Welcome to the Web ConferencePediatric Research: Challenges for Institutional Review Boards: Welcome to the Web Conference Pediatric Research: Challenges for Institutional Review Boards Conference Moderators: Dr. Jennifer Puck University of California, San Francisco Chair, CTSA Pediatric Oversight Committee Dr. Alexander Kon University of California, Davis


Clinical and Translational Science Award (CTSA) Sites: Clinical and Translational Science Award (CTSA) Sites Columbia University: Irving Institute for Clinical and Translational Research Duke University: Duke Clinical and Translational Science Institute Mayo Clinic: Mayo Clinic Center for Clinical and Translational Research Oregon Health & Science University: Oregon Clinical and Translational Science Institute The Rockefeller University: Transforming Clinical and Translational Research and Education at Rockefeller University of California, Davis: UC Davis Clinical and Translational Science Center University of California, San Francisco: The UCSF Clinical and Translational Science Institute University of Pennsylvania: Institutional Clinical and Translational Science Award University of Pittsburgh: University of Pittsburgh Clinical and Translational Science Institute University of Rochester College of Medicine and Dentistry: University of Rochester Clinical and Translational Sciences Institute University of Texas Health Science Center at Houston: Center for Clinical and Translational Sciences Yale University: Yale Center for Clinical Investigation


Conference Goals: Conference Goals Highlight some of the challenges in assessing pediatric research proposals; Build a culture of harmonization and trust among institutions involved with pediatric research; Demonstrate the feasibility of multi-institutional teams to communicate and collaborate to reach common objectives.


Follow Through: Follow Through The conference will be recorded and archived on CTSA website. The conference is planned to generate one or more publications. The conference format can serve as a model for inter-institutional and public discussion of issues related to clinical research.


Focus on the Institutional Review Board (IRB) : Focus on the Institutional Review Board (IRB) CTSA pediatric researchers identified improved IRB collaboration as a means of improving pediatric research. The IRB is responsible for inspecting the end product to determine if it is safe, prior to approval. We must encourage IRBs to develop expertise and utilize appropriate processes for assessing pediatric clinical research projects.


Acknowledgements: Acknowledgements Conference Planning Committee Stacey Berg, Baylor University School of Medicine Cheryl Boyce, NIH/NIMH Judith Burk, NIH/NHLBI Michael Carome, OHRP Elaine Collier, NIH/NCRR Courtney Ferrell, NIH/NIMH Bruce Gordon, University of Nebraska Richard Gorman, NIH/NIAID Sharon Hampp, NIH/NHLBI Lynne Haverkos, NIH/NICHD Anthony Hayward, NIH/NCRR Rosemary Higgins, NIH/NICHD Steven Hirschfeld, NIH/NICHD Eric Kodish, Cleveland Clinic and Case Western Reserve Alexander Kon, University of California, Davis Robert M Nelson, FDA Mirjana Nesin, NIH/NIAID Iris G. Obrams, NIH/NCRR Jonah Odim, NIH/NIAID Gail Pearson, NIH/NHLBI Victoria Pemberton, NIH/NHLBI Jennifer Puck, University of California, San Francisco Barbara Radziszewska, NIH/NHLBI Jennifer Read, NIH/NICHD Daniel Rosenblum, NIH/NCRR Susan Shurin, NIH/NHLBI Malcolm Smith, NIH/NCI Connie Wells, NIH/NHLBI Dave Wendler, NIH Clinical Center Bioethics Program Anne Zajicek, NIH/NICHD


Acknowledgements (continued): Acknowledgements (continued) Case Review Subcommittee Steven Hirschfeld Alexander Kon David Wendler Anne Zajicek National Center for Research Resources Barbara Alving, Director Lynn Bergquist Anthony Hayward Kameha Kidd Elaine Collier Iris Obrams Andrea Sawczuk Terrie Squadere NIH CIT John Riston Lawrence Hammond NICHD Duane Alexander, Director Yvonne Maddox, Deputy Director David Songco, Chief Information Officer Daniel Ha Sandra Ott Rich Smothers Linda Stephens Booz Allen Hamilton Support Jim Hollahan Shawn Redfern Rajni Samavedam Kelly Johnson


Acknowledgements (continued): Acknowledgements (continued) CTSA Pediatric Oversight Committee Silva Arslanian Cheryl Boyce Nancy Bridges Thomas Carpenter Joe Frascella Lynne Haverkos Anthony Hayward Rosemary Higgins Steven Hirschfeld Deborah Hirtz W. Charles Huskins Rae-Ellen Kavey Sudha Kashyap Kathleen Kennedy Alexander Kon Jennifer Li Carole Marcus James McNamara Deborah Merke Mirjana Nesin Gail Pearson Victoria Pemberton Jennifer Puck (Chair) Jennifer Read Vince Smeriglio Malcolm Smith Robert Steiner Peter Szilagyi Sandy Vasan


Conference Agenda: Conference Agenda


Conference and Case Study Outline: Conference and Case Study Outline All IRB representatives on case study panels are volunteers from CTSA sites. The outlines of the case studies were suggested by CTSA investigators, and chosen to discuss issues related to Institutional Review Boards (IRBs). Case study discussions will have an emphasis on IRB related issues and not the technical aspects of a specific case study.