Food and Drug Administration

Pediatric Ethics Subcommittee of the

Pediatric Advisory Committee

June 28, 2005

Briefing Information

Complete Final Version of the Original OHRP Cover Letter Dated January 13, 2005, Dr. Kimberly Spence (PDF)

Complete Final Version of the Original OHRP Cover Letter Providing Clarification on the Nature of IRB Deliberations Dated February 7, 2005, Dr. Kimberly Spence (PDF)

FDA Correspondence to Philip Ludbrook, MD, Washington University Medical Center (PDF)

Protocol: Precursor Preference in Surfactant Synthesis of Human Preterm Infants (PDF)

Amendment to the Protocol (PDF)

Relevant Excerpts From the Grant Appication, Dr. Kimberly Spence (PDF)

Data and Safety Monitoring Plan: Data Reviewed October 2004 (PDF)

Informed Consent to Participate in a Research Study - Consent for Full Time Infants (PDF)

Informed Consent to Participate in a Research Study - Consent for Pre-Term Infants (PDF)

Complete Final Version of the New Protocol Committee Minutes From October 9, 2002, Dr. Kimberly Spence (PDF)

Complete Final Version of the Continuing Review Minutes From December 4, 2003, Dr. Kimberly Spence (PDF)

Complete Final Version of the Form 7, Dr. Kimberly Spence (PDF)

Complete Final Version of the Continuing Review Minutes From November 18, 2004, Dr. Kimberly Spence (PDF)

Complete Final Version of the Coninuing Review Minutes From Decmeber 16, 2004, Dr. Kimberly Spence (PDF)

Complete Fianl Version of the Drug Preparation Protocol, Dr. Kimberly Spence (PDF)

Complete Final Version of the Certificate of Analysis, Dr. Kimberly Spence (PDF)

Complete Final Version of the Cover Letter From the PI, Dr. Kimberly Spence (PDF)

Complete Version of the Email Correspondence Dated December 21, 2005, to Dr. Spence from Cathy Jackson (PDF)