| Description: |
Ethical and Regulatory Aspects of Clinical Research
Department of Clinical Bioethics
This course is designed to provide a historical context for research regulations and to help researchers and others working in human subject research gain insights and skills into the development of research protocols and their ethical implementation.
Objectives of the Course:
To learn the codes, declarations, and other documents that govern the ethical conduct of human subject research; review the critical elements of informed consent and their implementation in actual informed consent documents for
clinical research; explore controversial issues relating to human subject research, including Phase I research, randomization, children in research, international research, etc; review the purpose if IRBs and provide IRB-like
experience in reviewing research protocols; understand the experience of human subjects who have participated in research protocols.
8:30-8:40 Pre-test
8:40-9:20 Intro and Framework for the Ethics of Research with
Human Subjects
Ezekiel Emanuel MD,
PhD (Grady backup)
NIH Clinical Center Dept of Bioethics
9:20-9:30 Discussion
9:30-
10:15 History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest
Susan E. Lederer Ph.D.
University of Wisconsin
10:15- 10:25 Discussion
10:25-10:40 Break
10:40-11:20 Do the Codes Apply to My Research? Nuremberg, Helsinki, the Belmont Report, CIOMS, and the Common Rule
Jerry Menikoff MD
JD
Director,
Office of Human Research Protections
11:20-11:30 Discussion
For more information, visit
http://www.bioethics.nih.gov
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