2004N-0337 - (Subpart D IRB Referral) Solicitation of Public Review and Comments on Research Protocol: Effects of a Single Dose of Dextroamphetamine in ADHD; A Functional Magnetic Resonance Study
FDA Comment Number : EC1
Submitter : Dr. Ann Mayo Date & Time: 08/10/2004 02:08:10
Organization : Kaiser Permanente
Health Professional
Category :
Issue Areas/Comments
Study is needed to generate important information. Written consents need to be clear for both parents and children. Assent documents need to be written at age appropriate reading levels.