It’s Not Really Ethics Review

IRBs review research proposals. We determine if the benefits justify the risks and if the information to be given to subjects is accurate. We also take into account other considerations, such as whether subjects are vulnerable. What should we call that process?

The traditional answer is, “ethics review,” because IRBs were created to protect subjects and thereby make research more ethical. This is true as far as it goes, and that is the usage I followed in calling this blog Balanced Ethics Review. But calling our work ethics review has significant drawbacks.

The phrase “ethics review” is nonspecific, because many processes serve ethical ends. It is ethical for the FAA to ensure that airplanes are safe (thereby protecting passenger welfare) and for police to abide by the Constitution (thereby protecting citizen rights), but although both the FAA and the police make decisions that protect citizens’ rights and welfare, we do not describe their operations as ethics review.

If ethics review refers to IRBs invoking general principles, such as those in the Belmont Report, and applying those principles to specific cases, that does not describe what we actually do, as Laura Stark and Will van den Hoonaard have observed. Instead, IRBs debate such questions as whether or not a protocol’s risk/benefit ratio is acceptable and whether the consent form is accurate. The principle of autonomy, for instance, can be applied to almost anything, but in everyday practice we do not invoke it when we make decisions like this.

When we call our work ethics review, on the grounds that it builds on the Belmont Report’s ethical principles, we invite scientists and scholars to construct their own ethical arguments in rebuttal. We can say that our interpretation of the principles is binding; but why invite this kind of argument?

We certainly do conduct review, so the only question is, what kind of review. I believe we could do better than “ethics review.”

Our primary concern is the rights and welfare of subjects. We could call this “rights and welfare review,” but phrase is too cumbersome for ordinary use.

I believe that we should call our work “safety review.” This doesn’t cover all of the relevant considerations. But it reflects our primary concern, and, unlike “ethics review,” it doesn’t point people in the wrong direction.

Of course, this suggests that this blog has the wrong title—it should be called Balanced Safety Review! Let me think it over—perhaps I’ll add a clarifying subtitle.