 We shall also bracket the question of whether quality improvement and quality assurance projects qualify as clinical research. To briefly consider the type of research at the heart of this debate, consider a hospital which proposes to evaluate the impact of checklists on the quality of patient care. Half the nurses in the hospital are told to continue to provide care as usual; the other half are provided with a checklist and instructed to mechanically check off each item as they complete it when caring for their patients. The question of whether this activity constitutes clinical research is of theoretical interest as a means to clarifying the precise boundaries of the concept. Should we say that this is not clinical research because the checklist is used by the nurses, not administered to the patients? Or should we say this is clinical research because it involves the systematic testing of a hypothesis which is answered by collecting data on patient outcomes? The answer has significant practical implications, determining whether these activities must satisfy existing regulations for clinical research, including whether the clinicians need to obtain patients’ informed consent before the nurses taking care of them can use the checklist.