NIH VideoCast - OHSRP Education Series-Considerations for Informed Consent in Cell and Gene Therapy Trials

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OHSRP Education Series-Considerations for Informed Consent in Cell and Gene Therapy Trials

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Air date:	Thursday, October 5, 2023, 3:00:00 PM Time displayed is Eastern Time, Washington DC Local
Views:	Total views: 180 (83 Live, 97 On-demand)
Category:	Special
Runtime:	00:52:57
Closed captioning:	Check box to display CC outside of the video Note: You can drag the captioning window around and resize it
Description:	Our speaker for this presentation is Daniel Kavanagh, PhD, RAC (Regulatory Affairs Certification). He is Senior Scientific Advisor, Gene Therapy, Vaccines, and Biologics at WCG where he serves as a scientific and regulatory lead for gene transfer research. Prior to joining WCG, he was Assistant Professor of Medicine at Harvard Medical School, and Vice Chair of the MGH-Brigham Institutional Biosafety Committee. During this session, Dr. Kavanagh will address the following questions: When a clinical trial involves gene therapy / human gene transfer research, what aspects of the informed consent process require special attention? What issues pose special challenges for adult and pediatric participants? How can IRBs and Institutional Biosafety Committees collaborate most effectively in this area? How can participant viewpoints be engaged to improve the process?

NLM Title:	Considerations for informed consent in cell and gene therapy trials / Daniel Kavanagh.
Author:	Kavanagh, Daniel. National Institutes of Health (U.S.). Office of Human Subjects Research Protections,
Publisher:
Abstract:	(CIT): Our speaker for this presentation is Daniel Kavanagh, PhD, RAC (Regulatory Affairs Certification). He is Senior Scientific Advisor, Gene Therapy, Vaccines, and Biologics at WCG where he serves as a scientific and regulatory lead for gene transfer research. Prior to joining WCG, he was Assistant Professor of Medicine at Harvard Medical School, and Vice Chair of the MGH-Brigham Institutional Biosafety Committee.During this session, Dr. Kavanagh will address the following questions: When a clinical trial involves gene therapy / human gene transfer research, what aspects of the informed consent process require special attention? What issues pose special challenges for adult and pediatric participants? How can IRBs and Institutional Biosafety Committees collaborate most effectively in this area? How can participant viewpoints be engaged to improve the process?
Subjects:	Cell- and Tissue-Based Therapy--ethics. Clinical Trials as Topic--ethics Ethics, Research Genetic Therapy--ethics Informed Consent Patient Safety--standards
Publication Types:	Lecture Webcast

NLM Classification:	QU 21
NLM ID:	9918716283006676
CIT Live ID:	52552
Permanent link:	https://videocast.nih.gov/watch=52552

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