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
GENERAL
GENERAL
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.