While working on a recent project involving researching FDA warning letters, it astonished me the number of investigators and investigative sites who had issues with informed consent.  I was surprised at the seemingly little familiarity study staff had regarding Federal Regulations when it came to the informed consent and the consenting process.

This blog was written by a newer monitor with IMARC Research.  This is her experience, and certainly not representative of all research coordinators and monitors.  We thank her for sharing this, and hope others who have made the similar transition will chime in with their experiences!