The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over.

It’s usually not a good idea to rely solely on a single statistic to draw conclusions about your process. Do that, and you could fall into the clutches of the “duck-rabbit” illusion shown below.

It is vitally important for lean people to know nothing when working on improvement. This sounds like a crazy idea, but it is another 100-percent turnaround from traditional management thinking.