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CTSA Consortium Child Health Oversight Committee Meetings

Pediatrics Oversight Committee September 25, 2007
Meeting Materials	Agenda  Meeting Summary

Pediatrics Oversight Committee - Workshop September 11, 2007
Meeting Materials	Agenda
Presentations	Introduction  Pediatric Research: Challenges for Institutional Review Boards Jennifer Puck, MD Program Director UCSF Children's Hospital CCRC Unit Duane Alexander, MD Director NICHD, NIH Alexander Comments 20070911.pdf View Recording Case Studies  Case Study #1: Maintenance Therapy for Systemic Lupus Erythematosis Moderator: Nancy Bridges, MD Chief NIAID View Recording Case Study #2: Insulin Clamp, Body Mass Index and Risk of Diabetes Moderator: Victoria Pemberton Clinical Trials Specialist NHLBI View Recording Case Study #3: Screening for Autism Spectrum Disorders in Infants Moderator: Rosemary Higgins, MD Program Scientist NICHD View Recording Case Study #5: Gene Therapy for Glioblastoma Multiforme Moderator: Cheryl Boyce, Ph D Associate Director NIMH View Recording Case Study #4: Emergent Intervention for Treatment of Self Inflicted Injury Moderator: Malcolm Smith, MD, PhD Associate Branch Chief, Pediatrics Cancer Therapy Evaluation Program NCI View Recording Presentations  Cooperative IRB Review Arrangements for Multicenter Research: Regulatory Considerations Michael Carome, MD Associate Director for Regulatory Affairs Office for Human Research Protections, DHHS View Recording Applying the Additional Safeguards for Children: 21 CFR 50, Subpart D Robert Nelson, MD, PhD Associate Professor of Anesthesiology and Critical Care UPENN View Recording (Dr. Nelson’s presentation begins at 23:00 in the recording) NCI Pediatric Central IRB Initiative Bruce Gordon, MD Professor, Pediatrics University of Nebraska Medical Center View Recording Cooperative IRB Review Arrangements for Multicenter Research: Central IRB Perspective Felix Khin-Maung-Gyi, PharmD, MBA, CIP, RAC Chief Executive Officer Chesapeake Research Review, Inc. View Recording (Dr. Gyi’s presentation begins at 20:10 in the recording) Expert Panel Discussion and Summary of Workshop  Representatives from the Office for Human Research Protection and the Food and Drug Administration View Recording Summary of the Workshop Alexander Kon, MD Associate Professor of Pediatrics and Bioethics University of California, Davis

Pediatrics Oversight Committee June 21, 2007
Meeting Materials	Meeting Summary

First Pediatric Steering Committee March 22, 2007
Meeting Materials	Agenda  Meeting Summary
Presentations	Presentations by NIH Staff  Overview Anthony Hayward, MD, PhD Director, Division of Clinical Research NCRR CTSA Communications Activities Joyce McDonald Director of Communications NCRR No More Hand-Me-Downs: Research Designed for Children Victoria Pemberton Clinical Trials Specialist NHLBI Site Presentations  UCSF Clinical and Translational Research Institute Jennifer Puck, MD Program Director University of California, San Francisco Duke Translational Medicine Institute: Pediatrics Core Jennifer Li, MD Associate Professor of Pediatrics Duke Clinical and Translational Science Institute, Duke University Columbia University Irving Institute for Clinical and Translational Research Sudha Kashyap, MD Associate Director, of the PCIR for Pediatric Research Columbia University Mayo Clinic College of Medicine W. Charles Huskins, MD Assistant Professor of Pediatrics Mayo Clinic College of Medicine The Rockefeller University Hospital Kevin N. Heller, MD Clinical Scholar Laboratory of Viral Immunology, The Rockefeller University Children’s Hospital of Philadelphia Carole Marcus, MBBCh Co-Program Director University of Pennsylvania Institute for Translational Medicine and Therapeutics Pediatric Clinical & Translational Research Center Silva Arslanian, MD Director University of Pittsburgh Clinical and Translational Science Institute Oregon Clinical and Translational Research Institute Robert Steiner, MD Professor, Pediatrics and Molecular and Medical Genetics Oregon Health and Science University University of Rochester’s CTSA: Pediatric Involvement Peter Szilahyi, MD, MPH Professor of Pediatrics University of Rochester Clinical and Translational Sciences Institute University of Texas Houston Center for Clinical and Translational Sciences Kathleen A. Kennedy, MD, MPH Professor; Department of Pediatrics University of Texas Houston Center for Clinical and Translational Sciences UC Davis Clinical and Translational Science Center Alexander Kon, MD Associate Professor UC Davis Yale Center for Clinical Investigation Thomas Carpenter, MD Professor of Pediatrics Yale University