Quality improvement initiatives: When is quality improvement actually a form of human subjects research?

The Case Suarez et al. published an article in the Journal of Neurosurgery examining outcomes after human albumin (HA) administration in patients with subarachnoid hemorrhage (SAH). Because some believed that HA increased mortality in critically ill patients, the authors' hospital developed an administrative policy restricting its use. The authors examined patient outcomes and costs before and after the introduction of the restriction. They concluded that administration of human albumin after SAH probably improved clinical outcomes and reduced hospital costs.Critics argued that the decision to change the “standard of care” with regard to human albumin administration failed to take into account animal data suggesting that albumin might be neuroprotective in patients with SAH. They charged that patients had been subjected to a change in the “standard of care” because of a corporate cost containment activity that could be “more accurately described as a system level ‘experiment’ with the dual hypothesis of no harm and less cost.” Furthermore, it was an experiment “in which no disclosure occurred, nor was informed consent obtained in an institution receiving federal funds for both patient care and clinical research. The critics questioned who would voluntarily submit to an experiment with “the main dependent variables being money saved and increased morbidity and death rate.