Medical Devices: "Significant Risk" Versus "Nonsignificant Risk" Determinations

By Robert Romanchuk, IRB Chair

In medical device research, the determination of “significant risk” or “nonsignificant risk” is sometimes confusing, especially for those new to device research. Unique to the device space, this risk determination is not the same as a “no more than minimal risk” determination often made for studies potentially eligible for expedited institutional review board (IRB) review.

Let’s take a closer look at what significant risk (SR) and nonsignificant risk (NSR) determinations mean for medical device clinical trials.