# Presentation: 375947

## Report on Planned Conference from Clinical and Translational Science Awards Program Pediatrics Oversight Committee 
Presented to:
National Advisory Research Resources Council Meeting
September 11. 2007 

Steven Hirschfeld, MD PhD 
Associate Director for Clinical Research 
National Institute of Child Health and Human Development 
Co-Chair NIH CTSA Pediatric Oversight Committee

***Presented to:***
**National Advisory Research Resources Council Meeting**
**September 11. 2007**** **
**Steven Hirschfeld, MD PhD **
**Associate Director for Clinical Research **
**National Institute of Child Health and Human Development **
**Co-Chair NIH CTSA Pediatric Oversight Committee**

## Workshop Details

**Title**: Pediatric Research: Challenges for Institutional Review Boards
**Time**: September 11, 2007 at 11 AM Eastern Daylight Time
**Audience**: CTSA Sites, NIH Institutes and Centers, Health and Human Services Agencies, Academic Researchers, Interested Stakeholders

## Conference Structure

**Conference Structure**

## Conference Goals

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

## Focus on the Institutional Review Board (IRB)

- CTSA pediatric researchers identified improved collaboration among IRBs 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 enhance expertise and utilize appropriate processes for assessing pediatric clinical research projects.

## 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.

## Conference Agenda

| 11:30 AM – 12:00 PM | Case Study #1 - Maintenance therapy for Systemic Lupus Erythematosus |
| --- | --- |
| 12:00 PM – 12:30 PM | Case Study #2 - Insulin Clamp. Body Mass Index and Risk of Diabetes |
| 12:30 PM – 12:45 PM | Break |
| 12:45 PM – 1:15 PM | Case Study #3 - Screening for autism spectrum disorders in infants |
| 1:15 PM – 1:45 PM | Case Study #5 - Emergent intervention for treatment of self inflicted injury |
| 1:45 PM – 2:15 PM | Case Study #4 - Gene therapy for glioblastoma multiforme |
| 2:15 PM – 2:30 PM | Break |
| 2:30 PM – 3:15 PM | Presentations - Representatives from the Office for Human Research Protection and the Food and Drug Administration will each make 20 minute presentations |
| 3:15 PM – 4:00 PM | Presentation - Experience using a central IRB for pediatric research |
| 4:00 PM – 4:15 PM | Break |
| 4:15 PM – 4:50 PM | Expert Panel and Discussion - General discussion with an expert panel and audience participation |
| 4:50 PM to 5:00 PM | Closing Comments - Brief summary and perspective |

## 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)

**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)

**CTSA Pediatric Oversight Committee**
- Silva Arslanian
- Cheryl Boyce
- Nancy Bridges
- Thomas Carpenter
- Joe Frascella
- Lynne Haverkos
- Anthony Hayward (NIH Coordinator)
- Rosemary Higgins
- Steven Hirschfeld (NIH Coordinator)
- 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 (NIH Coordinator)
- Victoria Pemberton
- Jennifer Puck (Chair)
- Jennifer Read
- Vince Smeriglio
- Malcolm Smith
- Robert Steiner
- Peter Szilagyi
- Sandy Vasan

## Follow through

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