STAT+: NIH redefines ‘clinical trials,’ dividing researchers

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Source: STAT News

Original: https://www.statnews.com/pharmalot/2026/02/12/nih-clinical-trial-definition-rese...

Published: Thu, 12 Feb 2026 15:59:47 +0000

The National Institutes of Health (NIH) is redefining the term "clinical trial," dividing researchers.[2] NIH will no longer consider Basic Experimental Studies involving Humans (BESH) as clinical trials.[2] This change will take effect for applications submitted on or after May 25, 2026.[2] BESH studies will thus not have to meet clinical trial requirements, including registration and reporting of results at ClinicalTrials.gov.[2] The change is based on a 2014 NIH definition that expanded the term clinical trial to include BESH studies for better transparency and accountability.[2] The aim is to reduce the administrative burden for research that does not directly aim to improve health.[2] This is a long-discussed step.[2]