NIH-CTSA Webconference on Pediatric Research:
"Challenges Facing Institutional Review Boards"

September 11, 2007, 8 AM - 2 PM Pacific Time: Please note that the time on the agenda below still reads 11am for Eastern Standard time. We will in fact begin at 8am Pacific Time.

Location: UCSF Alumni House, 745 Parnassus Avenue at the corner of 5th Avenue

• Review Agenda, Case Studies

Continental Breakfast and Lunch will be served

The focus of the conference will be composite protocol examples that highlight challenges in the review of pediatric research. Topics include:

• Experimental therapy for Systemic Lupus Erythematosus
• Screening children at risk for Type 2 Diabetes and healthy controls
• Following infants from birth to assess risk of autism spectrum disorder
• New treatment children with brain tumors that have a poor prognosis
• Emergency intervention in suicidal adolescents with self-inflicted injuries

If you plan to attend

Please RSVP at your earliest convenience to Lynn Goldman, lgoldman@peds.ucsf.edu; (415) 476-2190.

Case histories for discussion.

For more information

Contact Steven Hirschfeld at NIH.

Facilitating inter-institutional studies and feasibility of a central Institutional Review Board will be addressed.

CHR and CTSI members, investigators, pediatricians and all interested in human subject research are welcome to attend.

Discussants will be IRB/CHR members from Clinical and Translational Science Award (CTSA) sites who will be pre-assigned to specific scenarios.

The conference will be introduced by Dr. Jennifer Puck of UCSF. Representatives of NICHD, the Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA) will participate.

Originated by the CTSA Pediatric Oversight Committee with special thanks to:

• Steven Hirschfeld, NICHD
• Alexander Kon, University of California, Davis
• Jennifer Puck, UCSF
• Anthony Hayward, NCRR, NIH
• And others at NIH, OHSR, CTSAs