The Ethics of Clinical Investigation.pptVIP

The Ethics of Clinical Investigation Walter S. Davis, MD Center for Biomedical Ethics Research Subject Advocate General Clinical Research Center University of Virginia School of Medicine Objectives Review the basic tenets of informed consent (IC), and outline how the concept is different in research vs. clinical medicine Explore and discuss the concept of vulnerability in human subjects research Discuss the changing role of IRB’s in the current and evolving research ethics climate Research Ethics – The Historical Perspective Code of Nuremburg – 1947 Jewish Chronic Disease Hospital Case - 1963 Beecher’s NEJM paper - 1966 Willowbrook State School case revealed - 1970 Tuskegee Syphilis Study revealed – 1972 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research – The Belmont Report - 1979 Jesse Gelsinger – 1999 National Bioethics Advisory Commission – Report and Recommendations - 2001 Ethical Challenges for Clinical Research Increasing scientific complexity of protocols Increasing federal, state, and institutional oversight of human subjects research A human subject population living in the “Information Age” Increasing attention to conflicts of interest IC is a relatively “new” concept No mention of IC in the Hippocratic Oath Beneficence and non-maleficence sufficient Implied trust=implied consent The notion of questioning or refusing treatment foreign in some cultures Consent itself was (is) implied in many traditional societies and cultures IC as evolution of pt autonomy Respect for pt autonomy was perhaps the most basic and formative principle of biomedical ethics, balanced by its counter-principle – physician paternalism Autonomy-focused bioethics as part of 60’s Atmosphere of challenge of authority The inherent worth of the individual Technology with the capacity to extend life in seriously ill patients IC as process, not event The process involves information presented in an interactive “educational” model, rather than si