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Ethical Issues in Research with Children & Research Involving Persons at Risk for Impaired Decision (Session 4)

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Air date: Wednesday, October 14, 2009, 8:30:00 AM
Time displayed is Eastern Time, Washington DC Local
Views: Total views: 175 * This only includes stats from October 2011 and forward.
Category: Bioethics
Runtime: 02:55:36
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 Ethical issues in research with children

Robert Nelson MD PhD

FDA



9:15-9:25 Discussion



9:25- 10:10 Research Involving Persons at Risk for Impaired Decision-Making

Don Rosenstein, M.D.

University of North Carolina Medical Center



10:10- 10:20 Discussion



10:20- 10:35 Break



10:35- 11:30 Informed Consent

Christine Grady RN PhD

NIH Clinical Center Department of Bioethics



For more information, visit
http://www.bioethics.nih.gov
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NLM Title: Ethical issues in research with children & research involving persons at risk for impaired decision / Robert Nelson, Don Rosenstein, and Christine Grady.
Author: Nelson, Robert.
National Institutes of Health (U.S.). Clinical Center.
Publisher:
Abstract: (CIT): 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. NIH Clinical Center Department of Bioethics For more information, visit http://www.bioethics.nih.gov.
Subjects: Child
Human Experimentation--ethics
Informed Consent--ethics
Mentally Disabled Persons
Patient Selection--ethics
Publication Types: Lectures
Webcasts
Download: To download this event, select one of the available bitrates:
[384k]    How to download a Videocast
NLM Classification: W 20.55.H9
NLM ID: 101518974
CIT Live ID: 7867
Permanent link: https://videocast.nih.gov/launch.asp?15357

 

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