Sep
13

By David Jensen PhD, RAC

I am not one to usually nit-pick (and having survived a month of those lousy louses with my daughters, I know what that means) but I was recently reminded that not all of my regulatory colleagues know (or remember) that the US FDA does not require “compliance with the Declaration of Helsinki.” It was at a training I recently attended in which the materials included brief reports of clinical trails; e.g. abstract, methods, tables of data. At the end of every study abstract was the phrase “This study was performed in compliance with the Declaration of Helsinki.” I was surprised to read this because the US FDA has not required such a statement of sponsors and investigators for some time; indeed the US has not been a signatory to the Declaration of Helsinki since before 2000.