Research ethics and law of healthcare system quality improvement: The conflict of cost containment and quality
- 1 March 2003
- journal article
- review article
- Published by Wolters Kluwer Health in Critical Care Medicine
- Vol. 31 (Supplement) , S143-S152
- https://doi.org/10.1097/01.ccm.0000054902.85329.50
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.Keywords
This publication has 23 references indexed in Scilit:
- Collaborating with Industry — Choices for the Academic Medical CenterNew England Journal of Medicine, 2002
- Academic Freedom in Clinical ResearchNew England Journal of Medicine, 2002
- A National Survey of Provisions in Clinical-Trial Agreements between Medical Schools and Industry SponsorsNew England Journal of Medicine, 2002
- The Quality Improvement–Research Divide and the Need for External OversightAmerican Journal of Public Health, 2001
- Further trials stopped by OHRPNature Medicine, 2000
- Developing and Testing Changes in Delivery of CareAnnals of Internal Medicine, 1998
- Rationing critical care services in the United StatesCurrent Opinion in Critical Care, 1997
- The Willowbrook Hepatitis Studies Revisited: Ethical AspectsClinical Infectious Diseases, 1986
- Protecting the Medical Commons: Who Is Responsible?New England Journal of Medicine, 1975
- Ethics and Clinical ResearchNew England Journal of Medicine, 1966