Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 8, August, 2023

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Excerpt from pg. 3 … IRBs and Decentralized Clinical Trials (DCTs) (#1)

Study closings and research shutdowns throughout the country were forced by numerous COVID related
quarantines. Even without that impetus, a clinical trial trend has been accelerating.

That trend is a movement away from traditional clinical trial settings to instances where distances may be involved between experimental sites — possibly very remote distances.

This trend has raised new challenges for the IRBs that review such “decentralized” studies. Fortunately, a new FDA guidance offers useful tips for affected IRBs. The guidance is titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.”