NIH stops calling EEG studies clinical trials

It’s admin burden week in the AGF Innovation Policy vertical. Let’s start with the good: last week the NIH announced that they will no longer consider “Basic Experimental Studies Involving Humans (BESH)” to be clinical trials. Since 2014, these studies – broadly, interventional experiments designed to produce fundamental knowledge about biology or behavior, rather than directly inform health or treatment – had been subject to the same policies and requirements as full clinical trials. From a neuroscientist: “The fact that collecting EEG data from healthy young adults while they did a simple visual memory task was considered a ‘clinical trial’ made a lot of our research a lot more difficult. I’m very happy to see this is no longer the case.”