Dr Stimler argues that "There is virtually never any need for [IRB] oversight for a true, well-formulated QI project." Dr Groman and I agree and are trying to identify those situations in which there is a need for such oversight. The difficulty is that some projects that are called QI do not fit his definition and are significantly different from the examples he cites.1,2 Furthermore, even Dr Stimler's definition would include some ethically problematic projects, for example, attempts to implement practice standards that are not evidence-based but instead are based on "widely accepted" utilization review targets. Moreover, there are incentives to characterize a project as QI rather than research to avoid IRB review in many institutions. Our article suggests how to identify those projects that are called QI but should have independent oversight and perhaps patient consent.2 We are skeptical of a categorical approach that treats all projects labeled as QI in a similar manner. Our recommendations would not burden projects that pose only minimal risk to participants, including those that Dr Stimler envisages, while protecting subjects in other studies from serious harm.
Lo B. Quality Improvement Projects: Inaction Presents the Greatest Risk—Reply. Arch Intern Med. 2003;163(21):2649. doi:10.1001/archinte.163.21.2648