STAT+: NIH redefines \u2018clinical trials,\u2019 dividing researchers\u00a0
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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 \u2014 or reported to \u2014 a government database.<\/p>\n
The agency made this decision, which was disclosed in late January<\/a>, 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.<\/p>\n 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 \u201chealth-related biomedical or behavioral outcomes.\u201d But its definition quickly prompted controversy over whether basic research on humans should follow the same rules and requirements as studies for testing \u00a0medicines. \u00a0<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n