Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 39, No. 11, November, 2024
Back Issues
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 Research With Decentralized Elements (#1)
A final FDA guidance contains several sections of immediate relevance for many IRBs and researchers. Titled “Conducting Clinical Trials With Decentralized Elements,” the guidance:
“… provides recommendations regarding the implementation of decentralized elements in clinical trials for drugs, biological products, and devices. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants (e.g., telehealth visits with investigators or visits with local healthcare providers (HCPs)) ….
To help ensure the appropriate oversight of trials with decentralized elements, the integrity of trial data, and the safety of trial participants, this guidance covers the responsibilities of sponsors [including investigator-sponsors] and investigators” (89 Fed. Reg. 76481-76482, September 18).