April 20, 2004

 

Bernard A. Schwetz, D.V.M., Ph.D.

Director

Office for Human Research Protections

The Tower Building

1101 Wootton Parkway, Suite 200

Rockville, Maryland 20852

 

Dear Dr. Schwetz;

 

The Institutional Review Board (IRB) of the National Institute of Mental Health has reviewed the enclosed protocol entitled “ Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; A Functional Magnetic Resonance Study.”  The IRB has found the proposed research not otherwise approvable, but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

 

In accord with the terms of 45 CFR 46. 407, this is to request that your office facilitate consideration of this research by the Secretary, DHHS following consultation with an appropriately constituted panel of experts.

 

Please let me know if I may assist in any way in expediting this process.

 

                                                                        Sincerely,

 

                                                                             /s/

                                                                        Michael M. Gottesman, M.D.

                                                                 Deputy Director for Intramural

                                                                    Research, NIH

 

Enclosure

 

cc:  Dr. Rapoport

       Dr. Rosenstein

       Dr. Sandler

       Dr. Wichman