As a former chair of an institutional review board (IRB), I sympathize with the concern expressed in Scott Kim and colleagues' Commentary 'Pruning the regulatory tree' (Nature 457, 534–535; 2009) about the heavy burden imposed by dealing with exempt research. Unfortunately, their fix won't work.

Many years ago, before the US National Institutes of Health clamped down, exemption was handled very casually at many institutions, even to the extent of researchers declaring themselves or their students exempt without any formal review. The result was a widespread culture of non-compliance with the common rule, with many dubious and improper claims of exemption. That is why IRBs at some institutions do not grant them — exemptions got a bad name.

A new regulation that “exempts minimal-risk research from IRB review” would certainly send a clear and unambiguous message: an invitation to return to the abusive practices of the past. If an IRB chair or a full review board feels the need to clamp down on exemption declarations to help researchers remain sensitive to their obligations to protect their human subjects, please give them your understanding and support. They are doing the right thing.

Kim's comments in Nature Network ( include an example of financial regulations that may seem too fussy. He is right on target with his choice of domain from which to draw analogies. I think most would agree that the streamlining of regulations in the financial industry — the undoing of rules requiring transparency and accountability, record-keeping and review — tempted people into excesses that have now severely damaged our economy. Let us not make a similar mistake with IRBs.

Without truly independent review of research protocols involving human subjects, at best preventable mistakes will happen because nobody looked and, at worst, significant harm may result.