Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 38, No. 8, August, 2023
Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt, below. Click the image below for the first two pages of this issue.
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.”