It should come as no surprise that FDA has released a new draft guidance regarding informed consent.  Every year, FDAs Bioresearch Monitoring Program (BIMO) releases summative information on the results of the inspections they have conducted on their website.  The results of the inspections conducted are a yearly focus of IMARC as we try to make sense of what the FDA is most concerned with regarding the conduct of research involving human subjects.  Almost inevitably, the most frequent citation from an FDA inspection at a clinical investigation site pertains to improper or inadequate informed consent.  Given that informed consent is one of the most important parts of the research process, it makes sense in that FDA is sharing yet again their “current views” on the concept.