STAT News · Feb 12, 2026 · Collected from RSS
In a long-debated move, the NIH will no longer characterize basic experimental studies involving humans as clinical trials.
By Ed SilvermanFeb. 12, 2026 Pharmalot Columnist, Senior Writer In a long-debated move, the National Institutes of Health will no longer characterize basic experimental studies involving humans as clinical trials, a step that was cheered by many researchers, but is also raising transparency concerns because the work will no longer have to be registered with — or reported to — a government database. The agency made this decision, which was disclosed in late January, after years of discussion about the definition of a clinical trial that was established in 2014. At the time, the NIH faced pressure to increase transparency for trials it funded and ensure researchers registered their studies with ClinicalTrials.gov and reported results to the database. So the agency defined a clinical trial as a research study in which one or more human subjects are given a medication to evaluate its “health-related biomedical or behavioral outcomes.” But its definition quickly prompted controversy over whether basic research on humans should follow the same rules and requirements as studies for testing medicines. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe