For The Consortium

Pediatric Research Ethics Meetings

CTSA Consortium Child Health Oversight Committee - Pediatric Research Ethics Group
November 23, 2009
Meeting Materials  Agenda


CTSA Consortium Child Health Oversight Committee - Pediatric Research Ethics Group
July 27, 2009
Meeting Materials  Agenda


Meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP)
July 21, 2009
Meeting Materials  Agenda

Presentations
CTSA Pediatric Multisite IRB Issues 
CTSA Pediatric Multisite IRB Issues
Steven Hirschfeld, M.D., Ph.D.
Associate Director for Clinical Research
National Institute of Child Health and Human Development

CTSA Consortium Child Health Oversight Committee - Pediatric Research Ethics Group
June 22, 2009
Meeting Materials  Agenda


CC-CHOC Pediatric Research Ethics Group
June 5, 2009
Meeting Materials  Agenda


CTSA Consortium Child Health Oversight - Pediatric Research Ethics Group - Comparing IRB Models for Multisite Pediatric Studies
April 23, 2009
Meeting Materials  Agenda
  Meeting Recording

Presentations
High level review on steps to protocol activation 
High level review on steps to protocol activation
Susan B. Shurin
National Heart, Lung, and Blood Institute
Current Office of Human Research Protections regulations 
Current Office of Human Research Protections regulations
Julie Kaneshiro, Ivor Pritchard
Office of Human Research Protections Perspective on IRB approval for multi-site studies
CRpac’s Efforts to Promote Consideration of Other Models of Efficient, Consistent, and Rigorous IRB Review 
CRpac’s Efforts to Promote Consideration of Other Models of Efficient, Consistent, and Rigorous IRB Review
Phil Budashewitz
National Institutes of Health
Overview of Structure of Panel Discussions 
Overview of Structure of Panel Discussions
Steven Hirschfeld
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Panel 1: Central IRB Model 
National Cancer Institute Pediatric Oncology Central IRB
Jacquelyn Goldberg
National Cancer Institute
VA Central IRB
K. Lynn Cates
Department of Veterans Affairs
Panel 2: Reciprocal IRB Agreement Model 
Dana-Farber/Harvard Cancer Center: Pediatric IRB Review
Michele Russell-Einhorn
Harvard Institutions Reciprocal Agreement
Southern California Inter-Institutional Reciprocal IRB Agreement
Keith Norris
Charles Drew University
Panel 3: Rotating IRB Model 
Rotating IRB Model
J. Michael Dean
University of Utah School of Medicine
Panel 4: Commercial IRB Model 
Commercial IRB Model
Stephen Rosenfeld
Western Institutional Review Board
Closing Discussion 
Comments on IRB Modeling
Francis P. Crawley
Good Clinical Practice Alliance
Comparing IRB Models for Multisite Pediatric Studies
Debbie Gipson
University of North Carolina, Chapel Hill

CTSA Consortium Child Health Oversight Committee - Pediatric Research Ethics Group
March 23, 2009
Meeting Materials  Meeting Summary


CTSA Child Health Oversight Committee - Pediatric Research Ethics Group - IRB Web Conference Planning
March 13, 2009
Meeting Materials

CTSA Consortium Child Health Oversight - Pediatric Research Ethics Group - Conference Planning Call
February 27, 2009
Meeting Materials

CTSA Consortium Child Health Oversight - Pediatric Research Ethics Group - Conference Planning Call
February 11, 2009
Meeting Materials

CTSA Consortium Child Health Oversight - Pediatric Research Ethics Group - Conference Planning Call
February 5, 2009
Meeting Materials

CTSA Consortium Child Health Oversight Committee - Pediatric Research Ethics Group
January 26, 2009
Meeting Materials

CTSA Consortium Child Health Oversight Committee - Pediatric Research Ethics Group Conference Planning Call
January 21, 2009
Meeting Materials  Meeting Summary