Food and Drug Administration

Pediatric Advisory Committee

Pediatric Ethics Subcommittee

September 10, 2004

"Effects of a Single Dose of Dextroamphetamine in Atttention Deficit Hyperactivity Disorder (ADHD): A function Magnetic Resonance Study"

Briefing Information

"Notice to the reader: These documents have been provided by the National Institutes of Health."

Table of Contents for the Protocol (Word) (HTM) (PDF)

Protocol (PDF) (Word)

Consent to Participate in a Clinical Research Study - Parent of Health Child (Word) (PDF)

Consent to Participate in a Clinical Research Study - Parent of Child with ADHD (Word) (PDF)

Minor Patient's Assent to Participate in a Clinical Research Study - Standard Assent for Healthy Subjects (Word) (PDF)

Minor Patient's Assent to Participate in a Clinical Research Study - Child with ADHD (Word) (PDF)

NIMH IRB Minutes for 10/28/034 (Word) (HTM) (PDF)

Minutes for 11/4/03 (Word) (HTM) (PDF)

NIMH IRM Minutes for 1/27/04 (Word) (HTM) (PDF)

September 8, 2004 Memo from Director, Intramural Research Program, NIMH (Word) (HTM) (PDF)

March 5, 2004 Memor from Chair, NIMH IRB to Michael Gottesman, Deputy Director (Word) (HTM) (PDF)

April 20, 2004 Letter from Michael M Gottewsman, MD, Deputy Director for Intramural Research, NIH to Bernard A Schwetz, DVM, PhD, Director, Office for Human Research Protections (Word) (HTM) (PDF)

21 CFR Part 50 Subpart A—General Provisions (PDF)

21 CFR Part 50 Subpart D—Additional Safeguards for Children in Clinical Investigations (PDF)

21 CFR Part 46 Subpart A—Basic HHS Policy for Protection of Human Research Subjects (PDF)

21 CFR Part 46 Subpart D—Additional Protections for Children Involved as Subjects in Research (PDF)

Algorithm for Subpart D Analysis (45 CFR 46 and 21 CFR 50) (HTM) (PDF) (Word)

Cover Letter for Backgrounder From Dr. Dianne Murphy, MD, FDA (HTM) (PDF) (Word)

June 14, 2004 Letter Dated From Dr. Dianne Murphy, MD, FDA to Dr. Michael Gottesman, MD, NIH (HTM) (PDF) (Word)

July 23, 2004 Letter Dated From Dr. Terrie Crescenzi, RPh to Dr. Michael Gottesman, MD (HTM) (PDF) (Word)

The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research—The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979 (HTM) (PDF) (Word)

Algorithm for Pediatric Protocol Analysis (Subpart A and D - 45 CFR 46 and 21 CFR 50) (PDF)

Subpart D Presentation, Dr. Goldkind and Dr. Schwetz (HTM) (PPT)

Analysis of Research Protocols Involving Children: Combining Subparts A and D, Dr. Robert Nelson, MD, PhD, University of Pennsylvania (HTM) (PPT)

Effects of Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity, P.I. Judith Rapoport, MD (HTM) (PPT)

Public Comments

Comment by Dr. Ann Mayo, Kaiser Permanente Health Professional (PDF)

Comment by Dr. Ellen Bernal, Individual Consumer (PDF)

Comment by Jacki Altman (HTM) (PDF) (Word)