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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
Views: Total views: 223 * This only includes stats from October 2011 and forward.
Category: Bioethics
Runtime: 02:30:32
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

Debug: Show Debug
NLM Title: Ethical and regulatory aspects of clinical research. Session 1, History, guidance, and framework for ethical clinical research / Ezekiel Emanuel ... [et al.].
Author: Emanuel, Ezekiel J.
National Institutes of Health (U.S.)
Publisher:
Abstract: (CIT): NIH Clinical Center Ethics Grand Rounds. 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.
Subjects: Biomedical Research--ethics
Ethics, Research--history
Guidelines as Topic
Human Experimentation--ethics
Human Experimentation--history
Publication Types: Lectures
Webcasts
Download: To download this event, select one of the available bitrates:
[384k]    How to download a Videocast
NLM Classification: W 20.5
NLM ID: 101516509
CIT Live ID: 7862
Permanent link: https://videocast.nih.gov/launch.asp?15307

 

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