Food and Drug Administration

Pediatric Ethics Subcommittee of the Pediatric Advisory Committee

November 15, 2005

Briefing Information

Cover Letter and Overview, Dianne Murphy, MD, FDA (PDF)

June 22, 2005 Letter to Office for Human Research Protections, DHHS, Mary Sheridan, PhD, University of Chicago Hospitals (PDF)

March 4, 2005 Letter to IO Regarding Review of Protocol, Jonathan Moss, MD, PhD, Institutional Review Board (PDF)

June 20, 2005 Letter Providing Information on Two Amendments Approved by the IRB, Tasha Osafo, IRB (PDF)

Gonadotropin Releasing Hormone (GnRH) Agonist Test in Disorders of Puberty -- Detailed Narrative (PDF)

Amendment I (PDF)

Amendment II (PDF)

The Grant (PDF)

Protocol Submission Form (PDF)

Protocol Submission Form C - Patients (PDF)

Protocol Submission Form C - Volunteers (PDF)

Form G - Genetic Testing (PDF)

Permission Disordered - Patients (PDF)

Permission Disordered - Volunteers (PDF)

Assent to Participate in Research (Protocol #13472A) - Patients (PDF)

Assent to Participate in Research (Protocol #13472A) - Volunteers (PDF)

IRB Meeting Minutes of November 9, 2004 (PDF)

IRB Meeting Minutes of January 11, 2005 (PDF)

IRB Meeting Minutes of March 8, 2005 (PDF)

IRB Meeting Minutes of May 3, 2005 (PDF)

IRB Certification Letter - New (PDF)

IRB Certification Letter - Revised Pending-Conditional (PDF)

IRB Certification Letter - Amendment I (PDF)

Memorandum Regarding Protocol #13472A Amendment I (PDF)

Product Information (PDF)

Clinical Research Center Documents (PDF)

Clinical Research Center Protocol Review Form (PDF)

December 7, 2004 Letter Regarding New Protocol 13472A (PDF)

Recruitment Flier (PDF)

January 23, 2004 Letter Regarding Whether This Research is Approvable Without 407 Review (PDF)

November 29, 2004 Email to IRB (PDF)

April 19, 2005 Email From IRB (PDF)

September 24, 2004 Email From IRB (PDF)

October 12, 2004 Letter to IRB (PDF)

Letter to PI Outlining the Findings From the 2nd Pre-review (PDF)

Letter to IRB Regarding a Summary of Additional Concerns and Suggested Changes (PDF)

Email to IRB Regarding 13472A Revision (PDF)

Algorithm for Pediatric Protocol Analysis (PDF)

The Belmont Report (PDF)

Federal Register Regulation Part 50 Protection of Human Subjects (PDF)