Insights

On September 17, 2024, the Office of Research Integrity (ORI) in the U.S. Department of Health and Human Services published a long-awaited revision of the Public Health Service (PHS) Policies on Research Misconduct (42 CFR 93 in the Code of Federal Regulations). The new rule modernizes the federal framework that governs how institutions handle allegations of fabrication, falsification, and plagiarism in PHS-funded research.

Decentralized clinical trials (DCTs) have evolved from a future concept to a present-day necessity. As protocols become more complex, competition for funding increases, and recruitment challenges persist, traditional site-centric models often fail to keep pace.

While clinical research professionals typically understand what has to be submitted to an Institutional Review Board (IRB), the board’s decision-making processes can seem like a ‘black box.’ A mock IRB meeting can be very illuminating, illustrating how regulatory mandates and ethical principles are reconciled with the realities of current clinical research.