A key motivation behind efforts to distinguish QI from human subjects research is the desire to circumvent the perceived burden of compliance with research regulations and review by IRBs. Indeed, Lynn and colleagues describe IRB review as cumbersome, inflexible, and “minimally relevant to the structure and processes of QI” (10). Others appear to agree. Motivated by similar concerns, social scientists, oral historians, epidemiologists, health services researchers, and educational researchers have tried to distinguish their activities from the kind of human subjects research for which IRBs were created (14 - 17). Human subjects researchers also express frustration over considerable variation in IRB decisions, which often include demands for minor changes that appear to offer little in terms of protecting participants (18 - 20). Although independent review has moral value, it need not, and should not, take a one-size-fits-all approach. I agree with Lynn and colleagues that IRB review as currently practiced is not appropriate for all QI activities. As currently practiced, however, IRB review is also not appropriate for all activities that are indisputably human subjects research. In fact, federal regulations recognize that certain types of human subjects research are exempt from IRB review or can be reviewed by expedited procedures. Furthermore, the current practice of IRB review can be burdensome, lengthy, overly rigid, and driven by fear of lawyers and regulators. The degree of scrutiny and oversight for an activity should vary, regardless of whether the activity is called QI or human subjects research, according to the project's specific aims, methods, risks, invasiveness, likely beneficiaries, and characteristics of the sample to be included. The guiding principle should be that activities whose goals extend beyond the immediate interests of patients should undergo independent review to ensure that patient interests are protected.