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Ethical and Regulatory Aspects of Clinical Research - Session 5
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.
Christine Grady RN PhD
NIH Clinical Center Dept of Bioethics
Comparative Effectiveness Trials and Informed Consent
Frank Miller PhD
NIH CC Dept of Bioethics
Conflicts of Interest
Steve Joffe MD MPH
Associate Professor of Medical Ethics and Health Policy
University of Pennsylvania
Ethical and regulatory aspects of clinical research. Informed consent, comparative effectiveness trials and informed consent, conflicts of interest / Christine Grady, Frank Miller, Steve Joffe.
Grady, Christine. Miller, Franklin G. Joffe, Steven. National Institutes of Health (U.S.),
Comparative Effectiveness Research--legislation & jurisprudence Conflict of Interest Informed Consent Pragmatic Clinical Trials as Topic--legislation & jurisprudence Research Subjects