What’s involved in making a determination of “noncompliance,” both at the time of initial review of the event and after the determination is made? This blog entry on the Ampersand blog — an online publication of Public Responsibility in Medicine & Research — gives an overview of the considerations related to noncompliance.
One important addition to note: Findings of “serious” or “continuing” noncompliance in federally funded or regulated research are required to be reported to the overseeing agency. While it’s not something we want to do every day, such reporting is not necessarily a bad thing. Appropriate reports indicate that the human research protection program is doing its job correctly. In fact, federal agency representatives have been heard to say at conferences that never reporting anything is the sort of thing that might raise red flags, in that regulatory agencies begin to wonder if your program has adequate oversight.