Citation: Sorrell, J., (August 20, 2008) Column: Ethics in Healthcare Organizations: Struggling with New Questions OJIN: The Online Journal of Issues in Nursing, Vol. 13, No. 3. Available: www.nursingworld.org/MainMenuCategories/ANAMarketplace/ANAPeriodicals/OJIN/Columns/Ethics/EthicsandNewQuestions.aspx is a pause to wonder, to question, to step back, to notice. (Moules, 2006, p. 7.) In 2006, researchers at Johns Hopkins University published results of a program designed to prevent specific types of hospital infections in intensive care units. The program involved a simple, five-step checklist to remind physicians that before implementing specific procedures, such as inserting central lines into patients, they should carry out routine precautions, for example washing their hands and wearing a sterile gown and gloves. After three months of using the checklist, the rate of bloodstream infections from the central lines was decreased by two-thirds. Researchers estimated that in the 18-month period following implementation of the checklist, the program saved more than 1,500 lives and nearly $200,000,000 (Gawande, 2007). In spite of these amazing results, the Office for Human Research Protections (OHRP) in Michigan, where the checklist program had been implemented by Johns Hopkins University researchers, halted the program. Further, Johns Hopkins was required to discontinue its plans to extend the program to hospitals in New Jersey and Rhode Island. Why was this decision made? The Office for Human Research Protections ruled that federal monitoring and written informed consent from patients should be required for the study in the same way that these would be required for the research (Gawande, 2007). This scenario raises interesting, ironic, and difficult ethical questions for healthcare professionals. With increasing evidence of unnecessary surgery, inappropriate use of medications, inadequate preventive measures, avoidable exacerbations of chronic conditions, and other errors and waste, initiatives to improve of care have become a major force in shaping healthcare. These diverse initiatives share a common goal of generating knowledge that will guide improvements in healthcare (Casarett, Karlawish, & Sugarman, 2000). Some of the most effective approaches have evolved from methods pioneered in manufacturing: pursuing high by systematically implementing changes, and monitoring the effects of those changes to guide ongoing improvement. This general approach has come to be called quality (Johnson, Vermeulen, & Smith, 2006). Previously, organizational efforts that focused on improvement of healthcare had been exempt from scientific research regulations (Gawande, 2007). Increasingly, however, organizational efforts are focusing on more scientific approaches to studying enhancement of in healthcare. How will future decisions be made to ensure that vital improvement initiatives are implemented within appropriate guidelines focused on patient safety? Ethical issues arise in improvement because attempts to improve care for some patients may inadvertently cause harm or may benefit some at the expense of others; these ethical concerns mirror those in which patients are used as subjects in medical research (Casarett, Karlawish, & Sugarman, 2000). Gawande (2007) notes that although the decision of Michigan's Office for Human Research Protections in response to the improvement checklist initiative was questionable and even dangerous, there was a certain logic to it: A checklist is an alteration in medical care similar to an experimental drug. It is unethical to use an experimental drug in people without federal monitoring and explicit written permission from each patient. Therefore, the ruling stated, it is unethical to do the same with a checklist. In fact, the agency concluded that a checklist may require even more stringent oversight because collecting data might bring risk to not only patients, but also healthcare providers, whose failure to follow basic infection-prevention procedures might be exposed. …
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