Pediatric Ethics Subcommittee of the Pediatric Advisory Committee

 

DoubleTree Hotel, Regency Room

1750 Rockville Pike, Rockville, Maryland 20852

 

"Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; A Functional Magnetic Resonance Study "

 

Agenda for September 10, 2004

8:30-3:30 pm

 

 

8:30      Call to Order, Introductions                                      Meeting Chair

                                                                                               

            Meeting Statement                                                     Jan Johannessen, PhD

                                                                                                Executive Secretary

 

8:40            Subpart D Expert Panel Process                         Bernard Schwetz, MD

Director, Office of Human Research Protection

 

Sara Goldkind, MD, MA

Bioethicist, Office of Pediatric Therapeutics, FDA

 

 

9:00            Overview, Charge to Panel and Final Outcome            Meeting Chair

 

9:20            Background on ADHD/Protocol Overview                Judith L. Rapoport, MD

                                                                                                Principal Investigator, NIMH

 

9:40      IRB Comments                                                      NIMH IRB Rep

 

10:00    Break

 

10:15            Summary of Submitted Public Comments                  Meeting Chair                                                               

10:45    Open Public Hearing

 

11:45    Lunch                                     

 

12:45            Questions                                                                  Meeting Chair

 

12:50    Panel Discussion                                                      Subcommittee Members

 

2:45      Break

 

3:00            Summary of the Deliberations                                      Meeting Chair

 

3:30      Close