title: Research ethics and law of healthcare system quality improvement: the conflict of cost containment and quality.
abstract: Quality improvement (QI) activities have been done as long as medicine has been practiced and are integral to safety and efficacy of patient care. The 20th century witnessed sophisticated advances of QI methods, with concurrent advances in research ethics. The suggestion that some interventional QI activities resemble research has led to a complex conundrum, with disparate forces driving for improvement and maintenance of patient care quality vs. the societal mandate to control healthcare costs. In the middle of these conflicting priorities are QI systems charged with effecting cost-effective and efficacious healthcare processes. Given the advances in research ethics, substantially grounded in the Nuremberg Code, and the increasing resemblance of interventional QI activities to research, the concern is raised of widespread and systematic Nuremberg Code violations occurring under the guise of QI in health care. Moreover, evidence is cited to suggest that if this is the case, then such activities may be subject to litigation or prosecutorial action. The ethical and legal foundations exist to support the systematic practice of informing patients of their participation in some types of QI procedures.
authors.affiliation: Department of Anesthesia, University of Pennsylvania, Philadelphia 19104-4283, USA. kofkea@uphs.upenn.edu
authors.forename: W Andrew
authors.initials: WA
authors.lastname: Kofke
authors.forename: Michael A
authors.initials: MA
authors.lastname: Rie
mesh_terms: D032781:Codes of Ethics; D016265:Conflict of Interest / Q000191:economics; D003363:Cost Control / Q000941:ethics; D003422:Critical Care / Q000191:economics / Q000941:ethics / Q000592:standards; D017598:Efficiency, Organizational; D004991:Ethics, Institutional; D032984:Ethics, Research; D006302:Health Services Research / Q000191:economics / Q000941:ethics* / Q000379:methods; D006761:Hospitals / Q000941:ethics; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000191:economics / Q000941:ethics / Q000379:methods; D011785:Quality Assurance, Health Care / Q000191:economics / Q000941:ethics* / Q000331:legislation & jurisprudence*; D014481:United States