Jennifer Puck, UCSF

1
Challenges in Pediatric Research

• Jennifer Puck, UCSF
• Chair,
• CTSA Pediatrics Oversight Committee

2
Challenges

• Unique pediatric research issues include
• Vast changes from infancy through teen years
• Rare disorders manifesting themselves in
  childhood
• Lags in drug development approval
• Logistics of dealing with children, families
• Lack of normative data
• Consent, IRB issues in pediatrics
• OHSR guidelines for minimal risk
• Pediatric expertise limited in some IRB panels
• Fewer pediatric researchers in pipeline

3
CTSA Pediatric Opportunities

• CTSAs are a platform for integration,
  collaboration
• Common research agendas
• Joint protocols
• Accumulation of normal control data
• Establishment of sample biobanks
• Extend existing pediatric research networks and
  establish new ones across CTSA sites

4
Pediatric Oversight Committee Priorities

• Quarterly teleconferences or meetings
• Working groups to address agenda items
• Regulations involving research with infants and
  children
• Foster academic rewards for team pediatric
  research

5
Pediatric Oversight Committee First Workshop,
Sept. 11

• Challenges in the Review of Pediatric Research
  for Institutional Review Boards
• Pediatric researchers, IRB members, regulatory
  officials
• Case discussion to identify critical issues and
  build trust among IRBs
• Thanks to Dr. Steven Hirschfeld, NICHD