History, Guidance, and Framework for Ethical Clinical Research - 2009 (Session 1)
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Air date: Wednesday, September 23, 2009, 8:30:00 AM
Time displayed is Eastern Time, Washington DC Local
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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
Author: Ezekiel Emanuel, Susan E. Lederer, Jerry Menikoff and Christine Grady
Runtime: 180 minutes
CIT File ID: None
CIT Live ID: 7862