It’s only fitting, with the revised Common Rule in limbo, that there should remain some uncertainty about what constitutes human research — and what doesn’t.

“For IRBs, one issue that they should think about is how do they see their own purview,” says Carl H. Coleman, JD, a professor of law at Seton Hall University in Orange, NJ. “Do they want to be reviewing things in this sort of borderline area? What is their constituency and how do they see their IRB’s purview? The bottom line is that there are some gray areas. Whether they require IRB review, whether it is research — it’s really going to depend on a judgment call.”

The Common Rule defines research, in part, as an effort to create “generalizable knowledge,” he notes, adding that it leaves ambiguity in discerning research from a hospital quality improvement effort or public health surveillance of disease.

“It’s often hard to know where to draw that line between something that is just feeding back information into a quality program so it can be used to improve the program, versus developing new knowledge,” he says.

A broad and indiscriminate definition of research for regulatory purposes could “sweep in many benign activities for which the costs and burdens of IRB review are not justifiable,” Coleman warned in a recent paper.1

There was discussion of creating an “exemption tool,” in the early iterations of the Common Rule, but the current version proposed for finalization jettisoned the idea.

“Based on the response and the comments, it seemed like they decided there just wasn’t enough buy-in at this point,” Coleman says. “I think it would be a good idea. It doesn’t have to happen now, but one of the concerns with exemptions is that the process of applying for one [is laborious]. It’s not as burdensome as going through the whole review process, but it almost defeats the purpose of having an exemption.”

In any case, the generalizable knowledge definition remains an “imperfect proxy” by which to separate research from other activities, he notes.

“The idea is that there is something special when the use of [data] is for the development of generalizable knowledge,” he says. “As if that is the only situation where you might be interacting with people or using their private data for reasons other than their own benefit. I think that is a false idea. It is not a perfect standard.”


1. Coleman, CH. Reining in IRB Review in the Revised Common Rule. IRB: Ethics & Human Research. November-December 2017;(39):6. Available at: