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 "

 

 

8:30      Call to Order, Introductions                                      Robert M. Nelson, M.D., Ph.D.

                                                                                                Chair, Pediatric Ethics Subcommittee

                                                                                               

            Meeting Statement                                                     Jan N. Johannessen, Ph.D.

                                                                                                Executive Secretary

 

8:40            Subpart D Expert Panel Process                         Bernard Schwetz, D.V.M, Ph.D.

Director, Office for Human Research Protections

 

Sara Goldkind, M.D,. M.A.

Bioethicist, Office of Pediatric Therapeutics, FDA

 

9:00            Overview, Charge to Panel and Final Outcome            Robert M. Nelson, M.D., Ph.D.

                                                                                                Chair, Pediatric Ethics Subcommittee

 

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

                                                                                                Principal Investigator, NIMH, NIH

 

9:40      IRB Questions                                                                   Pediatric Ethics Subcommittee

                                                                                                Donald L. Rosenstein, M.D.

Chair, NIH IRB           

                       

10:00    Break

 

10:15            Summary of Submitted Public Comments                  Robert M. Nelson, M.D., Ph.D.

                                                                                                Chair, Pediatric Ethics Subcommittee  

 

10:30            Questions and Panel Discussion                              Subcommittee Members                                               

11:00    Open Public Hearing

 

12:00    Lunch                                     

 

1:00            Questions and Panel Discussion                              Subcommittee Members

 

2:30      Break

 

2:45            Summary of the Deliberations                                      Robert M. Nelson, M.D., Ph.D.

                                                                                                Chair, Pediatric Ethics Subcommittee

3:30      Close