Risks and Benefits - 2009 (Session 5)
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Air date: Wednesday, October 21, 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.

8:30-9:15                    Assessment of Risks and Benefits

                                    Dave Wendler PhD

                                    NIH Clinical Center Dept of Bioethics

             

9:15-9:25                    Discussion

 

9:25-10:10                  Ethical Issues in the Use of Stored Tissue and Data

Sara Chandros Hull, Ph.D.

NHGRI and Dept of Bioethics

 

10:10-10:20                Discussion

 

10:20-10:35                Break

 

10:35- 11:30              Investigator Panel

                                                Crystal Mackall MD (pediatrics)

                                                Jorge Tavel MD  (HIV/ international/ flu vaccine)

                                                Tito Fojo MD  (medical oncology)

For more information, visit
http://www.bioethics.nih.gov
Author: Dave Wendler, Sara Chandros Hull, Crystal Mackall, Jorge Tavel and Tito Fojo
Runtime: 180 minutes
CIT File ID: None
CIT Live ID: 7868