April 23, 2009

Sponsor/Co-Sponsor(s): Office of the Director, NICHD; National Center for Research Resources, NIH

Location: Natcher Conference Center (Building 45), NIH Main Campus, Bethesda, Maryland and simultaneous videocast at http://www.videocast.nih.gov

Purpose: The purpose of this workshop is to learn, in a structured manner, about different models for IRB evaluation of multi-site pediatric clinical research protocols. The workshop will begin with presentations from experts on regulatory and policy expectations and will continue with discussions of examples of different models of facilitated IRB review (such as central IRB, reciprocal IRB agreements, rotating IRB, and commercial IRB review). A panel will also provide general comments.

The Pediatric Research Ethics Workgroup of the Clinical and Translational Science Awards (CTSA) Consortium Child Health Oversight Committee will use information from this conference, plus feedback from an accompanying Request for Information to select a pilot model to determine what should be adopted by the CTSA Consortium to facilitate multi-site pediatric research.

The combination live and video conference is open to anyone with interest in facilitated IRB review of multi-site pediatric research.

Contact:
Dr. Steven Hirschfeld, Associate Director of Clinical Research, NICHD
Tel: (301) 496-0044
E-mail: hirschfelds@mail.nih.gov