What is Greater than Minimal Risk?

Greater than minimal risk is a term commonly uttered in the Institutional Review Board (IRB)world.

45 CFR 46.102(i):

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The tricky part of this definition is what is considered "routine." What is routine for one person--a cancer patient, for example--may not be the same as a healthy individual with no illnesses. Or suppose someone is bipolar or schizophrenic. Her routine tests may be quite unroutine for others even if they are the same exact procedure.

What appears to be a simple definition can actually be something quite complicated.