History, Guidance, and Framework for Ethical Clinical Research

Ethical and Regulatory Aspects of Clinical Research - Session 1 The Department of Bioethics offers this seven to eight week course annually each fall. The course is designed to provide an overview of the important issues in the ethics of human subject research for clinical investigators and others who participate in the conduct of research and is open to the entire NIH community as well as to those from outside NIH. Topics include the history of human subject research ethics, principles and guidelines, study design, subject recruitment, informed consent, and international research. The course is open to the entire NIH community as well as to those from outside NIH. The recommended textbook is Ethical and Regulatory Aspects of Clinical Research, edited by Emanuel et al (Johns Hopkins University Press). The course is taught by guest faculty and faculty members from the National Institutes of Health. This is a required academic program for Bioethics fellows. Framework for the Ethics of Research with Human Subjects Christine Grady RN PhD NIH Clinical Center Dept of Bioethics History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest Susan E. Lederer PhD Robert Turell Professor of Medical History and Bioethics, Chair University of Wisconsin The DHHS Secretary’s Advisory Committee for Human Research Protections Jeffrey R. Botkin, MD, MPH Chair, SACHRP Professor of Pediatrics and Medical Ethics Associate Vice President for Research University of Ut...
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