative branded as Operation TrialBlazer.1 HHS is positioning this as an effort to bring early-stage clinical research back to the U.S., accelerate drug development, and restore American competitiveness. The announcement identifies a real issue in that clinical research sponsors increasingly see other countries as faster, cheaper, and more predictable places to generate early human dat
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