I applaud Drs Morris and Dracup11 for focusing attention on the dilemma of discerning whether a quality improvement (QI) study conducted in a healthcare setting should be regarded and scrutinized as research covered under 45 CFR (Code of Federal Regulations) 46.22 I believe that the Hastings Center Special Report33 cited by the authors would be particularly helpful to QI administrators in both academic and nonacademic healthcare organizations.

Our hospital has completed its first year of administering a QI-IRB following nearly all of the recommendations from the special report authored by Baily et al.44 The QI-IRB contains some of the same members of our research IRB, but it is distinguished by members whose expertise lies both in clinical research and QI.

Because we work diligently to ensure that all of our QI...

You do not currently have access to this content.